Positive results were announced from the ORAL Shift study, a phase 3b/4 study evaluating tofacitinib (Xeljanz) 11 mg once daily as a monotherapy with or without methotrexate in adult patients with moderately to severely active rheumatoid arthritis (RA). The study results were presented during a late-breaking oral session at the Annual European Congress of Rheumatology.
The 12-month, randomized, double-blind study included patients who had achieved low disease activity with tofacitinib extended release 11 mg once daily plus methotrexate after a 24-week open-label run-in period. Approximately 694 patients with moderate to severe RA received open-label tofacitinib 11 mg once daily plus methotrexate. After 24 weeks, patients who achieved low disease activity were randomized into a 24-week double-blind, placebo-controlled methotrexate withdrawal phase.
This stage of the study evaluated tofacitinib 11 mg once daily without methotrexate compared with the therapy plus methotrexate at week 48. The study authors noted that any adverse effects and discontinuations due to adverse effects were comparable between treatment arms. Adverse effects were reported in approximately 40.5% of patients in the monotherapy group and 41.0% of patients in the tofacitinib plus methotrexate group.
Tofacitinib is approved in the United States for adult patients in 3 indications: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis. Globally, tofacitinib is approved in more than 130 countries for the treatment of moderately to severely active RA and has been prescribed to an estimated 205,000 patients.
  1. Pfizer Announces Results from XELJANZ XR (tocfacitinib) ORAL Shift Study, the First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor [press release]. Pfizer website. Published June 12, 2019. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_results_from_xeljanz_xr_tofacitinib_oral_shift_study_the_first_phase_3b_4_study_to_evaluate_methotrexate_withdrawal_with_a_jak_inhibitor. Accessed June 19, 2019.