Patient Safety, TB Risk Not Compromised by Secukinumab Use

Secukinumab (Cosentyx) is not associated with increased risk of tuberculosis (TB) reactivation and is supported for use in treating psoriasis and other chronic systemic inflammatory conditions, according to a study in JAMA Dermatology.

TB is rare in the United States, with 8916 cases in 2019 representing a 90% decrease from when tracking began in 1953; the incidence rate of 2.7 cases per 100,000 persons represents a 95% decrease, according to the CDC. However, TB remains a major global threat: about 1 in 4 individuals across the world have latent tuberculosis infection (LTBI), and TB causes more than 1.5 million deaths per year.

Despite this, methotrexate, cyclosporine, and tumor necrosis factor (TNF) inhibitors—all used to treat chronic systemic inflammatory conditions—are associated with increased risk of TB and LTBI activation. This led the authors to conduct a pooled cohort study examining the association of secukinumab treatment with TB reactivation in patients with moderate to severe psoriasis, active psoriatic arthritis, or active ankylosing spondylitis.

The study involved 12,319 patients with 1 of the 3 conditions. The analysis included 5-year data from 28 phase 3 and 4 clinical trials. Approximately 70% of the total study population was from the World Health Organization (WHO) region of Europe, and 20% were from the WHO region of the Americas.

No cases of active TB were reported as an adverse event for any of the conditions. LTBI was identified in only 13 patients (0.1%) overall: 8 with psoriasis, 3 with psoriatic arthritis, and 2 with ankylosing spondylitis. Seven of the 13 cases were considered new LTBI.

All trial participants received at least 1 subcutaneous dose of secukinumab (150 or 350 mg). Patients with active TB were excluded, and patients with LTBI were treated under local guidelines.

The authors focused on the continuing need to detect and treat LTBI in at-risk populations to reduce the number of active TB cases. About 23% of the global population, or 1.7 billion, is estimated to have LTBI. Although only a small proportion of those with Mycobacterium tuberculosis end up developing active TB, and most show no clinical signs of the disease, a majority of cases of active TB are associated with the development of LTBI.

Due to the increased risk of TB or LTBI activation, guidelines have been created to manage patients starting anti-TNF therapy. Other treatments, such as interleukin (IL)-12/23 or IL-17, appear to have lower risk, but data on long-term use are limited. In addition, the role of IL-17 has been controversial due to safety concerns related to TB and LTBI.

References

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. 2021;157(1):43-51. Published online September 30, 2020. doi:10.1001/jamadermatol.2020.3257