Pfizer RA drug candidate tofacitinib shows promise in ulcerative colitis

Patients with moderately to severely active ulcerative colitis treated with drug behemoth Pfizer’s (NYSE PFE) tofacitinib were more likely to have clinical response and remission than those receiving placebo, according to the findings of a company funded Phase II study published in the New England Journal of Medicine.

The primary outcome, clinical response at eight weeks, occurred in 32%, 48%, 61%, and 78% of patients receiving tofacitinib at a dose of 0.5mg (P=0.39), 3 mg (P=0.55), 10mg (P=0.10) and 15mg (P<0.001), respectively, as compared with 42% of patients receiving placebo.

Clinical remission (defined as a Mayo score ≤2, with no sub-score >1) at eight weeks occurred in 13%, 33%, 48% and 41% of patients receiving tofacitinib at a dose of 0.5mg (P=0.76), 3mg (P=0.01), 10mg (P<0.001) and 15mg (P<0.001), respectively, compared with 10% of patients receiving placebo. There was a dose-dependent increase in both low-density and high-density lipoprotein cholesterol. Three patients treated with tofacitinib had an absolute neutrophil count of less than 1500.