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Rheumatoid arthritis (RA) is a debilitating condition caused by inflammation of the joints, last year's NICE guidance quotes figures which show that about 400,000 people in the UK have RA with between 2 and 4 times more women than men being affected. In recent years a group of drugs known as 'biologics' have been developed which are designed to block key protein messenger proteins or cells which are the 'key drivers' of the inflammatory process. These drugs have demonstrated impressive results in slowing down inflammation and generally improving health. As they are expensive, biologics should only be prescribed when other treatments have failed.
Earlier this week, Arthritis Research and Therapy published a new study which appears to suggest that "real world" results for biologics are not as impressive as clinical trials would suggest. This North American study looked at the changes in health status and function of 18,485 adults with RA at six month intervals over a period of 11 years. 4,911 patients switched to biologic therapy during this period.
The study found that the onset of RA caused an "immediate and substantial" deterioration in physical health but did not affect mental health status. Study members were assessed using three internationally accepted methods for measuring physical health and one for measuring mental health. Surprisingly, the study found no significant difference between the mental health scores of those with RA and the general population- other smaller studies have suggested that the incidence of depression is higher in people with RA. After the immediate deterioration in physical health at the onset of RA, the rate of decline was found to be slow and in line with the rate experienced in the general population although it is important to remember that all these patients were receiving some kind of treatment throughout the 11 years.
With regard to biologic therapy, the study found that the improvement achieved over 10 years only slightly exceeded the minimal level of clinically important change. The findings also show an effect that is six times less than that shown in a recent meta-analysis of 3-year trials. The researchers point out that their results suggest that the use of biologics is much less cost-effective (by a factor of 5-10) than indicated by clinical trials.
This is at variance with the NICE guidance published last year which states that the addition of a biological drug alongside a disease modifying drug "adds significant benefits for symptom control, function and quality of life". NICE has also approved the use of some biological therapies if all other forms of treatment have failed to make a difference. This new study makes the point that clinical trials have assumed that initial improvements associated with biologics would continue whereas this data over eleven years shows that this isn't the case.
This study throws up some key questions, why is there such a big difference between the results of this large 'real world' study and other clinical trials? Do these findings mean that biological therapies are no longer cost-effective? Why isn't there continuous improvement with biologics? I am aware that many people feel that they have benefited from these new drugs and I wouldn't wish to detract from that but I am concerned that the strong evidence no longer looks very solid at all and that we may be paying a lot for not much gain.
John Armstrong. Benefitsnow Ltd. March 4th 2010.
