Stelara Study Shows Efficacy for Ulcerative Colitis

Stelara (ustekinumab) demonstrated strong efficacy and safety throughout 4 years of treatment in adult patients with moderately to severely active ulcerative colitis (UC), the Janssen Pharmaceutical Companies of Johnson & Johnson said at the United European Gastroenterology (UEG) Week 2022 congress¹ in Vienna, Austria, October 8-11.

Janssen’s long-term extension (LTE) of its Phase 3 UNIFI study found that, among all patients who had achieved clinical response with Stelara during induction, 64.9% were in symptomatic remission after 44 weeks of maintenance, the pharmaceutical maker said in a news release.²

The majority (96.4%) were not receiving corticosteroids. Among the 174 patients receiving Stelara as their first biologic for UC (biologic-naïve), 71.8% were in symptomatic remission after 44 weeks of maintenance, and 67.2% were in remission at 4 years.

A separate presentation³ of UNIFI LTE study data showed the majority (79%) of Stelara randomized patients who received corticosteroids at maintenance baseline and were treated with Stelara in the LTE were able to eliminate the use of corticosteroids by 4 years.

In the 4-year corticosteroid-sparing data, which included patients receiving 90 mg of Stelara every 8 weeks (q8w) or every 12 weeks (q12w) at baseline, 94.8% in the q8w group and 97.9% in the q12w group were corticosteroid-free.

The final LTE results of the UNIFI study demonstrated that Stelara can be an effective long-term treatment option for patients living with moderately to severely active UC, including in patients who are biologic-naïve," said UNIFI presenting study author Waqqas Afif, MD, associate professor the Division of Experimental Medicine and Division of Gastroenterology at McGill University Health Centre in Montreal, Quebec, in the news release.

"Importantly, the vast majority of patients who achieved remission in the study were able to eliminate the use of steroids, which can cause significant side effects and are not a long-term treatment solution for the disease,” Afif added.

Stelara is already approved in the United States to treat adults with moderately to severely active UC. It is also approved for adults and children aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adults and children aged 6 years and older with active psoriatic arthritis; and adult patients with moderately to severely active Crohn's disease.

References

1. Afif W, Abreu MT, Danese S, et al. Efficacy and safety of ustekinumab for ulcerative colitis through 4 years: final results from the UNIFI long-term extension. Poster PO396. Presented at: UEG Week 2022, October 8-11 2022; Vienna, Austria.
2. Stelara (ustekinumab) demonstrated sustained symptomatic and corticosteroid-free remission through four years in adults with moderately to severely active ulcerative colitis. News release. Janssen. Published October 10, 2022. Accessed October 10, 2022. https://www.prnewswire.com/news-releases/stelara-ustekinumab-demonstrated-sustained-symptomatic-and-corticosteroid-free-remission-through-four-years-in-adults-with-moderately-to-severely-active-ulcerative-colitis-301644223.html
3. Arasaradnam RP, Scherl EJ, Rowbotham D, et al. Corticosteroid-sparing effects of ustekinumab therapy for ulcerative colitis through 4 years: UNIFI long-term extension. Poster PO395. Presented at: UEG Week 2022, October 8-11 2022; Vienna, Austria.