Publications

Mirikizumab was evaluated for its ability to achieve disease clearance (DC) across two years in adults with moderately to severely active ulcerative colitis within the LUCENT trial programme. DC required concurrent symptomatic, endoscopic, and histologic remission.

Danese et al. report that in the TUSCANY-2 study, afimkibart showed a favourable
benefit–risk profile with clinically meaningful improvements and early onset of response during induction, sustained through maintenance, and an acceptable safety profile with no safety signals. Danese et al. describe results from the Phase 2b TUSCANY-2 trial that evaluated the safety and efficacy of 50mg, 150mg, and 450mg doses of afimkibart in adults with moderately-to-severely active UC.

Danese et al. showed that patients who achieved disease clearance 8 weeks after ustekinumab induction were more likely to be in long-term clinical, symptomatic and quality of life remission with ustekinumab maintenance treatment than patients who did not. Authors evaluated disease clearance in the Phase 3 UNIFI program and its association with long-term outcomes.

Danese et al. observed that efmarodocokin alfa did not demonstrate efficacy compared to the PBO, and this Phase II study ended early for futility; however, there was evidence of target engagement (skin AEs, regenerating islet derived protein 3-alpha).

Vermeire et al. provides data that supports the long-term efficacy and safety of obefazimod 50mg QD, with a substantial proportion of patients achieving clinical remission at Weeks 48 and 96. Vermeire et al. evaluated the 2-year outcome data of an OLM study, which assessed the long-term safety and efficacy of obefazimod 50mg QD.

This interim analysis by Panaccione et al. supports the positive long–term risk–benefit profile for UPA 15mg and 30mg among patients with moderately to severely active UC. U–ACTIVATE is a Phase 3 LTE study evaluating the long-term safety and efficacy of UPA in patients with moderately to severely active UC who enrolled in the preceding induction and maintenance studies. Panaccione et al. reported the interim results from the U-ACTIVATE study after approximately 3 years of total treatment, showing that the risk–benefit profile of UPA in patients with moderately to severely active UC is favourable.

The ACCURE Study Group aimed to evaluate the clinical effectiveness of laparoscopic appendicectomy in maintaining remission in patients with UC. Authors showed that appendicectomy is a viable and safe strategy for reducing the relapse rate in patients with UC compared with standard medical therapy at 1 year, offering a potential addition to standard medical therapies.

Reinisch W, et al. report that the efficacy of RZB induction therapy is independent of CS use, with high rates of CS-free outcomes observed in the overall population and among patients with baseline CS use.