DePuy Orthopaedics, Inc., announced an advancement in online education for the more than 200,000 Americans who undergo hip replacement each year.1 This extensive patient Web site, hipreplacement, provides hip pain patients with a broad range of resources from mobility assessment tools to surgical options and recovery information, as well as linking to an online discussion group for peer-to-peer support.
"While many sites offer information about osteoarthritis and hip replacement, hipreplacement takes this a step further by helping find information to sort through the decision making process," says Randy Kilburn, director of Hip Marketing at DePuy. "DePuy's goal is to educate, empower, and encourage patients to seek treatment by informing them about orthopaedic solutions and bringing them together with surgeons."
hipreplacement also features extensive information about hip pain treatment options, including the latest advances in hip surgery such as computer-assisted surgery and the Anterior Approach; education about what to expect before, during and after hip replacement surgery; testimonials from patients who have had hip replacement; and an orthopaedic surgeon locator.
About Hip Replacement
The demand for hip replacement is growing rapidly. It is estimated that the number of primary total hip replacements will increase by 174 percent to 572,000 in 2030. The demand for hip revision procedures is projected to double by the year 2026. Overall, total hip revisions are projected to grow by 137 percent between 2005 and 2030.2 This is due in part to the growing number of Baby Boomers with osteoarthritis and the rise in obesity among the population.3
The performance of hip replacements depends on age, weight, activity level, and other factors. There are potential risks and recovery takes time. People with conditions limiting rehabilitation should not have this surgery. Only an orthopaedic surgeon can tell if hip replacement is right for a patient.
To learn more, please visit hipreplacement.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is advancing the standard of orthopaedic patient care, with a focused commitment to help surgeons achieve excellence in surgical practice. Countless surgeons worldwide rely upon DePuy Orthopaedics every day in their treatment of patients. The company designs, manufactures and distributes orthopaedic devices and supplies including hip, knee, extremity, trauma, cement, orthobiologics, and operating room products. As a global leader in joint replacement products, DePuy Orthopaedics is committed to Restoring the Joy of Motion™ for patients whose mobility is restricted by severe osteoarthritis or other debilitating injury.
References:
1 Data on file at DePuy Orthopaedics, Inc.
2 "Projections of Primary and Revision Hip and Knee Arthroplasty in the United States from 2005 to 2030." Steven Kurtz, Kevin Ong, Edmund Lau, Fionna Mowat and Michael Halpern. The Journal of Bone and Joint Surgery (American). July 2007;89:780-785.
3 "Total Knee and Hip Replacement Surgery Projections Show Meteoric Rise by 2030. Orthopaedic procedures set to continue gaining widespread acceptance as means to restore quality-of-life," American Academy of Orthopaedic Surgeons (AAOS) Web site: www6.aaos/news/Pemr/press_release.cfm?PRNumber=442. Accessed July 11, 2007.
понедельник, 29 августа 2011 г.
пятница, 26 августа 2011 г.
Subclinical Markers Predict Relapse In Juvenile Idiopathic Arthritis Post Methotrexate Withdrawal
Elevated levels of the inflammatory biomarkers Myeloid Related Protein (MRP*) 8/14 predict an increased risk of relapse following withdrawal of methotrexate (MTX) therapy in children with juvenile idiopathic arthritis (JIA) who have achieved inactive disease status, according to a new study presented at PReS 2009, a joint congress with the 2009 Congress of the European League Against Rheumatism (EULAR) in Copenhagen, Denmark.
Effective treatment options are available to treat rheumatic diseases, many of which have the potential to induce remission, defined as absence of signs or symptoms of disease. While there is evidence-based advice regarding when to initiate therapy in rheumatic diseases, there is no specific guidance on the timing of treatment withdrawal once a state of remission on medication is achieved. While this holds true for many autoimmune disease (such as Rheumatoid Arthritis, Crohn's disease, Ulcerative Colitis, or Autoimmune Hepatitis), in the case of MTX therapy for JIA, a continuation of MTX for 12 to 24 months after induction of remission has been proposed by researchers.1
The risk of relapse in JIA patients, once MTX is discontinued, is approximately 50%.2 However, the results of this study have shown that continuing MTX therapy past the point of remission does not affect the risk of relapses after withdrawal of therapy. Clinical (disease subtype, duration or dosage of therapy, duration of MTX therapy) or standard laboratory tests (c-reactive protein and erythrocyte sedimentation rate as measurements of inflammation) could not differentiate between patients at-risk for relapse and those without this risk. However, MRP8/14 levels were significantly higher at MTX withdrawal in remission in those patients who subsequently developed relapses (715?±140 ng/ml) compared to patients with stable remission (400?±105 ng/ml; p=0.003).
Levels of MRP8/14 were especially high in patients with relapses occurring within 6 months, compared to 12 months. (955?±270 ng/ml; p< 0.001).
Professor Dirk Foell of the University of Muenster, Germany, who conducted the study, said: "Methotrexate is effective in children with JIA and can induce a status of inactive disease. This is the first controlled trial analyzing the necessary time of treatment continuation once remission is achieved in a rheumatic disease. Our study shows that patients with elevated levels of MRP 8/14 may specifically benefit from prolonged treatment and also that a longer duration of MTX therapy after achieving remission does not influence the risk of relapse on patients with JIA. The results of our research help to make the case for the tracking of levels of biomarkers as predictors of treatment responses in this unique patient population."
In the PRINTO** study, 364 JIA patients with inactive disease for at least 3 months were randomised to receive additional MTX for either 6 or 12 months. Serum sample analysis using ELISA (Enzyme-Linked Immunosorbent Assay) was conducted in 188 patients to track MRP8/14 levels at 3 month baseline, and again at either 6 or 12 months according to study protocol. Patients were followed-up for at least 12 months after MTX discontinuation.
A log-rank analysis confirmed the differences in relapse rates between patients with MRP8/14 levels of 900ng/ml or above, compared to those with lower levels (p< 0.001). ROC (Receiver operating characteristics) analysis revealed a sensitivity of 50% and a specificity of 78% for predicting relapses at this cut-off (likelihood ratio for relapse 2.3), while the specificity was increased to 90% at a cut-off at 1400ng/ml (likelihood ratio 3.4).
At baseline, demographic and clinical characteristics were well balanced and all patients had inactive disease status. 59 (31%) had the JIA subtype of persistent oligoarthritis, 27 (14%) extended oligoarthritis, 64 (34%) polyarthritis RF-negative, 10 (5%) polyarthritis RF-positive, 12 (6%) systemic and 16 (9%) other JIA subtypes. Patients had previously been treated with MTX at a dose of 11.6?±2.8 mg/m2/week for 2.3?±2.1 years. The overall rate of flares was 92/188 (49%) patients.
JIA is the most common inflammatory autoimmune childhood disease, affecting approximately 1 in 1,000 children. Despite advances in diagnosis and treatment options, it remains a chronic condition for most affected children with a significant disease burden.
