A randomized Phase II study of efmarodocokin alfa, an interleukin-22 agonist, versus vedolizumab in patients with ulcerative colitis

Clinical Gastroenterology and Hepatology 2025;23:1387–1397 doi: 10.1016/j.cgh.2024.11.013

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).

Brandt-Jürgens et al. identified a difference between the incidence rates of uveitis in patients with PsA or axSpA when treated with secukinumab compared to placebo. The authors conducted a post hoc analysis of 11 placebo-controlled clinical trials which has observed that uveitis incidences in patients with PsA are consistent with clinical trial data, and patients with axSpA show a lower incidence of uveitis compared to other publications.

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.

UPA has shown effectiveness in treating IMIDs like RA, axSpA, PsA, CD, and UC. Chai et al. evaluated evidence from a synthesis of RCTs and provided insights that may guide clinical decision-making and improve treatment outcomes for IMIDs. UPA effectively alleviated symptoms, reduced disease activity, and showed notable benefits in improving quality of life.

June 2025

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.

Wieczorek et al. present the first evidence supporting the use of a dual JAK and ROCK inhibitor as a potential treatment option for patients with RA who have inadequate response to MTX. Wieczorek et al. conducted a randomised, Phase 2 study of CPL’116 in patients with RA with inadequate response to MTX, to evaluate dose-dependent effects on disease control and pharmacokinetics, and its effect on laboratory abnormalities among other safety assessments.

Heiting et al. investigated whether the initiation of IL-17 blockade with secukinumab improves bone turnover, bone mineral density, and microarchitecture in axSpA patients. Despite symptomatic benefits of therapy with secukinumab, with improvements in pain and function, there were few biochemical, densitometric, or microarchitectural changes in skeletal health over two years of treatment with secukinumab. Larger, longer-term controlled studies using sensitive metrics such as HR-pQCT to follow bone quality are needed to improve our understanding of bone health in axSpA and the relation to disease activity and therapy.

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.

May 2025

Lin et al. compared the risk of CVD in patients with psoriasis who were prescribed biologics or oral therapies and assessed the association between different classes of biologics and CVD risk. Patients with psoriasis-prescribed biologics exhibited a reduced risk of incident CVDs compared with those receiving oral antipsoriatic drugs.