Pfizer announced findings from the head-to-head Phase 3b/4 study comparing Xeljanz (tofacitinib citrate; Pfizer) with or without methotrexate vs. Humira (adalimumab; AbbVie) with methotrexate for the treatment of moderate to severe rheumatoid arthritis. The ORAL Strategy also compared Xeljanz alone vs. Xeljanz in combination with methotrexate. Full findings were published in The Lancet and presented during the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
The non-inferiority study found that ACR50 response, the primary efficacy endpoint, was achieved in 46% of the Xeljanz 5mg twice daily + methotrexate group, 38.3% of the Xeljanz 5mg twice daily group, and in 43.8% of the Humira 40mg every other week + methotrexate group.
Study author, Dr. Roy Fleischmann, stated, “Although Xeljanz monotherapy did not demonstrate non-inferiority 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 methotrexate and as monotherapy for patients who do not respond to or are intolerant to methotrexate.”
Regarding safety data, the most commonly reported adverse events for each study arm were upper respiratory tract infections, alanine aminotransferase elevation, nasopharyngitis, urinary tract infections, and nausea. Between treatment arms, the overall rate of adverse events were similar.
Adverse events were seen in 61.4% of the Xeljanz 5mg twice daily + methotrexate group, 58.9% of the Xeljanz 5mg twice daily group, and in 65.5% of Humira 40mg every other week + methotrexate group. Serious adverse events were noted in 7.2% of the Xeljanz 5mg twice daily + methotrexate group, 9.1% of the Xeljanz 5mg twice daily group, and in 6.2% of Humira 40mg every other week + methotrexate group.
Xeljanz and Xeljanz XR are Janus kinase (JAK) inhibitors indicated to treat moderately to severely active rheumatoid arthritis when methotrexate therapy is inadequate. Xeljanz and Xeljanz XR may be used alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
For more information visit Xeljanz.com.