Guselkumab Evidence: Trial Results and Peer-Reviewed Publications

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

The clinical evidence base for Guselkumab comprises 109 peer-reviewed publications across 15 journals, 44 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Arthritis, Psoriatic, Psoriasis, Skin Diseases, and Colitis, Ulcerative. Most recent publication: Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial., Lancet Gastroenterol Hepatol, 2026.

Top peer-reviewed publications

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

  1. Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab: A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA).
    Reich K, Bianchi L, Khemis A, et al. · Dermatol Ther (Heidelb) · 2024
    PubMed: PMID 38300408 · NCT04533737 (COBRA) · Psoriasis
  2. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease.
    Kucharzik T, Wilkens R, D'Agostino MA, et al. · Clin Gastroenterol Hepatol · 2022
    PubMed: PMID 35842121 · NCT07246460 (UPGRADE) · Constriction, Pathologic
  3. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study.
    Hart A, Panaccione R, Steinwurz F, et al. · Gastroenterology · 2025
    PubMed: PMID 40113101 · NCT07246460 (UPGRADE) · Constriction, Pathologic
  4. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies.
    Rubin DT, Allegretti JR, Panés J, et al. · Lancet · 2025
    PubMed: PMID 39706209 · NCT04033445 (QUASAR) · Colitis, Ulcerative
  5. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study.
    Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. · Br J Dermatol · 2025
    PubMed: PMID 39708367 · NCT03451851 (PROTOSTAR) · Psoriasis
  6. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
    Panaccione R, Feagan BG, Afzali A, et al. · Lancet · 2025
    PubMed: PMID 40684778 · NCT03466411 (GALAXI) · Crohn Disease
  7. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial.
    McMichael A, Shahriari M, Stein Gold L, et al. · JAMA Dermatol · 2025
    PubMed: PMID 40560554 · NCT05272150 (VISIBLE)
  8. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial.
    Long M, Allegretti JR, Danese S, et al. · Lancet Gastroenterol Hepatol · 2026
    PubMed: PMID 41544637 · NCT05528510 (ASTRO) · Colitis, Ulcerative

