Publications

Results are reported from an analysis exploring the safety and efficacy of open-label tofacitinib (TOF) following blinded treatment with TOF or adalimumab (ADA) in patients with moderate to severe RA. The analysis included patients from ORAL Sequel, an open-label long-term extension study, which all patients entered following ORAL Standard (one of the studies in the TOF phase 3 program). Only those patients who had been randomized to ADA 40 mg Q2W + MTX or 10 mg TOF + MTX in ORAL Standard were included in the current analysis. Upon entering ORAL Sequel, these were all switched to TOF 10 mg ± MTX.Switching directly from either ADA or TOF resulted in ACR response improvements in all rates assessed, and improvements in DAS28-4(ESR) scores and HAQ-DI scores. However, there was an increase in discontinuations due to AEs, serious AEs, and serious infections in the three months after the switch. It is considered that this may be due to the study design rather than any overlapping effects of ADA and TOF.