July 2025

Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): A multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, Phase 2b trial

Lancet Gastroenterol Hepatol 2025;10:882–95 Doi: 10.1016/S2468-1253(25)00129-3

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.

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Efficacy and safety of upadacitinib for patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis

Front Immunol 2025;16:1586792 doi: 10.3389/fimmu.2025.1586792

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.

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June 2025

Comparative risk of incident malignancies in rheumatoid arthritis patients treated with janus kinase inhibitors or bDMARDs: observational data from the German RABBIT register

Ann Rheum Dis 2025;25:01024-6 doi: 10.1016/j.ard.2025.05.014

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.

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Clinical trial: Association between early disease clearance and long-term outcomes—4-year results from the Phase 3 UNIFI study of ustekinumab in ulcerative colitis

Alimentary Pharmacology & Therapeutics 2025;62:483–492 Doi: 10.1111/apt.70264

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.

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Risk of new-onset inflammatory bowel disease in psoriasis patients treated with five different interleukin inhibitors: a systematic review and meta-analysis

Front Immunol 2025;16:1594998 doi: 10.3389/fimmu.2025.1594998

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.

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Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study

Lancet Gastroenterol Hepatol 2025;10:507–19 doi: 10.1016/S2468-1253(25)00017-2

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.

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Frailty and cardiovascular safety of JAK inhibitors versus TNF inhibitors in rheumatoid arthritis: a real-world comparative study of drug effects and patient profiles

Front. Pharmacol. 2025;16:1565909 DOI: 10.3389/fphar.2025.1565909

Silvagni et al. aimed to comparatively assess the risk of cardiovascular events (CVE) in RA patients treated with JAKis or TNFis and to explore the interactions with patient profiles [including age, baseline cardio-cerebrovascular (CV) risk, and frailty, which is a state of decreased physiological reserve, assessed using a validated frailty index for Administrative Heathcare Databases (AHD)]. This AHD-based study highlighted no significantly increased risk of CVEs or MACEs for JAKis with respect to TNFis. The CV risk remains mainly driven by the patient profiles. The frailty, in parallel with baseline CV risk, emerged as an important determinant of CVEs, MACEs, and thromboembolic events (TEs). Frailty and baseline CV risk are key predictors of CVEs, MACEs, and TEs, and should be considered in both clinical assessment and trial design for RA patients on ts/b-DMARDs.

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Risk of major adverse cardiovascular events and venous thromboembolic events between patients with psoriasis or psoriatic arthritis on tumor necrosis factor inhibitors, interleukin 17 inhibitors, interleukin 12/23 inhibitors, and interleukin 23 inhibitors: An emulated target trial analysis

J Am Acad Dermatol 2025;92:1015-23 DOI: 10.1016/j.jaad.2024.12.025

Chen et al. investigated the risk of MACE and VTE among patients with biologic-naïve psoriasis or PsA receiving biologic therapy. No significant difference in the risks of MACE and VTE was found between new biologics (IL-17i, IL-12/23i, or IL-23i) and TNFi.

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Appendicectomy plus standard medical therapy versus standard medical therapy alone for maintenance of remission in ulcerative colitis (ACCURE): a pragmatic, open-label, international, randomised trial

Lancet Gastroenterol Hepatol. 2025; 10: 550–61 DOI: 10.1016/S2468-1253(25)00026-3

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.

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May 2025

Four-year secukinumab treatment outcomes in European real-world patients with axial spondyloarthritis and psoriatic arthritis

Joint Bone Spine 2025;92:105-824 doi: 10.1016/j.jbspin.2024.105824

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.  

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