Pfizer announced top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint. There were three comparisons,which found:
• XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX
• XELJANZ 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX
“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,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “We are pleased that we demonstrated non-inferiority of XELJANZ plus MTX versus Humira plus MTX, reinforcing the efficacy of XELJANZ combination therapy. 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.”
ORAL Strategy is a 12-month, double-blind, head-to-head study which included 1,152 patients randomized into one of three study arms that were independently compared against each other:
• XELJANZ 5 mg BID as monotherapy (n=386)
• XELJANZ 5 mg BID in combination with a weekly dose of MTX (15-25 mg) (n=378)
• Humira 40 mg every-other-week via subcutaneous injection in combination with a weekly dose of MTX (15-25 mg) (n=388)
The safety findings were consistent with the known adverse events and serious adverse events profile for XELJANZ.
The RA clinical development program has over 20 clinical trials and to-date represents more than 21,100 patient-years of drug exposure. The long-term extension program, spanning over eight years of safety experience, is one of the largest in the RA category with respect to number of patients and patient-years of exposure.
Filed Under: Drug Discovery