Long-term data supports the established efficacy and safety of ustekinumab in UC

The UNIFI long-term extension study demonstrated that approximately two-thirds of patients with moderate-to-severe ulcerative colitis (UC) were in clinical remission after 4 years. Moreover, no new safety signals were observed.

“For the first time, an endoscopy outcome is included in a long-term study,” emphasised Prof. Silvio Danese (Vita-Salute San Raffaele University, Italy). Prof. Danese presented the final clinical outcomes based on the full Mayo score, including the endoscopy subscore, of the UNIFI LTE (NCT02407236) study through 4 years of ustekinumab treatment [1]. The IL-12/23p40 monoclonal antibody ustekinumab has already been approved for the treatment of moderate-to-severe UC.

The maintenance study re-randomised 523 participants who responded to ustekinumab therapy 8 weeks after intravenous induction. In the maintenance study, the participants were treated with either 90 mg ustekinumab every 8 weeks or every 12 weeks. The participants who completed week 44 (n=284), entered a long-term extension until week 200. From week 56 onwards, dose adjustments were possible at any time based on the clinical judgement of the investigator. In the analysis, all patients with long-term extension were included who either had Mayo score data including endoscopy at week 200 or experienced treatment failure before week 200 (imputed as non-responder).

At week 200, 58% of the participants were in clinical remission (defined as a Mayo score ≤2 points and no individual subscore >1; see Figure). “Overall, there were very similar results for the 12-week and 8-week dose intervals,” Prof. Danese said. 80% of participants showed a clinical response (defined as a decrease in Mayo score of ≥30% and ≥3 points from the induction baseline with either a decrease in rectal bleeding subscore of ≥1 from the induction baseline or a rectal bleeding subscore of 0 or 1). In addition, 67.3% of participants achieved endoscopic improvement with an endoscopy subscore of 0 or 1, with no major differences according to the dose intervals. “Around 30% of patients need a shorter dose interval,” Prof. Danese commented on his experience.

Figure: Clinical and endoscopic outcomes after 4 years of ustekinumab treatment in the UNIFI LTE study [1]



Q8w, every 8 weeks; q12w; every 12 weeks; UST, ustekinumab.

In conclusion, the UNIFI LTE study showed that approximately two-thirds of participants with moderate-to-severe UC treated with ustekinumab were in clinical remission, clinical response, and/or demonstrated endoscopic improvement after 4 years. With continued ustekinumab treatment in the long-term extension, clinical remission was generally maintained through week 200 among participants who were in clinical remission at maintenance baseline or after 1 year of ustekinumab maintenance treatment.

1. Danese S, et al. Efficacy of ustekinumab for Ulcerative Colitis through 4 years: Final clinical and endoscopy outcomes from the UNIFI long-term extension. OP15, ECCO 2023, 1-4 March, Copenhagen, Denmark.

Posted on 4 May 20238 April 2024