The risk for serious infection events (SIEs) in patients with rheumatoid arthritis (RA) using tofacitinib is comparable to risk rates of biologic disease-modifying antirheumatic drugs (bDMARDs) and the investigational drug baricitinib, according to a study presented at the Association of Women in Rheumatology National Conference, held in Hilton Head, South Carolina, from August 17 to 20, 2017.

Vibeke Strand, MD, FACP, and fellow researchers conducted an updated meta-analysis using systematic literature research and reviews of published randomized controlled trials and long-term extension studies to determine whether the risk for SIEs in patients with RA using tofacitinib, an oral Janus kinase (JAK) inhibitor for RA treatment, is comparable to several bDMARDs and baricitinib, a JAK inhibitor being investigated for RA treatment.

The researchers used 6 randomized controlled trials that included baricitinib in the updated analysis, whereas the original analysis used 70 randomized controlled trials and 18 long-term extension studies that met inclusion criteria for tofacitinib and bDMARDs. 

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The SIE incidence rates for baricitinib were 4.75 (95% CI, 2.32-9.74; I2=19%) for 2 mg and 3.67 (95% CI, 2.33-5.78; I2=36%) for 4 mg. The results further expressed that the risk ratios analysis for baricitinib (P =0.22 for 2 mg, 0.95 for 4 mg) and risk differences (P =0.41 for 2 mg, 1.00 for 4 mg) did not show significant differences from control for both 2 and 4 mg baricitinib.

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The researchers note that these values are consistent with analyses of tofacitinib and the selected bDMARDs. “The results from these meta-analyses suggest that the risk of SIEs (IRs, risk ratios, and risk differences) with tofacitinib is comparable with published rates for bDMARDs and baricitinib in patients with moderate to severe RA,” the researchers write.

Study Disclosures

The study was sponsored by Pfizer Inc. Several authors note that they are employees and stockholders of Pfizer Inc.           

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Strand V, Ahadieh S, DeMasi R, et al. Meta-analysis of serious infections with baricitinib, tofacitinib, and biologic DMARDs in rheumatoid arthritis. Presented at: Association of Women in Rheumatology National Conference; August 17-20, 2017; Hilton Head, SC.