Risankizumab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Risankizumab comprises 79 peer-reviewed publications across 15 journals, 43 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Psoriasis, Crohn Disease, Arthritis, Psoriatic, and Colitis, Ulcerative. Most recent publication: Efficacy and Safety of Risankizumab in Genital or Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16., Dermatol Ther (Heidelb), 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.
    Östör A, Van den Bosch F, Papp K, et al. · Ann Rheum Dis · 2022
  2. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial.
    Kristensen LE, Keiserman M, Papp K, et al. · Ann Rheum Dis · 2022
  3. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse).
    Stein Gold LF, Bagel J, Tyring SK, et al. · Br J Dermatol · 2023
  4. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.
    Peyrin-Biroulet L, Chapman JC, Colombel JF, et al. · N Engl J Med · 2024
  5. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study.
    Östör A, Van den Bosch F, Papp K, et al. · Rheumatology (Oxford) · 2023
  6. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials.
    Louis E, Schreiber S, Panaccione R, et al. · JAMA · 2024
  7. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1.
    Kristensen LE, Soliman AM, Papp K, et al. · Rheumatology (Oxford) · 2023
  8. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study.
    Kristensen LE, Keiserman M, Papp K, et al. · Rheumatology (Oxford) · 2023

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT02672852PsoriasisPercentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
Baseline, Week 16
Placebo (Part A1)2.0 percentage of participants
Risankizumab (Part A1)73.2 percentage of participants
NCT02672852PsoriasisPercentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
Week 52
Risankizumab/Placebo (Part B; Rerandomized Responders)61.3 percentage of participants
Risankizumab/Risankizumab (Part B; Rerandomized Responders)87.4 percentage of participants
NCT02672852PsoriasisPercentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Week 16
Placebo (Part A1)7.0 percentage of participants
Risankizumab (Part A1)83.5 percentage of participants
NCT02684357PsoriasisPercentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16
Placebo (Part A)2.0 percentage of participants
Risankizumab (Part A)74.8 percentage of participants
NCT02684357PsoriasisPercentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16
Placebo (Part A)5.1 percentage of participants
Risankizumab (Part A)83.7 percentage of participants
NCT02684370PsoriasisPercentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16
Placebo (Part A)4.9 percentage of participants
Risankizumab (Part A)75.3 percentage of participants
NCT02684370PsoriasisPercentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16
Placebo (Part A)7.8 percentage of participants
Risankizumab (Part A)87.8 percentage of participants
NCT02694523PsoriasisPercentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
Week 16
Adalimumab (Part A)47.4 percentage of participants
Risankizumab (Part A)72.4 percentage of participants
NCT02694523PsoriasisPercentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
Week 16
Adalimumab (Part A)60.2 percentage of participants
Risankizumab (Part A)83.7 percentage of participants
NCT02694523PsoriasisPercentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
Week 44
Adalimumab/Rerandomized to Adalimumab (Part B)21.4 percentage of participants
Adalimumab/Rerandomized to Risankizumab (Part B)66.0 percentage of participants
NCT03022045PsoriasisPercentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
Week 16
EP Risankizumab 150 mg100 percentage of participants
EP Risankizumab 75 mg100 percentage of participants
NCT03022045PsoriasisPercentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
Week 16
GPP Risankizumab 150 mg100 percentage of participants
GPP Risankizumab 75 mg100 percentage of participants
NCT03047395
LIMMITLESS
PsoriasisNumber of Participants With Serious Adverse Events and Non-Serious Adverse Events
Median follow-up time of 1905 days
Risankizumab 150 mg435 Participants
Risankizumab 150 mg1215 Participants
NCT03104413Crohn DiseaseGlobal Outside of US: Percentage of Participants With Clinical Remission
Week 12
Placebo (Induction Period 1)11.2 percentage of participants
Placebo (Induction Period 1)8 percentage of participants
Risankizumab 1200mg (Induction Period 1)34.2 percentage of participants
Risankizumab 1200mg (Induction Period 1)18.3 percentage of participants
Risankizumab 600mg (Induction Period 1)28.8 percentage of participants
