October 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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Relationship of radiographic progression status to low disease activity in patients with PsA receiving secukinumab treatment for 2 years

Rheumatology 2025;0:1–8 Doi:10.1093/rheumatology/keaf488

Mease et al. report that patients without radiographic progression through 2 years of secukinumab treatment had greater achievement of LDA states at Week 104 than patients with radiographic progression. This post hoc analysis by Mease et al. of the FUTURE 5 study evaluated the relationship between radiographic progression status at Week 104 and achievement of LDA or remission and identified demographics and clinical characteristics that were associated with radiographic progression status at Week 104.

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Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: Results through Week 24 of the Phase 3b, randomised, double-blind, placebo-controlled APEX study

Ann Rheum Dis 2025;0:1−12 Doi: 10.1016/j.ard.2025.08.006

Mease et al. showed that guselkumab provided significantly higher rates of clinical improvement and significant inhibition of structural damage progression versus PBO, with no new safety signals, at Week 24 in biologic-naïve participants with active and erosive PsA. Mease et al. report primary efficacy and safety results for the double-blind PBO-controlled phase (Weeks 0-24) of the 3-year APEX study.

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Impact of dactylitis and enthesitis resolution on disease control in guselkumab-treated psoriatic arthritis patients with TNFi-IR: COSMOS post hoc analysis

Rheumatology 2025;00:1–10 Doi: 10.1093/rheumatology/keaf490

Marzo-Ortega et al. report that dactylitis and enthesitis are associated with a greater disease burden and worse prognosis, highlighting the importance for physicians to identify these conditions and provide adequate treatment. Authors evaluated guselkumab’s efficacy on dactylitis resolution (DR) and enthesitis resolution (ER), and their impact on subsequent disease control, in patients with active PsA and prior inadequate response to tumour necrosis factor inhibitors (TNFi-IR).

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Sonelokimab, an IL-17A- and IL-17F- inhibiting nanobody for active psoriatic arthritis: A randomized, placebo-controlled Phase 2 trial

Nat Med 2025; doi.10.1038/s41591-025-03971-6. Epub ahead of print

In this first global clinical study of a nanobody in inflammatory arthritis, sonelokimab, an
IL-17A- and IL-17F-inhibiting nanobody demonstrated strong efficacy across multiple domains including high-hurdle composite joint and skin responses. McInnes et al. reported on the Phase 2, randomized, double-blind, PBO-controlled ARGO trial which evaluated the efficacy and safety of sonelokimab in patients with active PsA.

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September 2025

Risk of adverse events of psoriasis treatment with biologic agents and new small molecules—BIOBADADERM Registry

J Eur Acad Dermatol Venereol 2025;39:1643–55 Doi: 10. 1111/ jdv. 20831

This study by Olivares-Guerrero et al. provides comparative safety data from a clinical practice point of view, potentially contributing to facilitate the drug selection process for clinicians. New biologic treatments have a superior safety profile in real-world practice compared to adalimumab and its biosimilars. Olivares-Guerrero et al. used data from the BIOBADADERM registry of AEs to analyse the long-term safety profile of systemic treatments, including biological agents as well as new small oral molecules approved for the treatment of moderate-to-severe PsO, using adalimumab and its biosimilars as comparators.

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Cardiovascular safety of systemic psoriasis treatments: A prospective cohort study in the BIOBADADERM registry

J Eur Acad Dermatol Venereol 2025;39:1631–42 https:// doi. org/ 10. 1111/ jdv. 20828

This study by Lluch-Galcerá et al. provides valuable RWE to inform personalized clinical decision-making in the treatment of PsO. Authors evaluated the incidence of MACE associated with each systemic treatment used for patients with PsO and compared these rates to those observed with MTX.

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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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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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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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