Two different dosing regimens of Stelara helped patients with moderate-to-severe ulcerative colitis achieve clinical remission and maintain a clinical response through 44 weeks, according to data presented at the Congress of the European Crohn’s and Colitis Organisation.
William J. Sandborn, MD, director of the inflammatory bowel disease center at University of California, San Diego Health, told Healio Gastroenterology and Liver Disease that the results build on previous data from the UNIFI trail which showed that Stelara (ustekinumab, Janssen) was effective for inducing clinical remission, clinical response and endoscopic improvement, as well as other outcome measures.
Sandborn said they randomly assigned patients to different dosing regimens of ustekinumab. After 12 weeks, patients who had received induction therapy with the drug and had achieved clinical response were again randomly assigned to receive more long-term maintenance therapy with the two dosing regiments of ustekinumab (90 mg every 8 weeks, n = 176; and every 12 weeks, n = 172) or placebo (n = 175).
“You are looking to see how those patients did in terms of having remission at the end of the year, steroid free remission, endoscopic improvement, histologic improvement and remission, a new mucosal healing definition,” Sandborn said. “If you initially responded to induction therapy with Stelara, how do you do over the next year?”
At week 44 of the trial, researchers found that greater proportions of patients in the every 8-week and every 12-week ustekinumab groups were in clinical remission (43.8% and 38.4%, respectively) compared with placebo (24%; P < .001 and P = .002). A greater proportion of patients in the ustekinumab groups were able to maintain clinical response through week 44 and achieve endoscopic healing, as well as corticosteroid-free remission.
While a greater proportion of patients in the ustekinumab groups were able to maintain clinical remission, the difference was only significant in the every 12-week group.
Investigators found that the drug was also well-tolerated among patients, and they did not identify any new safety signal for any serious adverse events, infections or malignancies.
“One of the important sub messages is that you could see an effect in patients who had never received biologic therapy that was statistically significant, and then you could see a significant effect as well in patients who had previously failed biologic therapy,” Sandborn said. “Interestingly, the previous biologics could include anti-TNF agents or failure of the anti-integrin agent vedolizumab or both. About half of the patients had failed one or multiple biologics going into this, and you could see the effect of Stelara in those patients.” – by Alex Young
Reference: Sandborn WJ, et al. Abstract OP37. Presented at: Congress of the European Crohn’s and Colitis Organisation; Mar. 7-9, 2019; Copenhagen.
Disclosures: Sandborn reports he receives consultant fees from AbbVie, Akros, Allergan, Ambrx, Amge, Ardelyx, Arena, Atlantic, Avaxia, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Conatus, Cosmo Technologies, Escalier Biosciences, Ferring, Ferring Research Institute, Forward Pharma, Galapagos, Genentech, Gilead Sciences, Immune Pharmaceuticals, Index Pharmaceuticals, Janssen, Kyowa Hakko Kirin Pharma, Lilly, Medimmune, Mesoblast, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Oppilan Pharma, Otsuka, Palatin, Paul Hastings, Pfizer, Precision IBS, Progenity, Prometheus Laboratories, Qu Biologics, Regeneron Ritter Pharmaceuticals, University of Western Ontario, Salix, Seattle Genetics, Seres Therapeutics, Shire, Sigmoid Biotechnologies, Takeda, Theradiag, Theravance, Tigenix, Tillotts Pharma, UCB, Pharma, Vascular Biogenics and Vivelix. He reports receiving research grants from AbbVie, Atlantic Healthcare Ltd., Amgen, Celgene/Receptos, Genentech, Gilead Sciences, Janssen, Lilly and Takeda. He also reports receiving payments for lectures/speakers bureau from AbbVie, Janssen and Takeda. He also holds stock/stock options in Escalier Biosciences, Oppilan Pharma, Precision IBD, Progenity and Ritter Pharmaceuticals. Please see the ECCO disclosure database for all other authors’ relevant financial disclosures.