Drug Therapy for Rheumatoid Arthritis in Adults
Comparative Adverse Effects of Biologic DMARDs (3 of 3)
The systematic review investigated adverse effects associated with biologic DMARDs in treatment of RA.
Studies present no consistent evidence of elevated risk of lymphoma or other cancer types associated with biologic DMARDs (relative to either oral DMARDs or placebo), and the actual risk to patients with RA is not clear (study durations range from 3 months to 5 years). Six observational studies (N = 70,377), 4 meta-analyses, and 1 Adverse Event Reporting System (AERS) data review provided evidence of low strength in support of this finding.
For biologics, the likelihood of withdrawals from trials, when compared with placebo or MTX, was:
- Overall, about half that of the MTX and placebo groups (41 RCTs, N = 18, 029)
- Due to adverse events, 1.4-fold more likely than with placebo or MTX (43 RCTs, N = 11,243)
- Due to lack of efficacy, about one-fifth (0.2x the rate) as likely as MTX or placebo (34 RCTs, N = 13,079)
The strength of evidence for all these findings is low.
DMARD = disease-modifying anti-rheumatic drug; MTX = methotrexate; RA = rheumatoid arthritis; RCT = randomized controlled trial
Keywords: rheumatoid arthritis | RA | DMARDs | disease-modifying | antirheumatic | anti-rheumatic | rheumatic | biologic DMARD | lymphoma | methotrexate
- Donahue KE, Jonas D, Hansen RA, et al. Drug Therapy for Rheumatoid Arthritis in Adults: An Update. Comparative Effectiveness Review No. 55 (Prepared by the RTI International–University of North Carolina Evidence-based Practice Center under Contract No. 290-2007-10056-I). Rockville, MD: Agency for Healthcare Research and Quality; April 2012. AHRQ Publication No. 12-EHC025-EF. Available at www.effectivehealthcare.ahrq.gov/dmardsra.cfm.
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