Association of Secukinumab Treatment With Tuberculosis Reactivation JAMA Dermatology

TAKE-HOME MESSAGE

• The authors reviewed data from 28 clinical trials that evaluated secukinumab use for up to 5 years in patients with psoriasis, psoriatic arthritis, and ankylosing spondylitis. The Novartis Secukinumab Compound Pool Database was utilized to identify 12,319 patients (8819 with psoriasis, 2523 with psoriatic arthritis, and 977 with ankylosing spondylitis) who received at least one dose of secukinumab (150 mg subcutaneous or 300 mg subcutaneous). In each of these trials, patients were screened for tuberculosis (TB), and those with active TB were excluded, whereas those with latent tuberculosis infection (LTBI) were treated as indicated by local treatment guidelines. Overall, 684 (5.6%) were positive for LTBI at screening and were treated appropriately prior to study enrollment. During the observation period for these trials, there were no active TB cases reported as an adverse event (AE). Thirteen patients (0.1%) were reported to have an AE of LTBI and of these, 6 were not considered new LTBI cases because they had a positive LTBI test or reported history of LTBI test during the screening period, whereas 7 were considered new LTBIs (4 with psoriasis, 1 with psoriatic arthritis, and 2 with ankylosing spondylitis). Discontinuation of secukinumab because of an LTBI AE was rare, with only 2 of these patients being permanently removed from their clinical trials (one of these was due to noncompliance).

• This qualitative study found that no active TB or LTBI activation was reported among 12,319 patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis receiving secukinumab treatment for up to 5 years. These findings are consistent with similar studies and illustrate no correlation between secukinumab therapy and an increased risk of active TB or LTBI reactivation in patients with prior LTBI.

– C. Alexis Noble, MD

Abstract 

IMPORTANCE

Approximately one-quarter of the global population have latent tuberculosis infection (LTBI), and tuberculosis (TB) is accountable for more than 1.5 million deaths annually. Methotrexate, cyclosporine, and tumor necrosis factor inhibitors may be associated with increased risk of TB and LTBI reactivation, although data are limited on the risks of TB with use of newer biologics.

OBJECTIVE

To assess the association of secukinumab with reporting of active TB development, TB reactivation, and LTBI activation as an adverse event (AE) in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis.

DESIGN, SETTING, AND PARTICIPANTS

This qualitative study pooled data from 28 clinical trials of secukinumab used in psoriasis (17 phase 3 or 3b and 2 phase 4 trials), psoriatic arthritis (5 phase 3 trials), and ankylosing spondylitis (4 phase 3 trials). A search of the Novartis Secukinumab Compound Pool Database was conducted for the 28 trials. All trial participants who had received at least 1 approved subcutaneous dose of secukinumab (150 mg or 300 mg) were included. Before randomization in these trials, patients underwent screening for TB. Patients with active TB were excluded, and patients with LTBI were treated according to local guidelines. Data were analyzed from the start of treatment in the individual studies through December 25, 2018.

MAIN OUTCOMES AND MEASURES

Reporting of active TB or LTBI as an AE over a 5-year period using exposure-adjusted incidence rates (EAIR; incidence rates per 100 patient-years).

RESULTS

A total of 12 319 patients were included, of whom 8819 patients had psoriasis (71.6%; 5930 men [67.2%]; mean [SD] age, of 44.9 [13.5] years), 2523 had psoriatic arthritis (20.5%; 1323 women [52.4%]; mean [SD] age, 48.8 [12.1] years), and 977 had ankylosing spondylitis (7.3%; 658 men [67.3%]; mean [SD] age, 42.3 [11.9] years). In the total population, 684 patients (5.6%) had tested positive for LTBI at screening. Over 5 years, LTBI as an AE during secukinumab treatment was reported in 13 patients (0.1% of 12 319). Of these 13 patients, 6 had a prior positive LTBI test result, and 7 were newly diagnosed as having LTBI. Four of the 7 patients had psoriasis (EAIR, 0.03; 95% CI, 0.01-0.07), 1 had psoriatic arthritis (EAIR, 0.02; 95% CI, 0.00-0.11), and 2 had ankylosing spondylitis (EAIR, 0.08; 95% CI, 0.01-0.28). No cases of active TB were reported.

CONCLUSIONS AND RELEVANCE

This study found that LTBI reported as an AE after secukinumab treatment was uncommon and appeared to support the use of secukinumab in chronic systemic inflammatory conditions.

JAMA Dermatology

Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis

JAMA Dermatol 2020 Sep 30;[EPub Ahead of Print], BE Elewski, JW Baddley, AA Deodhar, M Magrey, PA Rich, ER Soriano, J Soung, W Bao, D Keininger, K Marfo, M Patekar, A Sharma, A Shete, MG Lebwohl 

Sent from my iPhone

Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

Please excuse the shortness of this message, as it has been sent from
a mobile device.