08-Oct-2008
Rheumatoid arthritis: treatment should consider patients' perspective
Summary
Current treatments for rheumatoid arthritis (RA) are failing to control patients' pain adequately, and health care professionals are not fully addressing patients' concerns, new research suggests. At the recent Annual Congress of Rheumatology meeting (EULAR) in Paris this summer, findings of a study presented during a UCB-sponsored symposium highlighted a mismatch between perceptions of patients and professionals as to what constitutes effective management of RA
Last Updated: 27-Aug-2010
Rheumatologists who treat RA tend to monitor a patient’s response to treatment focussing on how many joints remain tender and swollen, and by the level of markers of active inflammatory disease in the circulation, Dr Peter Taylor of The Kennedy Institute of Rheumatology, at Imperial College London, explained. If these are reduced by treatment, patients should feel the benefit. However many patients experience insufficient improvement to make a difference to their everyday quality of life. They feel doctors are not sufficiently focussed on aspects of their illness that concern them most and which play a major role in their wellbeing. Residual pain despite treatment, disturbed sleep, fatigue and depression do not always abate in line with markers of suppressed inflammation, he noted. The result is that patients’ ability to work, or to be productive whilst at work, or to carry out household chores, suffers.
“Suppression of synovitis in RA suggests to us a good outcome,” he remarked; “but this is a physician-centric view that is really begging the question. How does this really measure up to what is a good outcome from the patient’s viewpoint?” Patients’ concerns are centred on controlling day-to-day pain, reducing fluctuations in physical mobility, addressing low energy, stopping worsening swelling and increasing stiffness, and in overcoming restrictions on daily life, he stressed.
Some health care teams are now gathering the evidence to support patients’ views of what really matters when evaluating the impact of drug treatments. Trials are now being designed from a more patient-focussed perspective and are turning towards assessing the impact of disease on the whole person. Studies designed with the input of patients themselves, are now examining ways of assessing the effects of treatments holistically and new instruments are being devised to measure aspects of life affected by RA but previously overlooked by researchers.
DESIGN looks at RA from the patient angle
One such study that set out to answer the question of what really matters to patients, is the DESIGN study. This has been devised with the help of patients’ input to get a better patient perspective on the full impact of RA. The study, which is running in parallel in both the USA and Europe, also set out to examine patients’ claims that RA patients on current standard treatment continue to experience unacceptable levels of pain.
The European arm of the study was conducted with 756 RA patients, who had received treatment from a rheumatologist for at least the past 12 months, and 501 rheumatologists. It interviewed patients about disease-specific topics, rheumatologist visits, and RA medication, and quizzed rheumatologists on their clinical practice, their patients’ disease status, their approach to therapy and patient relationships.
“We found that inadequately controlled pain emerged as THE major issue,” Dr Taylor told health professionals attending EULAR. “For 83 per cent of patients it was the main reason behind unscheduled visits made to their rheumatologist. What’s more there was a high and significant correlation between pain as perceived by patients and other areas such as fatigue, walking ability, hand function and mobility,” he added. Only 12 per cent of patients interviewed were satisfied with their pain control over the past 30 days while 34 per cent said they were very dissatisfied. Almost a third of patients expressed strong fears for the future, anticipating a life filled with pain, and 37 per cent worried their medication would not control pain adequately over time. Almost twice as many patients were dissatisfied about control of fatigue as were satisfied (28 vs 15 per cent) and there was a strong correlation between pain severity and use of anti-depressants.
“There really is an unmet need for adequate pain control in RA,” Dr Taylor concluded. And uncontrolled pain impacts on other areas of health such as fatigue, mood, and ability to function well at work. Patients who were taking biologic treatments for RA reported greater satisfaction with pain control, he noted. Reduction in pain was cited as the chief reason for liking anti-TNF biologic treatments along with improved quality of life overall; but currently available biologics were still failing up to 40 per cent of patients, he pointed out.
There is hope that the next generation of biologic drugs will offer greater benefits. In the randomised double-blind RAPID 1 and 2 studies investigating a new anti-TNF alpha drug, Cimzia (certolizumab pegol), added to methotrexate (MTX), compared to MTX and placebo, there was very significant pain relief with both doses tested, starting as early as week one, and significant reductions in fatigue also, he observed. “Pain relief as assessed by patients is a key measure of treatment success that should be factored into clinical trials. We also need better tools to look at how treatments affect functionality, mobility and social and emotional aspects of patients’ experience.”
