Pfizer recently announced top-line results from its Phase 3b/4 trial evaluating Xeljanz (tofacitinib citrate) as a treatment for moderate-to-severe rheumatoid arthritis (RA). The trial demonstrates that Xeljanz is more effective in combination with methotrexate (MTX) than as a monotherapy, the company said.
The trial, called ORAL Strategy (NCT02187055), compared 5 mg of Xeljanz twice daily as monotherapy or in combination with MTX versus Humira (adalimumab) plus MTX in people without an adequate response to MTX.
To compare the treatments, researchers used the American College of Rheumatology measurement of a 50 percent response (ACR50) at month six as the primary endpoint.
ACR50 response corresponds to a greater than or equal to 50 percent improvement in tender or swollen joint counts and 50 percent improvement in three of the following five criteria: 1) physician’s global evaluation of disease activity; 2) subject’s evaluation of disease activity; 3) subject’s assessment of pain; 4) subject’s assessment of functional disability by a specialized health questionnaire; and 5) C-reactive protein levels.
The main finding was that Xeljanz 5 mg plus MTX successfully demonstrated non-inferiority compared to Humira plus MTX. However, Xeljanz 5 mg as a monotherapy did not demonstrate non-inferiority versus Humira plus MTX or versus Xeljanz plus MTX.
“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,” Michael Corbo, Pfizer’s chief development officer of inflammation and immunology, said in a press release.
The trial was a 12-month analysis of 1,152 patients randomized into one of three arms that were independently compared against each other: Xeljanz as monotherapy (386 patients), Xeljanz in combination with MTX (378 patients), and Humira in combination with MTX (388 patients).
The trial’s safety findings were not different from those previously reported for Xeljanz, which has been approved for use in more than 50 countries. The U.S. Food and Drug Administration approved its use in 2012, and in January 2017, the European Union’s Committee for Medicinal Products for Human Use (CHMP) recommended its approval in the EU’s 28 member countries for the treatment of adults with moderate to severe RA.