This article is more than 5 years old. Information may no longer be current.
Tofacitinib for RA showed safety up to 8.5 years
Tofacitinib for the treatment of rheumatoid arthritis showed safety up to 8.5 years, according to results of a recently published study.
Stanley B. Cohen, at the University of Texas Southwestern Medical School and Rheumatology Associates in Dallas, and colleagues pooled tofacitinib data from two phase 1, nine phase 2, six phase 3 and two long-term extension studies of adults with active rheumatoid arthritis. In total, there were 6,194 patients and 19,406 patient-years of tofacitinib exposure in the analysis. The median exposure was 3.4 patient-years, and some patients had exposure up to 8.5 years.
Cohen, who is a HEALIO RHEUMATOLOGY board member, and colleagues found the incidence rate was 9.4 per 100 patient-years for serious adverse events; 2.7 per 100 patient-years for serious infections; 3.9 per 100 patient-years for herpes zoster; 0.3 per 100 patient-years for disseminated or multidermatomal herpes zoster; 0.3 per 100 patient-years for opportunistic infections besides tuberculosis; 0.2 per 100 patient-years for tuberculosis; 0.9 per 100 patient-years for malignancies besides non-melanoma skin cancer (NMSC); 0.6 per 100 patient-years for NMSC; and 0.1 for gastrointestinal perforations. In the 6-month interval analysis, there was no significant increase in incident rates with longer exposure to tofacitinib. – by Will Offit
Disclosure: Cohen reports he is a consultant for and receives speaker fees and honoraria from Pfizer.