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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Roflumilast foam, 0.3%, for psoriasis of the scalp and body the ARRECTOR Phase 3 randomized clinical trial

JAMA Dermatol 2025;7:698–706 doi: 10.1001/jamadermatol.2025.1136

Gooderham et al. observed that roflumilast foam, 0.3%, improved signs and symptoms of PsO on the scalp and body, including pruritus, with low rates of AEs in patients ≥12 years of age. Authors assessed efficacy and safety of roflumilast foam, 0.3%, versus vehicle administered QD for 8 weeks in patients with PsO of the scalp and body.

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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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Uveitis in patients with axial spondyloarthritis or psoriatic arthritis: A post hoc analysis from placebo-controlled Phase 3 studies with secukinumab

Ther Adv Musculoskelet Dis. 2025;17:1–7

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.

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Ixekizumab and malignant neoplasms A pooled analysis of data from 25 randomized clinical trials

Merola et al. JAMA Dermatol 2025; 9:e252056

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.

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Dual JAK and ROCK inhibition with CPL’116 in patients with rheumatoid arthritis with inadequate response to methotrexate: a randomised, double-blind, placebo controlled, phase 2 trial

Lancet Rheumatol 2025;25:00060-8 doi: 10.1016/S2665-9913(25)00060-8

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.

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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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Benefit–risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease

RMD Open 2025;11:e005371 doi: 10.1136/rmdopen-2024-005371

Burmester et al. provide insights into the benefit–risk profiles of UPA and adalimumab in patients with varying cardiovascular (CV) risks, suggesting that UPA may offer efficacy advantages over adalimumab irrespective of baseline CV risk, with generally similar rates of AEs. To better understand the benefits and risks of RA treatments in patients with different background CV risk, Burmester et al. assessed the short-term and long-term benefit–risk profiles of UPA and adalimumab in patients enrolled in SELECT-COMPARE.

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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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