Data Presented At Two Global Medical Congresses Reinforce Benefit Of Enbrel® (etanercept) For Patients With Chronic Inflammatory Conditions

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 31 May 2011 – 0:00 PDT

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Amgen (NASDAQ: AMGN) and Pfizer Inc. (NYSE: PFE) announced new results from multiple studies of ENBREL, further expanding the body of evidence supporting the efficacy and safety profile of ENBREL, the most prescribed biologic by rheumatologists in the United States (U.S.). Eighteen abstracts across four indications, including moderate-to-severe rheumatoid arthritis (RA), ankylosing spondylitis (AS), moderate-to-severe plaque psoriasis (PsO), and psoriatic arthritis (PsA), will be published at two global medical congresses, the European League Against Rheumatism (EULAR) and World Congress of Dermatology (WCD), this week.

“The breadth of data being presented at these congresses underscores our ongoing commitment to the rigorous study of these conditions where treatment has been shown to improve patient outcomes,” said Yvonne Greenstreet, senior vice president and head of the Medicines Development Group for Pfizer’s Specialty Care Business Unit. “With its first approval for RA in 1998, ENBREL has 2.5 million patient-years of collective clinical experience, and we continue to gain important knowledge about these conditions and the potential benefits of treating patients with certain chronic inflammatory diseases.”

Selected abstracts of interest include:

Rheumatoid Arthritis

Impact of Etanercept-Methotrexate (MTX) Therapy on Disease Activity and Radiographic Progression in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial

Persistent inflammation and associated joint damage may play a critical role in causing impairment in joint function in RA. Previous studies exploring treatment with biologics focused primarily on patients with severe disease. The radiographic data are an exploratory endpoint and represent results from Period 1 of a 2-period study from the initial open-label portion of the PRESERVE trial examining patients with moderately active rheumatoid arthritis. The results demonstrated that treatment with ENBREL added to MTX reduced radiographic progression in 82 percent (modified Total Sharp Score [mTSS] change less than or equal to 0.5) of these patients, all of whom had an inadequate response to MTX alone. Results also showed that 86 percent of patients achieved Disease Activity Score (DAS) 28 low disease activity and 67 percent achieved DAS28 clinical remission with continuous treatment with ENBREL plus MTX.

Improvement in Patient-Reported Outcomes with Etanercept-Methotrexate (MTX) Therapy in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial

Patients with RA often experience impairment in physical function, health-related quality of life (HR-QOL) and productivity at work. Patient-reported outcomes from the initial open-label portion of the PRESERVE trial examining patients with moderate rheumatoid arthritis showed clinically important improvements in measures of physical function, disease activity, pain, fatigue, HR-QOL and work productivity after 36 weeks of ENBREL added to MTX.

Ankylosing Spondylitis

Association Between Nocturnal Back Pain and Fatigue in Ankylosing Spondylitis and Improvements in Both Patient-Reported Outcomes with Etanercept Therapy

Nocturnal back pain in AS patients is a strong predictor of fatigue. In an exploratory pooled analysis, data combined from four clinical trials of AS patients were analyzed and found that nocturnal back pain was a significant predictor of fatigue and showed that ENBREL provided reductions in nocturnal back pain and fatigue.

Psoriatic Arthritis

Psoriasis Patients with Psoriatic Arthritis and Axial Involvement Have a Higher Disease Burden than Those without Axial Involvement but Similar Treatment Outcomes: Results from PRESTA Trial

Patients who have PsO and PsA with axial disease (disease involvement in the spine) have a higher burden of disease than those without axial disease (patients who have disease in the peripheral joints only). Data from an exploratory analysis of the PRESTA trial examining patients with moderate-to-severe PsO and PsA found that patients presenting with and without axial disease showed benefit from treatment with ENBREL compared with baseline.

Psoriasis

Effects of Etanercept on Cardiometabolic Biomarkers in Subjects with Moderate-to-Severe Plaque Psoriasis: The PRISTINE Trial

Psoriasis patients may have an increased incidence of co-morbid conditions, such as diabetes and cardiovascular disease. Data from this exploratory endpoint from the PRISTINE trial studying patients with moderate-to-severe plaque psoriasis found at week 12, ENBREL 50mg once or twice weekly did not negatively impact various biomarkers of cardiometabolic disease like apolipoprotein B/apolipoprotein A1 ratio, hsCRP, and NT-proBNP. The clinical significance of these findings needs to be studied further, but the results are important for consideration as the medical community continues to explore the potentially broader effects of inflammatory disease in the body.

