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Ulcerative colitis patients benefit from Stelara induction
PHILADELPHIA — Patients with ulcerative who receive a single intravenous dose of Stelara experienced clinical, endoscopic and quality of life improvements, according to data from the UNIFI study presented at the American College of Gastroenterology Annual Meeting.
“Patients with moderate-to-severe ulcerative colitis who received a single IV infusion of [Stelara (ustekinumab, Janssen)], either a 130 mg dose or a dose approximating 6 mg/kg induced clinical remission, endoscopic healing, clinical response, improved health-related quality of life and induced mucosal healing at week 8,” Bruce E. Sands, MD, MS, of the Icahn School of Medicine at Mount Sinai, said during his presentation.
Investigators analyzed data from 961 patients with moderate-to-severely active UC who had an inadequate response or were not able to tolerate conventional or biologic therapies. They randomly assigned patients to receive either a 130 mg dose or approximately 6 mg/kg dose of ustekinumab or placebo. They included data form 941 patients who completed through week 8 of the study.
Researchers found that more patients in both the ustekinumab groups achieved clinical remission, endoscopic healing, clinical response and mucosal healing at week 8 compared with the placebo group (P < .001). They also experienced better improvement from baseline IDBQ scores.
“This was associated with improvements in biologic markers of inflammation,” Sands said. “It appeared that this was well tolerated and very safe with a consistent adverse event profile from what we had previously seen.” – by Alex Young
Reference: Sands BE, et al. Abstract 54A. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 5-10, 2018; Philadelphia.
Disclosure: Sands reports financial ties to 4D Pharma, AbbVie, Allergan, Amgen, Arena, Boehringer-Ingelheim, Capella Biosciences, Celltrion Healthcare, EnGene, Ferring, Gilead, Lyndra, Oppilan, Otsuka, Palatin Technologies, Progenity, Protagonist Therapeutics, Rheos Medicines, Seres Therapeutics, Sienne Biopharmaceuticals, Takeda, Theravance, Vivelix, Celgene, Lilly, MedImmune, Millennium, and Pfizer. Please see the study abstract for all other authors’ relevant financial disclosures.