Risankizumab 600mg (Induction Period 1)17.3 percentage of participants
NCT03104413Crohn DiseaseGlobal Outside of US: Percentage of Participants With Endoscopic Response
Week 12
Placebo (Induction Period 1)19.3 percentage of participants
Risankizumab 1200mg (Induction Period 1)39.8 percentage of participants
Risankizumab 600mg (Induction Period 1)34.6 percentage of participants
NCT03104413Crohn DiseaseUS Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Week 12
Placebo (Induction Period 1)19.8 percentage of participants
Placebo (Induction Period 1)11.2 percentage of participants
Risankizumab 1200mg (Induction Period 1)40.3 percentage of participants
Risankizumab 1200mg (Induction Period 1)19.4 percentage of participants
Risankizumab 600mg (Induction Period 1)42.0 percentage of participants
Risankizumab 600mg (Induction Period 1)20.9 percentage of participants
NCT03104413Crohn DiseaseUS Specific: Percentage of Participants With Endoscopic Response
Week 12
Placebo (Induction Period 1)11.2 percentage of participants
Risankizumab 1200mg (Induction Period 1)34.2 percentage of participants
Risankizumab 600mg (Induction Period 1)28.8 percentage of participants
NCT03105128Crohn DiseaseGlobal Outside of US: Percentage of Participants With Clinical Remission
Week 12
Placebo (Period 1)9.1 percentage of participants
Placebo (Period 1)21.7 percentage of participants
Risankizumab 1200mg (Period 1)41.0 percentage of participants
Risankizumab 1200mg (Period 1)21.2 percentage of participants
Risankizumab 600mg (Period 1)43.5 percentage of participants
Risankizumab 600mg (Period 1)21.0 percentage of participants
NCT03105128Crohn DiseaseGlobal Outside of US: Percentage of Participants With Endoscopic Response
Week 12
Placebo (Period 1)12.0 percentage of participants
Risankizumab 1200mg (Period 1)32.1 percentage of participants
Risankizumab 600mg (Period 1)40.3 percentage of participants
NCT03105128Crohn DiseaseUS Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Week 12
Placebo (Period 1)24.6 percentage of participants
Placebo (Period 1)10.3 percentage of participants
Risankizumab 1200mg (Period 1)41.6 percentage of participants
Risankizumab 1200mg (Period 1)18.9 percentage of participants
Risankizumab 600mg (Period 1)45.2 percentage of participants
Risankizumab 600mg (Period 1)18.4 percentage of participants
NCT03105128Crohn DiseaseUS Specific: Percentage of Participants With Endoscopic Response
Week 12
Placebo (Period 1)12.0 percentage of participants
Risankizumab 1200mg (Period 1)32.1 percentage of participants
Risankizumab 600mg (Period 1)40.3 percentage of participants
NCT03255382PsoriasisPercentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
Week 24
Fumaderm10.0 percentage of participants
Risankizumab83.3 percentage of participants
NCT03398148Colitis, UlcerativeSub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
Week 12
Substudy 1, Induction Period 1: Double-blind Placebo IV1 Participants
Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV6 Participants
Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV6 Participants
Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV7 Participants
Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV42 Participants
NCT03398148Colitis, UlcerativeSub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
Week 12
Substudy 2, Induction Period 1: Double-blind Placebo IV6.2 percentage of participants
Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV20.3 percentage of participants
NCT03478787PsoriasisPercentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Week 16
Risankizumab73.8 percentage of participants
Secukinumab65.6 percentage of participants
NCT03478787PsoriasisPercentage of Participants With a PASI 90 at Week 52
Week 52
Risankizumab86.6 percentage of participants
Secukinumab57.1 percentage of participants
NCT03671148
KEEPsAKE2
Arthritis, PsoriaticPercentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Baseline and Week 24
Placebo26.5 percentage of participants
Risankizumab51.3 percentage of participants
NCT03675308
KEEPsAKE 1
Arthritis, PsoriaticPercentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Baseline and Week 24
Placebo33.5 percentage of participants
Risankizumab57.3 percentage of participants
NCT03875482PsoriasisPercentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
At Week 16
Placebo3.8 percentage of participants
Risankizumab62.9 percentage of participants
NCT03875482PsoriasisPercentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
At Week 16
Placebo9.6 percentage of participants
Risankizumab78.1 percentage of participants
