Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)

Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-z

Post-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in daily practice, where clinicians base dose adjustments on clinical need. Consequently, there is a need for some clarity of what physicians should expect in terms of a loss or gain of efficacy when adjusting dose based on clinical need, and whether dose switches are associated with particular AEs. As such, Mueller, et al. used data from the long-term extension, tofacitinib ORAL Sequel study to assess the impact of switching versus staying on the same tofacitinib dose on efficacy and safety in patients with RA.