August 2025

Safety profile of upadacitinib: Descriptive analysis in over 27,000 patient‑years across rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, and inflammatory bowel disease

Adv Ther 2025 Doi: 10.1007/s12325-025-03328-y Epub ahead of print

This descriptive analysis indicates a long-term safety profile of UPA consistent with previous reports, further supporting long-term treatment of chronic diseases with UPA. Burmester at al. characterized the safety profile of UPA across multiple approved indications and offer insights into its long-term use to help inform clinical decision-making.

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Comparative effectiveness and safety of adalimumab, secukinumab, and upadacitinib in psoriatic arthritis: A prospective cohort study based on PARWCH cohort

J Dermatol 2025 Doi: 10.1111/1346-8138.17906 Epub ahead of print

Wang et al. validated the effectiveness and safety of UPA in this real-world study of Chinese PsA patients. UPA demonstrated comparable effectiveness to secukinumab (SEC) in psoriatic lesion improvement while showing comparable joint symptom relief compared with adalimumab (ADA), coupled with a favourable safety profile.

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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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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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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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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

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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