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
NCT02203032
NAVIGATE
PsoriasisNumber of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40
Week 28 through Week 40
Guselkumab (Randomized)1.5 visits (±1.57 Standard Deviation)
Ustekinumab (Randomized)0.7 visits (±1.26 Standard Deviation)
NCT02207231
VOYAGE 1
PsoriasisPercentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16
Guselkumab85.1 percentage of participants
Placebo6.9 percentage of participants
NCT02207231
VOYAGE 1
PsoriasisPercentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16
Guselkumab73.3 percentage of participants
Placebo2.9 percentage of participants
NCT02207244
VOYAGE 2
PsoriasisPercentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16
Guselkumab 100 mg84.1 percentage of participants
Placebo8.5 percentage of participants
NCT02207244
VOYAGE 2
PsoriasisPercentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16
Guselkumab 100 mg70.0 percentage of participants
Placebo2.4 percentage of participants
NCT02641730PsoriasisChange From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
Baseline and Week 16
Guselkumab 100 mg-15.08 Units on a scale (±11.252 Standard Deviation)
Guselkumab 200 mg-11.07 Units on a scale (±7.779 Standard Deviation)
Placebo-7.79 Units on a scale (±10.596 Standard Deviation)
NCT02905331PsoriasisPercentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Week 16
Guselkumab75.8 Percentage of participants
Placebo0 Percentage of participants
NCT02905331PsoriasisPercentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Week 16
Guselkumab80.6 Percentage of participants
Placebo0 Percentage of participants
NCT02951533
POLARIS
PsoriasisPart I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
At Week 24
Part I: Fumaric Acid Esters (FAE)13.6 Percentage of Participants
Part I: Guselkumab (GUS)81.7 Percentage of Participants
NCT03090100
ECLIPSE
PsoriasisPercentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Week 48
Guselkumab 100 mg + Placebo84.5 Percentage of participants
Secukinumab 300 mg70.0 Percentage of participants
NCT03158285Arthritis, PsoriaticPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Week 24
Guselkumab 100 mg q4w63.7 percentage of participants
Guselkumab 100 mg q8w64.1 percentage of participants
Placebo to Guselkumab 100 mg q4w32.9 percentage of participants
NCT03162796
Discover-1
Arthritis, PsoriaticPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Week 24
Guselkumab 100 mg q4w59.4 percentage of participants
Guselkumab 100 mg q8w52.0 percentage of participants
Placebo22.2 percentage of participants
NCT03451851
PROTOSTAR
PsoriasisPart 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
At Week 16
Group 1 (Part 1): Placebo (Week 0-16)16.0 Percentages of participants
Group 2 (Part 1): Guselkumab (Week 0-16)65.9 Percentages of participants
Group 3 (Part 1): Etanercept (Week 0-16)69.2 Percentages of participants
NCT03451851
PROTOSTAR
PsoriasisPart 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
At Week 16
Group 1 (Part 1): Placebo (Week 0-16)20.0 Percentage of Participants
Group 2 (Part 1): Guselkumab (Week 0-16)75.6 Percentage of Participants
Group 3 (Part 1): Etanercept (Week 0-16)69.2 Percentage of Participants
NCT03466411
GALAXI
Crohn DiseaseGALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Baseline and Week 12
GALAXI 1 (Group 1) Guselkumab 1200 mg IV q4w Followed by 200 mg SC q4w-143.7 Units on a scale (±96.58 Standard Deviation)
GALAXI 1 (Group 2) Guselkumab 600 mg IV q4w Followed by 200 mg SC q4w-139.2 Units on a scale (±100.71 Standard Deviation)
GALAXI 1 (Group 3) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w-159.8 Units on a scale (±110.52 Standard Deviation)
GALAXI 1 (Group 5) Placebo q4w Followed by Placebo q4w-34.4 Units on a scale (±104.85 Standard Deviation)
NCT03466411
GALAXI
Crohn DiseaseGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Weeks 48
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w38.4 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w39.2 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w5.3 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseGlobal: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
Weeks 48
GALAXI 2 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w54.8 Percentage of participants
GALAXI 2 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w49.0 Percentage of participants
GALAXI 2 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w11.8 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Weeks 48
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w36.0 Percentage of participants
GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w33.6 Percentage of participants
GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w5.6 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseGlobal: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48
Weeks 48
GALAXI 3 (Group 1) Guselkumab 200 mg IV q4w Followed by 200 mg SC q4w48.0 Percentage of participants
GALAXI 3 (Group 2) Guselkumab 200 mg IV q4w Followed by 100 mg SC q8w46.9 Percentage of participants
GALAXI 3 (Group 4) Placebo q4w Followed by Placebo q4w or Ustekinumab 6 mg/kg IV Then 90 mg SC q8w12.5 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseRegional: GALAXI 2: Percentage of Participants With Clinical Remission at Week 12
Week 12
GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)47.1 Percentage of participants
