Malignancy risks associated with tofacitinib and biological drugs in rheumatoid arthritis

Primary tabs

Malignancy risks associated with tofacitinib and biological drugs in rheumatoid arthritis

The last decade has witnessed significant advances in treating rheumatoid arthritis (RA), especially for patients who do not respond to traditional disease-modifying anti-rheumatic drugs (DMARDs). The most important finding is the development of biologics, a class of drug. There is large number of biologics approved to treat RA, such as abatacept, abatacept, etanercept, golimumab, infliximab, rituximab, and tofacitinib. Among these tofacitinib is used to treat severe arthritis for those who do not respond to methotrexate.

Maneiro J R and colleagues conducted a study to do a comparative analysis of the risks of malignancies following biologic DMARDs (b-DMARDs) and tofacitinib in RA by randomized clinical trials (RCTs) and long-term extension studies (LTEs). The articles are present in Medline, Embase, Cochrane Library, and the Web of Science dated from 2000 to February 2015.

Articles meeting the following criteria were included in the study: (1) focuses on RCTs or LTEs in RA (2) treatment with b-DMARDs or tofacitinib (3) data on malignancies (4) a minimum follow-up of 12 weeks. Data included publication details, study design, the risk of bias, number and types of malignancies, patient characteristics and treatments.

Of 113 articles and one updated report of meta-analysis of overall malignancies (in RCTs) showed odds ratio (95% confidence intervals; CI) of 1.01 (0.72, 1.42) for all tumor necrosis factors (TNF) antagonists, 1.12 (0.33, 3.81) for abatacept, 0.54 (0.20, 1.50) for rituximab, 0.70 (0.20, 2.41) for tocilizumab, and 2.39 (0.50, 11.5) for tofacitinib. Network meta-analysis of overall malignancies showed odds ratio (95% predictive intervals) of 1.68 (0.18-5.92) for infliximab, 0.79 (0.44-1.40) for etanercept, 0.93 (0.43-2.03) for adalimumab, 0.87 (0.28-2.75) for certolizumab, 0.87 (0.39-1.95) for golimumab, 1.04 (0.32-3.32) for abatacept, 0.58 (0.21-1.56) for rituximab, 0.60 (0.16-2.28) for tocilizumab, and 1.15 (0.24-5.47) for tofacitinib. Marginal numerical differences in the incidence rate of solid and hematological malignancies and non-melanoma skin cancers appeared in LTEs.

Results showed that there was no increase in the risk of malignancy when RA was treated with b-DMARDs or tofacitinib in randomized clinical trials (RCT). Generalizability of the differences in the rate of specific malignancies encountered in LTEs requires continuous pharmacovigilance of real-world patients.


Seminars in Arthritis and Rheumatism.

Link to the source:

The original title of the article:

Risks of malignancies related to tofacitinib and biological drugs in rheumatoid arthritis: Systematic review, meta-analysis, and network meta-analysis


Jose Ramon Maneiro et al.

Log in or register to post comments