Pfizer announced top-line results from its first Phase 3 study, OPAL Broaden, evaluating the efficacy and safety of tofacitinib for the treatment of active psoriatic arthritis (PsA) in adults who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.
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Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).
Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).
Pfizer announced detailed results from the first 2 pivotal Phase 3 trials of the OCTAVE program evaluating oral tofacitinib 10mg twice daily in inducing remission in adults with moderately to severely active ulcerative colitis (UC). Findings were orally presented at the 11th Congress of ECCO Scientific Session.
Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).
The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.