The 4-year results of the UNIFI long-term extension study show ustekinumab is safe and effective in moderate to severe UC.

The interleukin 12/23p40 antagonist ustekinumab is already approved for the treatment of moderate to severe UC. Silvio Danese, MD, PhD, of Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital in Italy, presented the final clinical outcomes based on the full Mayo score, including the endoscopy subscore from the UNIFI LTE study through 4 years of ustekinumab treatment.

The researchers re-randomized 523 patients who responded to therapy with ustekinumab 8 weeks after IV induction in the maintenance study. In that study, they were treated either with 90 mg ustekinumab every 8 weeks or every 12 weeks. In total, 284 patients completed week 44 and entered the long-term extension until week 200. From week 56 onward, dose adjustments were possible at any time based on the clinical judgement of the investigator. In the analysis, all patients of the long-term extension were included that either had Mayo score data including endoscopy at week 200 or experienced treatment failure before week 200 and were imputed as non-responder.

At week 200, 58% of the patients were in clinical remission (defined as a Mayo score ≤2 points and no individual subscore >1). “Overall, there were very similar results for the 12-week and 8-week dose intervals,” Dr. Danese said.

Most patients (80%) showed a clinical response (defined as a decrease in Mayo score of ≥30% and ≥3 points from induction baseline with either a decrease in rectal bleeding subscore of ≥1 from induction baseline or a rectal bleeding subscore of 0 or 1). In addition, 67.3% achieved endoscopic improvement with an endoscopy subscore of 0 or 1; again, there were no major differences according to the dose intervals. “Around 30% of patients need a shorter dose interval,” Dr. Danese noted.

In conclusion, the UNIFI LTE study showed that approximately two-thirds of patients with moderate to severe UC treated with ustekinumab were in clinical remission, clinical response, and/or demonstrated endoscopic improvement after 4 years. According to Dr. Danese, it is unique to include endoscopy in a study over such a long time period.

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