ORAL Strategy was a 1 year, double-blind, phase 3b/4, headto-head, non-inferiority, randomised controlled trial that compared the different strategies of treatment of patients with active rheumatoid arthritis despite methotrexate: an addition of tofacitinib or adalimumab to methotrexate or a switch to monotherapy with tofacitinib. Two regimens of combination therapy had similar efficacy and safety profile. Tofacitinib monotherapy was not shown to be non-inferior to either combination. However, the response rate to tofacitinib was comparable to that in the previous trials of tofacitinib monotherapy. The results of ORAL Strategy suggest that patients with active rheumatoid arthritis despite methotrexate should be treated with combination of tofacitinib and methotrexate. Monotherapy with tofacitinib is justified in patients who are intolerant of methotrexate or other conventional DMARDs or have contraindications to their administration.
Rheumatoid arthritis, treatment, tofacitinib, adalimumab, methotrexate.