GALAXI 2 Placebo (From Group 4)22.4 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseRegional: GALAXI 2: Percentage of Participants With Endoscopic Response at Week 12
Week 12
GALAXI 2 Combined Guselkumab 200 mg IV (Group 1+ Group 2)37.7 Percentage of participants
GALAXI 2 Placebo (From Group 4)10.5 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseRegional: GALAXI 3: Percentage of Participants With Clinical Remission at Week 12
Week 12
GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)47.1 Percentage of participants
GALAXI 3 Placebo (From Group 4)15.3 Percentage of participants
NCT03466411
GALAXI
Crohn DiseaseRegional: GALAXI 3: Percentage of Participants With Endoscopic Response at Week 12
Week 12
GALAXI 3 Combined Guselkumab 200 mg IV (Group 1+ Group 2)36.2 Percentage of participants
GALAXI 3 Placebo (From Group 4)13.9 Percentage of participants
NCT03818035
GUIDE
PsoriasisGroup 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
Week 68
Part 2 Group 2a: Guselkumab 100 mg Q8W92.6 Percentage of participants
Part 2 Group 2b: Guselkumab 100 mg Q16W91.9 Percentage of participants
NCT04033445
QUASAR
Colitis, UlcerativeInduction Study 1: Percentage of Participants With Clinical Response at Week I-12
At Week I-12
IS-1: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-861.4 Percentage of participants
IS-1: Period 1: Guselkumab 400 mg IV at Weeks I-0, I-4 and I-860.7 Percentage of participants
IS-1: Period 1: Placebo IV at Weeks I-0, I-4 and I-827.6 Percentage of participants
NCT04033445
QUASAR
Colitis, UlcerativeInduction Study 2: Percentage of Participants With Clinical Remission at Week I-12
At Week I-12
IS-2: Period 1: Guselkumab 200 mg IV at Weeks I-0, I-4 and I-822.6 Percentage of participants
IS-2: Period 1: Placebo IV at Weeks I-0, I-4 and I-87.9 Percentage of participants
NCT04033445
QUASAR
Colitis, UlcerativeMaintenance Study: Percentage of Participants With Clinical Remission at Week M-44
At Week M-44
MS: Randomized: Guselkumab 100 mg SC q8w45.2 Percentage of participants
MS: Randomized: Guselkumab 200 mg SC q4w50.0 Percentage of participants
MS: Randomized: Placebo SC Every 4 Weeks (q4w)18.9 Percentage of participants
NCT04397263Crohn DiseaseNumber of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With Concomitant Medications for Crohn's Disease
From screening (Week -8) up to Week 48
Guselkumab 200 Milligrams (mg)12 Participants
Guselkumab 200 Milligrams (mg)16 Participants
Guselkumab 200 Milligrams (mg)28 Participants
NCT04397263Crohn DiseaseNumber of Participants With TEAEs of Infections
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)11 Participants
NCT04397263Crohn DiseaseNumber of Participants With TEAEs of Injection-site Reactions
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)3 Participants
NCT04397263Crohn DiseaseNumber of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With TEAEs Temporally Associated With Infusion
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)3 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)2 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)5 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)5 Participants
Guselkumab 200 Milligrams (mg)7 Participants
Guselkumab 200 Milligrams (mg)4 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)7 Participants
Guselkumab 200 Milligrams (mg)7 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)1 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)9 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)9 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)18 Participants
Guselkumab 200 Milligrams (mg)0 Participants
Guselkumab 200 Milligrams (mg)2 Participants
Guselkumab 200 Milligrams (mg)3 Participants
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)33 Participants
NCT04397263Crohn DiseaseNumber of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)0 Participants
NCT04397263Crohn DiseaseNumber of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
From baseline (Week 0) up to Week 48
Guselkumab 200 Milligrams (mg)3 Participants
NCT04882098
APEX
Arthritis, PsoriaticPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
At Week 24
Group 1: Guselkumab 100 mg q8w68.3 percentage of participants
Group 2: Guselkumab 100 mg q4w66.6 percentage of participants
Group 3: Placebo Followed by Guselkumab47.0 percentage of participants
NCT04936308
SOLSTICE
Arthritis, PsoriaticPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
At Week 24
Guselkumab 100 mg q4w60.9 Percentage of participants
Guselkumab 100 mg q8w63.0 Percentage of participants
Placebo Followed by Guselkumab 100 mg35.9 Percentage of participants
NCT05197049
GRAVITI
Crohn DiseasePercentage of Participants Who Achieved Clinical Remission at Week 12
At Week 12
Combined: Guselkumab 400 mg56.1 Percentage of participants
Placebo21.4 Percentage of participants
NCT05197049
GRAVITI
Crohn DiseasePercentage of Participants Who Achieved Endoscopic Response at Week 12
At Week 12
Combined: Guselkumab 400 mg41.3 Percentage of participants
Placebo21.4 Percentage of participants
NCT05528510
ASTRO
Colitis, UlcerativePercentage of Participants in Clinical Remission at Week 12
Week 12
Combined Guselkumab 400 mg27.6 Percentage of participants
Placebo6.5 Percentage of participants
NCT06039189
SPECTREM
—Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Week 16
Group 1: Placebo Followed by Guselkumab 100 mg12.4 Percentage of participants
Group 2: Guselkumab 100 mg74.2 Percentage of participants

