The US Food and Drug Administration has approved Actemra (tocilizumab), a new option for people suffering from moderate to severe rheumatoid arthritis, which despite proven results also carries substantial side-effect risks.
In five clinical trials to test the effectiveness and safety of Actemra all patients treated with the drug experienced greater improvement in tender or swollen joints than patients treated with a placebo.
The recommended use of the drug, however, is limited to patients who have failed other approved therapies because of the serious safety concerns noted during studies.
The side-effects include elevated low-density lipoprotein (LDL) or bad cholesterol, respiratory tract infections, headaches, inflammation of the nose or nasal passages, high blood pressure and increased liver enzymes.
The FDA wants the manufacturer, Genentech, a division of Roche, to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra, specifically focusing on cardiovascular health risks.
A risk evaluation and mitigation strategy (REMS) will also require the drug sponsor to implement a communication plan for physicians, telling them how to appropriately monitor patients for liver and gastrointestinal side-effects.