NCT03875508PsoriasisParticipant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Day 1, Week 4, Week 16, Week 28
Risankizumab8.82 units on a scale (±1.415 Standard Deviation)
Risankizumab9.458 units on a scale (±1.0500 Standard Deviation)
Risankizumab9.725 units on a scale (±0.8911 Standard Deviation)
Risankizumab9.39 units on a scale (±0.971 Standard Deviation)
Risankizumab9.34 units on a scale (±1.614 Standard Deviation)
Risankizumab8.358 units on a scale (±2.3613 Standard Deviation)
Risankizumab8.556 units on a scale (±2.0646 Standard Deviation)
Risankizumab9.056 units on a scale (±1.0321 Standard Deviation)
Risankizumab9.817 units on a scale (±0.4469 Standard Deviation)
Risankizumab9.53 units on a scale (±1.261 Standard Deviation)
Risankizumab8.478 units on a scale (±2.0024 Standard Deviation)
Risankizumab8.112 units on a scale (±2.6313 Standard Deviation)
Risankizumab9.096 units on a scale (±1.1572 Standard Deviation)
Risankizumab9.700 units on a scale (±0.5710 Standard Deviation)
Risankizumab8.84 units on a scale (±1.240 Standard Deviation)
Risankizumab9.16 units on a scale (±1.964 Standard Deviation)
Risankizumab8.750 units on a scale (±1.8483 Standard Deviation)
Risankizumab8.367 units on a scale (±2.5921 Standard Deviation)
Risankizumab9.229 units on a scale (±1.1517 Standard Deviation)
Risankizumab9.763 units on a scale (±0.4576 Standard Deviation)
Risankizumab8.93 units on a scale (±1.394 Standard Deviation)
Risankizumab9.28 units on a scale (±1.678 Standard Deviation)
Risankizumab8.675 units on a scale (±2.0661 Standard Deviation)
Risankizumab8.795 units on a scale (±2.3034 Standard Deviation)
NCT03875508PsoriasisPercentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
At Week 16
Risankizumab46.3 percentage of participants
NCT03875508PsoriasisPercentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16
At Week 16
Risankizumab84.3 percentage of participants
NCT03875508PsoriasisPercentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
At Week 16
Risankizumab66.7 percentage of participants
NCT03875508PsoriasisPercentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
At Week 16
Risankizumab81.5 percentage of participants
NCT03875508PsoriasisPercentage of Participants Who Had No Potential Hazards as Measured by an Observer
Day 1 and Week 28
Risankizumab100 percentage of participants
Risankizumab100 percentage of participants
NCT03875508PsoriasisPercentage of Participants With an Observer Rating of Successful Participant Self-administration
Day 1 and Week 28
Risankizumab100 percentage of participants
Risankizumab100 percentage of participants
NCT04102007Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
At Week 16
Risankizumab152 Participants
Risankizumab140 Participants
NCT04435600
OptIMMize-1
PsoriasisPercentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Part 1: Risankizumab83.3 percentage of participants
Part 2 Period A: Risankizumab85.2 percentage of participants
Part 2 Period A: Ustekinumab85.7 percentage of participants
Part 3: Risankizumab92.3 percentage of participants
Part 4: Risankizumab86.7 percentage of participants
NCT04435600
OptIMMize-1
PsoriasisPercentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
At Week 16 of initial treatment in each part of the study (Parts 1-4)
Part 1: Risankizumab83.3 percentage of participants
Part 2 Period A: Risankizumab79.6 percentage of participants
Part 2 Period A: Ustekinumab75.0 percentage of participants
Part 3: Risankizumab84.6 percentage of participants
Part 4: Risankizumab90.0 percentage of participants
NCT04435600
OptIMMize-1
PsoriasisPercentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Part 1: Risankizumab83.3 percentage of participants
Part 2 Period A: Risankizumab68.5 percentage of participants
Part 2 Period A: Ustekinumab67.9 percentage of participants
Part 2 Period C: Risankizumab0.0 percentage of participants
Part 2 Period C: Risankizumab62.5 percentage of participants
Part 3: Risankizumab84.6 percentage of participants
Part 4: Risankizumab83.3 percentage of participants
NCT04713592
IMMprint
PsoriasisNumber of Participants With Treatment-Emergent Adverse Events
From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)
Placebo20 Participants
Placebo0 Participants
Placebo/Risankizumab0 Participants
Placebo/Risankizumab29 Participants
Risankizumab25 Participants
Risankizumab5 Participants
Risankizumab/Risankizumab40 Participants
Risankizumab/Risankizumab5 Participants
NCT04713592
IMMprint
PsoriasisPercentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16
Baseline, Week 16
Placebo16.1 percentage of participants
Risankizumab33.3 percentage of participants

