ArticleDermatology and therapy2024
Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: A Comprehensive Analysis from Clinical Trials.
Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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, 1 synthesis or guideline pooled it.
- Safety of Interleukin Inhibitors in Psoriatic Patients with Latent Tuberculosis Infection Without Chemoprophylaxis: A Systematic Review.Acta dermato-venereologica · 2025Pooled it
- Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.Journal of Crohn's & colitis · 2025Trial
- A Literature Review of Interleukins in the Development and Treatment of Breast Cancer.International journal of molecular sciences · 2026Review
- Real-World Efficacy of IL-23 Inhibitors in Psoriasis Affecting High-Impact Areas: Indirect Comparison of Tildrakizumab 200 mg, Risankizumab, and Guselkumab-IL PSO (Italian Landscape Psoriasis).Dermatology and therapy · 2026Article
- Efficacy of Risankizumab in Moderate to Severe Psoriasis Considering Body Mass Index: A Scoping Review.Cureus · 2026Review
- Tumor safety of biologic agents and targeted therapies in immune-mediated inflammatory arthritides.Frontiers in immunology · 2026Review
- Comparative safety profiles of risankizumab versus guselkumab: a pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2026Article
- Therapeutic Modulation Of Peripheral Blood Cells And Inflammatory Indices During 52 Weeks Of Risankizumab In Responder Patients With Moderate-to-Severe Psoriasis: Results From A Multicenter Prospective Study.Dermatology practical & conceptual · 2025Article
- Real-World Skin Clearance and Quality of Life with risankizumab in Patients with Psoriasis with Moderate Skin Involvement and Those Eligible for Systemic Therapy Per International Psoriasis Council Classification.Dermatology and therapy · 2025Article
- Tapinarof Nanogels as a Promising Therapeutic Approach.Pharmaceutics · 2025Review
- Real-World Effectiveness of Risankizumab in Patients with Moderate-to-Severe Psoriasis: Interim Analysis from the VALUE Global Prospective Post-marketing Observational Study at 25 Months.Dermatology and therapy · 2025Article
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRisankizumab has demonstrated a favourable safety profile in patients with psoriatic disease (moderate-to-severe psoriasis [PsO] and psoriatic arthritis [PsA]). We evaluated the long-term safety of risankizumab in psoriatic disease.
methodsLong-term safety was evaluated by analysing data from 20 (phase 1-4) clinical trials for plaque PsO and four (phase 2-3) trials for PsA. Treatment-emergent adverse events (TEAEs) and AEs in areas of special interest were reported among patients receiving ≥ 1 dose of risankizumab. Exposure-adjusted event rates were presented as events (E) per 100 patient-years (PY).
resultsThe long-term safety data analyses included 3658 patients with PsO (13,329.3 PY) and 1542 patients with PsA (3803.0 PY). The median (range) treatment duration for patients with PsO and PsA was 4.1 (0.2-8.8) years and 2.8 (0.2-4.0) years, respectively. In the PsO population, rates of TEAEs, serious AEs and AEs leading to discontinuation were 145.5 E/100 PY, 7.4 E/100 PY and 1.9 E/100 PY, respectively; in the PsA population, these rates were 142.6 E/100 PY, 8.6 E/100 PY, and 1.8 E/100 PY, respectively. The rates of serious infections (excluding COVID-19-related infections) in the PsO and PsA populations were 1.2 and 1.4 E/100 PY, respectively. The rates of opportunistic infections (excluding tuberculosis and herpes zoster) were low (< 0.1 E/100 PY) in both populations. The rates of both nonmelanoma skin cancer (NMSC) and malignant tumours excluding NMSC were 0.6 and 0.5 E/100 PY in PsO and PsA, respectively, which are within the benchmarks of prior epidemiological studies. Adjudicated major cardiovascular event rates were 0.5 E/100 PY in PsO and 0.3 E/100 PY in PsA, which are within the epidemiologic reference benchmarks for both indications. No additional safety concerns were identified with this long-term exposure.
conclusionsThe results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns and similar safety profiles among both PsO and PsA populations.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.