Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials
Cohen BS, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Shoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. - Ann Rheum Dis 2017;76:1253-1262. DOI 10.1136/annrheumdis-2016-210457
This analysis of exposure to tofacitinib, an oral JAKi for the treatment of RA, for up to 8.5 years allowed estimation of safety events with improved precision versus previous tofacitinib reports. Adverse events were generally stable over time; no new safety signals were observed compared with previous tofacitinib reports.
Data were collated into an integrated safety summary of tofacitinib in adult patients with active RA, and included data spanning the tofacitinib clinical programme: from 2 Phase 1, 9 Phase 2,
6 Phase 3, and 2 long-term extension studies.
In this analysis, 6194 patients received tofacitinib for a total 19 406 patient-years’ exposure; median exposure was 3.4 patient-years. Analysis of incidence rates (IR) for serious infections, Herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in
incidence rate with longer-duration tofacitinib exposure. This study provides long-term data to support the existing safety profile of tofacitinib.