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.

Merola et al. showed that the safety profile of ixekizumab (IXE) supports its long-term use in patients with PsO, PsA, or axSpA, without an increased risk for malignant neoplasm development. Merola et al. investigated the incidence rates of malignant neoplasms among patients with PsO, PsA, or axSpA who underwent long-term treatment with IXE, an IL- 17A antagonist.

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.

Schaefer et al. showed that treatment with JAKis (predominantly BARI and TOF) was associated with an increased HR of malignancies compared to treatment with bDMARDs in the overall study cohort, consistent with results from the ORAL surveillance trial. To better understand the complex role of JAKis in cancer development in RA patients, Schaefer et al. estimated the effects of JAKis compared to bDMARDs on the risk of malignancy (excluding NMSC) in patients with RA.

June 2025

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.

Zhang et al. observed that, compared to the control group, ixekizumab was associated with an increased risk of new-onset IBD in psoriasis patients, and that there is insufficient evidence to confirm that ustekinumab, bimekizumab, secukinumab, and brodalumab significantly increase the risk of new-onset IBD. Zhang et al. evaluated the risk of new-onset IBD in psoriasis patients treated with five IL inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab, and ustekinumab), providing insights to inform clinical decision-making. Additionally, compared to the control group, no significant difference was observed in the risk of diarrhoea as an AE.

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.

In more than 1500 patients from 13 European countries, Pons et al. demonstrated that secukinumab retention rates after four years were approximately 50% in both axSpA and PsA patients. Pons et al. aimed to assess retention rates and proportions of patients achieving remission and LDA, according to disease activity measures and patient-reported outcomes at 24 and 48 months, in axSpA and PsA patients initiating secukinumab. In this large real-world study, Pons et al., for the first time, report 48-month retention rates as well as rates of remission and LDA. Importantly, b/tsDMARD naïve patients demonstrated higher retention, remission and LDA rates than patients with prior b/tsDMARDs exposure, particularly in axSpA.