Secukinumab Does Not Increase Risk of TB Reactivation in Rheumatic Disease Patients

Human IgG1κ monoclonal antibody secukinumab used to treat patients with psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis was not associated with latent tuberculosis infection (LTBI) activation, according to a study.

An estimated 25% of the worldwide population has LTBI, the study authors noted, with T claiming more than 1.5 million lives each year. It has been suggested that certain rheumatic treatments including methotrexate, cyclosporine, and tumor necrosis factor inhibitors may elevate TB and LTBI reactivation risks. However, less is known about the correlation between newer biologics and these risks.

To learn more, the researchers of this study collected data from 28 clinical trials evaluating the use of secukinumab in PsO (n=17), PsA (n=5), and ankylosing spondylitis (n=4). For all 28 trials, they searched the Novartis Secukinumab Compound Pool Database. Eligible patients received at least one 150 mg or 300 mg secukinumab dose. TB screening was conducted before randomization, and any patients with active TB were eliminated from the study; patients with LTBI underwent local guideline-approved treatment. The primary outcome was active TB or LTBI as an adverse event (AE) related to treatment over a five-year period.

Final analysis encompassed 12,319 patients: 8,819 PsO patients (71.6%; 5,930 [67.2%] were male; mean [SD] age, 44.9 [13.5] years), 2.523 PsA patients (20.5%; 1,323 [52.4%] were female; mean [SD] age, 48.8 [12.1] years), and 977 ankylosing spondylitis patients (20.5%; 658 [67.3%] were male; mean [SD] age, 42.3 [11.9] years). Upon screening, 684 patients (5.6%) tested positive for LTBI; over a five-year period, LTBI emerged as a treatment-related AE in 13 patients (0.1% of the total population). Of the patients who presented LTBI, about half previously tested positive for LTBI (n=6), and the rest were receiving a new LTBI diagnosis (n=7). Of the new diagnosis patients, four had PsO, two had ankylosing spondylitis, and one had PsA. There were no reported cases of active TB.

The study was published in JAMA Dermatology.

“In this large, pooled qualitative study involving 12 319 patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis, spontaneously reported new LTBI during secukinumab treatment was rare. No cases of active TB or LTBI activation were reported,” the researchers concluded. “We believe this study provides a broader understanding of the safety of secukinumab and supports its long-term use in chronic systemic inflammatory conditions.”