Notes:
*MRP 8 and 14 are pro-inflammatory damage associated molecular pattern (DAMP) molecules that play an important role in inflammatory and immunological responses. They have recently been identified as activators of Toll like receptor (TLR-4), a molecule that amplifies phagocyte activation (a type of white blood cell (leukocyte), that supports the immune system by neutralising or engulfing bacteria or other invading micro-organisms.
**PRINTO (Paediatric Rheumatology International Trials Organization) is an international not-for-profit research network that fosters, facilitates and co-ordinates international trials of children with rheumatic diseases.
Abstract number: THU0412
References:
1 Ravelli A, Viola S, Ramenghi B, Aramini L, Ruperto N, Martini A. Frequency of relapse after discontinuation of methotrexate therapy for clinical remission in juvenile rheumatoid arthritis. J Rheumatol 1995;22:1574-6].
2 Gottlieb BS, Keenan GF, Lu T, Ilowite NT. Discontinuation of methotrexate treatment in juvenile rheumatoid arthritis. Pediatrics 1997;100:994-7].
Source:
Rory Berrie
European League Against Rheumatism
Effective treatment options are available to treat rheumatic diseases, many of which have the potential to induce remission, defined as absence of signs or symptoms of disease. While there is evidence-based advice regarding when to initiate therapy in rheumatic diseases, there is no specific guidance on the timing of treatment withdrawal once a state of remission on medication is achieved. While this holds true for many autoimmune disease (such as Rheumatoid Arthritis, Crohn's disease, Ulcerative Colitis, or Autoimmune Hepatitis), in the case of MTX therapy for JIA, a continuation of MTX for 12 to 24 months after induction of remission has been proposed by researchers.1
The risk of relapse in JIA patients, once MTX is discontinued, is approximately 50%.2 However, the results of this study have shown that continuing MTX therapy past the point of remission does not affect the risk of relapses after withdrawal of therapy. Clinical (disease subtype, duration or dosage of therapy, duration of MTX therapy) or standard laboratory tests (c-reactive protein and erythrocyte sedimentation rate as measurements of inflammation) could not differentiate between patients at-risk for relapse and those without this risk. However, MRP8/14 levels were significantly higher at MTX withdrawal in remission in those patients who subsequently developed relapses (715?±140 ng/ml) compared to patients with stable remission (400?±105 ng/ml; p=0.003).
Levels of MRP8/14 were especially high in patients with relapses occurring within 6 months, compared to 12 months. (955?±270 ng/ml; p< 0.001).
Professor Dirk Foell of the University of Muenster, Germany, who conducted the study, said: "Methotrexate is effective in children with JIA and can induce a status of inactive disease. This is the first controlled trial analyzing the necessary time of treatment continuation once remission is achieved in a rheumatic disease. Our study shows that patients with elevated levels of MRP 8/14 may specifically benefit from prolonged treatment and also that a longer duration of MTX therapy after achieving remission does not influence the risk of relapse on patients with JIA. The results of our research help to make the case for the tracking of levels of biomarkers as predictors of treatment responses in this unique patient population."
In the PRINTO** study, 364 JIA patients with inactive disease for at least 3 months were randomised to receive additional MTX for either 6 or 12 months. Serum sample analysis using ELISA (Enzyme-Linked Immunosorbent Assay) was conducted in 188 patients to track MRP8/14 levels at 3 month baseline, and again at either 6 or 12 months according to study protocol. Patients were followed-up for at least 12 months after MTX discontinuation.
A log-rank analysis confirmed the differences in relapse rates between patients with MRP8/14 levels of 900ng/ml or above, compared to those with lower levels (p< 0.001). ROC (Receiver operating characteristics) analysis revealed a sensitivity of 50% and a specificity of 78% for predicting relapses at this cut-off (likelihood ratio for relapse 2.3), while the specificity was increased to 90% at a cut-off at 1400ng/ml (likelihood ratio 3.4).
At baseline, demographic and clinical characteristics were well balanced and all patients had inactive disease status. 59 (31%) had the JIA subtype of persistent oligoarthritis, 27 (14%) extended oligoarthritis, 64 (34%) polyarthritis RF-negative, 10 (5%) polyarthritis RF-positive, 12 (6%) systemic and 16 (9%) other JIA subtypes. Patients had previously been treated with MTX at a dose of 11.6?±2.8 mg/m2/week for 2.3?±2.1 years. The overall rate of flares was 92/188 (49%) patients.
JIA is the most common inflammatory autoimmune childhood disease, affecting approximately 1 in 1,000 children. Despite advances in diagnosis and treatment options, it remains a chronic condition for most affected children with a significant disease burden.
Notes:
*MRP 8 and 14 are pro-inflammatory damage associated molecular pattern (DAMP) molecules that play an important role in inflammatory and immunological responses. They have recently been identified as activators of Toll like receptor (TLR-4), a molecule that amplifies phagocyte activation (a type of white blood cell (leukocyte), that supports the immune system by neutralising or engulfing bacteria or other invading micro-organisms.
**PRINTO (Paediatric Rheumatology International Trials Organization) is an international not-for-profit research network that fosters, facilitates and co-ordinates international trials of children with rheumatic diseases.
Abstract number: THU0412
References:
1 Ravelli A, Viola S, Ramenghi B, Aramini L, Ruperto N, Martini A. Frequency of relapse after discontinuation of methotrexate therapy for clinical remission in juvenile rheumatoid arthritis. J Rheumatol 1995;22:1574-6].
2 Gottlieb BS, Keenan GF, Lu T, Ilowite NT. Discontinuation of methotrexate treatment in juvenile rheumatoid arthritis. Pediatrics 1997;100:994-7].
Source:
Rory Berrie
European League Against Rheumatism
вторник, 23 августа 2011 г.
Adolescents With Arthritis Need More Information When Transitioning To Adult Care
Helping adolescents with arthritis develop the skills and secure resources to assure that their health care needs are met as they transition to adulthood is an important issue in the U.S. In general, the frequency of which young people with special health care needs receive transition services is low and, to date, no studies have examined this frequency.
A new study examined the extent to which adolescents with arthritis receive transition services and compared these rates to youth with other special care health needs. The study was published in the January issue of Arthritis Care & Research (www3.interscience.wiley/journal/77005015/home).
Led by Peter Scal of the University of Minnesota, researchers used information from the 2005-2006 National Survey of Children with Special Health Care Needs to identify adolescents aged 12 to 17 who had arthritis and to assess responses to questions about the transition to adulthood and adult-oriented health care.
The results showed that nearly three-quarters of adolescents with arthritis were encouraged to take responsibility for their health care needs and about half discussed how their needs might change when they became an adult. Only one in five, however, received counseling about the need to transfer to adult-oriented physicians and how to obtain health insurance as an adult. These results were similar to young people with special health care needs nationally, but lag behind those with diabetes.
"Health care transition is a complex set of tasks that are embedded within a complex developmental period and a complex heath care system," the authors note. "It is not surprising, then, than the development and evaluation of services to facilitate health care transition has been slow." However, a systematic approach to this problem can show results.
