RA Treatment Combination an Effective Alternative for Methotrexate-Refractory Patients

Tofacitinib in combination with methotrexate is likely an effective alternative treatment for patients with rheumatoid arthritis (RA) who had previous inadequate responses to methotrexate alone, a recent study showed.

The Oral Rheumatoid Arthritis trial (ORAL) Strategy evaluated the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate as potential alternatives to treat RA in patients who were refractory to methotrexate.
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For the 1-year randomized controlled ORAL Strategy trial, the researchers assessed 1146 adult patients with active RA. The study was conducted in 25 countries, and the researchers randomly assigned patients to receive 5 mg oral tofacitinib monotherapy, 5 mg oral tofacitinib plus methotrexate twice daily, or 40 mg subcutaneous adalimumab plus methotrexate every other week. Eligible patients also received a live zoster vaccine at the discretion of the researchers.

The primary outcome was an American College of Rheumatology response of at least 50% (ACR50) at 6 months in the full analysis set, which included all patients who received at least one dose of the study treatment.

By 6-month follow-up, ACR50 response was achieved by 147 (38%) of 384 patients with tofacitinib monotherapy, 173 (46%) of 376 patients with tofacitinib and methotrexate, and 169 (44%) of 386 patients with adalimumab and methotrexate.

“Tofacitinib and methotrexate combination therapy was non-inferior to adalimumab and methotrexate combination therapy in the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate in this trial,” the researchers concluded. “Tofacitinib monotherapy was not shown to be non-inferior to either combination.”

—Christina Vogt

Reference:

Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial [Published online June 16, 2017]. Lancet. doi:10.1016/S0140-6736(17)31618-5.