Evaluating treatment effects on work inside and outside the home
Professor Johanna Mieke Hazes of the University Medical Centre, Rotterdam, The Netherlands, also suggested health care teams should focus as much, if not more so, on keeping patients functioning well in their daily work as in monitoring structural damage to joint tissues. Another aspect of treatment evaluated by the RAPID 1 and 2 studies was to assess how treatment affected RA patients’ performance at work, she explained. This was carried out using the RA-specific Work Productivity Survey, a novel validated questionnaire that estimates the extent to which RA has limited a patient’s productivity in work outside the home, in household work, and in social activities over the past month. It reflects both absenteeism when patients feel too ill and incapacitated to go to work at all and “presenteeism” where they attend work but are unable to function as productively as normal.
Results of the questionnaire survey as applied in RAPID 1 and 2 showed patients who received Cimzia and MTX gained at least one extra paid work day per month by week 4 and that this increased to up to 3 extra days by week 24. In RAPID 1 these gains were sustained for the 52 weeks of the study. Results for patients receiving placebo and MTX showed less than 2 extra days were gained by week 4 and only half a day by week 24.
In terms of household work, patients receiving Cimzia and MTX gained an extra 11 days of productive activity over a three-month period. They gained between 1 and 2.7 per month by week 4 and more than 4 days per month by week 24 compared to less than 1.5 extra days of productivity by week 24 gained by placebo and MTX-treated patients. “Considering that most RA patients are women and that 60 per cent are not in paid employment, this is an important measure of the difference treatment makes to what they can do at home,” Professor Hazes commented.
Patients were asked to rate the extent to which RA interfered with their productivity at home on a scale of 1 to 10 at the start and finish of the RAPID studies. Patients who received the new treatment saw their score improved by up to 2.6 points compared to patients receiving placebo and MTX who saw improvement rated between 0.2 and 0.6 of a point.
Robert Johnson, an RA sufferer of over 50 years and immediate past president of the patients’ organisation PARE (Patients with Arthritis and Rheumatism in Europe) commented: “This is the first time in attending rheumatology meetings when I feel my experience as a patient has been honoured and respected. Patients would like to see more opportunities where patients can work together with physicians, not just in their own care, but in planning future studies such as these.“
“By influencing research we can gather the information that’s really relevant and take the findings into arenas where perhaps our voices speak louder,” he suggested. “Patient groups like PARE represent millions of voters in Europe with arthritis and when we show evidence of a need for earlier diagnosis, rapid intervention and better medications, politicians will listen,” he believes. It is not just provision of effective new medical treatments that matter although that is a priority, he adds, but also improvements in the accessibility of workplaces, of flexible arrangements to allow people with RA to travel on public transport at less crowded times, and other measures that make it less challenging for RA patients to play as full a part in community life as they would wish. “Working together, physicians, nurses and patients can be more effective in reaching our goals.”
“Suppression of synovitis in RA suggests to us a good outcome,” he remarked; “but this is a physician-centric view that is really begging the question. How does this really measure up to what is a good outcome from the patient’s viewpoint?” Patients’ concerns are centred on controlling day-to-day pain, reducing fluctuations in physical mobility, addressing low energy, stopping worsening swelling and increasing stiffness, and in overcoming restrictions on daily life, he stressed.
Some health care teams are now gathering the evidence to support patients’ views of what really matters when evaluating the impact of drug treatments. Trials are now being designed from a more patient-focussed perspective and are turning towards assessing the impact of disease on the whole person. Studies designed with the input of patients themselves, are now examining ways of assessing the effects of treatments holistically and new instruments are being devised to measure aspects of life affected by RA but previously overlooked by researchers.
DESIGN looks at RA from the patient angle
One such study that set out to answer the question of what really matters to patients, is the DESIGN study. This has been devised with the help of patients’ input to get a better patient perspective on the full impact of RA. The study, which is running in parallel in both the USA and Europe, also set out to examine patients’ claims that RA patients on current standard treatment continue to experience unacceptable levels of pain.
The European arm of the study was conducted with 756 RA patients, who had received treatment from a rheumatologist for at least the past 12 months, and 501 rheumatologists. It interviewed patients about disease-specific topics, rheumatologist visits, and RA medication, and quizzed rheumatologists on their clinical practice, their patients’ disease status, their approach to therapy and patient relationships.
