Trial Data Further Supports Xeljanz Plus Methotrexate Combination in Rheumatoid Arthritis

New data from a phase 3b/4 study demonstrated the overall safety and efficacy of tofacitinib citrate (Xeljanz) as a monotherapy or in combination with methotrexate (MTX) in patients with moderate-to-severe rheumatoid arthritis (RA).

The ORAL Strategy study is the first to compare a JAK inhibitor as a monotherapy or in combination with MTX versus adalimumab (Humira) plus MTX, according to a Pfizer press release.

“Our extensive RA clinical development program has demonstrated the overall efficacy and safety of Xeljanz with or without methotrexate in patients living with moderate-to-severe RA,” Michael Corbo, chief development officer, Inflammation & Immunology, Pfizer Global Product Development, said in a release. “ORAL Strategy is a bold study that directly compared Xeljanz as a monotherapy or in combination with methotrexate to Humira in combination with methotrexate.

“The totality of the ORAL Strategy results adds to [the] body of evidence of Xeljanz and further demonstrates Pfizer’s commitment to putting patients first by helping physicians make informed treatment decisions.”

The primary endpoint of ORAL Strategy was the percentage of patients who achieved an ACR 50 response at month 6.

The results of the study showed that 46% of patients who received 5 mg of tofacitinib citrate twice daily plus MTX achieved an ACR50 response, as well as 38.8% of patients who received 5 mg of tofacitinib citrate monotherapy.

Among patients administered 40 mg of adalimumab every other week plus MTX, 43.8% achieved an ACR50 response.

“As expected, Xeljanz in combination with methotrexate provided similar ACR50 response rates to Humira plus methotrexate,” study author Dr Roy Fleischmann said in a release. “Although Xeljanz monotherapy did not demonstrate noninferiority to either combination arm, the clinical responses observed are reflective of those in the phase 3 clinical program and affirm our understanding that Xeljanz is an important option both in combination with MTX and as monotherapy for patients who do not respond to or are intolerant to methotrexate.”

The safety profile in ORAL Strategy was consistent with known adverse events (AEs) for tofacitinib citrate, according to the release. The most common AEs were upper respiratory tract infections, alanine aminotransferase elevation, nasopharyngitis, urinary tract infections, and nausea. Most of the AEs were mild to moderate in severity, and the overall rates were comparable between treatment arms.

Discontinuation of treatment due to AEs and rates of serious AEs were generally similar between treatment arms, according to the release.

The findings were published in The Lancet, and presented at the Annual European Congress of Rheumatology in Madrid, Spain.