William J. Sandborn
WASHINGTON — Mirikizumab, an anti-interleukin-23 therapy developed by Eli Lilly, showed efficacy in treating patients with moderate-to-severe ulcerative colitis, according to research presented at Digestive Disease Week.
William J. Sandborn, MD, of the University of California San Diego, said this was the first study of an IL-23 monoclonal antibody in patients with UC.
“The pro-inflammatory cytokine interleukin-23 plays a critical role in the pathogenesis of inflammatory bowel disease,” Sandborn said in a presentation. “The blockade of the IL-23 pathway has previously demonstrated efficacy in Crohn’s disease.”
For the phase 2 trial, the researchers randomly placed patients who had failed at least one conventional therapy for UC into four groups; placebo (n = 63), mirikizumab 50 mg (n = 63), mirikizumab 200 mg (n = 62) with the possibility of exposure-based increases, or a fixed mirikizumab dose of 600 mg (n = 61). The investigators then compared the groups for rates of clinical remission, clinical response, endoscopic healing, endoscopic remission and symptomatic remission.
At week 12, Sandborn and colleagues found that patients treated with the 200 mg dose had better clinical remission rates than placebo (P < .01), while the 50 mg and 600 mg groups did not. Endoscopic healing rates were greater for both the 50 mg and 200 mg groups compared with placebo (P < .05). Clinical response was greater in all the mirikizumab groups, Sandborn said.
While symptomatic remission rates were greater in the 200 mg and 600 mg groups (P < .01), endoscopic remission rates were similar among all groups.
Sandborn said the findings show that mirikizumab was efficacious in the induction treatment for patients with moderate-to-severe UC.
“Subgroup analysis based on prior biologic therapy, demonstrates trends towards efficacy in both biologic naive and biologic experienced patients, with a relatively greater effect in biologic naive patients,” Sandborn said. – by Alex Young
Sandborn WJ, et al. Abstract 882. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Sandborn reports financial ties to Qu Biologics, Seattle Genetics, Avaxia, Celgene, Takeda, Medimmune, Arena Pharmaceuticals, Ferring Research Institute, Ambrx, Kyowa Hakko Kirin Pharma, AbbVie, Palatin, Akros Pharma, UCB Pharma, Index Pharmaceuticals, Vascular Biogenics, and Atlantic Healthcare Pharmaceuticals. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.