Pfizer Inc. recently published noninferiority results from its study of Xeljanz, a twice-daily monotherapy to be used in combination with methotrexate in treating patients with moderate to severe rheumatoid arthritis (RA).
“As expected, Xeljanz in combination with methotrexate provided similar ACR50 response rates to Humira plus methotrexate,” Dr. Roy Fleischmann, study author and clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center, said.
In a head-to-head analysis comparing Xeljanz to Humira, the study showed that Xeljanz was not inferior. Pfizer showcased the details of this study at an oral session of the EULAR Annual European Congress of Rheumatology in Madrid.
“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 of Inflammation & Immunology for Pfizer Global Product Development, said in a statement. "ORAL Strategy is a bold study that directly compared Xeljanz as a monotherapy or in combination with methotrexate to Humira in combination with methotrexate."