GOLIMUMAB SAFETY ACCORDING TO CLINICAL FINDINGS

• Published in: Nauchno-prakticheskai͡a︡ revmatologii͡a Vol. 53; no. 2; pp. 200 - 204
• Main Authors: Lukina, G. V., Sigidin, Ya. A.
• Format: Journal Article
• Language: English; Russian
• Published: IMA PRESS LLC 29.04.2015
• Subjects: adverse events; rheumatic diseases; safety
• ISSN: 1995-4484; 1995-4492
• DOI: 10.14412/1995-4484-2015-200-204

The review analyzes trials dealing with the safety of golimumab (GLM)  used in rheumatology.  This drug was the latest Contact: Galina Lukina;gvl3@yandex.ru Поступила 12.05.14tumor necrosis factor α (TNF-α) inhibitor introduced  into clinical practice and therefore the estimation of its tolerability is particularly relevant. The data obtained in large-scale clinical trials suggest that GLM has a good safety profile. The most common  adverse events (AE) were infections, more often mild. The rate of infections was higher with the use of GLM 100 mg than with that of 50 mg. The overall cancer rate did not increase during a follow-up of less than 160 weeks. However, the rate of lymphomas in patients receiving GLM 100 mg proved to be higher than in those taking GLM 50 mg, in the general population, and in the placebo group in particular. AE were evenly distributed among patients with rheumatoid  arthritis, psoriatic arthritis, or ankylosing spondylitis. Overall, the findings are in agreement with the data on the safety of previously used TNF-α inhibitors. No fundamentally new AE have been encountered. It is necessary to accumulate  data on the use of GLM in real clinical practice, which will be able to more objectively define its place in the current therapy of rheumatic diseases.