About Rheumatoid Arthritis

Rheumatoid arthritis affects approximately 0.6 to 0.9 percent of the adult population worldwide and can start at any age, but usually occurs between 40 and 70 years. RA can cause pain, stiffness, swelling and limitation in the motion and function of multiple joints. In RA, joint damage can significantly worsen over time, especially if left untreated. Joint damage may impair function, and potentially disable some patients.

About Psoriasis

Psoriasis affects approximately 7.5 million American adults and is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients suffer from plaque psoriasis, which can cause painful and itchy red, scaly patches to appear on the skin.

About Psoriatic Arthritis

Psoriatic arthritis is an auto-immune disease that causes pain, stiffness and swelling in and around the joints. In addition, psoriatic arthritis patients may experience skin lesions similar to those seen in plaque psoriasis.

Approximately 600,000 Americans have psoriatic arthritis. In fact, up to 30 percent of people diagnosed with plaque psoriasis may actually have psoriatic arthritis.

About Ankylosing Spondylitis

Ankylosing spondylitis is a debilitating condition that may affect two to three times as many men as women, and typically presents in patients during the second and third decades of life. AS typically causes inflammation, stiffness and pain in the spine (known as axial disease), but can also affect the peripheral joints. As a result of the disease, patients with symptomatic AS can lose productivity owing to work disability and unemployment, and may have substantial use of healthcare resources and an overall reduced quality of life.

ABOUT ENBREL

ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was approved in 2004 to treat adult chronic moderate to severe plaque psoriasis. ENBREL has more than 18 years (with more than 12 years of post-marketing experience in RA) and 2.5 million patient-years of collective clinical experience.

ENBREL indications in the U.S:

— ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.

— ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.

— ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

— ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

— ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ENBREL in the EU is approved for the following indications:

— Rheumatoid arthritis: ENBREL in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. ENBREL can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. ENBREL is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. ENBREL, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

— Polyarticular juvenile idiopathic arthritis: Treatment of active polyarticular juvenile idiopathic arthritis (JIA) in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. ENBREL has not been studied in children aged less than 4 years.

— Psoriatic arthritis: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. ENBREL has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.

— Ankylosing spondylitis: Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

— Plaque psoriasis: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. The European Commission recently approved a new 50mg ENBREL once-weekly dosage regimen as an alternative to the currently approved 25mg ENBREL twice-weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis.

— Pediatric plaque psoriasis: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Source: Amgen



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Augurex Reports Positive Data For RA Blood Test And Drug Target At The Annual European Congress Of Rheumatology (EULAR)

Main Category: Arthritis / Rheumatology
Also Included In: Blood / Hematology;  Medical Devices / Diagnostics
Article Date: 31 May 2011 – 0:00 PDT

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Augurex Life Sciences Corp. reported that in London at the European League Against Rheumatism (EULAR) Conference, leading arthritis researchers presented important data on Augurex’s rheumatoid arthritis (RA) biomarker blood test and novel drug target.

RA is a disease that affects approximately 10 million people worldwide; however, it can be difficult for a primary care physician to diagnose because the joint pain symptoms are common to other conditions. This often delays RA patient referral to an arthritis specialist where they could otherwise receive therapies to treat or possibly halt the disease. RA is a particularly debilitative form of arthritis that, if left untreated, results in 70% of patients developing irreversible joint damage within 2 years of symptom onset.

This blood test measures 14-3-3, a protein that is elevated in the blood of patients with RA while it is relatively absent in healthy people and those with other types of auto-immune conditions. The 14-3-3 protein was evaluated in 135 RA patients and 130 controls showing that if patients were positive for the protein, they had a 5 to 50 times greater likelihood of having RA and that its levels were independent of another commonly used blood test called Rheumatoid Factor or RF. What this means is that 14-3-3 may be combined with other blood tests to accurately capture at least 87% of patients with RA.

