Malignancies Not Increased with Biologic Therapies Save

The risk of malignancy in rheumatoid arthritis (RA) patients receiving biologic agents was evaluated by metanalysis of randomized controlled trials (RCTs) and found no significant increased risk of malignancy compared with other disease-modifying antirheumatic drugs (DMARDs) or with placebo.

RCTs of at least 6 mos. duration that evaluated abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab in RA from inception through July 9, 2012 were included in this study. Biologics were compared to DMARDs or placebo and/or any traditional disease-modifying antirheumatic drugs with a minimum of 24 weeks of follow-up.

Data were derived from 63 RCTs (29 423 RA patients). Overall, 211 developed a malignancy (118 solid tumors, 48 skin cancers, 14 lymphomas, 5 hematologic nonlymphomas, and 26 not specified).  Malignancy incidence rates during the first year of therapy was low with: 

• Biologic plus methotrexate (0.77%; 95% CI, 0.65%-0.92%)
• Biologic monotherapy (0.64%; 95% CI, 0.42%-0.95%)
• Controls (0.66%; 95% CI, 0.52%-0.84%)

Anakinra plus methotrexate showed lower odds compared with methotrexate alone (Peto odds ratio, 0.11; 95% CI, 0.03-0.45). 

While there was no statistically significant risk for specific cancer sites, the odds ratio for lymphoma was 2.1 (95% CI, 0.55-8.4) in patients on TNF inhibitors compared with controls.