Pooled analysis demonstrates favorable long-term safety profile of secukinumab
medwireNews: Analysis of data from 21 randomized controlled trials indicates that the interleukin-17A inhibitor secukinumab has a favorable long-term safety profile among patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS), or psoriasis.
The study included 1380 participants from three phase III trials of secukinumab in PsA, 794 participants from three phase III AS trials, and 5181 participants from 15 psoriasis trials (14 phase III and one phase IV). The maximum duration of follow-up in these trials was 5 years, 4 years, and 5 years, respectively, and the current study also included postmarketing data with estimated cumulative secukinumab exposure of 96,054 patient–years.
Atul Deodhar (Oregon Health & Science University, Portland, USA) and co-investigators report in Arthritis Research & Therapy that “secukinumab was associated with a generally low frequency of AEs [adverse events], with no discernible pattern regarding [serious] AEs across the treatment groups in all indications.” The most frequently occurring AE was upper respiratory tract infection, and the researchers say that exposure-adjusted incidence rates for serious infection, Candida infection, inflammatory bowel disease (IBD), and major adverse cardiovascular events were “were consistent with previous reports.”
Deodhar et al caution that IBD events were not adjudicated in their analysis, and the clinical trials “may not fully reflect real-world clinical experience.”
Nonetheless, they conclude that these “reassuring findings” provide “a broader understanding of the safety of secukinumab and [support] its long-term use in these chronic systemic inflammatory conditions.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
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