“The real focus in RA these days is to ensure that patients are identified, ideally early in the course of disease, so that they can get on appropriate treatments that may significantly improve their short and long-term outcome. What we are seeing in the data is that a blood test like this one, could assist in identifying more patients that may have gone longer before being diagnosed”, says Dr. Walter Maksymowych who is the lead investigator on this study, co-discoverer of 14-3-3 in arthritis and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.

Other data presented by Dr. Maksymowych at EULAR, described what 14-3-3’s biological role could be in the development of inflammatory arthritis. Although the protein normally exists inside of healthy cells, in RA it is externalized and acts back on cells activating key intracellular pathways causing harmful substances such as, TNF-α, IL-6, RANKL and MMP-9 to be produced which in turn cause inflammation and joint damage. Antibody compounds targeted at the 14-3-3 protein were shown to block its disease-related effects in cells. The uniqueness of the 14-3-3 protein is that it’s not only measurable in blood to help identify patients with RA but it seems that if you reduce its harmful biological effects with antibodies or other drugs that could inactivate this protein you may be able to treat the disease.

In RA, not unlike cancer, the development of the disease includes multiple factors that act to varying degrees in different patients. Therefore, in multi-factorial diseases like RA, targeted therapies are highly desirable that focus on the most prominent disease contributors in individual patients. “If you have a direct companion diagnostic blood test that can specifically identify patients who most need the therapy and that also gives you an indication of how well the drug is working, that’s the ideal therapeutic management scenario”, states Dr. Maksymowych.

If the continued development efforts of the drug are successful then this protein may represent the first “personalized medicine” target in rheumatology. The way this would work is that, in patients who have very little, or no 14-3-3 you would not treat them with the drug that targets the protein, while in those who have higher levels, you can dose them with the appropriate amount of anti-14-3-3 drug to remove it from the body and use the blood test to monitor their response over time.

Source: Augurex Life Sciences Corp.



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Association Between Financial Conflicts Of Interest And Positive Study Outcomes

Main Category: Clinical Trials / Drug Trials
Also Included In: Pharma Industry / Biotech Industry;  Arthritis / Rheumatology
Article Date: 29 May 2011 – 2:00 PDT

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Results demonstrate that 91% of RCTs recording this kind of FCOI achieved a positive – outcome, compared to 66.7% of RCTs without specific FCOI (p=0.02) and adjusting for confounding factors did not change this finding.

Results of this American study demonstrate that between the two periods 2002-3 and 2006-7 there was a significant increase in the number of RA RCTs listing lead authors as receiving consulting fees/honoraria (14.6% in the first time period compared to 40% in the second (p=0.004)). FCOIs including research grants, employment by sponsoring pharmaceutical company and share ownership were disclosed by at least one author in 53.4% of the 103 eligible RCTs studied. It could be possible that the difference noted between the two periods simply reflects a natural increase in the number of authors proactively reporting conflicts of interest.

“The number of pharmaceutical treatment options for RA has increased remarkably in recent years, partly as a result of increased funding from pharmaceutical companies,” said Dr. Khan an Assistant Professor from the Division of Rheumatology at the University of Arkansas for Medical Sciences, USA. “Our study has shown that certain FCOIs among study authors have an increased likelihood of positive outcomes favouring the sponsor‟s drug. There are many potential reasons for these results – it could be possible that more experienced clinicians hired by industry have a greater likelihood of achieving positive results because of superior trial design or that positive trials results are more likely to be published than negative ones.”

FCOIs were disclosed by at least one author in 55 of the 103 (53.4%) eligible RCTs assessed by the study authors. Forty nine (47.6%) were employed by the industry sponsor, 29 (28.2%) had received consulting fees/honoraria, 14 (13.6%) had received research grants, and 13 (12.6%) owned shares in the pharmaceutical company. However, study authors found the correlation of reporting positive outcomes was only significant in one group – for those authors receiving consulting fees/honoraria from the industry.

Study authors go on to state that “reporting of RCTs with such a high frequency of positive outcomes (72% in the overall study and approximately 90% for RCTs with authors receiving consultancy fees/honoraria or a research grant from Industry) raises ethical issues.” Dr. Khan recommends that “an RCT should only be conducted if there is substantial uncertainty about the relative value of one treatment versus another.”

