The safety profiles of these trials were comparable to rheumatoid arthritis (RA) safety trials. The most serious adverse events in adult RA studies were serious infections and malignancies. In the PsA-II trial, the most common adverse events were bronchitis, nasopharyngitis and upper respiratory tract infections.
The Arthritis Advisory Committee of the FDA voted against recommending approval of sirukumab for the treatment of moderate to severe active RA in adults, … [citing] safety concerns.
Sirukumab Approval Stalls
On Aug. 2, the Arthritis Advisory Committee of the FDA voted against recommending approval of sirukumab for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to or are intolerant to one or more DMARDs.3 The committee cited safety concerns and voted 12–1 that the benefits of the treatment do not outweigh its risks.4
According to the innovator company, Johnson & Johnson, sirukumab is an anti-interleukin (IL)-6 monoclonal antibody, but it blocks the IL-6 pathway differently from other IL-6 inhibitors that are currently FDA approved for treating RA.
At the advisory committee meeting, the efficacy and safety data of sirukumab were reviewed. These data came from five Phase 3 clinical trials with more than 3,000 patients with RA, who include patients with active disease despite previous DMARD and biologic treatment. Doses used in the trials included 50 mg sirukumab every four weeks and 100 mg sirukumab every two weeks. The agent showed significant efficacy in improving the signs and symptoms of RA, inhibiting structural damage progression and showing improvements in measured patient-reported outcomes, such as fatigue, pain, physical function and quality of life.
During the trials, common adverse events included laboratory abnormalities, colds, upper respiratory tract infections and injection site redness, pain or swelling. Serious adverse events included infections, such as abscess, cellulitis, gastrointestinal perforations, hypersensitivity reactions, lipid level elevations, osteomyelitis, pneumonia, thrombocytopenia and sepsis. Cardiovascular adverse events, malignancies and deaths were also observed.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- U.S. Food and Drug Administration. Letter: Bristol Myers Squibb supplemental approval letter. 2017 Jun 30.
- Bristol-Myers Squibb Co. News release: Bristol-Myers Squibb’s Orencia (abatacept) receives FDA approval for treatment of active psoriatic arthritis (PsA) in adults. 2017 Jul 6.
- Johnson & Johnson Services Inc. News release: FDA advisory committee does not recommend approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. 2017 Aug 2.
- Barber J. FDA advisory panel votes against approval of Johnson & Johnson’s experimental RA drug, Plivensia. FirstWord Phrama. 2017 Aug 2.
