TOPLINE:

In steroid-responsive patients with moderate-to-severe ulcerative colitis (UC), a 10-week regimen of prednisolone tapering was more effective than a 6-week tapering regimen in achieving steroid-free clinical remission at 6 months and lengthened the time to relapse.

METHODOLOGY:

• Due to uncertainty surrounding the optimal duration for tapering systemic corticosteroid therapy in moderate-to-severe UC, researchers in India conducted a single-center, double-blind randomized controlled trial to evaluate the efficacy and safety of long- vs short-duration steroid tapering in this patient population.
• They included 94 patients older than 12 years with moderate-to-severe UC who had responded to a 2-week course of standard steroid therapy between 2021 and 2024. Therapy for outpatients was 40 mg/d of oral prednisolone, and for inpatients, it was an intravenous steroid for 5-7 days followed by 40 mg/d of oral prednisolone for 9 days.
• After the 2-week initial therapy, patients were randomly assigned one of two 10-week interventions: the long-taper arm (48 patients) or the short-taper arm (46 patients). The mean age in both groups was about 38, and both groups comprised about 58% men.
• Patients in the long-taper arm received oral prednisolone tapered over the full 10 weeks (5 mg weekly through week 9 and then 2.5 mg in week 10), and those in the short-taper arm received tapered dosing over 6 weeks (10 mg weekly through week 5 and then 5 mg in week 6) followed by a matching placebo for the remaining 4 weeks.
• The primary outcome was steroid-free clinical remission at 6 months. Secondary outcomes included symptomatic remission rates, relapse rates, and safety.

TAKEAWAY:

• At 6 months, patients in the long-taper vs short-taper arm arm achieved higher steroid-free complete clinical remission (symptomatic and endoscopic; 44% vs 20%; relative risk, 2.19; P = .02). There was no statistically significant difference in symptomatic remission.
• The between-group difference in relapse rates was not statistically significant, although the median time to relapse was longer in the long-taper vs short-taper arm (5 months vs 2 months), with a 61% lower risk for relapse (P = .006).
• Adverse events such as myopathy, skin changes, and headaches were mild, with comparable incidence between arms; none required discontinuation of therapy.

IN PRACTICE:

“The present study suggests that a longer taper of steroids was better than a short taper of steroids in patients with moderate-to-severe ulcerative colitis who initially responded to steroid therapy,” the authors wrote.

SOURCE:

The study, led by Ankit Kumar and Amol N. Patil, Postgraduate Institute of Medical Education and Research in Chandigarh, India, was published online in Alimentary Pharmacology & Therapeutics.

LIMITATIONS:

The single-center nature of the study may have limited its generalizability. The findings may not be generalizable to healthcare settings where biologic agents are used as first-line therapy for induction and maintenance of remission in UC. 

DISCLOSURES:

The authors reported receiving no specific funding for this study and declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.