Publications by year

19782026: 79 publications.

1978
1
2004
1
2015
1
2016
2
2017
2
2018
4
2019
6
2020
2
2021
7
2022
15
2023
10
2024
11
2025
14
2026
3

Publications by indication

Psoriasis (36)

  • Efficacy and Safety of Risankizumab in Genital or Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16.
    Dermatol Ther (Heidelb) · 2026 · PMID 41139175 · NCT05969223
  • Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.
    Am J Clin Dermatol · 2025 · PMID 40728772 · NCT03047395
  • Psoriasis harbors multiple pathogenic type 17 T-cell subsets: Selective modulation by risankizumab.
    J Allergy Clin Immunol · 2025 · PMID 39978685 · NCT04630652
  • Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis.
    Dermatol Ther (Heidelb) · 2024 · PMID 39073712 · NCT02694523
  • A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.
    Dermatol Ther (Heidelb) · 2024 · PMID 39358667 · NCT03047395

Crohn Disease (19)

  • Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.
    J Crohns Colitis · 2025 · PMID 41344313 · NCT04524611
  • Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment.
    Clin Gastroenterol Hepatol · 2025 · PMID 39909280 · NCT03105128
  • Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis.
    Pharmacoecon Open · 2025 · PMID 37296268 · NCT03105128
  • Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
    Cochrane Database Syst Rev · 2025 · PMID 40357993 · NCT04524611
  • Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease.
    Gastro Hep Adv · 2025 · PMID 39802486 · NCT03105102

Arthritis, Psoriatic (14)

  • Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naïve patients in two phase 3 clinical trials.
    Arthritis Res Ther · 2026 · PMID 41318485 · NCT03675308
  • Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials.
    Rheumatol Ther · 2025 · PMID 41028616 · NCT03675308
  • Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.
    Rheumatol Ther · 2025 · PMID 39120849 · NCT03675308
  • Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial.
    Rheumatol Ther · 2024 · PMID 38498139 · NCT03671148
  • Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials.
    Dermatol Ther (Heidelb) · 2024 · PMID 38739215 · NCT03671148

Colitis, Ulcerative (4)

  • Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment.
    Clin Gastroenterol Hepatol · 2026 · PMID 40953785 · NCT03398148
  • Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis.
    J Crohns Colitis · 2025 · PMID 40168091 · NCT03398135
  • Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies.
    J Crohns Colitis · 2025 · PMID 39804294 · NCT03398148
  • Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials.
    JAMA · 2024 · PMID 39037800 · NCT03398135

