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Stelara Maintains Clinical Response, Remission Through 2 Years in Crohn’s Disease
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Patients with moderate-to-severe active Crohn’s disease maintained clinical response and remission with Stelara for up to 2 years, according to data from the ongoing IM-UNITI long-term extension study presented at the 12th Congress of the European Crohn’s and Colitis Organization.
Stelara (ustekinumab, Janssen) is the first biologic for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines. It was approved by the FDA in September 2016 and shortly after by the European Commission in November for patients with moderate-to-severe active Crohn’s disease for whom previous therapies have failed.
William J. Sandborn
“Maintaining control of disease symptoms is paramount in the treatment of Crohn’s disease,” William J. Sandborn, MD, chief of the division of gastroenterology and professor of medicine at University of California, San Diego School of Medicine, said in a press release. “The 2-year clinical response and remission rates from the IM-UNITI study provide further evidence that ustekinumab can be an effective therapeutic option for people living with this chronic and often debilitating disease.”
Overall, 1,281 patients entered the IM-UNITI maintenance study, of whom 397 were responders in the UNITI-1 and -2 induction trials. Sandborn and colleagues randomly assigned these responders to receive 90 mg subcutaneous maintenance injections every 8 or 12 weeks, or placebo for 44 weeks.
They found significantly greater proportions of patients receiving either dose of ustekinumab were in remission at 44 weeks, which served as the primary endpoint; 53.1% of the every 8-week dose group and 48.8% of the 12-week dose group were in remission vs. 35.9% of the placebo group (P = .005 and P = .04, respectively).
Then, 567 randomized and non-randomized patients treated with ustekinumab entered the IM-UNITI long-term extension (LTE) period, which was unmasked after week 44, and will span weeks 44 to 252, from which Sandborn and colleagues presented interim data at the ECCO Congress.
Randomized patients who lost response to the every 8-week ustekinumab dose between weeks 8 and 32 were allowed a single dose adjustment before entering the LTE phase.
At week 96, 79.2% of the 77 patients who continued to receive ustekinumab every 12 weeks and 87.1% of the 70 patients who continued to receive ustekinumab every 8 weeks were in remission. Further, 90.9% and 94.3%, respectively, had clinical response at week 92, and when pooling all 516 patients treated with ustekinumab through week 96, 70.7% achieved remission and 84.7% achieved clinical response at week 92.
Finally, Sandborn and colleagues observed no new safety signals, and safety events were comparable between treatment and placebo groups. Two deaths and a seminoma occurred in patients treated with ustekinumab and a papillary thyroid cancer occurred in a patient who only received placebo. – by Adam Leitenberger
Reference:
Sandborn WJ, et al. Abstract OP010. Presented at: ECCO Congress; February 15-18, 2017; Barcelona.
Disclosures: Sandborn reports financial relationships with Janssen and numerous other financial disclosures. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures.