Pfizer announced findings from a phase3b/4 trial evaluating the efficacy and safety of tofacitinib extended release (Xeljanz XR) monotherapy after methotrexate withdrawal in patients with moderate to severe rheumatoid arthritis (RA). The study results will be presented at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain.
The ORAL Shift study, which enrolled RA patients who were inadequate responders to methotrexate alone (N=694), included a run in phase where patients received tofacitinib extended release 11mg daily plus their previous methotrexate dose; patients who achieved low disease activity at week 24 (n=530) were then randomized into the 24 week double blind, placebo controlled methotrexate withdrawal phase for a total of 48 weeks. The primary endpoint of the study was change in Disease Activity Score (DAS28-4[ESR]) between the 2 treatment groups: tofacitinib extended release plus methotrexate (n=266) and tofacitinib extended release plus placebo (n=264).
Results showed that treatment with tofacitinib extended release monotherapy was noninferior to tofacitinib extended release plus methotrexate at 48 weeks (least squares [LS] mean changes in DAS28-4[ESR] from weeks 24 to 48 of 0.33 and 0.03, respectively [LS mean difference = 0.3; 95% CI, 0.12-0.48; noninferiority P <.0005]). With regard to safety, the rate of adverse events and discontinuations due to adverse events were similar between the treatment groups; nasopharyngitis, upper respiratory tract infection, and bronchitis were the most frequently reported.
“The results of ORAL Shift provide important information on the use of [tofacitinib extended release] as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate,” said Stanley Cohen, MD, Metroplex Clinical Research Center, Dallas, TX. “From a clinical perspective, these results give physicians data to help inform the decision to take appropriate patients off methotrexate.”
The extended release tablet formulation of tofacitinib, a Janus kinase inhibitor, is marketed under the brand name Xeljanz XR for the treatment of rheumatoid arthritis and psoriatic arthritis.
For more information visit pfizer.com.