Comprehensive tuberculosis screening program in patients with inflammatory arthritides treated with golimumab, a human anti–tumor necrosis factor antibody, in Phase III clinical trials

Objective 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 ps...

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Bibliographic Details
Published in:Arthritis care & research (2010) 2013-02, Vol.65 (2), p.309-313
Main Authors: Hsia, Elizabeth C., Cush, John J., Matteson, Eric L., Beutler, Anna, Doyle, Mittie K., Hsu, Benjamin, Xu, Stephen, Rahman, Mahboob U.
Format: Article
Language:English
Subjects:
Adult
Aged
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - therapeutic use
Antitubercular Agents - therapeutic use
Arthritis - complications
Arthritis - drug therapy
Arthritis - microbiology
Chemical and Drug Induced Liver Injury - etiology
Female
Humans
Isoniazid - therapeutic use
Latent Tuberculosis - complications
Latent Tuberculosis - drug therapy
Male
Middle Aged
Mycobacterium tuberculosis
Recurrence
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Young Adult
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Summary:Objective 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. Methods 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. Results 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 (
ISSN:2151-464X
2151-4658
DOI:10.1002/acr.21788