medwireNews: Latent tuberculosis infection (LTBI) is uncommon among people receiving secukinumab for psoriasis, psoriatic arthritis, or ankylosing spondylitis, shows a pooled analysis of clinical trial data.
Writing in JAMA Dermatology, Boni Elewski (University of Alabama at Birmingham, USA) and co-authors say their findings “provide a broader understanding of the safety of secukinumab and appear to support its long-term use in chronic systemic inflammatory conditions.”
The researchers explain that methotrexate, cyclosporine, and tumor necrosis factor inhibitors have been associated with an increased risk for TB and LTBI reactivation. They say the risk with biologic treatment targeting other pathways, such as interleukin (IL)-12/23 or IL-17, may be lower, but data are limited.
To address this, Elewski and team conducted a pooled analysis of data from 28 clinical trials among 12,319 participants with psoriasis (71.6%), psoriatic arthritis (20.5%), or ankylosing spondylitis (7.9%) who received at least one subcutaneous dose of the IL-17A inhibitor secukinumab 150 mg or 300 mg.
Of these, 684 (5.6%) tested positive for LTBI at baseline screening and were treated according to local guidelines. Individuals with active TB were not eligible to participate in the trials.
Among the adverse events (AEs) reported during the 5-year observation period, there were no cases of active TB, but 13 (0.1%) patients had LTBI of which seven were considered new LTBI.
All seven cases of newly diagnosed LTBI were among men (mean age 51 years), four of whom had psoriasis, one had psoriatic arthritis, and two had ankylosing spondylitis, giving exposure-adjusted incidence rates of 0.03, 0.02, and 0.08 per 100 person–years, respectively.
Elewski et al conclude that their findings “are consistent with those of other studies, demonstrating that secukinumab is not associated with an increased risk of active TB or TB reactivation in patients with a history of LTBI.”
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