Dermatitis, Atopic (1)

  • Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.
    Dermatol Ther (Heidelb) · 2023 · PMID 36588137 · NCT03706040

COVID-19 (1)

  • SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
    Cochrane Database Syst Rev · 2021 · PMID 34473343 · NCT04583956

Publications by journal

Trial-results highlights

Clinical trials have evaluated the effectiveness of Risankizumab for psoriasis. In NCT02672852, 73.2% of participants in the Risankizumab arm achieved 90% improvement in Psoriasis Area and Severity Index (PASI90) at Week 16, compared to 2.0% in the Placebo arm. Similarly, at Week 16 in NCT02684357, 74.8% of participants in the Risankizumab arm achieved PASI90, versus 2.0% in the Placebo arm. In NCT02684370, 75.3% of participants on Risankizumab achieved PASI90 at Week 16, while 4.9% on Placebo did. Regarding skin clearance, in NCT02672852, 83.5% of participants in the Risankizumab arm achieved a Static Physician Global Assessment (sPGA) score of Clear or Almost Clear at Week 16, compared to 7.0% in the Placebo arm. In NCT02684357, 83.7% of participants on Risankizumab achieved an sPGA score of Clear or Almost Clear at Week 16, versus 5.1% on Placebo. In NCT02684370, 87.8% of participants in the Risankizumab arm achieved an sPGA score of Clear or Almost Clear at Week 16, compared to 7.8% in the Placebo arm.

Longer-term data from NCT02672852 showed that among rerandomized responders at Week 52, 87.4% of participants who continued on Risankizumab achieved an sPGA score of Clear or Almost Clear, while 61.3% of those rerandomized to Placebo achieved this outcome. In a separate study, NCT02694523, 72.4% of participants in the Risankizumab arm achieved PASI90 at Week 16, compared to 47.4% of participants in the Adalimumab arm.

All values presented are sourced from primary registry reporting; individual clinical papers should be consulted for comprehensive details and clinical decision-making.

All Risankizumab publications (79)

2026 (3 papers)

  1. Efficacy and Safety of Risankizumab in Genital or Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16.
    Song EJ, Ehst B, Glick B, et al. · Dermatol Ther (Heidelb) · 2026 · Derived
  2. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment.
    Panaccione R, Melmed GY, Drobne D, et al. · Clin Gastroenterol Hepatol · 2026 · Derived
    PubMed: PMID 40953785 · NCT03398148 · Colitis, Ulcerative
  3. Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naïve patients in two phase 3 clinical trials.
    Gossec L, Balanescu A, D'Agostino MA, et al. · Arthritis Res Ther · 2026 · Derived

2025 (14 papers)

  1. 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.
    Warren RB, Pavlovsky L, Costanzo A, et al. · Dermatol Ther (Heidelb) · 2025 · Derived
  2. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis.
    Reinisch W, Loftus EV, Schreiber S, et al. · J Crohns Colitis · 2025 · Derived
  3. Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.
    Peyrin-Biroulet L, Atreya R, Danese S, et al. · J Crohns Colitis · 2025 · Derived
  4. Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.
    Papp KA, Lebwohl MG, Puig L, et al. · Am J Clin Dermatol · 2025 · Derived
  5. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies.
    Panaccione R, Louis E, Colombel JF, et al. · J Crohns Colitis · 2025 · Derived
    PubMed: PMID 39804294 · NCT03398148 · Colitis, Ulcerative
  6. Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment.
    Panaccione R, Ferrante M, Dotan I, et al. · Clin Gastroenterol Hepatol · 2025 · Derived
  7. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials.
    Östör A, Van den Bosch F, Papp K, et al. · Rheumatol Ther · 2025 · Derived
  8. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.
    Mease PJ, Warren RB, Nash P, et al. · Rheumatol Ther · 2025 · Derived
  9. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis.
    Loftus EV, Ananthakrishnan AN, Lee WJ, et al. · Pharmacoecon Open · 2025 · Derived
  10. Psoriasis harbors multiple pathogenic type 17 T-cell subsets: Selective modulation by risankizumab.
    Kim J, Lee J, Lee J, et al. · J Allergy Clin Immunol · 2025 · Derived
  11. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
    Hasskamp J, Meinhardt C, Timmer A, et al. · Cochrane Database Syst Rev · 2025 · Derived
  12. Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease.
    Feagan BG, Colombel JF, Panaccione R, et al. · Gastro Hep Adv · 2025 · Derived
  13. Evaluation of the Effect of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease.
    D'Cunha R, Azam T, Kalabic J, et al. · Clin Pharmacokinet · 2025 · Derived
  14. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.
    Atreya R, Ferrante M, Panaccione R, et al. · J Crohns Colitis · 2025 · Derived

