UPDATE ON BIOLOGICAL AGENTS FOR RHEUMATOID ARTHRITIS FROM THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) ANNUAL MEETING, 2008
I recently wrote a blog hailing the oral "small molecules" for the treatment of rheumatoid arthritis. But I certainly have not forgotten that the biologics are the most effective agents currently available to rheumatologists. Nor have I forgotten that there are many biologics in the pipeline, some of them about to splash onto the market very soon.
Cimzia is the first PEGylated anti-TNF (tumor necrosis factor) agent. Two-year data presented at this year's ACR meeting showed rapid, sustained and significant improvements in both physical function and pain when added to background methotrexate therapy. Other data has shown that Cimzia inhibits progression of joint damage due to rheumatoid arthritis, with sustained results for up to one year. In fact, it was shown that the combination of Cimzia and methotrexate had a rapid and significant effect in improving active rheumatoid arthritis as early as the first week of treatment; signs of preventing long-term structural damage to joints were noted by week 16 of the combination treatment.
It was concluded that Cimzia is the first anti-TNF agent to demonstrate such an early impact on disease progression.
The most commonly reported serious adverse reactions including infections and malignancies. The most commonly reported side effects were headache, nasopharyngitis, and upper respiratory infections. Injection site burning and stinging was rare. Few patients taking Cimzia had to discontinue the drug due to side effects; in general, it was well-tolerated.
Actemra continues to look interesting. This interleukin-6 inhibitor was found in a clinical trial presented at the meeting to slow structural joint damage by 85% after one year when combined with methotrexate, compared to the 67% figure noted when methotrexate was used as the sole treatment. Actemra was also shown to improve physical function, and enabled 47% of patients to achieve clinical remission, compared to an 8% remission rate found when patients take only methotrexate.
Rheumatoid arthritis is currently an incurable disease. Therefore, the ultimate goal is remission. The clinical remission numbers (47%) are truly exciting.
Rheumatologists are anxiously awaiting Actemra to make its market debut. (In September, the FDA delayed Actemra's release pending submission of extra product manufacturing and product label information by the drug manufacturer, Roche Holding AG.)
Finally, an update on Rituxan. Results of a trial involving 2,578 patients were presented, showing that the number of rheumatoid arthritis patients achieving clinical remission doubled over three successive courses of Rituxan when used in combination with methotrexate. (Only 8.8% achieved clinical remission if methotrexate was the sole treatment.)
The study also found that approximately twice as many rheumatoid arthritis patients achieved a 70% improvement in their symptoms after the third course of Rituxan compared to the first course of Rituxan. In addition, progression of joint damage over a period of two years was found to be significantly reduced.
This B cell-targeting biologic continues to impress.
There were many other presentations, including talks about the continued long-term safety and benefit of Enbrel, Humira, and Remicade. I did not include these here because the data simply confirmed what many rheumatologists and patients already know: These continue to be excellent treatments for rheumatoid arthritis.
Whether the newer biologics are superior to what we have been using for many years remains to be seen. For the time being, as it is well known that no drug is perfect for all patients, my philosophy is: The more biologics, the merrier.
Published On: November 17, 2008