UNITI-2 trial: Stelara effective for treating Crohn's disease
HONOLULU — In the UNITI-2 clinical trial, researchers found Stelara to be a safe and effective therapy for Crohn’s disease, according to findings presented at ACG 2015.
Brian Feagan, MD, FACG, professor of medicine at the Robarts Research Institute, University of Western Ontario, London, Ontario, Canada, and colleagues randomly assigned 628 patients with moderate to severely active Crohn’s to a single dose of IV placebo (n = 210), 130 mg of Stelara (ustekinumab, Janssen Biotech Inc.; n = 209) or weight-based tiered dosing of 6 mg/kg of ustekinumab (n = 209). Of all the patients, 418 received combined ustekinumab, according to the research.
“These patients had previously demonstrated a prior inadequate response or failure to tolerate corticosteroids or immunomodulators,” Feagan said during his presentation.
The primary endpoint was clinical response at 6 weeks. At 8 weeks, patients either transitioned to the maintenance study or had follow-up through 20 weeks, according to the research.
At 6 weeks, 51.7% of patients who received 130 mg of ustekinumab and 55.5% of patients who received 6 mg/kg of ustekinumab achieved a clinical response compared with 28% of patients who received placebo (P < .001).
At 8 weeks, 47% of patients who received 130 mg of ustekinumab and 58% of patients who received 6 mg/kg of ustekinumab achieved clinical response compared with 32% of patients who received placebo (P < .001).
Thirty-one percent of patients who received 130 mg of ustekinumab and 40% of patients who received 6 mg/kg of ustekinumab achieved clinical remission at 8 weeks.
Adverse events and serious adverse events were similar between the groups. No malignancies, deaths, opportunistic infections or tuberculosis occurred in patients treated with ustekinumab.
“Adverse events during or within an hour of infusion were infrequent, and did not occur at a higher rate in ustekinumab groups vs. placebo,” Feagan said.
Newman Yeilding, MD, head of immunology development at Janssen Research and Development stated in a press release: “The Stelara phase 3 UNITI-2 induction results are important findings, as induction of clinical response and clinical remission are important goals in the management of Crohn’s disease. We look forward to filing applications this year seeking approval of Stelara for the treatment of moderate-to-severe Crohn’s disease and remain committed to the continued development of this innovative medicine for the treatment of immune-mediated diseases.”
Feagan concluded: “Both IV ustekinumab induction regimens were well-tolerated, without higher rates of key safety events observed over IV placebo.” – by Melinda Stevens
Feagan B, et al. Abstract 54. Presented at: ACG; Oct. 16-21, 2015; Honolulu.
Disclosures: Yeilding is employed by Janssen. Please see the abstract for a full list of all other authors’ relevant financial disclosures.