The MEDLINE and Cochrane Central Register for Controlled Trials databases were searched for original, parallel-designed RA drug trials from 2002-3 and 2006-7 with clinical primary outcomes that randomly allocated patients to different treatment groups. Search terms included „Rheumatoid Arthritis‟, „Arthritis‟, „Rheumatoid‟, with a limitation to “Clinical Trials‟ and “English‟. RCT outcome was defined as positive if a statistically significant result favoring the experimental intervention for primary outcome was found.

Abstract Number: FRI0250

Source:
Rory Berrie

European League Against Rheumatism



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Is It Ethical To Use Placebo In Rheumatoid Arthritis Clinical Trials?

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 May 2011 – 0:00 PDT

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The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia®), golimumab (Simponi®) or tocilizumab (Actemra®), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.

“According to the Helsinki-Declaration of the World Medical Association*, a placebo-controlled study design is deemed to be ethically acceptable when there is no other effective treatment,” said Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany. “However, this analysis confirms that patients in the placebo-group are at a disadvantage as they are given no change in medication to reduce their active inflammatory condition or halt disease progression. Our recommendation is that future clinical trials should include an active comparator group to ensure that all patients receive effective treatments to improve their quality of life.”

In the analysis, researchers used studies from the European Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for abatacept, golimumab and tocilizumab as samples. The studies chosen had to be placebo controlled at the beginning and state clinical relevant outcome criteria (e.g. DAS28**, ACR20***, Health Assessment Questionnaire and joint erosion scores).

Notes:

Abstract Number: FRI0339

*The World Medical Association (WMA) is an organisation promoting the highest possible standards of medical ethics. The WMA provides ethical guidance to physicians through its Declarations, Resolutions and Statements.

**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual’s RA is.

***ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts.

Source:
Rory Berrie

European League Against Rheumatism



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New Study Finds That Medicare Beneficiaries With Higher Medical Spending Have Better Health Outcomes

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Public Health
Article Date: 30 May 2011 – 0:00 PDT

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A new study from George Mason University and the Urban Institute reveals that greater spending on medical services means better overall health for Medicare participants. Health Administration and Policy Professor Jack Hadley and his co-authors, Urban Institute researchers Timothy Waidmann, Stephen Zuckerman, and Robert Berenson, analyzed data from more than 17,000 Medicare beneficiaries to draw this conclusion.

Previous reports showed that Medicare spending varies greatly by geographic area, but with little to show for it-the health outcomes for people who live in expensive geographic areas are not necessarily better than those who live in less expensive geographic areas. As a result, policymakers have considered limiting Medicare payments in high-cost areas.

But, as described in their recent study, “Medical Spending and the Health of the Elderly,” the research team found that spending more on Medicare medical expenses actually resulted in greater survival and a better overall health score, using an index that measures perceived health and activity limitations.

“The motivation for the study was a large body of research that’s been done over the past ten years that typically has found that there is little or no relationship between how much Medicare spends and the health outcomes of elderly people,” Hadley says.

But these studies looked at large swathes of populations, typically by geographic location, and used averages to draw their conclusions. “The implication was that higher spending was not contributing to better health,” Hadley says.

He explains, “While that finding is very persuasive, it doesn’t look at individuals and the amount of medical care that they each receive.” So in this study, the research team used data from the Medicare Current Beneficiary Survey, which collects extensive information from Medicare participants over a three-year span, to determine whether a relationship existed between medical spending and better health.

“The surveys provide much richer information about the person’s health condition than one can typically get from insurance claims data,” Hadley says.

The full results of the study will appear in an upcoming edition of the journal Health Services Research, which is published by the Health Research and Educational Trust and is an official journal of AcademyHealth.

“Over this three-year period-controlling for people’s health when they first come into the survey and new diagnoses they may have had over the course of the three years-what was their health like at the end of the observation period? And did that vary with how much medical care they received as individuals?” Hadley asks.

The statistical analysis indicates that the individuals’ health did vary with their medical care spending. Over a three-year span, for a 10 percent increase in medical spending, there was 1.9 percent increase in the patient’s health score, called the Health and Activity Limitations Index and a 1.5 percent greater survival probability.

The researchers classify this finding as a “modest effect” but stress that “the key thing is that we did find a positive relationship as opposed to other studies which have suggested that there’s no relationship between how much care a person receives and what their health outcomes are.”

