July 2025

Long-term cardiovascular safety of ustekinumab in psoriasis and psoriatic arthritis: Results from an observational postauthorization safety study based on Swedish national registers

J Am Acad Dermatol 2025;93:104–14 doi: 10.1016/j.jaad.2025.03.016

In this nationwide study of Swedish PsO and PsA patients treated with ustekinumab, etanercept, adalimumab, or secukinumab, spanning more than 10 years, the overall risk of MACE was low across treatment groups. There was no meaningful difference in risk of MACE between ustekinumab and the other treatments.

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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).

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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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June 2025

Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study

Journal of Crohn's and Colitis 2025;19:jjaf074 doi: 10.1093/ecco-jcc/jjaf074

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.

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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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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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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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Prevalence and predictors of achieving sustained remission in psoriatic arthritis. A Swedish nationwide registry study

J Rheumatol 2025 doi: 10.3899/jrheum.2024-1250 Epub ahead of print

Palsson et al. aimed to estimate the prevalence and predictors of ever achieving remission and sustained remission (SR) in PsA patients initiating b/tsDMARDs therapy in Sweden, using three different remission criteria (DAPSA28, DAS28CRP and EGA). Palsson et al. found that despite increased availability and a wider selection of b/tsDMARDs with different modes of action, a considerable proportion of PsA patients receiving such treatments never achieve remission and approximately half never achieve SR. Fewer swollen joints at baseline predicted a greater likelihood of SR according to all assessed remission definitions, while male sex predicted the likelihood of SR according to DAPSA28 and EGA.

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Deucravacitinib in patients with plaque psoriasis who screened positive for psoriatic arthritis: improvements in joint pain and the impact of musculoskeletal symptoms

Dermatol Ther (Heidelb) 2025 DOI: 10.1007/s13555-025-01428-9

Merola et al. undertook a post hoc analysis of prospective cohorts that compared the effects of deucravacitinib vs placebo and vs apremilast on joint pain, and the impact of musculoskeletal symptoms, at Weeks 16 and 24 in the pooled POETYK PSO-1 and PSO-2 populations who self-reported joint symptoms on the PASE questionnaire. Patients who screened positively for PsA reported greater improvements in joint pain and peripheral joint disease with deucravacitinib vs placebo at Week 16 and vs apremilast at Week 24. Findings from this pooled analysis suggest that deucravacitinib may be used to treat both dermatologic and joint symptoms effectively in patients with psoriasis and probable arthritis.

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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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