Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A, has demonstrated efficacy, short-term safety, rapid onset of action, and sustained responses in patients with moderate to severe plaque psoriasis or psoriatic arthritis (PsA).
Among research findings presented on Sunday, the first full day of the 2017 annual meeting of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP), a group of authors demonstrated the treatment’s longer-term safety in patients with the chronic conditions.
Philip J. Mease, MD, of the Swedish Medical Center and University of Washington, Seattle, and co-authors presented an abstract titled “Secukinumab Demonstrates Consistent Safety Over Long-Term Exposure in Patients with Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses.”
The researchers examined safety data from nine phase III clinical trials of secukinumab in moderate to severe psoriasis and three phase III clinical trials of secukinumab in PsA. Consistent with previous reports, the researchers found a comparable and favorable safety profile, supporting the long-term use of secukinumab for the treatment of chronic psoriasis and PsA.
The pooled studies included samples of 3,893 and 1,380 patients from psoriasis and PsA studies, representing exposure of 7,769.0 and 2,841.3 patient years, respectively. Doses differed among studies; secukinumab was delivered intravenously (up to 10 mg/kg) or via subcutaneous loading dose (75–300 mg) followed by subcutaneous maintenance dose (300, 150, or 75 mg). Patients originally receiving placebo were re-randomized to secukinumab at 12–24 weeks depending on study design.
The researchers adjusted for differences in treatment exposure by calculating exposure-adjusted incident rates, and their analyses included all patients who received at least one dose of secukinumab.
In both psoriasis and PsA, the most frequently reported adverse events with secukinumab were nasopharyngitis, headache, non-serious infections of the upper respiratory tract, and arthralgia. The exposure-adjusted incident rates of adverse events of particular interest with secukinumab (including serious infection, Candida infection, inflammatory bowel disease, and major adverse cardiac events) were similar in both psoriasis and PsA indications, and they were comparable to those reported previously. No cases of tuberculosis were reported.
The authors concluded that secukinumab is safe for long-term use to treat chronic psoriasis or PsA.