Based on phase III data from a recent study, the FDA has expanded the indication for Actemra, the rheumatoid arthritis (RA) drug tocilizumab. The Actemra label now includes inhibition and slowing of structural joint damage and improvement of physical function in adult patients with moderately to severely active RA, when given in combination with methotrexate.
RA is a debilitating disease afflicting almost two million Americans.
The FDA decision follows on a study of 1,196 patients with moderate to severe RA and an inadequate response to methotrexate. Participants either received tocilizumab infusions every four weeks along with methotrexate, or just methotrexate in combination with placebo. After 12 months of treatment, those given tocilizumab showed significantly reduced progression of structural joint and bone damage.
ACSH's Dr. Gilbert Ross notes that this is part of a larger pattern of progress in RA therapy over the last 20 years. “Back in the old days,” he says, “RA patients were treated with either non-steroid anti-inflammatory drugs to relieve pain, or they were given steroids to treat the arthritis, even though the side effects were devastating. That’s why the discovery of effective immunomodulator therapies such as Humira, Remicade and Enbrel — all biotech drugs — were rightly hailed as near-miraculous.”