Acute severe UC: Mesalamine–corticosteroid combo no added benefit vs monotherapy

The combination of mesalamine plus corticosteroid does not appear to be more beneficial than corticosteroid alone in the treatment of hospitalized patients with acute severe ulcerative colitis (UC), as shown in a study.

Of the 346 patients hospitalized with acute severe UC (Lichtiger score ≥10) from 10 centres in seven countries, 149 (median age 41 years, 47 percent female) were randomized to receive corticosteroid alone (n=76) or in combination with mesalamine (4 g/day; n=73)

The primary outcome was the percentage of patients who responded to treatment by day 7. Response was defined as a drop of >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy.

There was no between-group difference seen in the primary outcome, with response documented in 53 patients (72.6 percent) in the combination group vs 58 (76.3 percent) in the corticosteroid monotherapy group (odds ratio, 0.82, 95 percent confidence interval, 0.39–1.72; p=0.60).

Duration of hospitalization, C-reactive protein normalization rate, and colectomy rate up to day 90 were similar in the two groups.

However, numerically fewer patients in the combination vs monotherapy group required biologics by day 30 (p=0.11) and day 90 (p=0.07).

The exploratory signal for a reduced need for biologics at day 90 among patients who received add-on mesalamine warrants further evaluation.