In the UK, for example, the British Society of Paediatric and Adolescent Rheumatology has developed a comprehensive health care transition program for youth with arthritis that appears to have a positive impact.
In the U.S., there seems to be much room for improvement is assisting adolescents with arthritis in achieving a successful health care transition into adulthood. "More research is needed to understand youth's perspectives regarding their health care transition needs that should include items related specifically to health care transition, as well as how health care transition needs intersect with social, educational, and vocational concerns," the authors conclude.
Article: "Preparing for Adulthood: Health Care Transition Counseling for Youth with Arthritis," Peter Scal, Keith Horvath, Ann Garwick, Arthritis & Rheumatism (Arthritis Care & Research), January 2009; 61:1; pp. 52-57.
Source: Sean Wagner
Wiley-Blackwell
A new study examined the extent to which adolescents with arthritis receive transition services and compared these rates to youth with other special care health needs. The study was published in the January issue of Arthritis Care & Research (www3.interscience.wiley/journal/77005015/home).
Led by Peter Scal of the University of Minnesota, researchers used information from the 2005-2006 National Survey of Children with Special Health Care Needs to identify adolescents aged 12 to 17 who had arthritis and to assess responses to questions about the transition to adulthood and adult-oriented health care.
The results showed that nearly three-quarters of adolescents with arthritis were encouraged to take responsibility for their health care needs and about half discussed how their needs might change when they became an adult. Only one in five, however, received counseling about the need to transfer to adult-oriented physicians and how to obtain health insurance as an adult. These results were similar to young people with special health care needs nationally, but lag behind those with diabetes.
"Health care transition is a complex set of tasks that are embedded within a complex developmental period and a complex heath care system," the authors note. "It is not surprising, then, than the development and evaluation of services to facilitate health care transition has been slow." However, a systematic approach to this problem can show results.
In the UK, for example, the British Society of Paediatric and Adolescent Rheumatology has developed a comprehensive health care transition program for youth with arthritis that appears to have a positive impact.
In the U.S., there seems to be much room for improvement is assisting adolescents with arthritis in achieving a successful health care transition into adulthood. "More research is needed to understand youth's perspectives regarding their health care transition needs that should include items related specifically to health care transition, as well as how health care transition needs intersect with social, educational, and vocational concerns," the authors conclude.
Article: "Preparing for Adulthood: Health Care Transition Counseling for Youth with Arthritis," Peter Scal, Keith Horvath, Ann Garwick, Arthritis & Rheumatism (Arthritis Care & Research), January 2009; 61:1; pp. 52-57.
Source: Sean Wagner
Wiley-Blackwell
суббота, 20 августа 2011 г.
Centocor Ortho Biotech Inc. Submits Application To FDA Seeking To Expand SIMPONI(R) Label In Treatment Of Rheumatoid Arthritis
Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI® (golimumab) physician label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance of reducing signs and symptoms and improving physical function in the treatment of moderately to severely active rheumatoid arthritis (RA).
SIMPONI received U.S. FDA approval in April 2009 and became the first once-monthly anti-tumor necrosis factor (TNF)-alpha therapy approved for the treatment of adults with moderately to severely active RA, active psoriatic arthritis and active ankylosing spondylitis. For the RA indication, SIMPONI is given in combination with the drug methotrexate.
The sBLA is supported by long-term efficacy and safety data from three pivotal Phase 3 registration trials of three diverse moderately to severely active RA patient populations - patients na??ve to methotrexate, patients who had an inadequate response to methotrexate and patients previously treated with one or more anti-tumor necrosis factor (TNF)-alpha agents.
"This application represents yet another milestone for the SIMPONI clinical development program," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. "We look forward to collaborating with the FDA in reviewing the data from our Phase 3 registration trials that support the efficacy of SIMPONI in inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis."
About Rheumatoid Arthritis
RA is a chronic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability. More than one million Americans are living with RA, the majority of whom are women. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the Unites States, Europe and Canada, SIMPONI is approved for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is available either through the SIMPONI SmartJect™ autoinjector or a prefilled syringe. For more information about SIMPONI, visit SIMPONI.
Centocor Ortho Biotech Inc. discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.
Important Safety Information
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
- fever, sweat, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more than normal
- feel very tired
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines.
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
- feel very tired
- skin or eyes look yellow
- little or no appetite
- vomiting
- muscle aches
- dark urine
- clay-colored bowel movements
-fevers
- chills
- stomach discomfort
- skin rash
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers, including SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, chest pain.
Common side effects of SIMPONI® include: upper respiratory tract infection, nausea, abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.
Please read the Medication Guide for SIMPONI® and discuss any questions you have with your doctor.
Source:
Centocor Ortho Biotech Inc.
View drug information on Kineret; Orencia; Rituxan.
SIMPONI received U.S. FDA approval in April 2009 and became the first once-monthly anti-tumor necrosis factor (TNF)-alpha therapy approved for the treatment of adults with moderately to severely active RA, active psoriatic arthritis and active ankylosing spondylitis. For the RA indication, SIMPONI is given in combination with the drug methotrexate.
The sBLA is supported by long-term efficacy and safety data from three pivotal Phase 3 registration trials of three diverse moderately to severely active RA patient populations - patients na??ve to methotrexate, patients who had an inadequate response to methotrexate and patients previously treated with one or more anti-tumor necrosis factor (TNF)-alpha agents.
"This application represents yet another milestone for the SIMPONI clinical development program," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. "We look forward to collaborating with the FDA in reviewing the data from our Phase 3 registration trials that support the efficacy of SIMPONI in inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis."
About Rheumatoid Arthritis
RA is a chronic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability. More than one million Americans are living with RA, the majority of whom are women. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA.
About SIMPONI
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the Unites States, Europe and Canada, SIMPONI is approved for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is available either through the SIMPONI SmartJect™ autoinjector or a prefilled syringe. For more information about SIMPONI, visit SIMPONI.
Centocor Ortho Biotech Inc. discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.
Important Safety Information
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:
- fever, sweat, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more than normal
- feel very tired
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.
Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines.
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI®. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:
- feel very tired
- skin or eyes look yellow
- little or no appetite
- vomiting
- muscle aches
- dark urine
- clay-colored bowel movements
-fevers
- chills
- stomach discomfort
- skin rash
Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.
Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.
Low blood counts have been seen with people using TNF blockers, including SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.
Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.
New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.
Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, chest pain.
Common side effects of SIMPONI® include: upper respiratory tract infection, nausea, abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.
Please read the Medication Guide for SIMPONI® and discuss any questions you have with your doctor.
Source:
Centocor Ortho Biotech Inc.
View drug information on Kineret; Orencia; Rituxan.
среда, 17 августа 2011 г.