2024 (11 papers)

  1. Efficacy and safety of risankizumab by baseline corticosteroid use and achievement of corticosteroid-free clinical and endoscopic outcomes in patients with moderately to severely active Crohn's disease.
    Schreiber S, Cross RK, Panaccione R, et al. · Aliment Pharmacol Ther · 2024 · Derived
  2. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies.
    Peyrin-Biroulet L, Colombel JF, Louis E, et al. · Gastro Hep Adv · 2024 · Derived
  3. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.
    Peyrin-Biroulet L, Chapman JC, Colombel JF, et al. · N Engl J Med · 2024 · Derived
  4. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial.
    Östör A, Van den Bosch F, Papp K, et al. · Rheumatol Ther · 2024 · Derived
  5. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials.
    Louis E, Schreiber S, Panaccione R, et al. · JAMA · 2024 · Derived
  6. Content Validity and Psychometric Evaluation of the Crohn's Symptom Severity (CSS) Questionnaire in Patients with Moderately to Severely Active Crohn's Disease.
    Louis E, Lee WJ, Litcher-Kelly L, et al. · Adv Ther · 2024 · Derived
  7. Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials.
    Kwatra SG, Khattri S, Amin AZ, et al. · Dermatol Ther (Heidelb) · 2024 · Derived
  8. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial.
    Kristensen LE, Keiserman M, Papp K, et al. · Rheumatol Ther · 2024 · Derived
  9. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis.
    Hsieh CY, Hsu FL, Tsai TF, et al. · Dermatol Ther (Heidelb) · 2024 · Derived
  10. Maintenance Risankizumab Sustains Induction Response in Patients with Crohn's Disease in a Randomized Phase 3 Trial.
    Ferrante M, Irving PM, Abreu MT, et al. · J Crohns Colitis · 2024 · Derived
  11. A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.
    Alexis AF, Gooderham M, Kwatra SG, et al. · Dermatol Ther (Heidelb) · 2024 · Derived

2023 (10 papers)

  1. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.
    Tyring SK, Rich P, Tada Y, et al. · Dermatol Ther (Heidelb) · 2023 · Derived
    PubMed: PMID 36588137 · NCT03706040 · Dermatitis, Atopic
  2. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse).
    Stein Gold LF, Bagel J, Tyring SK, et al. · Br J Dermatol · 2023 · Derived
  3. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study.
    Östör A, Van den Bosch F, Papp K, et al. · Rheumatology (Oxford) · 2023 · Derived
  4. Efficacy, Safety, Patient Experience, and Tolerability of Risankizumab Administered by On-Body Injector for Moderate to Severe Crohn's Disease.
    Loftus EV, Griffith J, Neimark E, et al. · Adv Ther · 2023 · Derived
  5. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1.
    Kristensen LE, Soliman AM, Papp K, et al. · Rheumatology (Oxford) · 2023 · Derived
  6. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study.
    Kristensen LE, Keiserman M, Papp K, et al. · Rheumatology (Oxford) · 2023 · Derived
  7. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial.
    Kimball AB, Prens EP, Passeron T, et al. · Dermatol Ther (Heidelb) · 2023 · Derived
    PubMed: PMID 36892753 · NCT03926169 (DETERMINED 1) · Hidradenitis Suppurativa
  8. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.
    Dubinsky M, Ma C, Griffith J, et al. · Adv Ther · 2023 · Derived
  9. First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer.
    Tsai LL, Phillips WW, Hung YP, et al. · Ann Surg · 2023 · Background
  10. Intratumoral drug-releasing microdevices allow in situ high-throughput pharmaco phenotyping in patients with gliomas.
    Peruzzi P, Dominas C, Fell G, et al. · Sci Transl Med · 2023 · Background

