(ChemotherapyAdvisor) – Among patients with rheumatoid arthritis (RA) included in randomized clinical trials (RCTs) followed for at least 6 months, use of biologic response modifiers (BRMs) did not increase risk of malignancy vs other disease-modifying antirheumatic drugs or placebo, investigators reported in the September 5 issue of JAMA.
“To our knowledge, this is the largest systematic review and meta-analysis examining the risk of malignancy in patients with RA receiving BRMs in RCTs,” Maria E. Suarez-Almazor, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, TX, and colleagues wrote.
They assessed this risk by conducting a meta-analysis of 63 RCTs with 29,423 patients that compared the safety of any BRMs used with placebo or traditional disease-modifying antirheumatic drugs with a minimum follow-up of 24 weeks. Included were RCTs that evaluated abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab.
“No statistically significant increased risk of developing malignancy was observed,” Dr. Suarez-Almazor stated. “Of the 29,423 patients, 211 developed a malignancy during the trial (118 solid tumors, 48 skin cancers, 14 lymphomas, 5 hematologic nonlymphomas, and 26 not specified).”
During the first year of therapy, incidence rate for any malignancy was very low in three groups: BRM plus methotrexate (0.77%; 95% CI, 0.65%–0.92%); BRM monotherapy (0.64%; 95% CI, 0.42%–0.95%), and controls (0.66%; 95% CI, 0.52%–0.84%). Compared with methotrexate alone, anakinra plus methotrexate showed lower odds (Peto odds ratio, 0.11; 95% CI, 0.03–0.45). Although no statistically significant risk was observed for specific cancer sites, the Peto odds ratio for lymphoma was 2.1 (95% CI, 0.55–8.4) in patients who received tumor necrosis factor inhibitors vs controls.
“Although the findings suggest that BRMs may be generally safe with respect to risk of malignancy in the short term, the risk of recurrence in patients with RA with history of cancer or cancer risk factors remains unknown,” they concluded.