Clinical Trial: Long Versus Short Tapering of Steroids in Steroid Responsive Moderate to Severely Active Ulcerative...

Appropriate tapering strategy for corticosteroids in ulcerative colitis (UC) is uncertain.

To compare the efficacy and safety of two steroid tapering regimens in patients with active UC.

We randomised patients with active UC with initial steroid response after 2 weeks to short (total 6 weeks) or long taper (total 10 weeks). Randomization was stratified for acute severe UC. The primary outcome was steroid-free clinical remission at 6 months. Secondary outcomes included assessment of symptomatic remission, relapse rate, endoscopic and histological scores, and safety.

Of 94 patients (48 in long, 46 in short taper) randomised, short taper was inferior to long taper in inducing clinical remission at 6 months (RR = 2.19; CI 1.08-4.46; p = 0.02). The relapse rates were similar in the long (37%) and short taper (46%) arms (HR: 0.34; CI: 0.10-1.11; p = 0.42). The median UCEIS scores (3 vs. 2; p = 0.23) and Nancy scores [2 (IQR 0-3) vs. 1.5 (0.75-3); p = 0.4] were not different between arms. Adverse events in the long and short taper arms, such as acne (14.58% vs. 2.16%), myopathy (8.33% vs. 6.52%), skin changes (2.08% vs. 2.17%), mood changes (0% vs. 4.34%), cytopenia (0% vs. 2.17%), and headache (6.25% vs. 6.52%) were similar.

A shorter taper duration of 6 weeks was inferior to a longer taper of 10 weeks in achieving clinical remission of UC at 6 months.

CTRI Number: CTRI/2021/06/034129.