RA Patients Suffer In Silence To Stay On Drugs, UK
New research highlighting the devastating impact of rheumatoid arthritis (RA) on peoples' lives has found that one third of people with RA do not always tell their healthcare professionals the true extent of their symptoms.1
When asked why, 19% of respondents to the ICM poll confessed that they were worried about having their treatment taken away1 and one in four admitted that they were worried that there might not be any other treatment options available.1
Dr Andrew Ost?¶r, Consultant Rheumatologist at Addenbrooke's Hospital Cambridge, said: "These findings make for worrying reading. We know the key to effective disease management is open and honest communication between patients and their clinician and these results suggest this isn't happening, leaving patients in unnecessary pain. There are a variety of treatments available, including recently approved therapies such as rituximab which targets the B-cells in the inflammatory cascade. It should be within the grasp of all people with RA to have their disease effectively managed."
Sue Oliver, a Nurse Consultant in Rheumatology, commented: "We need to make sure we are encouraging patients to talk openly about their symptoms. Ensuring that they not only know what to expect from their current treatments but also what options are available should these not work. Only when we have open and honest communication with patients will we be able to make truly informed treatment decisions, minimising the impact of this debilitating disease on the lives of those affected."
Stakeholders are calling for better communication between healthcare professionals and patients to improve management of this debilitating condition.
The ReAlife Campaign, sponsored by Roche Products Ltd, strives to improve understanding of the day-to-day impact of RA and make sure the real price of the disease is not forgotten.
About the research
The research was conducted amongst 400 people with rheumatoid arthritis. It found that:1
?· 61% of people think their RA has had a negative effect on their sex life
?· 70% of people aged 25-34 feel that RA has had a negative impact on their relationship with their partner
?· 15% agree it was a contributing fact in their divorce/ separation
?· 36% agree the disease makes it difficult to embark on new relationships
About RA
There are currently over 487,000 people in England and Wales with RA,2,3 many of whom will only be in their 30s when the disease onsets.4 The disease can cause relentless pain, extreme fatigue, disability and has significant impact on peoples' social and working lives. Between 1999-2000, 9.4 million working days were lost in Great Britain due to this disease, the equivalent of ??833 million in lost production.5 RA is an autoimmune disease characterised by inflammation that leads to painful, stiff and swollen joints.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at rocheuk
1. ICM Research. Rheumatoid Arthritis. June 2007
2. Symmons D, Turner G, Webb R et al. The prevalence of rheumatoid arthritis in the United Kingdom: new estimates for a new century. Rheumatology 2002; 41: 793 - 800.
3. National Statistics Online, UK Population Estimates, Please click here. Accessed 6/08/2007
4. NetDoctor. Please click here.
5. Department of Works and Pensions. Analytical Services Division dwp.uk In Arthritis Research Campaign (ARC) Arthritis: the big picture 2002 please click here. [Accessed 19/06/06]
rocheuk
When asked why, 19% of respondents to the ICM poll confessed that they were worried about having their treatment taken away1 and one in four admitted that they were worried that there might not be any other treatment options available.1
Dr Andrew Ost?¶r, Consultant Rheumatologist at Addenbrooke's Hospital Cambridge, said: "These findings make for worrying reading. We know the key to effective disease management is open and honest communication between patients and their clinician and these results suggest this isn't happening, leaving patients in unnecessary pain. There are a variety of treatments available, including recently approved therapies such as rituximab which targets the B-cells in the inflammatory cascade. It should be within the grasp of all people with RA to have their disease effectively managed."
Sue Oliver, a Nurse Consultant in Rheumatology, commented: "We need to make sure we are encouraging patients to talk openly about their symptoms. Ensuring that they not only know what to expect from their current treatments but also what options are available should these not work. Only when we have open and honest communication with patients will we be able to make truly informed treatment decisions, minimising the impact of this debilitating disease on the lives of those affected."
Stakeholders are calling for better communication between healthcare professionals and patients to improve management of this debilitating condition.
The ReAlife Campaign, sponsored by Roche Products Ltd, strives to improve understanding of the day-to-day impact of RA and make sure the real price of the disease is not forgotten.
About the research
The research was conducted amongst 400 people with rheumatoid arthritis. It found that:1
?· 61% of people think their RA has had a negative effect on their sex life
?· 70% of people aged 25-34 feel that RA has had a negative impact on their relationship with their partner
?· 15% agree it was a contributing fact in their divorce/ separation
?· 36% agree the disease makes it difficult to embark on new relationships
About RA
There are currently over 487,000 people in England and Wales with RA,2,3 many of whom will only be in their 30s when the disease onsets.4 The disease can cause relentless pain, extreme fatigue, disability and has significant impact on peoples' social and working lives. Between 1999-2000, 9.4 million working days were lost in Great Britain due to this disease, the equivalent of ??833 million in lost production.5 RA is an autoimmune disease characterised by inflammation that leads to painful, stiff and swollen joints.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at rocheuk
1. ICM Research. Rheumatoid Arthritis. June 2007
2. Symmons D, Turner G, Webb R et al. The prevalence of rheumatoid arthritis in the United Kingdom: new estimates for a new century. Rheumatology 2002; 41: 793 - 800.
3. National Statistics Online, UK Population Estimates, Please click here. Accessed 6/08/2007
4. NetDoctor. Please click here.
5. Department of Works and Pensions. Analytical Services Division dwp.uk In Arthritis Research Campaign (ARC) Arthritis: the big picture 2002 please click here. [Accessed 19/06/06]
rocheuk
воскресенье, 14 августа 2011 г.
Winston Laboratories, Inc. Submits NDA For CIVANEX(R) (Civamide Cream) For Treatment Of Osteoarthritis
Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. ("Winston") (OTC PINK: WPHM), a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee. Winston anticipates that the application will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2011.
The NDA submission is supported by randomized, double-blind, well-controlled clinical studies of CIVANEX® in more than 1,200 patients. Clinical trials show that CIVANEX®-treated patients experienced a statistically significant reduction in the Western Ontario and McMaster Universities Arthritis Index ("WOMAC") Pain scale, the WOMAC Physical Function Subscale and a Patient Global Evaluation over a 12-week treatment period, relative to those in a lower dose control group. Since there is no systemic absorption of civamide, CIVANEX® can be administered either as a monotherapy or in combination with other systemic pain relief medications. The most common adverse reactions associated with CIVANEX® were transient burning or stinging at the application site.
"We are pleased to have submitted our NDA for CIVANEX® in the United States," said Joel E. Bernstein, M.D., President and CEO of Winston. "In addition to this regulatory milestone, we have ongoing reviews of our marketing authorization application (MAA) in the European Union and our new drug submission (NDS) in Canada. We anticipate a decision on the NDS in the third quarter of 2010, and eagerly anticipate the commercial launch of CIVANEX® in both North America and the European Union."
About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting more than 21 million Americans, mainly adults over age 45. Women are more susceptible to this condition. Osteoarthritis affects the fingers, spinal column and weight-bearing joints such as the hips, knees and feet. The main symptom of osteoarthritis is pain, the degree of which ranges from mildly inconvenient to debilitating. By 2030, an estimated 67 million Americans aged 18 years or older will have doctor-diagnosed arthritis. For some patients with osteoarthritis, relief of mild-to-moderate joint pain is afforded by acetaminophen (e.g. Tylenol®) or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (e.g. Motrin®, Advil®, etc.), but even these OTC medications have systemic side effects and drug interactions. A topical medication without systemic absorption, which can be utilized as either monotherapy or adjunctive therapy absent risk of systemic side effects or drug interactions, would be quite advantageous. Alternate approaches include intra-articular therapies such as hyaluronic acid and glucocorticoids.
