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news.Pfizer said its rheumatoid arthritis drug, Xeljanz, met primary endpoint in combination with methotrexate as compared to AbbVie's drug Humira, although it did not meet the primary endpoint on its own.
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The firm has 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).
Tofacitinib citrate, which is a prescription medicine called JAK inhibitor, was approved in around 50 countries.
It is claimed to be the first once-daily oral JAK inhibitor approved to treat moderate to severe RA in the US Argentina, and Macau.
The trial compared JAK inhibitor as monotherapy or in combination with MTX against adalimumab plus MTX in MTX inadequate responders using ACR50 at month six as the primary endpoint.
Pfizer’s study showed Xeljanz 5mg plus MTX met its primary endpoint in demonstrating non-inferiority against Humira plus MTX,
Xeljanz 5mg monotherapydid not meet its primary endpoint of non-inferiority against Humira plus MTX or Xeljanz plus MTX.
Oral strategy is a one year, double-blind and head-to-head study that randomized 1,152 patients into one of three study arms, which were independently compared against each other
Pfizer inflammation and immunology global product development chief development officer Michael Corbo said: “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.”
“We are pleased that we demonstrated non-inferiority of Xeljanz plus MTX versus Humira plus MTX, reinforcing the efficacy of Xeljanz combination therapy.”
Image: Xeljanz bottle image. Photo: courtesy of Pfizer Inc.