“This suggests that policymakers need to understand that across-the-board reductions in Medicare spending in a geographic area or on a national level could have harmful effects on beneficiaries’ health,” The Urban Institute’s Timothy Waidmann explains. “To look for inefficiencies, you need to look more closely at specific conditions and diseases and how those are treated. Analysis from 40,000 feet just doesn’t do that for you.”

The study was supported from a grant from the Robert Wood Johnson Foundation’s program on Health Care Financing and Organization.

Source:
Leah K. Fogarty

George Mason University


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AACE Applauds Introduction Of House And Senate Bills To Preserve Patient Access To Osteoporosis Testing Under Medicare

Main Category: Bones / Orthopedics
Also Included In: Medicare / Medicaid / SCHIP
Article Date: 30 May 2011 – 2:00 PDT

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The American Association of Clinical Endocrinologists (AACE) applauds the introduction of legislation in both the U.S. House of Representatives and the U.S. Senate that will preserve patient access to osteoporosis testing and treatment services under the Medicare program.

The legislation introduced last night, “Preservation of Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2011,” (H.R. 2020, S. 1096) will extend current Medicare payment rates for energy x-ray absorptiometry (DXA) tests, through 2013. Without congressional action, Medicare payment rates for this service will be reduced by approximately 50% at the beginning of next year. Physicians will be forced to discontinue DXA tests because payment rates will not cover the cost of providing the procedures.

Osteoporosis testing is done by measuring bone density with a DXA machine. Providing a DXA test in the office allows a physician to identify patients at high fracture risk and immediately implement a treatment plan if required. A DXA test is also used to monitor the effectiveness of medical therapy to prevent and treat osteoporosis. Early diagnosis and treatment of osteoporosis has been proven to reduce painful and costly fractures.

“The introduction of this legislation demonstrates a strong commitment to disease prevention, improved health outcomes, and reducing growing health care costs,” said Dr. Yehuda Handelsman, AACE President. “AACE calls on Congress to enact this important legislation this year.”

In 2005, osteoporosis was responsible for an estimated two million fractures and $19 billion in costs. By 2025, experts predict that osteoporosis will be responsible for approximately 3 million fractures and $25.3 billion in costs each year, according to National Osteoporosis Foundation.

AACE commends the sponsors of the legislation in the House, Representatives Michael Burgess (R-26th-TX) and Shelley Berkley (D-1st-NV) and the sponsors of the identical Senate bill, Senators Olympia Snowe (R-ME) and Debbie Stabenow (D-MI) for their leadership on this issue.

AACE works closely with other interested clinical societies and patient groups on this issue, including the American College of Obstetricians and Gynecologists, American College of Rheumatology, American Society for Bone and Mineral Research, International Society for Clinical Densitometry, The Endocrine Society and National Osteoporosis Foundation.

Source:

American Association of Clinical Endocrinologists



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Survey Reveals HCPs Are Failing To Set Goals With RA Patients

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Main Category: Arthritis / Rheumatology
Article Date: 29 May 2011 – 2:00 PDT

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While the majority of patients with Rheumatoid Arthritis (RA) feel that personalized goal setting would have a positive impact on disease management, many stated that their health care professionals (HCPS) are not discussing approaches to achieving personal or social goals, reports a survey presented at the Annual Meeting of the European League Against Rheumatism (EULAR) in London, May 25-28.

The “Getting to your destination faster” survey was conducted to examine patients’ expectations of treatment and outcomes in RA, with a particular focus on goal setting practices. The internet survey was completed by 1,829 responders, aged 25 to 65 years, from UK, Germany, Spain, France, Italy and US. Results showed:

  • That 87% of respondents agreed that establishing personal targets and achieving them would have a positive impact on their disease management.
  • 73% stated that their HCPs did not discuss approaches that achieved personal targets.
  • 62% agreed that decisions about how to treat their RA were generally shared between the HCP and themselves.
  • 60% of responders had not heard of the treat to target approach.

“The survey highlights that RA patients want to be proactively involved in the management of their condition and set what they see as realistic goals for improving quality of life. The results are a clarion call to HCPs to wake up and take note of this,” said Professor Peter Taylor, lead author of the study, from the Kennedy Institute of Rheumatology, London, adding that the best treatment outcomes arise when patients and HCPs work together in partnership.