About Civamide
Civamide (zucapsaicin; chemical name: cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced TRPV-1 receptor modulator, which selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides, substance P (SP) and calcitonin-gene related peptide (CGRP). Pain transmission and inflammation is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with suppression of the synthesis and transport of neuropeptides along the neuron.
Source:
Winston Pharmaceuticals
The NDA submission is supported by randomized, double-blind, well-controlled clinical studies of CIVANEX® in more than 1,200 patients. Clinical trials show that CIVANEX®-treated patients experienced a statistically significant reduction in the Western Ontario and McMaster Universities Arthritis Index ("WOMAC") Pain scale, the WOMAC Physical Function Subscale and a Patient Global Evaluation over a 12-week treatment period, relative to those in a lower dose control group. Since there is no systemic absorption of civamide, CIVANEX® can be administered either as a monotherapy or in combination with other systemic pain relief medications. The most common adverse reactions associated with CIVANEX® were transient burning or stinging at the application site.
"We are pleased to have submitted our NDA for CIVANEX® in the United States," said Joel E. Bernstein, M.D., President and CEO of Winston. "In addition to this regulatory milestone, we have ongoing reviews of our marketing authorization application (MAA) in the European Union and our new drug submission (NDS) in Canada. We anticipate a decision on the NDS in the third quarter of 2010, and eagerly anticipate the commercial launch of CIVANEX® in both North America and the European Union."
About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting more than 21 million Americans, mainly adults over age 45. Women are more susceptible to this condition. Osteoarthritis affects the fingers, spinal column and weight-bearing joints such as the hips, knees and feet. The main symptom of osteoarthritis is pain, the degree of which ranges from mildly inconvenient to debilitating. By 2030, an estimated 67 million Americans aged 18 years or older will have doctor-diagnosed arthritis. For some patients with osteoarthritis, relief of mild-to-moderate joint pain is afforded by acetaminophen (e.g. Tylenol®) or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (e.g. Motrin®, Advil®, etc.), but even these OTC medications have systemic side effects and drug interactions. A topical medication without systemic absorption, which can be utilized as either monotherapy or adjunctive therapy absent risk of systemic side effects or drug interactions, would be quite advantageous. Alternate approaches include intra-articular therapies such as hyaluronic acid and glucocorticoids.
About Civamide
Civamide (zucapsaicin; chemical name: cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced TRPV-1 receptor modulator, which selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides, substance P (SP) and calcitonin-gene related peptide (CGRP). Pain transmission and inflammation is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with suppression of the synthesis and transport of neuropeptides along the neuron.
Source:
Winston Pharmaceuticals
четверг, 11 августа 2011 г.
Breastfeeding And Arthritis
"Breast feeding your baby for at least a year can dramatically reduce the chance of contracting rheumatoid arthritis", the Daily Express reported. It went on to say that a study has found that women who breastfeed their babies for more than 13 months are half as likely to develop rheumatoid arthritis as women who don't. The scientists behind the research reportedly believe that hormonal changes in women who become pregnant and then breastfeed their baby "could help protect against the condition later in life".
The study behind these stories is a case-control study that looked at the duration of breastfeeding in women who had rheumatoid arthritis compared to women free of the condition. It found that a longer history of breastfeeding was associated with a reduced risk of rheumatoid arthritis. However, previous studies have had different findings, including some that have suggested that breastfeeding actually elevates the risk of rheumatoid arthritis in the short term.
The study design and the way the data were analysed limit the conclusions that can be drawn from this study. The authors themselves call for larger studies to corroborate their conclusions.
Where did the story come from?
Doctors Pikwer, Bergstr?¶m and colleagues from the Malm?¶ University Hospital in Sweden carried out the study. The study was funded by Lund University, the Craaford Foundation and the Swedish Rheumatism Association. The study was published in the peer-reviewed medical journal: Annals of the Rheumatic Diseases.
What kind of scientific study was this?
The objective of this nested case-control study was to investigate whether breastfeeding or the use of oral contraceptives affects the future risk of rheumatoid arthritis.
This study used information from a larger study, the Malmo Diet and Cancer Study (MDCS), a community-based health survey in Malmo, Sweden. The survey was performed between 1991 and 1996 and involved more than 30,000 women. The MDCS participants filled in a questionnaire that asked them about issues such as their use of oral contraceptives, how many children they had, whether each child was breastfed and for how long. The medical records of the survey participants were then found and reviewed. All women who had been diagnosed with rheumatoid arthritis since they were enrolled in the MDCS study were included in this study.
In total, the researchers found 136 women with a new diagnosis of rheumatoid arthritis. Each woman was matched for age and year of screening to four control females from the MDCS study, who were alive and free of rheumatoid arthritis at the time of the woman's diagnosis. The women with rheumatoid arthritis were compared with the control women for their use of oral contraceptives (never, one to five years of use, more than five years of use) and whether they breastfed (never, one to twelve months, 13 months or more). They also compared the women with respect to their smoking status and education.
What were the results of the study?
There was no significant difference in the number of children between women with rheumatoid arthritis and those without. However, the researchers suggest that there was a "trend towards a reduction in risk of rheumatoid arthritis for each child born".
The researchers also found that "a longer history of breastfeeding was associated with a reduced risk of rheumatoid arthritis". For example, compared to women who didn't breastfeed, those who breastfed for 13 months or more were half as likely to have rheumatoid arthritis (OR 0.46, 95% CI 0.24 to 0.91). There was no statistically significant effect of women breastfeeding for between one and twelve months on the risk of rheumatoid arthritis. The researchers report that when they took into account the effects of smoking and education, longer breastfeeding was still significantly associated with rheumatoid arthritis.
No association was found between a diagnosis of rheumatoid arthritis and the use of oral contraceptives.
What interpretations did the researchers draw from these results?
The researchers conclude that their study has shown that women who breastfeed for 13 months or more have a reduced risk of developing rheumatoid arthritis. Although the results for breastfeeding between one and 12 months were not significant, the researchers say that it appears that the more breastfeeding a woman does, the lower her risk of the disease.
Importantly, the researchers say it is difficult to differentiate the effect of breastfeeding from that of childbirth. They say that a larger study needs to confirm their finding that the reduced risk of rheumatoid arthritis is associated with breastfeeding and not with the number of children born.
What does the NHS Knowledge Service make of this study?
This design of this case-control study has weaknesses that limit the conclusions that can be drawn from its results. The researchers themselves highlight some of these limitations:
- Most importantly, the study included women in their 40s or older who may have breastfed their babies some time ago. This raises two issues; firstly, the women's recollection of how long they breastfed their children may have been inaccurate, and secondly, in the time between breastfeeding and onset of rheumatoid arthritis, other factors may have been at play that contributed to the condition. These would not necessarily have been measured or accounted for in the analyses.