“We found that inadequately controlled pain emerged as THE major issue,” Dr Taylor told health professionals attending EULAR. “For 83 per cent of patients it was the main reason behind unscheduled visits made to their rheumatologist. What’s more there was a high and significant correlation between pain as perceived by patients and other areas such as fatigue, walking ability, hand function and mobility,” he added. Only 12 per cent of patients interviewed were satisfied with their pain control over the past 30 days while 34 per cent said they were very dissatisfied. Almost a third of patients expressed strong fears for the future, anticipating a life filled with pain, and 37 per cent worried their medication would not control pain adequately over time. Almost twice as many patients were dissatisfied about control of fatigue as were satisfied (28 vs 15 per cent) and there was a strong correlation between pain severity and use of anti-depressants.
“There really is an unmet need for adequate pain control in RA,” Dr Taylor concluded. And uncontrolled pain impacts on other areas of health such as fatigue, mood, and ability to function well at work. Patients who were taking biologic treatments for RA reported greater satisfaction with pain control, he noted. Reduction in pain was cited as the chief reason for liking anti-TNF biologic treatments along with improved quality of life overall; but currently available biologics were still failing up to 40 per cent of patients, he pointed out.
There is hope that the next generation of biologic drugs will offer greater benefits. In the randomised double-blind RAPID 1 and 2 studies investigating a new anti-TNF alpha drug, Cimzia (certolizumab pegol), added to methotrexate (MTX), compared to MTX and placebo, there was very significant pain relief with both doses tested, starting as early as week one, and significant reductions in fatigue also, he observed. “Pain relief as assessed by patients is a key measure of treatment success that should be factored into clinical trials. We also need better tools to look at how treatments affect functionality, mobility and social and emotional aspects of patients’ experience.”
Evaluating treatment effects on work inside and outside the home
Professor Johanna Mieke Hazes of the University Medical Centre, Rotterdam, The Netherlands, also suggested health care teams should focus as much, if not more so, on keeping patients functioning well in their daily work as in monitoring structural damage to joint tissues. Another aspect of treatment evaluated by the RAPID 1 and 2 studies was to assess how treatment affected RA patients’ performance at work, she explained. This was carried out using the RA-specific Work Productivity Survey, a novel validated questionnaire that estimates the extent to which RA has limited a patient’s productivity in work outside the home, in household work, and in social activities over the past month. It reflects both absenteeism when patients feel too ill and incapacitated to go to work at all and “presenteeism” where they attend work but are unable to function as productively as normal.
Results of the questionnaire survey as applied in RAPID 1 and 2 showed patients who received Cimzia and MTX gained at least one extra paid work day per month by week 4 and that this increased to up to 3 extra days by week 24. In RAPID 1 these gains were sustained for the 52 weeks of the study. Results for patients receiving placebo and MTX showed less than 2 extra days were gained by week 4 and only half a day by week 24.
In terms of household work, patients receiving Cimzia and MTX gained an extra 11 days of productive activity over a three-month period. They gained between 1 and 2.7 per month by week 4 and more than 4 days per month by week 24 compared to less than 1.5 extra days of productivity by week 24 gained by placebo and MTX-treated patients. “Considering that most RA patients are women and that 60 per cent are not in paid employment, this is an important measure of the difference treatment makes to what they can do at home,” Professor Hazes commented.
Patients were asked to rate the extent to which RA interfered with their productivity at home on a scale of 1 to 10 at the start and finish of the RAPID studies. Patients who received the new treatment saw their score improved by up to 2.6 points compared to patients receiving placebo and MTX who saw improvement rated between 0.2 and 0.6 of a point.
Robert Johnson, an RA sufferer of over 50 years and immediate past president of the patients’ organisation PARE (Patients with Arthritis and Rheumatism in Europe) commented: “This is the first time in attending rheumatology meetings when I feel my experience as a patient has been honoured and respected. Patients would like to see more opportunities where patients can work together with physicians, not just in their own care, but in planning future studies such as these.“
“By influencing research we can gather the information that’s really relevant and take the findings into arenas where perhaps our voices speak louder,” he suggested. “Patient groups like PARE represent millions of voters in Europe with arthritis and when we show evidence of a need for earlier diagnosis, rapid intervention and better medications, politicians will listen,” he believes. It is not just provision of effective new medical treatments that matter although that is a priority, he adds, but also improvements in the accessibility of workplaces, of flexible arrangements to allow people with RA to travel on public transport at less crowded times, and other measures that make it less challenging for RA patients to play as full a part in community life as they would wish. “Working together, physicians, nurses and patients can be more effective in reaching our goals.”