2022 (15 papers)

  1. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.
    Östör A, Van den Bosch F, Papp K, et al. · Ann Rheum Dis · 2022 · Trial result
  2. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial.
    Kristensen LE, Keiserman M, Papp K, et al. · Ann Rheum Dis · 2022 · Trial result
  3. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis.
    Thakre N, D'Cunha R, Goebel A, et al. · Rheumatol Ther · 2022 · Derived
  4. Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders.
    Strober B, Armstrong A, Rubant S, et al. · J Dermatolog Treat · 2022 · Derived
  5. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up.
    Papp KA, Lebwohl MG, Puig L, et al. · Br J Dermatol · 2022 · Derived
  6. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2.
    Ostor AJK, Soliman AM, Papp KA, et al. · RMD Open · 2022 · Derived
  7. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation.
    Odnopozova L, Edin A, Sukharev A, et al. · Dermatol Ther (Heidelb) · 2022 · Derived
  8. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial.
    Mease PJ, Kellner H, Morita A, et al. · Rheumatol Ther · 2022 · Derived
    PubMed: PMID 35931879 · NCT02719171 · Arthritis, Psoriatic
  9. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials.
    Lebwohl MG, Soliman AM, Yang H, et al. · Dermatol Ther (Heidelb) · 2022 · Derived
  10. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial.
    Ferrante M, Panaccione R, Baert F, et al. · Lancet · 2022 · Derived
  11. Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study.
    Ferrante M, Feagan BG, Panés J, et al. · J Crohns Colitis · 2022 · Derived
  12. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials.
    D'Haens G, Panaccione R, Baert F, et al. · Lancet · 2022 · Derived
  13. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study.
    Crowley JJ, Langley RG, Gordon KB, et al. · Dermatol Ther (Heidelb) · 2022 · Derived
  14. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis.
    Blauvelt A, Gordon KB, Lee P, et al. · J Dermatolog Treat · 2022 · Derived
  15. A multiplex implantable microdevice assay identifies synergistic combinations of cancer immunotherapies and conventional drugs.
    Tatarova Z, Blumberg DC, Korkola JE, et al. · Nat Biotechnol · 2022 · Background

2021 (7 papers)

  1. 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.
    van der Schoot LS, van den Reek JMPA, Grine L, et al. · Trials · 2021 · Derived
  2. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis.
    Suleiman AA, Khatri A, Oberoi RK, et al. · Clin Pharmacokinet · 2021 · Derived
  3. Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial.
    Papp KA, de Vente S, Zeng J, et al. · Dermatol Ther (Heidelb) · 2021 · Derived
  4. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
    Kreuzberger N, Hirsch C, Chai KL, et al. · Cochrane Database Syst Rev · 2021 · Derived
  5. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial.
    Brightling CE, Nair P, Cousins DJ, et al. · N Engl J Med · 2021 · Derived
  6. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial.
    Blauvelt A, Leonardi CL, Gooderham M, et al. · JAMA Dermatol · 2021 · Derived
  7. Effect of Risankizumab on Patient-Reported Outcomes in Moderate to Severe Psoriasis: The UltIMMa-1 and UltIMMa-2 Randomized Clinical Trials.
    Augustin M, Lambert J, Zema C, et al. · JAMA Dermatol · 2021 · Derived