The type of goals mentioned by responders to the survey included feeling less tired so that they could do activities with their children, being able to sleep through the night without waking in pain, being able to open every day items such as jars, and being able to use their computer without pain.

The preferred EULAR guideline target is remission as assessed by a DAS28 less than or equal to 2.6. Where that is not possible a target of low disease activity is recommended as assessed by a DAS28 less than or equal to 3.2.

Appropriate personal and social goal setting, added Taylor, is particularly important for the large numbers of RA patients who fail to meet remission targets outlined by EULAR guidelines (remission defined as a DAS28 score below 2.6, low disease activity as a score less or equal to 3.2).

“The reality for many patients (particularly those who’ve had RA for several years prior to anti TNF treatments) is that EULAR targets are not achievable, which can be demoralizing. Helping patients to achieve personal targets is a way of showing them they’re doing well in keeping their disease under control.”

Reference
P Taylor, V Strand, T Sensky, et al. Patient Expectations of Treatment Goals and Goal-Setting Practices in Rheumatoid Arthritis. EULAR. FRI0256

Written by Janet Fricker

Copyright: Medical News Today

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No Overall Increased Cancer Risk Found For Arthritis Patients Taking Newer Treatments

Main Category: Arthritis / Rheumatology
Also Included In: Cancer / Oncology
Article Date: 29 May 2011 – 3:00 PDT

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Only three percent (n=181) of patients in the study cohort receiving anti-tumour necrosis factor agents (anti-TNFs) for treatment of their arthritis developed a first cancer within nine years and overall risk was not dependent on the type of arthritis.

The nine year follow-up study conducted at Gentofte University Hospital, Denmark demonstrated that relative risk ((RR)=1.03 (95%confidence interval 0.82-1.30)) was not increased in patients treated with anti-TNFs compared to patients who had never taken anti-TNFs during 23,965 person-years follow-up. Overall cancer risk was not dependent on the type of arthritis including rheumatoid arthritis (RA) (n=3,496) (RR=1.05, 95% CI 0.82-1.34), psoriatic arthritis (PsA) (n=670) (RR=1.98, 95% CI 0.24-16.18) or other arthritis (n=499) (RR=0.79 95% CI 0.08-8.33).

“Some studies have suggested that taking anti-TNFs may increase an individual’s risk of cancer however this study provides long term evidence that an overall risk of cancer is not associated with this group of treatments”, said Dr. PhD, Lene Dreyer from the Department of Rheumatology at Gentofte University Hospital. “TNF is a small signalling molecule called a cytokine and is able to inhibit the development of tumours by interfering with signalling pathways. Therefore drugs targeting TNF can influence the development of tumours, although the extent of this impact remains unclear.”

The study was based on the national Danish DANBIO registry which was initiated in the year 2000 to monitor treatment with biologic medicines in Denmark and includes patients with RA, PsA and ankylosing spondylitis. A national cohort of 13,699 patients was identified and of these, 5,598 (41 percent) had started anti-TNF treatment. The data from the DANBIO database was linked with the Danish Cancer Registry and analysed.

Incidence of cancer among patients ever treated with anti-TNF agents was compared to that of patients not treated, by evaluating relative risks. The risk of developing cancer was not shown to increase with time post initiation of anti-TNF therapy (p=0.51), nor with duration of anti-TNF therapy (p=0.19) and it was shown to be independent of the type of anti-TNF agent received (p=0.99). Analysis for the risk of developing specific cancers is still ongoing.

Separate study shows the risk of mortality is the same with both etanercept (Enbrel) and DMARDs (LB0007)

In a further study, data from a large UK observational cohort were analysed to compare mortality rates of 3,431 (71.5%) patients treated with the anti-TNF etanercept and 1,365 (28.5%) treated with disease modifying anti-rheumatic drugs (DMARDs). Results showed that whilst crude mortality rates were lower in the etanercept group at 1.31% versus 2.27%, the difference did not reach statistical significance in the more conservative of the scenarios modelled.

Source:
Rory Berrie

European League Against Rheumatism



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Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care
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MediLexicon International Ltd © 2004-2011 All rights reserved.

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