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UNITI-1: Stelara induction therapy safe, effective in moderate-to-severe refractory Crohn’s disease

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Stelara was well tolerated and induced clinical response and remission in patients with moderate-to-severe Crohn’s disease refractory to antitumor necrosis factor therapy, according to research presented at the European Crohn’s and Colitis Organization’s Congress.

Stelara (ustekinumab, Janssen) is a monoclonal antibody that targets interleukin-12 and -23 cytokines, “which are believed to play a role in immune-mediated diseases, including Crohn’s disease,” according to a press release.

Paul Rutgeerts

“The UNITI-1 study results show that ustekinumab ... is an efficient and safe biologic treatment for patients with moderate-to-severe Crohn’s disease who have already failed or were intolerant to antibodies against TNF,” Paul Rutgeerts, MD, professor of medicine and former director of the multidisciplinary department of endoscopy at Catholic University of Leuven, Belgium, told Healio Gastroenterology.

In this phase 3, double blind, multicenter trial, Rutgeerts and colleagues randomly assigned 741 Crohn’s disease patients with previous failure or intolerance to at least one TNF antagonist to receive a single dose of IV placebo, 130 mg ustekinumab, or a weight-based tiered dose of ustekinumab of about 6 mg/kg.

Clinical response at 6 weeks served as the primary endpoint. At 8 weeks, patients transitioned to the IM-UNITI maintenance study or completed safety follow-up through 20 weeks.

The primary endpoint was achieved by 33.7% of the tiered dose group and 34.3% of the 130 mg dose group vs. 21.5% of the placebo group (P = .003 and P = .002, respectively).

Clinical remission at week 8 was achieved by 20.9% and 15.9% vs. 7.3% (P < .001 and P = .003, respectively); clinical response at week 8 was achieved by 37.8% and 33.5% vs. 20.2% (P .001 for both). A 70-point response in Crohn’s Disease Activity Index (CDAI) at week 6 was achieved by 43.8% and 46.1% vs. 30.4% (P = .002 and P < .001, respectively), and at the first visit after baseline at week 3 by 40.6% and 38.4% vs. 27.1% (P = .001 and P = .009, respectively).

Both ustekinumab dose groups also achieved significant improvements in CDAI, IBD-Questionnaire, C-reactive protein, fecal lactoferrin and calprotectin compared with the placebo group. Further, adverse events, serious adverse events and infections occurred in comparable proportions. Listeria meningitis occurred in one patient in the tiered dose group, and no malignancies, deaths, major adverse cardiovascular events or tuberculosis occurred in the ustekinumab groups through 20 weeks of follow-up.

“The UNITI-2 study shows that Stelara is also efficacious in patients who have only failed or were intolerant to conventional therapies (steroids, immunomodulators). These results show that Stelara not only can be used to control disease in patients who have already failed anti-TNF but is also suitable to be used as a first-line biologic in patients who have not responded to conventional Crohn’s disease therapies,” Rutgeerts said. “Therefore, this drug is an important new treatment approach in Crohn’s disease. The results of the completed IM-UNITI study will show whether Stelara is also efficacious to maintain treatment benefit over the long-term in these patient populations with the excellent safety observed in the induction studies.”

Applications for approval of ustekinumab for moderate-to-severely active Crohn’s disease are currently under review in the U.S. and Europe, according to a press release. Ustekinumab is currently approved in many countries for moderate-to-severe plaque psoriasis and active psoriatic arthritis. – by Adam Leitenberger

Reference:

Rutgeerts P, et al. Abstract OP014. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.

Disclosure: Rutgeerts reports he received personal fees from Johnson & Johnson during the conduct of the study, and has received personal fees from Johnson & Johnson, Amgen, AstraZeneca, Medimmune, Merck, UCB, Genentech, BMS, AbbVie, Takeda and Robarts outside of this study. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures.