Worldwide, 3-year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis

Rheumatol Ther 2018 Jun; 5(1):283–91

This real-world analysis of tofacitinib (TOF) revealed that AEs reported by patients with RA from 2012 to 2015 were consistent with the known safety profile of TOF – no new safety risks were identified.As of August 2017, it is estimated that more than 102 000 patients worldwide have received TOF, but TOF safety has not been evaluated in patients with real-world experience. This analysis addressed this – by evaluating the safety of TOF from post-marketing surveillance (PMS) reports from patients with RA over a 3-year period. The analysis was completed after TOF received marketing authorisation in the United States in 2012. Data were reviewed from the worldwide TOF PMS data in the Pfizer safety database over a 3-year period. Worldwide exposure estimates were based on audited standard unit TOF sales from IMS Health’s multinational integrated data analysis system database. For each case report, the type and frequency of serious adverse events (SAEs) of interest were reviewed.25 417 AEs and 4 352 SAEs were reported from 2012 to 2015. For all AEs, the reporting rate was highest during the first year and, for most AEs, this decreased or stabilised over time. The most reported AEs included general, gastrointestinal and muscoskeletal disorders. The most reported SAEs included RA, condition aggravated pneumonia and arthropathy. Interestingly, 2 cases of histoplasmosis events were reported over the 3 years, but this AE has not been previously reported in TOF randomised controlled trials. After thorough analysis of patient AEs, the authors concluded that the types of AEs reported and the rate at which they were reported were consistent with the known TOF safety profile, which has been previously observed in randomised controlled trials.