14 June 2019 - - US-based biopharmaceutical company Pfizer Inc. (NYSE: PFE) has received positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis, the company said.
Patients who achieved low disease activity with Xelianz (tofacitinib) extended release 11 mg once daily plus methotrexate after a 24-week open-label run-in period, were randomised to evaluate the efficacy and safety of Xelianz XR 11 mg QD as monotherapy after MTX withdrawal compared with Xelianz XR with continued MTX.
The study demonstrated non-inferiority of MTX withdrawal with Xelianz XR 11 mg QD compared to Xelianz XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48.
The study results will be presented during a late-breaking oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (15 June).
For the primary efficacy analysis, patients who achieved Clinical Disease Activity Index low disease activity at week 24 were randomized into the MTX withdrawal phase resulting in least squares mean changes in DAS28-4(ESR) from weeks 24 to 48 of 0.33 and 0.03 in the Xelianz XR monotherapy and Xelianz XR plus MTX groups, respectively [LS mean difference = 0.3; 95% CI, 0.12-0.48; non-inferiority p