Trial reportClinical pharmacokinetics2020
Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis.
Trial report in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 13 papers, 2 of them syntheses 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.
A 48 Weeks Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Dose-ranging, Active-comparator-controlled (Ustekinumab), Double-blind Within Dose Groups of BI 655066)
BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)
BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Management of Erythrodermic Psoriasis with Systemic Therapies: A Systematic Review.American journal of clinical dermatology · 2025Pooled it
- Comparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis.JAMA dermatology · 2020Pooled it
- Mapping the global research landscape of risankizumab: a decade (2016-2025) of multi-database bibliometric analysis and emerging frontiers.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Treating Generalized Pustular Psoriasis (GPP): Timing and Rationale for Biologic Treatment Switching-A Japanese e-Delphi Survey.Dermatology and therapy · 2025Article
- Psoriasis in People With Skin of Color: An Evidence-Based Update.International journal of dermatology · 2025Review
- Real-World Long-Term Effectiveness of Risankizumab Among Patients with Moderate-to-Severe Psoriasis: Analysis from an International Medical Chart Review (RAPID) Study.Dermatology and therapy · 2024Article
- Treatment patterns and drug survival for generalized pustular psoriasis: A patient journey study using a Japanese claims database.The Journal of dermatology · 2024Article
- Genetics of Generalized Pustular Psoriasis: Current Understanding and Implications for Future Therapeutics.Genes · 2023Review
- Impact of Pharmacokinetic and Pharmacodynamic Properties of Monoclonal Antibodies in the Management of Psoriasis.Pharmaceutics · 2022Review
- Population pharmacokinetic/pharmacodynamic analysis of AK111, an IL-17A monoclonal antibody, in subjects with moderate-to-severe plaque psoriasis.Frontiers in pharmacology · 2022Article
- Pathophysiology of Generalized Pustular Psoriasis.American journal of clinical dermatology · 2022Review
- Updates on the Treatment of Erythrodermic Psoriasis.Psoriasis (Auckland, N.Z.) · 2021Review
- Clinical Pharmacokinetics and Pharmacodynamics of Risankizumab in Psoriasis Patients.Clinical pharmacokinetics · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveRisankizumab, a humanized monoclonal interleukin-23 antagonist antibody, has efficacy for treatment of plaque psoriasis, generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP). These analyses characterized the relationships between risankizumab exposures and key efficacy and safety variables in Japanese patients with moderate-to-severe plaque psoriasis, GPP, or EP following treatment with 75 or 150 mg subcutaneous doses at weeks 0, 4, and every 12 weeks thereafter.
methodsRisankizumab average plasma concentrations (Cavg) were correlated with probabilities of achieving efficacy end points (PASI 75, PASI 90, PASI 100, and sPGA 0/1) using data from Japanese patients (N = 225) and non-Japanese patients (N = 1678) with moderate-to-severe plaque psoriasis enrolled in global trials, or a Japan Phase 2/3 trial.
resultsThe exposure-efficacy relationships in Japanese patients were consistent with relationships for patients in global Phase 3 trials. At Week 16, a plateau of efficacy was demonstrated for 150 mg subcutaneous dose providing estimated PASI 90 and sPGA 0/1 response probabilities of 77%, and 88%, respectively. The exposures for 75 mg dose appeared to be suboptimal for PASI 100 response and other efficacy responses in heavier patients. Exposure-safety analyses (N = 242) indicated no apparent relationship between risankizumab Cavg and key safety variables, including any adverse event, serious adverse event, infection and infestation, and serious infection during treatment, consistent with observations in the global trials.
conclusionsOverall, risankizumab 150 mg maximized efficacy, including PASI 100 response, in Japanese patients with psoriasis with no apparent relationship between exposure and evaluated safety variables. CLINICAL
trial registrationNCT03000075, NCT03022045, NCT02672852, NCT02684357, NCT02684370, NCT02694523, NCT02054481.
Indexed as
Identifiers
31667790What OpenQuestion holds
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.