ArticleTrials2021
Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study-the BeNeBio study.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04340076 (Dose Reduction of the New Generation Biologicals), which is not on this map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study
Who cites it
10 citing papers in PubMed, 21 citations in OpenAlex.
- International consensus on dose reduction of biologics for patients with psoriasis: The DR. Delphi study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis (BeNeBio study): An International, Pragmatic, Multicentre, Randomised, Controlled, Non-Inferiority Trial.The Lancet regional health. Europe · 2026Article
- Bridging theory and practice in model-informed precision dosing of medication in inflammatory skin diseases.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Impact of Disease Activity-Guided Dose Reduction on IL-17 and IL-23 Inhibitors in Psoriasis: A Real-World Assessment of Efficacy, Safety, and Economic Benefits.Dermatology practical & conceptual · 2025Article
- Real-world Cost per Responder Among Different Classes of Biologics for the Treatment of Psoriasis.Acta dermato-venereologica · 2025Article
- IL-17 and IL-23 inhibitors dose spacing in adult psoriatic patients: a real-world pilot study.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025Article
- Dose Modulation Strategies in Psoriatic Patients: Real-Life Pilot Comparison Between Risankizumab and Guselkumab up to 12 Months After Dose Spacing.Experimental dermatology · 2025Article
- Risankizumab for the Treatment of Moderate to Severe Psoriasis: Impact on Health-Related Quality of Life and Psychological Wellbeing.Clinical, cosmetic and investigational dermatology · 2023Review
- Real-world Data Reveal Long Drug Survival for Guselkumab in Patients with Plaque Psoriasis.Acta dermato-venereologica · 2022Article
- Cytokine Profiles and the Relationship of Disease Severity in Patients with Psoriasis.Indian journal of dermatologyArticle
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundPsoriasis is a chronic immune-mediated inflammatory skin disease for which biologics are effective treatments. Dose reduction (DR) of the first generation biologics seems a promising way for more efficient use of expensive biologics. A substantial part of patients on tumor necrosis factor (TNF)-alfa inhibitors and ustekinumab could successfully lower their dose, after following a tightly controlled DR strategy. The objective of this study is to assess whether controlled DR of interleukin (IL)-17 and IL-23 inhibitors in psoriasis patients with low disease activity is non-inferior (NI) to usual care (UC).
methodsThis is an international, prospective, multicenter, pragmatic, randomized, non-inferiority trial. A total of 244 patients with stable low disease activity (Psoriasis Area and Severity Index (PASI) ≤ 5) for at least 6 months and using secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab in the standard dose, together with stable low disease activity, defined as a PASI ≤ 5 and Dermatology Life Quality Index (DLQI) ≤ 5 at the moment of inclusion, will be randomized 2:1 to DR or UC. In the DR group, dosing intervals will be prolonged stepwise to achieve 66% and 50% of the original dose. Disease activity is monitored every 3 months by PASI and DLQI. In case of disease flare (i.e., PASI and/or DLQI increase), treatment is adjusted to the previous effective dose. The primary outcome is the incidence proportion of persistent flares (PASI > 5 for ≥ 3 months), which will be compared between arms. Secondary outcomes include proportion of patients with successful DR, (course of) PASI and DLQI, serious adverse events (SAEs), health-related quality of life, costs, and pharmacokinetic profile. Outcomes of DR will be compared to UC. DISCUSSION: With this study, we aim to assess whether DR of IL-17 and IL-23 inhibiting biologics can be achieved for psoriasis patients with low disease activity, without losing disease control. Reducing the dose may lead to more efficient use of biologics.
trial registrationClinicalTrials.gov NCT04340076 . Registered on April 9 2020.
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