Patients with acute severe ulcerative colitis (ASUC) who responded to intravenous steroids (IVS) had a low rate of colectomy over 5 years of follow-up, despite frequent ASUC relapses, according to study data published in Alimentary Pharmacology & Therapeutics. Early IVS response and maintenance therapy with biologics were associated with lower risk for relapse.

Researchers conducted a retrospective cohort study on patients with ASUC treated with IVS at 4 tertiary care centers in Paris, France. They defined ASUC per the modified Truelove and Witts criteria. All eligible patients had ≥6 episodes of bloody diarrhea per day and had at least 1 of the following characteristics: heart rate ≥90 bpm, temperature ≥37.8°C, hemoglobin ≤10.5 g/dL, and C-reactive protein ≥30 mg/L. The researchers extracted patient demographic, clinical, and endoscopic characteristics through medical record review. During follow-up, patients were evaluated for disease activity, adverse events, and ongoing ulcerative colitis (UC) treatment including colectomy. The Lichtiger index for disease activity and Mayo Clinic scores were used to assess clinical activity. The primary outcome measure was ASUC relapse, defined as a partial Mayo score >4 and/or the need for another maintenance therapy, including oral steroids or biological agents. The researchers used Cox proportional hazards models to identify independent factors associated with relapse. They adjusted models for prior exposure to immunomodulators and/or biological agents. Relapse-free and colectomy-free survival were calculated using the Kaplan-Meier method.

The study cohort included 142 patients who received IVS for acute UC flares between 2006 and 2017. The median duration of hospitalization was 8.0 (range, 6.0-10.0) days. IVS therapy consisted of intravenous methylprednisolone at 0.8 mg/kg per day, with 5-aminosalycilic acid (5-ASA) and/or steroid enemas in 67.6% of cases. Significant mean improvements in disease activity were observed between IVS initiation and days 3 and 5. At the time of discharge, all patients received maintenance therapy: 5-ASA (n=59; 41.5%), immunomodulators (n=60; 42%), anti-tumor necrosis factors (n=18; 13%), or vedolizumab (n=5; 3.5%). Median follow-up time was 4.8 (range, 2.6-7.3) years, during which 90 (63.4%) patients relapsed on their initial maintenance therapy. Overall, 13 (9.2%) patients underwent colectomy for refractory UC. In multivariable analyses, the risk for relapse was significantly decreased in patients treated with anti-TNF (HR, 0.37; 95% CI, 0.16-0.87; P =.02), patients with a partial Mayo score <2 at day 5 after IVS initiation (HR, 0.41; 95% CI, 0.21-0.80; P =.009), and patients with fewer than 6 liquid stools per day at day 3 after IVS initiation (HR, 0.56; 95% CI, 0.34-0.91). Patients with a Lichtiger index >12 at hospital admission were more likely to undergo colectomy than their comparators with lower disease activity (HR, 10.12, 95% CI, 1.30-78.55, P =.03). The probabilities of relapse-free survival were 58%, 48%, 46%, 42%, and 40% at 1, 2, 3, 4, and 5 years after discharge, respectively. The probabilities of colectomy-free survival were 96%, 95%, 93%, 92%, 91%, and 88% at years 1, 2, 3, 4, 5, and 8 years, respectively.

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While prior studies suggest that the probability of colectomy is as high as 40% for individuals with ASUC, in a cohort of patients responding to IVS, the 5-year risk for colectomy was just 9.2%. Early IVS response and maintenance therapy with biologics were each associated with lower rates of relapse. The researchers note that further prospective studies are necessary to confirm these results. Given the high rate of maintenance therapy failure, investigators emphasized the need for a “more ambitious strategy after ASUC responds to IVS.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry.

Please see the original reference for a full list of authors’ disclosures.

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Reference

Salameh R, Kirchgesner J, Allez M, et al. Long-term outcome of patients with acute severe ulcerative colitis responding to intravenous steroids [published online April 28, 2020]. Aliment Pharmacol Ther. doi: 10.1111/apt.15751