Drs. Hsia, Beutler, Doyle, Hsu, and Rahman and Mr. Xu own stock and/or stock options in Johnson & Johnson, of which Janssen Research & Development, LLC, is a subsidiary.
Comprehensive tuberculosis screening program in patients with inflammatory arthritides treated with golimumab, a human anti–tumor necrosis factor antibody, in Phase III clinical trials
Version of Record online: 30 JAN 2013
Copyright © 2013 by the American College of Rheumatology
Arthritis Care & Research
Volume 65, Issue 2, pages 309–313, February 2013
How to Cite
Hsia, E. C., Cush, J. J., Matteson, E. L., Beutler, A., Doyle, M. K., Hsu, B., Xu, S. and Rahman, M. U. (2013), Comprehensive tuberculosis screening program in patients with inflammatory arthritides treated with golimumab, a human anti–tumor necrosis factor antibody, in Phase III clinical trials. Arthritis Care Res, 65: 309–313. doi: 10.1002/acr.21788
- Issue online: 30 JAN 2013
- Version of Record online: 30 JAN 2013
- Accepted manuscript online: 10 JUL 2012 11:38AM EST
- Manuscript Accepted: 22 JUN 2012
- Manuscript Received: 7 FEB 2012
- Janssen Research & Development, LLC
- Merck (formerly Schering-Plough)
Reactivation of Mycobacterium tuberculosis infection is a major complication in patients treated with anti–tumor necrosis factor (anti-TNF) agents. We report on the 5 cases of active tuberculosis (TB) that developed in the Golimumab Phase III Program (3 with rheumatoid arthritis, 1 with psoriatic arthritis, and 1 with ankylosing spondylitis) through 1 year among 2,210 patients receiving golimumab.
Data from global studies were used for an in-depth evaluation of the 5 cases of TB through week 52. Integrated safety data were evaluated for potential hepatotoxicity in patients treated with anti-TB therapy.
No active TB developed among 317 patients receiving golimumab and treated for latent TB with isoniazid. Active TB occurred in 5 patients not treated with isoniazid by week 52 (in 2 patients by week 24); all of the patients had negative TB screening tests (per the local guidelines) and resided in countries with high background rates of TB. No deaths were due to TB. Across all of the groups (placebo and golimumab), alanine aminotransferase and aspartate aminotransferase elevations occurred in greater proportions of patients treated for latent TB infection versus not treated; elevations were largely mild (<3 times the upper limit of normal).
Comprehensive TB screening kept the number of active TB cases relatively low despite conducting the studies in TB-endemic regions. Treatment for latent TB infection appeared effective, since no patients treated for latent TB had TB reactivation. Concurrent treatment with golimumab and anti-TB medication was generally well tolerated. Clinicians should remain vigilant for development of active TB after initiation of TNF inhibitors, since prompt diagnosis and treatment can improve outcomes.