Refractory Crohn’s disease responds well to risankizumab

In the treatment of patients with luminal Crohn’s disease (CD) and multiple prior drug failures, risankizumab induces clinical response in about three out of four patients and steroid-free clinical remission in about half, according to a study.

Researchers used data from 22 French GETAID centres and looked at 100 patients with refractory luminal CD treated with risankizumab. They evaluated the efficacy of treatment based on the primary outcome: steroid-free clinical remission at week 12 (Harvey-Bradshaw [HB] score <5). Secondary outcomes included clinical response (≥3-point decrease of HB score and/or (HB) score <5), biochemical remission (CRP ≤ 5 mg/L), need for CD-related surgery, and adverse events.

All patients were previously exposed to antitumour necrosis factor agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least three biologics), and 61 had a previous intestinal resection. Ninety-seven patients received a 600-mg risankizumab intravenous induction at weeks 0, 4, and 8.

At week 12, 45.8 percent of patients achieved steroid-free clinical remission, 58 percent had clinical remission, and 78.5 percent showed clinical response. On subgroup analysis restricted to patients with objective signs of inflammation at baseline (n=79), the proportion of patients who had steroid-free clinical remission at week 12 was 39.2 percent. Half of the population exhibited biochemical remission.

Treatment was ceased in six patients before the week-12 visit due to lack of efficacy. There were six patients who required CD-related hospitalization, and three underwent intestinal resection.

On multivariable regression analysis, clinical remission with risankizumab at week 12 was significantly associated with a history of ustekinumab loss of response (vs primary failure; odds ratio, 2.80, 95 percent confidence interval, 1.07–7.82; p=0.041).

A total of 20 patients developed adverse events (AEs), including serious AEs such as CD exacerbation in six patients and severe hypertension in one patient.