- The adjustments for smoking and education that the researchers made were based on information collected in the MDCS (i.e. they don't account for behaviour at the time of diagnosis).
- The group that the researchers compared breastfeeding duration with (i.e. those who didn't breastfeed) also included women who didn't have any children. This was because there were too few women in their sample who gave birth, but did not breastfeed. This means it was not possible to truly compare whether breastfeeding reduces rheumatoid arthritis risk compared to not breastfeeding in women who had children.
- It is unclear how the researchers performed some of their calculations. In particular, they have tried to look at subgroups and the small size of these groups of participants reduces confidence in the reliability of their conclusions.
These findings need to be replicated in larger studies, particularly since they are in contrast to the results of previous studies, some that have suggested that breastfeeding actually elevates the risk of rheumatoid arthritis in the short term. Importantly, future studies should involve enough women who have actually had children so that proper comparisons can be made between those who breastfeed and those who don't (i.e. excluding women who have not given birth).
There are few women who breastfeed for more than a year and it remains to be seen whether there is an ideal time at which the protective effect of breastfeeding, if it was proven, could be expected to begin.
Links to the headlines
Breastfeeding 'may cut arthritis'. BBC News, May 13 2008
Breast is best to fight rheumatoid arthritis. The Daily Telegraph, May 13 2008
This news comes from NHS Choices
The study behind these stories is a case-control study that looked at the duration of breastfeeding in women who had rheumatoid arthritis compared to women free of the condition. It found that a longer history of breastfeeding was associated with a reduced risk of rheumatoid arthritis. However, previous studies have had different findings, including some that have suggested that breastfeeding actually elevates the risk of rheumatoid arthritis in the short term.
The study design and the way the data were analysed limit the conclusions that can be drawn from this study. The authors themselves call for larger studies to corroborate their conclusions.
Where did the story come from?
Doctors Pikwer, Bergstr?¶m and colleagues from the Malm?¶ University Hospital in Sweden carried out the study. The study was funded by Lund University, the Craaford Foundation and the Swedish Rheumatism Association. The study was published in the peer-reviewed medical journal: Annals of the Rheumatic Diseases.
What kind of scientific study was this?
The objective of this nested case-control study was to investigate whether breastfeeding or the use of oral contraceptives affects the future risk of rheumatoid arthritis.
This study used information from a larger study, the Malmo Diet and Cancer Study (MDCS), a community-based health survey in Malmo, Sweden. The survey was performed between 1991 and 1996 and involved more than 30,000 women. The MDCS participants filled in a questionnaire that asked them about issues such as their use of oral contraceptives, how many children they had, whether each child was breastfed and for how long. The medical records of the survey participants were then found and reviewed. All women who had been diagnosed with rheumatoid arthritis since they were enrolled in the MDCS study were included in this study.
In total, the researchers found 136 women with a new diagnosis of rheumatoid arthritis. Each woman was matched for age and year of screening to four control females from the MDCS study, who were alive and free of rheumatoid arthritis at the time of the woman's diagnosis. The women with rheumatoid arthritis were compared with the control women for their use of oral contraceptives (never, one to five years of use, more than five years of use) and whether they breastfed (never, one to twelve months, 13 months or more). They also compared the women with respect to their smoking status and education.
What were the results of the study?
There was no significant difference in the number of children between women with rheumatoid arthritis and those without. However, the researchers suggest that there was a "trend towards a reduction in risk of rheumatoid arthritis for each child born".
The researchers also found that "a longer history of breastfeeding was associated with a reduced risk of rheumatoid arthritis". For example, compared to women who didn't breastfeed, those who breastfed for 13 months or more were half as likely to have rheumatoid arthritis (OR 0.46, 95% CI 0.24 to 0.91). There was no statistically significant effect of women breastfeeding for between one and twelve months on the risk of rheumatoid arthritis. The researchers report that when they took into account the effects of smoking and education, longer breastfeeding was still significantly associated with rheumatoid arthritis.
No association was found between a diagnosis of rheumatoid arthritis and the use of oral contraceptives.
What interpretations did the researchers draw from these results?
The researchers conclude that their study has shown that women who breastfeed for 13 months or more have a reduced risk of developing rheumatoid arthritis. Although the results for breastfeeding between one and 12 months were not significant, the researchers say that it appears that the more breastfeeding a woman does, the lower her risk of the disease.
Importantly, the researchers say it is difficult to differentiate the effect of breastfeeding from that of childbirth. They say that a larger study needs to confirm their finding that the reduced risk of rheumatoid arthritis is associated with breastfeeding and not with the number of children born.
What does the NHS Knowledge Service make of this study?
This design of this case-control study has weaknesses that limit the conclusions that can be drawn from its results. The researchers themselves highlight some of these limitations:
- Most importantly, the study included women in their 40s or older who may have breastfed their babies some time ago. This raises two issues; firstly, the women's recollection of how long they breastfed their children may have been inaccurate, and secondly, in the time between breastfeeding and onset of rheumatoid arthritis, other factors may have been at play that contributed to the condition. These would not necessarily have been measured or accounted for in the analyses.
- The adjustments for smoking and education that the researchers made were based on information collected in the MDCS (i.e. they don't account for behaviour at the time of diagnosis).
- The group that the researchers compared breastfeeding duration with (i.e. those who didn't breastfeed) also included women who didn't have any children. This was because there were too few women in their sample who gave birth, but did not breastfeed. This means it was not possible to truly compare whether breastfeeding reduces rheumatoid arthritis risk compared to not breastfeeding in women who had children.
- It is unclear how the researchers performed some of their calculations. In particular, they have tried to look at subgroups and the small size of these groups of participants reduces confidence in the reliability of their conclusions.
These findings need to be replicated in larger studies, particularly since they are in contrast to the results of previous studies, some that have suggested that breastfeeding actually elevates the risk of rheumatoid arthritis in the short term. Importantly, future studies should involve enough women who have actually had children so that proper comparisons can be made between those who breastfeed and those who don't (i.e. excluding women who have not given birth).
There are few women who breastfeed for more than a year and it remains to be seen whether there is an ideal time at which the protective effect of breastfeeding, if it was proven, could be expected to begin.
Links to the headlines
Breastfeeding 'may cut arthritis'. BBC News, May 13 2008
Breast is best to fight rheumatoid arthritis. The Daily Telegraph, May 13 2008
This news comes from NHS Choices
понедельник, 8 августа 2011 г.
Lessons From Vioxx Case: New Approach Needed To Restore Faith In Pharmaceutical Industry
The pharmaceutical industry, academia and government agencies need to work together to restore faith in drug development, say doctors in this weeks' BMJ.
They argue that the recent litigation over the drug Vioxx, produced by Merck and Co. Inc., has highlighted the failings of the current system, which can be open to abuse.
