Tofacitinib Versus Oral Prednisolone for Induction of Remission in Moderately Active Ulcerative Colitis [ORCHID]: A...

Area of Science:

• Gastroenterology
• Clinical Pharmacology
• Immunology

Background:

• Oral corticosteroids are standard for moderately active ulcerative colitis (UC) but have adverse effects.
• Tofacitinib offers an alternative therapeutic option for UC management.
• Comparing tofacitinib with prednisolone is crucial for optimizing UC treatment strategies.

Purpose of the Study:

• To compare the efficacy and safety of tofacitinib versus prednisolone for inducing remission in moderately active UC.
• To evaluate composite remission rates at 8 weeks as the primary endpoint.
• To assess time to symptomatic remission and adverse events in both treatment groups.

Main Methods:

• A single-center, prospective, open-label, randomized, active-controlled pilot study.
• Inclusion of patients aged 18 years or older with moderately active UC.
• Random assignment to 8 weeks of either oral prednisolone (40 mg daily, tapered weekly) or tofacitinib (10 mg twice daily).

Main Results:

• No significant difference in composite remission rates between tofacitinib (16.28%) and prednisolone (8.57%) groups at 8 weeks (p=0.31).
• Similar time to symptomatic remission was observed in both groups (10 days).
• Adverse events included pulmonary tuberculosis and pustular acne (one case each), and herpes zoster (one case with tofacitinib), with no serious adverse events or major adverse cardiovascular events.

Conclusions:

• Tofacitinib and oral prednisolone exhibit comparable efficacy and safety profiles for inducing remission in moderately active UC at 8 weeks.
• The findings suggest tofacitinib as a viable alternative to corticosteroids for initial UC treatment.
• Further research with larger cohorts is warranted to confirm these preliminary results.