Tofacitinib in Acute Severe Ulcerative Colitis (TACOS): A Randomized Controlled Trial

Area of Science:

• Gastroenterology
• Clinical Pharmacology
• Immunology

Background:

• Intravenous corticosteroids are standard treatment for acute severe ulcerative colitis (ASUC).
• A significant portion (30%-40%) of ASUC patients exhibit corticosteroid refractoriness.
• Novel therapeutic strategies are needed for corticosteroid-refractory ASUC.

Purpose of the Study:

• To evaluate the efficacy of tofacitinib combined with corticosteroids in treating ASUC.
• To determine if tofacitinib improves treatment responsiveness in patients with ASUC.

Main Methods:

• A single-center, double-blind, placebo-controlled trial was conducted.
• Adult ASUC patients received either tofacitinib (10 mg thrice daily) or placebo for 7 days, alongside intravenous corticosteroids.
• Treatment response was defined by a significant decline in the Lichtiger index without rescue therapy by day 7.

Main Results:

• 83.01% of patients receiving tofacitinib achieved treatment response compared to 58.82% on placebo (P=0.007).
• The need for rescue therapy by day 7 was significantly lower in the tofacitinib group (P=0.01).
• The cumulative probability of requiring rescue therapy by day 90 was substantially reduced with tofacitinib (0.13 vs 0.38, P=0.003).

Conclusions:

• Combination therapy with tofacitinib and corticosteroids enhances treatment responsiveness in ASUC patients.
• Adding tofacitinib to corticosteroids decreases the requirement for rescue therapy in ASUC.
• Tofacitinib represents a promising addition to the management of acute severe ulcerative colitis.