Vioxx (rofecoxib) was introduced in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDS) for the treatment of pain associated with osteoarthritis. It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30,000 people taking Vioxx who experienced a CV event while taking the drug.
In the course of the litigation and in dealings with medical journals it was revealed that Merck had obscured critical data on the drug's toxicity, given a biased presentation of Vioxx research and had used ghost writers to author papers on Vioxx which were published in a number of academic journals.
The authors argue that the Vioxx case is "bad news for industry, academics, journals and the public" but conclude that "its [Merck's] behaviour may not be any different from that of others in the pharmaceutical or biotechnology industry."
They say that academic medicine, industry, medical journals and government agencies must come together to define a set of principles governing drug development. They also call for new approaches to collaboration and development of drugs, including storing research data on independent academic sites - rather than with the pharmaceutical company, stricter scrutiny for research which has potentially immense financial implications and penalties for ghost-writing.
They conclude that "collaborations between academics, practicing physicians, industry and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients."
Click here to view paper: press.psprings/bmj/january/feat120.pdf.
British Medical Journal
BMA House, Tavistock Sq
London WC1H 9JP
United Kingdom
bmj/
View drug information on Vioxx.
They argue that the recent litigation over the drug Vioxx, produced by Merck and Co. Inc., has highlighted the failings of the current system, which can be open to abuse.
Vioxx (rofecoxib) was introduced in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDS) for the treatment of pain associated with osteoarthritis. It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30,000 people taking Vioxx who experienced a CV event while taking the drug.
In the course of the litigation and in dealings with medical journals it was revealed that Merck had obscured critical data on the drug's toxicity, given a biased presentation of Vioxx research and had used ghost writers to author papers on Vioxx which were published in a number of academic journals.
The authors argue that the Vioxx case is "bad news for industry, academics, journals and the public" but conclude that "its [Merck's] behaviour may not be any different from that of others in the pharmaceutical or biotechnology industry."
They say that academic medicine, industry, medical journals and government agencies must come together to define a set of principles governing drug development. They also call for new approaches to collaboration and development of drugs, including storing research data on independent academic sites - rather than with the pharmaceutical company, stricter scrutiny for research which has potentially immense financial implications and penalties for ghost-writing.
They conclude that "collaborations between academics, practicing physicians, industry and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients."
Click here to view paper: press.psprings/bmj/january/feat120.pdf.
British Medical Journal
BMA House, Tavistock Sq
London WC1H 9JP
United Kingdom
bmj/
View drug information on Vioxx.
пятница, 5 августа 2011 г.
'Shrug Off' Shoulder Surgery Myth, Study Suggests
Contrary to widespread belief, total surgical replacement of arthritic shoulder joints carries no greater risk of complications than replacement of other major joints, a Johns Hopkins study suggests.
In fact, the Johns Hopkins researchers say, their study shows that patients who undergo shoulder arthroplasty to relieve chronic and significant pain can expect significantly fewer complications, much shorter hospital stays and less costs than patients undergoing hip or knee replacement.
Arthritis is estimated to affect more than 16 million Americans and is a common cause of shoulder pain and mobility loss. However, many reject shoulder joint replacement, fearful of risks and costs. The Hopkins research team, led by Edward McFarland, M.D., director of the Division of Adult Orthopedics at The Johns Hopkins Hospital, analyzed anonymous patient information provided by the Maryland Health Services Cost Review Commission, the state's hospital rate-regulator. They looked at all arthroplasties performed in Maryland to alleviate osteoarthritis pain between 1994 and 2001, including details of 15, 414 hip surgeries, 34, 471 knee operations and 625 shoulder procedures.
"After looking at how all these patients fared, we concluded that, comparatively, total shoulder surgery is just as safe and effective as other types of arthroplasties," says McFarland. "Lower numbers of shoulder procedures done both regionally and nationally may indicate that many people live with shoulder pain because they fear that the corrective surgery is too risky or costs more than similar procedures. But we have found that this is just not true."
The findings appeared in a recent online version of the journal Clinical Orthopedics.
According to nationwide 2003 Medicare figures, 6,700 people had shoulder joints replaced that year, compared to 106,887 hip replacements and 199,195 total knee replacements.
Shoulder arthroplasty consists of placement of a metal and plastic artificial joint similar to the ball-and-socket construction used to substitute for hip and knee joints. The socket, or scapula, is scraped clean and fitted with a plastic mount, while the ball at the top of the humerus bone in the arm is replaced with a metal implant.
Patients in the study who had shoulder surgery had far less in-hospital post-surgical complications (7.5 percent) compared with those patients who had their hips and knees replaced (15.5 percent and 14.7 percent, respectively). McFarland's team also determined that the average time a person remained hospitalized after the surgery was lowest for those recovering from shoulder procedures (just 2.42 days for shoulder patients, versus more than four days for both the hip and knee equivalents).
Shoulder arthroplasty is also less expensive, according to McFarland. A shoulder replacement's total costs, on average, are $10, 351; whereas hip replacement surgery averages $15, 442, and knee arthroplasty, $14, 674.
In the study period, there were no fatalities associated with shoulder replacement, compared to 27 deaths among hip replacement patients and 54 among knee replacement patients. Given the small number of shoulder surgeries actually performed, McFarland noted that the mortality rates for the procedure were not statistically different from the other forms of arthroplasty. But finding no resulting deaths attributed to total shoulder replacement in the group of patients studied did add "clinical significance" to the idea that shoulder surgery is relatively safer. The study's authors suspect that the higher number of deaths related to hip and knee procedures may be related to repeat surgeries stemming from postoperative complications during the same hospitalization, a need for blood transfusions or extended intensive care stays.
McFarland says most patients who are candidates for total shoulder replacement surgery are "at the end of their rope" trying to manage chronic pain and disability with drugs. "Ninety-nine percent of the people who have a shoulder replacement for arthritis get pain relief and say that they wish they had done it sooner," says McFarland. "This study indicates there may be little reason to wait."
Contact: Jeff Ventura
hopkinsmedicine/
In fact, the Johns Hopkins researchers say, their study shows that patients who undergo shoulder arthroplasty to relieve chronic and significant pain can expect significantly fewer complications, much shorter hospital stays and less costs than patients undergoing hip or knee replacement.
Arthritis is estimated to affect more than 16 million Americans and is a common cause of shoulder pain and mobility loss. However, many reject shoulder joint replacement, fearful of risks and costs. The Hopkins research team, led by Edward McFarland, M.D., director of the Division of Adult Orthopedics at The Johns Hopkins Hospital, analyzed anonymous patient information provided by the Maryland Health Services Cost Review Commission, the state's hospital rate-regulator. They looked at all arthroplasties performed in Maryland to alleviate osteoarthritis pain between 1994 and 2001, including details of 15, 414 hip surgeries, 34, 471 knee operations and 625 shoulder procedures.
"After looking at how all these patients fared, we concluded that, comparatively, total shoulder surgery is just as safe and effective as other types of arthroplasties," says McFarland. "Lower numbers of shoulder procedures done both regionally and nationally may indicate that many people live with shoulder pain because they fear that the corrective surgery is too risky or costs more than similar procedures. But we have found that this is just not true."
