Secukinumab Not Associated With Tuberculosis

Researchers writing in JAMA Dermatology report that latent tuberculosis infection previously assumed to be an adverse event as a result of treatment with secukinumab, is actually uncommon in patients with chronic systemic inflammatory conditions.

The study, published on Sept. 30, is based on an analysis of 28 clinical trials of secukinumab for patients with psoriasis, psoriatic arthritis or ankylosing spondylitis. Ultimately, 12,319 patients were included in the analysis. No cases of active tuberculosis or latent tuberculosis infection activation were reported over the five years of this study.

"This qualitative study examined the reported active tuberculosis and latent tuberculosis infection in 12,319 patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis who were treated with secukinumab for up to five years. No active cases of tuberculosis were reported as an adverse event for any indication, which is consistent with findings in previous pooled analyses of patients with psoriasis who were treated with secukinumab," wrote researchers who were led by Boni E. Elewski, M.D., of the University of Alabama.

Approximately 1.5 million people in the world die from an tuberculosis infection each year. And, one-quarter of the global population has a latent tuberculosis infection. Methotrexate, cyclosporine, and tumor necrosis factor inhibitors may be associated with an increased risk of either a tuberculosis or latent tuberculosis infection.

In this study, 70 patients with psoriasis (0.8%) and 15 patients with psoriatic arthritis (0.6%), or less than 1%, had a history of active tuberculosis before the start of the study. This compares to 100 patients with ankylosing spondylitis (10.2%).

No cases of active tuberculosis were reported as an adverse event for any of the three indications during the course of the study. However, latent tuberculosis infection was identified as an adverse event in 13 (0.1%) of 12,319 patients (eight with psoriasis, three with psoriatic arthritis, and 2 with ankylosing spondylitis), seven of which were considered new latent infections. Among the remaining six patients in which a latent infection was not considered new, five had a positive latent infection test result at screening (four with psoriasis, and one with psoriatic arthritis).

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REFERENCE

Elewski BE, Baddley JW, Deodhar AA, et al. Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis. JAMA Dermatol. Published online September 30, 2020. doi:10.1001/jamadermatol.2020.3257