2020 (2 papers)

  1. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials.
    Suleiman AA, Minocha M, Khatri A, et al. · Clin Pharmacokinet · 2020 · Derived
  2. Lack of Effect of 12-Week Treatment with Risankizumab on the Pharmacokinetics of Cytochrome P450 Probe Substrates in Patients with Moderate to Severe Chronic Plaque Psoriasis.
    Khatri A, Cheng L, Camez A, et al. · Clin Pharmacokinet · 2020 · Derived

2019 (6 papers)

  1. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial.
    Ohtsuki M, Fujita H, Watanabe M, et al. · J Dermatol · 2019 · Derived
  2. Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study.
    Feagan BG, Panés J, Ferrante M, et al. · Lancet Gastroenterol Hepatol · 2019 · Derived
  3. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.
    Baeten D, Østergaard M, Wei JC, et al. · Ann Rheum Dis · 2019 · Derived
    PubMed: PMID 29945918 · NCT02047110 · Spondylitis, Ankylosing
  4. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial.
    Reich K, Gooderham M, Thaçi D, et al. · Lancet · 2019 · Background
  5. Reduction of Inflammatory and Cardiovascular Proteins in the Blood of Patients with Psoriasis: Differential Responses between Tofacitinib and Etanercept after 4 Weeks of Treatment.
    Kim J, Tomalin L, Lee J, et al. · J Invest Dermatol · 2019 · Background
  6. Proportion of CD4+CD49b+LAG-3+ Type 1 Regulatory T Cells in the Blood of Psoriasis Patients Inversely Correlates with Psoriasis Area and Severity Index.
    Kim J, Lee J, Gonzalez J, et al. · J Invest Dermatol · 2019 · Background

2018 (4 papers)

  1. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials.
    Gordon KB, Strober B, Lebwohl M, et al. · Lancet · 2018 · Derived
  2. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study.
    Feagan BG, Sandborn WJ, D'Haens G, et al. · Lancet · 2018 · Derived
  3. Highly Effective New Treatments for Psoriasis Target the IL-23/Type 17 T Cell Autoimmune Axis.
    Kim J, Krueger JG · Annu Rev Med · 2018 · Background
  4. Patients With Psoriasis and Personalized Trade-offs in Treatment Decisions-Lessons Learned From Focus Groups.
    Kim J, Kim DJ, Ortenzio FS, et al. · JAMA Dermatol · 2018 · Background

2017 (2 papers)

  1. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis.
    Papp KA, Blauvelt A, Bukhalo M, et al. · N Engl J Med · 2017 · Background
  2. The Spectrum of Mild to Severe Psoriasis Vulgaris Is Defined by a Common Activation of IL-17 Pathway Genes, but with Key Differences in Immune Regulatory Genes.
    Kim J, Bissonnette R, Lee J, et al. · J Invest Dermatol · 2017 · Background

2016 (2 papers)

  1. Molecular Phenotyping Small (Asian) versus Large (Western) Plaque Psoriasis Shows Common Activation of IL-17 Pathway Genes but Different Regulatory Gene Sets.
    Kim J, Oh CH, Jeon J, et al. · J Invest Dermatol · 2016 · Background
  2. An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors.
    Jonas O, Landry HM, Fuller JE, et al. · Sci Transl Med · 2016 · Background

2015 (1 paper)

  1. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial.
    Krueger JG, Ferris LK, Menter A, et al. · J Allergy Clin Immunol · 2015 · Background

2004 (1 paper)

  1. Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris.
    Lee E, Trepicchio WL, Oestreicher JL, et al. · J Exp Med · 2004 · Background

1978 (1 paper)

  1. Control of immunoglobulin secretion in the murine plasmacytoma line MOPC 315.
    Sonenshein GE, Siekevitz M, Siebert GR, et al. · J Exp Med · 1978 · Background

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).