I've discussed Actemra often in this blog, and once again it has been in the news: the British medical journal The Lancet earlier this month published two studies that showed its effectiveness in the treatment of rheumatoid arthritis and juvenile rheumatoid arthritis. Actemra, for those of you who may not yet know, is a drug that is currently being considered by the FDA for use in Rheumatoid Arthritis.
The results from the so-called OPTION trial were from a major Phase III international study. This study found that Actemra improved not only symptoms but also quality of life when compared to methotrexate.
The OPTION study was designed so that study subjects received either Actemra plus methotrexate OR placebo plus methotrexate. The study was conducted in 17 countries outside the United States. More than half the patients treated with Actemra -- 58.5% -- of achieved a 20% reduction in rheumatoid arthritis symptoms compared to just 26.5% who were taking the placebo plus methotrexate; and almost 44% of patients treated with Actemra plus methotrexate reached at least a 50% reduction in symptoms compared to 10.8% of patients receiving placebo plus methotrexate
In addition, patients receiving Actemra achieved greater improvement in things such as fatigue and mental function.
Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. It has been studied in five Phase III trials. At this time, four of the trials (including the one described in this blog) have been completed and have met their primary goals in improving rheumatoid arthritis.
The fifth and final trial, the LITHE trial, is a two year trial; but it is expected to report preliminary first-year data later this year.
Possible Actemra side effects
So far, the drug has been well-tolerated in rheumatoid arthritis. The most common adverse events reported have included upper respiratory tract infection, nasopharyngitis, headache and high blood pressure. More serious side effects have included more serious infections and severe allergic reactions. Increases in liver function tests were seen in a number of patients, but these were generally mild and not permanent.
As most rheumatoid arthritis patients know, it is always important to have a variety of treatment options available. Actemra may be an effective and new approach to help rheumatoid arthritis patients who are suffering despite the use of good medications such as methotrexate.