The FDA has approved the use of tocilizumab (Actemra) for moderate-to-severe rheumatoid arthritis (RA) in adults who have not acheived adequate response from onther tumor necrosis factor antagonist (TNF) therapies.

The drug is the first interleukin-6 receptor-inhibiting monoclonal antibody to receive FDA approval in the treatment of RA. It can be used alone or in combination with methotrextae or other disease modifying anti-rheumatic drugs (DMARDS).

The FDA approval came after 5 multi-national phase III trials enrolling more than 4000 patients found that the drug, when used alone or in combination, significantly reduced signs and symptoms of RA compared with DMARDs treatment alone.

Serious adverse events to the drug included infections, gastrointestinal perforations, and hypersensitivity reactions. Common adverse effects included upper respiratory tract infections, headache, inflammation of the nose and throat, elevated blood pressure, and increased liver enzymes.

Tocilizumab (Actemra) is manufactured and marketed in the US by Genentech.