Trial reportThe British journal of dermatology2022
Direct comparison of risankizumab and fumaric acid esters in systemic therapy-naïve patients with moderate-to-severe plaque psoriasis: a randomized controlled trial.
Trial report in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- New Tuberculosis Infection and Reactivation of Tuberculosis in Patients with Psoriasis or Psoriatic Arthritis Receiving IL-23 Inhibitors: A Systematic Literature Review.Dermatology and therapy · 2026Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2022Pooled it
- Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.American journal of clinical dermatology · 2025Trial
- Cardiovascular and Kidney Outcomes After Systemic Treatment for Plaque Psoriasis: A Systematic Review and Network Meta-analysis.Dermatology and therapy · 2025Article
- Biologic and Non-Biologic Therapies for Scalp Psoriasis: A Network Meta-analysis of Randomized Controlled Trials.Dermatology practical & conceptual · 2025Review
- Efficacy and Safety of Risankizumab in Patients with Psoriasis Showing Suboptimal Response to Secukinumab or Ixekizumab: Results from a Phase 3b, Open-Label, Single-Arm (aIMM) Study.Dermatology and therapy · 2024Article
- Using Automated Machine Learning to Predict Necessary Upcoming Therapy Changes in Patients With Psoriasis Vulgaris and Psoriatic Arthritis and Uncover New Influences on Disease Progression: Retrospective Study.JMIR formative research · 2024Article
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
- Banzhilian formula alleviates psoriasis-like lesionsFrontiers in pharmacology · 2023Article
- Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study.Dermatology and therapy · 2022Article
- Cardiovascular Safety of Biologics Targeting Interleukin (IL)-12 and/or IL-23: What Does the Evidence Say?American journal of clinical dermatology · 2021Review
Corrections and comments
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Authors and funding
8 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFumaric acid esters (FAEs; Fumaderm
objectivesTo compare risankizumab treatment to FAEs in patients with psoriasis.
methodsThis phase III randomized, active-controlled, open-label study with blinded assessment of efficacy was conducted in Germany. Patients were randomized (1 : 1) to subcutaneous risankizumab 150 mg (weeks 0, 4 and 16) or oral FAEs at increasing doses from 30 mg daily (week 0) up to 720 mg daily (weeks 8-24). Enrolled patients were adults naïve to and candidates for systemic therapy, with chronic moderate-to-severe plaque psoriasis. Phototherapy was not allowed within 14 days before or during the study.
resultsKey efficacy endpoints were met at week 24 for risankizumab (n = 60) vs. FAEs (n = 60) (P < 0·001): achievement of a ≥ 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83·3% vs. 10·0%), ≥ 100% improvement in PASI (50·0% vs. 5·0%), ≥ 75% improvement in PASI (98·3% vs. 33·3%), ≥ 50% improvement in PASI (100% vs. 53·3%) and a Static Physician's Global Assessment of clear/almost clear (93·3% vs. 38·3%). The rates of gastrointestinal disorders, flushing, lymphopenia and headache were higher in the FAE group. One patient receiving risankizumab reported a serious infection (influenza, which required hospitalization). There were no malignancies, tuberculosis or opportunistic infections in either treatment arm.
conclusionsRisankizumab was found to be superior to FAEs, providing earlier and greater improvement in psoriasis outcomes that persisted with continued treatment, and more favourable safety results, which is consistent with the known safety profile. No new safety signals for risankizumab or FAEs were observed.
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