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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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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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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December 2024

Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat through study

Lancet 2024;404:2423–36 doi: 10.1016/S0140-6736(24)01762-8

Ferrante et al. conducted a phase 3 trial evaluating the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease. The study demonstrated that mirikizumab significantly improved clinical and endoscopic outcomes compared with placebo at week 52, with a favourable safety profile and tolerable adverse events.

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June 2024

Efficacy and safety of ustekinumab for ulcerative colitis through 4 years: Final results of the UNIFI long-term maintenance study

Am J Gastroenterol. 2024;119:910–21 doi: 10.14309/ajg.0000000000002621

Long-term SC maintenance therapy of q8w and q12w ustekinumab in patients who responded to IV ustekinumab induction was safe and effective at maintaining symptomatic remission. Investigators aimed to present the final efficacy and safety results of the UNIFI LTE study through 4 years.

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October 2023

生物学的製剤と低分子化合物で治療している免疫介在性炎症疾患患者の主要心血管イベントリスク: ネットワークメタ解析

CClin Gastroenterol Hepatol 2023;22:961-970.e12

The results of this study show that anti-IL-12/23, JAK inhibitors, and anti-TNF-α were associated with slightly higher risk of MACE compared with placebo. The risk was no different between biologic treatments, and the magnitude of risk did not differ between IMID type.

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ウステキヌマブまたはTNF阻害薬で加療された乾癬性関節炎の性差: 実臨床データ

Rheumatology (Oxford) doi:10.1093/rheumatology/kead089.

Real-world data from the PsABio study indicated that females with PsA had more severe disease than males before the initiation of treatment. While both genders experienced treatment related improvements, fewer females than males were able to achieve a favourable disease state within 12 months. Treatment discontinuation and switching were also higher in females than males, due to lower efficacy and adverse events.      

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June 2023

乾癬性関節炎患者における3年間のウステキヌマブまたはTNF阻害薬の患者報告アウトカムと労働生産性の改善: PsABio 実臨床結果

Arthritis Res Ther. 2023 Jun 23;25(1):109. doi: 10.1186/s13075-023-03058-y

Results from the 3-year PsABio study demonstrated that, generally, ustekinumab and TNFi treatment led to an improvement in PROs. In coming to this conclusion, researchers aimed to evaluate the real-world effect of ustekinumab or a TNFi on PRO and their association with effectiveness endpoints in PsA patients over 3 years.

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March 2023

ウステキヌマブまたはTNF阻害薬で治療した乾癬性関節炎患者における性差: 実臨床データ

Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/kead089

These real-world data from PsABio on gender differences suggest that, at the start of biologic treatment, females have a worse clinical picture of PsA than males. In coming to these conclusions and others, this study sought to investigate effects of gender on disease characteristics and treatment impact in patients with PsA.

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November 2022

乾癬または乾癬性患者でウステキヌマブまたは他の生物学的製剤を開始後の重篤感染症による入院リスク

Arthritis Care Res (Hoboken) 2022 doi: 10.1002/acr.24630

In this investigation it was concluded that other biologics and apremilast were associated with a 1.4- to 3-times higher risk of hospitalisation for serious infections in PsO/PsA patients when compared to ustekinumab. These findings should be considered in the safety profile of these therapies when selecting appropriate treatment regimens in patients with PsO/PsA.

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