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Post-Approval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States–Based Rheumatoid Arthritis Registry

Kremer JM, Bingham CO 3rd, Cappelli LC, Greenberg JD, Madsen AM, Geier J, Rivas JL, Onofrei AM, Barr CJ, Pappas DA, Litman HJ, Dandreo KJ, Shapiro AB, Connell CA, Kavanaugh A. - ACR Open Rheumatol. 2021 Feb 11.

Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.

Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively throughout.

Results of the analysis (on data collected between 2012 and 2018) provide evidence that the risk of MACE, SIEs, malignancies and death are comparable in US patients with RA receiving tofacitinib, versus those receiving bDMARDs. Numerically incidence of VTE were also similar.

Consistent with the known safety profile of tofacitinib, initiators of tofacitinib had a higher rate of HZ than the comparators.

Overall, by putting tofacitinib data into context with bDMARDs, these real-world data will help to inform and reinforce existing safety data for the therapy.

Keywords: JAK, Tofacitinib, Clinical

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Upload date: March 2021

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