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Tofacitinib Noninferior to Adalimumab for Patients with Rheumatoid Arthritis
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Pfizer announced top-line results from the ORAL Strategy trial, which demonstrated noninferiority of tofacitinib compared with adalimumab — both combined with methotrexate — in the treatment of moderate-to-severe rheumatoid arthritis, according to a press release.
“ORAL Strategy is representative of the type of innovative and clinically meaningful trials that Pfizer Inflammation & Immunology believes are important to help advance patient care and the science of JAK inhibition,” Michael Corbo, chief development officer of inflammation & immunology and global product development at Pfizer, said in the release. “We are pleased that we demonstrated noninferiority of Xeljanz [tofacitinib, Pfizer] plus methotrexate (MTX) versus Humira [adalimumab, AbbVie] plus MTX, reinforcing the efficacy of Xeljanz combination therapy.”
ORAL Strategy — a 12-month, double-blind, head-to-head study — included 1,152 patients with rheumatoid arthritis, who were randomly assigned to receive either twice-daily oral tofacitinib as 5-mg monotherapy, tofacitinib in combination with weekly methotrexate or 40 mg of biweekly subcutaneous adalimumab in combination with weekly methotrexate.
Noninferiority of tofacitinib compared with adalimumab served as the primary endpoint.
Researchers found tofacitinib met its primary endpoint as a combination therapy, but not as monotherapy. In addition, tofacitinib’s safety findings were consistent with its known adverse event profile.
“We will continue to analyze the monotherapy data from this study and look forward to sharing the full results of ORAL Strategy at an upcoming scientific forum,” Corbo said.