IL-23 inhibitor maintains response, remission in Crohn’s disease

CHICAGO — Risankizumab was well tolerated and effective for maintaining clinical and endoscopic remission and response in patients with moderate-to-severe Crohn’s disease, according to the results of a phase 2 open-label randomized controlled trial presented at Digestive Disease Week.

Risankizumab (AbbVie) is an investigational interleukin-23 inhibitor that selectively blocks IL-23, and is currently under evaluation in Crohn’s disease, psoriasis, psoriatic arthritis and asthma.

Brian G. Feagan

“This trial has demonstrated that open label subcutaneous risankizumab was effective as maintenance therapy at week 52 in Crohn’s disease subjects in clinical remission at week 26,” Brian G. Feagan, MD, of Robarts Clinical Trials in Ontario, Canada, said during his presentation. Further, “the subjects randomized to 600 mg risankizumab during [the induction phase of the study] had higher rates of week 52 endoscopic endpoints than subjects randomized to the placebo or the 200-mg arm.”

The first phase of this trial was a double blind IV induction period, which showed risankizumab was more effective for inducing clinical and endoscopic remission at 12 weeks compared with placebo. This was then followed by a 14-week open-label IV re-induction or wash-out period, and then a 26-week open-label subcutaneous maintenance period, which showed re-induction with 600 mg risankizumab further increased rates of clinical remission rates at week 26.

Finally, patients who were in clinical remission at week 26 (n = 62) then entered the open label maintenance period and received 180 mg of subcutaneous risankizumab every 8 weeks until week 52, and Feagan reported safety and efficacy data from this period. Patients who were not in clinical remission but showed clinical response at week 26 were invited to participate in a separate open-label long-term extension study, and non-responders stopped treatment.

Fifty-four patients completed treatment through week 52, at which point 71% achieved clinical remission and 80.6% achieved clinical response.

Of 24 patients who achieved clinical remission at week 12, 87.5% remained in clinical remission through week 52.

The week 52 endoscopic response rate was 54.8% and the endoscopic remission rate was 35.5%, and of 13 patients who achieved endoscopic remission at week 12, 69.2% remained in endoscopic remission through week 52.

Overall, 29% of patients achieved deep remission (both endoscopic and clinical remission) at week 52. Two patients stopped treatment due to an adverse event, including worsening and exacerbation of their disease.

“Overall the drug was well tolerated with no new safety signals detected during the maintenance phase,” Feagan concluded. “This possible specific blockade of IL-23 warrants further investigation and this molecule is going to move into phase 3 studies.” – by Adam Leitenberger

Reference:

Feagan BG, et al. Abstract #874l. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosures: This study was funded by Boehringer Ingelheim. Feagan reports financial relationships with AbbVie and Boehringer Ingelheim, and reports numerous other financial disclosures which can be found at ddw.org.