Tofacitinib versus oral prednisolone for induction of remission in moderately active ulcerative colitis (ORCHID): A prospective, open-label, randomized, pilot study

Oral corticosteroids are first line agents to induce remission in moderately active ulcerative colitis (UC), but are associated with adverse effects. We compared the efficacy and safety of tofacitinib and prednisolone for induction of remission in moderately active UC.This was a single-center, prospective, open-label, randomized, active-controlled pilot study. Eligible patients (aged ≥18 years) had moderately active UC. Participants were randomly assigned to receive either prednisolone (40 mg daily, tapered by 5 mg every week) or tofacitinib (10 mg twice daily) for 8 weeks. The primary end-point was composite remission (defined as total Mayo clinic score ≤2, with endoscopic sub-score of 0 and fecal calprotectin <100 mcg/g) at 8 weeks.Seventy-eight patients were randomly assigned to either of the treatment groups. At week 8, the proportion of patients achieving composite remission in the tofacitinib (7/43,16.28%) and prednisolone groups (3/35,8.57%) were not significantly different (OR 2.07, 95%CI 0.49-8.70; p=0.31). The time to achieve symptomatic remission (normal stool frequency with absence of rectal bleeding) was similar (10[IQR 7-18.75] and 10[IQR 5-12.5] days for tofacitinib and prednisolone, respectively; p=0.25) in the two groups. One patient each in the tofacitinib and prednisolone group discontinued treatment due to development of pulmonary tuberculosis and pustular acne, respectively. One patient receiving tofacitinib developed herpes zoster, but did not require cessation of therapy. No serious adverse events or major adverse cardiovascular events were observed.In patients with moderately active ulcerative colitis, there was no difference in the efficacy and safety of tofacitinib and oral prednisolone for induction of remission at 8 weeks.