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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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

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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July 2025

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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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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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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May 2025

Efficacy and safety of zimlovisertib, ritlecitinib and tofacitinib, alone and in combination, in patients with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate

Arthritis Rheumatol. 2025 doi: 10.1002/art.43184 Epub ahead of print

Phase 2 study data show that zimlovisertib + tofacitinib was more effective than tofacitinib alone, in patients with moderate-to-severe RA and an inadequate response to MTX.

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April 2025

Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies

RMD Open. 2025;11:e005026. doi: 10.1136/rmdopen-2024-005026.

Mease et al. found that bimekizumab demonstrated a favourable long-term safety profile in patients with axSpA and PsA.

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February 2025

Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial

Lancet Gastroenterol Hepatol. 2025;10:210–221. doi: 10.1016/S2468-1253(24)00386-8.

Sands et al. evaluated tamuzimod, a selective sphingosine 1-phosphate receptor 1 modulator, in patients with moderately-to-severely active UC. At Week 13, clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) was achieved by 28% and 24% of patients receiving tamuzimod 60 mg and 30 mg, respectively, compared with 11% in the placebo group. The treatment was well tolerated; most AEs were mild or moderate.

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Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension

MD Open. 2025;11:e005081 doi: 10.1136/rmdopen-2024-005081

Deodhar et al. assessed the long-term safety, tolerability and efficacy of bimekizumab in patients with r-axSpA over five years. The study found that bimekizumab maintained disease control achieved at Wk48 through Wk256, with no new safety signals observed. Adverse events were consistent with previous reports, and clinical benefits, including improvements in disease activity and patient-reported outcomes, were sustained.

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