The findings appeared in a recent online version of the journal Clinical Orthopedics.
According to nationwide 2003 Medicare figures, 6,700 people had shoulder joints replaced that year, compared to 106,887 hip replacements and 199,195 total knee replacements.
Shoulder arthroplasty consists of placement of a metal and plastic artificial joint similar to the ball-and-socket construction used to substitute for hip and knee joints. The socket, or scapula, is scraped clean and fitted with a plastic mount, while the ball at the top of the humerus bone in the arm is replaced with a metal implant.
Patients in the study who had shoulder surgery had far less in-hospital post-surgical complications (7.5 percent) compared with those patients who had their hips and knees replaced (15.5 percent and 14.7 percent, respectively). McFarland's team also determined that the average time a person remained hospitalized after the surgery was lowest for those recovering from shoulder procedures (just 2.42 days for shoulder patients, versus more than four days for both the hip and knee equivalents).
Shoulder arthroplasty is also less expensive, according to McFarland. A shoulder replacement's total costs, on average, are $10, 351; whereas hip replacement surgery averages $15, 442, and knee arthroplasty, $14, 674.
In the study period, there were no fatalities associated with shoulder replacement, compared to 27 deaths among hip replacement patients and 54 among knee replacement patients. Given the small number of shoulder surgeries actually performed, McFarland noted that the mortality rates for the procedure were not statistically different from the other forms of arthroplasty. But finding no resulting deaths attributed to total shoulder replacement in the group of patients studied did add "clinical significance" to the idea that shoulder surgery is relatively safer. The study's authors suspect that the higher number of deaths related to hip and knee procedures may be related to repeat surgeries stemming from postoperative complications during the same hospitalization, a need for blood transfusions or extended intensive care stays.
McFarland says most patients who are candidates for total shoulder replacement surgery are "at the end of their rope" trying to manage chronic pain and disability with drugs. "Ninety-nine percent of the people who have a shoulder replacement for arthritis get pain relief and say that they wish they had done it sooner," says McFarland. "This study indicates there may be little reason to wait."
Contact: Jeff Ventura
hopkinsmedicine/
вторник, 2 августа 2011 г.
Rheumatoid Arthritis Doctor Visits Lack Depression Assessment
Patients with rheumatoid arthritis (RA), the most common chronic inflammatory arthritis, are twice as likely as other individuals to experience depression. Although depression in primary care has been well studied, no studies have examined whether rheumatologists and RA patients discuss depression during medical visits. A new study published in the February issue of Arthritis Care & Research found that patients whose activities were more restricted due to their arthritis were more than twice as likely to have moderately severe to severe symptoms of depression. It also found that few depressed patients discussed their condition with their rheumatologists and the subject was always brought up by the patients as opposed to the physicians.
Led by Betsy Sleath, of the University of North Carolina at Chapel Hill, NC, the study included 200 RA patients from four rheumatology clinics with eight participating doctors. Patient visits were audiotaped and patients were interviewed after their medical visits using a questionnaire to measure their mental status.
The results showed that almost 11% of the patients in the study had moderately severe to severe symptoms of depression and that those who were rated as being more restricted in their normal activities were significantly more likely to have these symptoms. Furthermore, only 1 in 5 of the patients who showed symptoms discussed depression with their rheumatologists and they were always the ones to bring up the topic. Even when depression was brought up, it was often not discussed at any length.
When patients visit their rheumatologists, their main focus is their RA, yet such chronic diseases can greatly impact a patient's psychosocial well-being. In addition, many RA patients see their rheumatologists more often then their primary care physician and depression can also affect a patient's adherence to treatment regimens. For these reasons the authors suggest that it is important for rheumatologists to consider addressing both the RA and the depression when they see their patients. The authors note that some physicians may not feel comfortable discussing depression with their patients, but they should consider having their office staff administer a brief depression screening before the patient's visits in order to identify problems early on.
In addition to screening for depression, the authors suggest it is important for patients to have access to appropriate treatment. Rheumatologists can treat the depression themselves, refer patients to a mental health professional, or communicate with the patient's primary care physician to coordinate a treatment plan. Also, given how common depression is in these patients, rheumatology training programs should educate physicians about the importance of screening for and treating depression.
"Failure to detect and treat depression may compromise patients' adherence to regimens and, ultimately, their health outcomes," the authors conclude. "Future research should examine patient- and physician-reported barriers to communicating about depression in rheumatology practices and use these findings to design innovative interventions that can be delivered effectively in busy rheumatologist practices."
Article: "Communication About Depression During Rheumatoid Arthritis Patient Visits," Betsy Sleath, Betty Chewning, Brenda M. De Vellis, Morris Weinberger, Robert F. De Vellis, Gail
Tudor, Ashley Beard, Arthritis Care & Research, February 2008.
Source: Amy Molnar
Wiley-Blackwell
Led by Betsy Sleath, of the University of North Carolina at Chapel Hill, NC, the study included 200 RA patients from four rheumatology clinics with eight participating doctors. Patient visits were audiotaped and patients were interviewed after their medical visits using a questionnaire to measure their mental status.
The results showed that almost 11% of the patients in the study had moderately severe to severe symptoms of depression and that those who were rated as being more restricted in their normal activities were significantly more likely to have these symptoms. Furthermore, only 1 in 5 of the patients who showed symptoms discussed depression with their rheumatologists and they were always the ones to bring up the topic. Even when depression was brought up, it was often not discussed at any length.
When patients visit their rheumatologists, their main focus is their RA, yet such chronic diseases can greatly impact a patient's psychosocial well-being. In addition, many RA patients see their rheumatologists more often then their primary care physician and depression can also affect a patient's adherence to treatment regimens. For these reasons the authors suggest that it is important for rheumatologists to consider addressing both the RA and the depression when they see their patients. The authors note that some physicians may not feel comfortable discussing depression with their patients, but they should consider having their office staff administer a brief depression screening before the patient's visits in order to identify problems early on.
In addition to screening for depression, the authors suggest it is important for patients to have access to appropriate treatment. Rheumatologists can treat the depression themselves, refer patients to a mental health professional, or communicate with the patient's primary care physician to coordinate a treatment plan. Also, given how common depression is in these patients, rheumatology training programs should educate physicians about the importance of screening for and treating depression.
"Failure to detect and treat depression may compromise patients' adherence to regimens and, ultimately, their health outcomes," the authors conclude. "Future research should examine patient- and physician-reported barriers to communicating about depression in rheumatology practices and use these findings to design innovative interventions that can be delivered effectively in busy rheumatologist practices."
Article: "Communication About Depression During Rheumatoid Arthritis Patient Visits," Betsy Sleath, Betty Chewning, Brenda M. De Vellis, Morris Weinberger, Robert F. De Vellis, Gail
Tudor, Ashley Beard, Arthritis Care & Research, February 2008.
Source: Amy Molnar
Wiley-Blackwell
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