Targeting the interlieukin-23 pathway with mirikizumab, a p19-directed IL-23 antibody, may be an effective option for maintenance therapy in ulcerative colitis, according to research presented at the Congress of the European Crohn’s and Colitis Organisation.
“IL-23 plays a key role in the pathogenesis of inflammatory bowel disease,” G. Geert R. D’Haens, MD, PhD, of Amsterdam University Medical Centers in the Netherlands, said in his presentation. “And IL-23 pathway blockade has been shown to be effective in psoriasis and Crohn’s Disease.”
Results through 12 weeks of this phase 2 trial demonstrated the drug’s efficacy in UC induction treatment.
Researchers randomly assigned patients (Mayo score 6–12 with a minimum endoscopic subscore no lower than 2) to receive either intravenous placebo (n = 63), mirikizumab 50 mg (n = 63) or 200 mg (n = 62) with possibility of exposure-based dose increases, or fixed mirikizumab 600 mg every 4 weeks (n = 61) to explore the efficacy of mirikizumab through 52 weeks of treatment. They randomly reassigned patients who achieved a clinical response at a week 12 efficacy assessment to receive mirikizumab 200 mg subcutaneously every 4 weeks (q4w; n = 47) or every 12 weeks (q12w; n = 46).
At week 52, D’Haens and colleagues found that 46.8% of patients in the q4w group and 37% of patients in the q12w group were in clinical remission, while 80.9% and 76.1% achieved clinical response, respectively. Additionally, 57.4% of patients in the q4w group and 47.8% of patients in the q12w group had an endoscopic score of zero or one.
One patient had to discontinue treatment during the maintenance phase, and investigators did not identify any unexpected safety signals.
“Mirikizumab demonstrated durable clinical efficacy and endoscopic healing through 52 weeks of treatment,” D’Haens concluded. “The efficacy was similar among patients with previous exposure to biologics and patients naive to biologics, and efficacy was observed in both dosing regimens.” – by Alex Young
Reference: D’Haens GR, et al. Abstract OP38. Presented at: Congress of the European Crohn’s and Colitis Organisation; Mar. 7-9, 2019; Copenhagen.
Disclosure: D’Haens reports consulting for AbbVie, Ablynx, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meyers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Echo Pharmaceuticals, Eli Lilly, Engene, Ferring, DrFalk Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Hospira/Pfizer, Immunic, Johnson & Johnson, Kintai Therapeutics, Lycera, Medimetrics, Millenium/Takeda, Medtronics, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Pfizer/Hospira, Photopill, Prodigest, Prometheus Laboratories/Nestle, Progenity, Protagonist, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestle, Setpoint, Shire, Teva, Tigenix, Tillots, Topivert, Versant and Vifor. Please see the ECCO disclosure database for all other authors’ relevant financial disclosures.