Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jan 1;157(1):43-51.
doi: 10.1001/jamadermatol.2020.3257.

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

Boni E Elewski  1 , John W Baddley  2 , Atul A Deodhar  3 , Marina Magrey  4 , Phoebe A Rich  5 , Enrique R Soriano  6 , Jennifer Soung  7 , Weibin Bao  8 , Dorothy Keininger  9 , Kwaku Marfo  9 , Manmath Patekar  9 , Abhishek Sharma  10 , Abhijit Shete  9 , Mark Gabriel Lebwohl  11
Affiliations

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

Boni E Elewski et al. JAMA Dermatol. .

Erratum in

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 pooled cohort 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Elewski reported receiving grants and personal fees from Novartis Pharma during the conduct of the study; grants from Pfizer, Eli Lilly, Merck, AbbVie, and Sun; and grants and personal fees from Amgen, Janssen, and Ortho Dermatologics outside the submitted work, and serving as a consultant to Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Leo, Eli Lilly, Menlo, Novartis Pharma, Pfizer, Sun, Valeant, Verrica, Ortho Dermatologics, and Arcutis. Dr. Baddley reported serving as a consultant (DSMB adjudication committee) for Pfizer, Eli Lilly, R-Pharm, and Viela Bio. Dr Deodhar reported receiving grants, personal fees, and nonfinancial support from Novartis Pharma during the conduct of the study, Amgen, Eli Lilly, GSK, Pfizer, and UCB outside the submitted work; personal fees from Celgene; and personal fees and nonfinancial support from Boeheringer Ingelheim, Gilead, and Janssen. Dr Magrey reported receiving personal fees from Novartis Pharma, Eli Lilly, Janssen, Pfizer, and UCB outside the submitted work, and involvement in clinical trials with AbbVie and Amgen. Dr Rich reported receiving grants from Novartis Pharma, Boehringer Ingelheim, Eli Lilly, Janssen-Ortho, Sun Pharma, UCB, Bristol Myers Squibb, and Pfizer during the conduct of the study and grants from Galderma, Moberg, and Kadmon outside the submitted work. Dr Soriano reported receiving grants and personal fees from AbbVie, Janssen, Novartis Pharma, Pfizer, Roche, and UCB outside the submitted work, and personal fees from Eli Lilly, Amgen, Bristol Myers Squibb, and Sanofi. Dr Soung reported receiving nonfinancial support from Novartis Pharma during the conduct of the study; personal fees from Celgene, Amgen, National Psoriasis Foundation, and Regeneron; grants and personal fees from Eli Lilly, AbbVie, Actelion, Leo Pharma, Dermira, UCB, Janssen, and Novartis Pharma outside the submitted work; grants from Pfizer, Galderma, and Cassiopeia; grants, personal fees, and nonfinancial support from Ortho Dermatologics and Dermavant; and grants and nonfinancial support from Boeringher Ingelheim. Mr Bao reported that his wife is an employee of and has stock in Novartis Pharma outside the submitted work. Ms Keininger reported being an employee and holding stock in Novartis Pharma. Drs Marfo, Patekar, and Sharma reported being employees of Novartis Pharma. Dr Shete reported being an employee and holding stock in Novartis Pharma.

References

    1. World Health Organization . Global Tuberculosis Report 2019. World Health Organization; 2019.
    1. Chee CBE, Reves R, Zhang Y, Belknap R. Latent tuberculosis infection: opportunities and challenges. Respirology. 2018;23(10):893-900. doi:10.1111/resp.13346 - DOI - PubMed
    1. Houben RM, Dodd PJ. The global burden of latent tuberculosis infection: a re-estimation using mathematical modelling. PLoS Med. 2016;13(10):e1002152. doi:10.1371/journal.pmed.1002152 - DOI - PMC - PubMed
    1. Snast I, Bercovici E, Solomon-Cohen E, et al. . Active tuberculosis in patients with psoriasis receiving biologic therapy: a systematic review. Am J Clin Dermatol. 2019;20(4):483-491. doi:10.1007/s40257-019-00432-y - DOI - PubMed
    1. Sartori N, Andrade N, Chakr R. AB1231 Incidence of tuberculosis with rheumatic diseases using TNF inhibitors: a systematic review. Ann Rheum Dis. 2019;78(suppl 2):2077-2078. doi:10.1136/annrheumdis-2019-eular.7921 - DOI

Publication types

MeSH terms