Publications by year

2003–2026: 109 publications.

2003
1
2005
1
2011
1
2015
1
2016
1
2018
1
2019
4
2020
7
2021
13
2022
15
2023
19
2024
23
2025
15
2026
7

Publications by indication

Arthritis, Psoriatic (39)

  • Guselkumab Improves Patient-Reported Outcomes Among Participants with Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors in the COSMOS Study.
    Rheumatol Ther · 2026 · PMID 41575731 · NCT03796858
  • Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials.
    Rheumatol Ther · 2026 · PMID 41396391 · NCT03162796
  • Guselkumab Efficacy in Biologic-Naïve Participants with Psoriatic Arthritis and Severe Disease Activity: Post Hoc Analysis of a Phase 3 Study.
    Rheumatol Ther · 2025 · PMID 40690163 · NCT03158285
  • Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial.
    Trials · 2025 · PMID 40102973 · NCT05669833
  • Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.
    Rheumatol Ther · 2025 · PMID 39261446 · NCT03162796

Psoriasis (33)

  • Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data.
    Paediatr Drugs · 2026 · PMID 41152645 · NCT03451851
  • Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study.
    Br J Dermatol · 2025 · PMID 39708367 · NCT03451851
  • Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial.
    Chin Med J (Engl) · 2025 · PMID 40921728 · NCT04914429
  • Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials.
    Dermatol Ther (Heidelb) · 2025 · PMID 38485863 · NCT02207231
  • Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab: A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA).
    Dermatol Ther (Heidelb) · 2024 · PMID 38300408 · NCT04533737

Skin Diseases (10)

  • Modified dose of guselkumab for treatment of pyoderma gangrenosum.
    JAAD Case Rep · 2022 · PMID 35146098 · NCT06563323
  • Ustekinumab for Extra-intestinal Manifestations of Inflammatory Bowel Disease: A Systematic Literature Review.
    J Crohns Colitis · 2021 · PMID 33367674 · NCT06563323
  • Successful treatment of a refractory pyoderma gangrenosum with risankizumab.
    Int Wound J · 2021 · PMID 32266771 · NCT06563323
  • Guselkumab as a treatment option for recalcitrant pyoderma gangrenosum.
    JAAD Case Rep · 2021 · PMID 33490346 · NCT06563323
  • Interleukin 23 and autoimmune diseases: current and possible future therapies.
    Inflamm Res · 2020 · PMID 32215665 · NCT06563323

Colitis, Ulcerative (7)

  • Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial.
    Lancet Gastroenterol Hepatol · 2026 · PMID 41544637 · NCT05528510
  • Multiomic characterisation of the clinical efficacy of guselkumab induction therapy in ulcerative colitis.
    BMJ Open Gastroenterol · 2026 · PMID 41871904 · NCT04033445
  • Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies.
    Lancet · 2025 · PMID 39706209 · NCT04033445
  • Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies.
    J Gastroenterol Hepatol · 2025 · PMID 40574492 · NCT04033445
  • Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions.
    Clin Pharmacol Ther · 2024 · PMID 38488354 · NCT03662542

Crohn Disease (5)

  • Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial.
    Inflamm Bowel Dis · 2026 · PMID 42065683 · NCT03466411
  • Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
    Lancet · 2025 · PMID 40684778 · NCT03466411
  • Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
    Cochrane Database Syst Rev · 2025 · PMID 40357993 · NCT03466411
  • Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial.
    Lancet Gastroenterol Hepatol · 2024 · PMID 38104569 · NCT03466411
  • Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study.
    Gastroenterology · 2022 · PMID 35134323 · NCT03466411

Constriction, Pathologic (2)

  • Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study.
    Gastroenterology · 2025 · PMID 40113101 · NCT07246460
  • Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease.
    Clin Gastroenterol Hepatol · 2022 · PMID 35842121 · NCT07246460

Publications by journal

Trial-results highlights

In studies evaluating **Guselkumab** for psoriasis, specific outcomes were observed. In the NCT02207231 (VOYAGE 1) trial, at Week 16, **85.1 percentage** of participants in the Guselkumab group achieved an Investigator's Global Assessment (IGA) score of cleared or minimal, compared to 6.9 percentage of participants in the placebo group. Also in VOYAGE 1, 73.3 percentage of participants in the Guselkumab group achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16, versus 2.9 percentage of participants in the placebo group. Similarly, in the NCT02207244 (VOYAGE 2) trial at Week 16, 84.1 percentage of participants receiving Guselkumab 100 mg achieved an IGA score of cleared or minimal, compared to 8.5 percentage of participants on placebo. In VOYAGE 2, 70.0 percentage of participants receiving Guselkumab 100 mg achieved a PASI 90 response at Week 16, versus 2.4 percentage of participants on placebo.

Further studies explored other aspects of Guselkumab’s effects. In the NCT02203032 (NAVIGATE) trial, participants randomized to Guselkumab had a mean of 1.5 visits where they achieved an IGA response of cleared or minimal and at least a 2-grade improvement from Week 16 through Week 40, compared to a mean of 0.7 visits for participants randomized to ustekinumab. For palmoplantar pustulosis, in NCT02641730, the mean change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16 was:

  • For Guselkumab 100 mg, **-15.08 Units**
  • For Guselkumab 200 mg, -11.07 Units
  • For placebo, -7.79 Units

In another study, NCT02905331, at Week 16, **75.8 Percentage** of participants in the Guselkumab group achieved a PASI 90 response, while 0 Percentage of participants in the placebo group achieved this. Also in NCT02905331, 80.6 Percentage of participants in the Guselkumab group achieved an IGA score of cleared or minimal at Week 16, compared to 0 Percentage of participants in the placebo group.

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

All Guselkumab publications (109)

2026 (7 papers)

  1. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial.
    Long M, Allegretti JR, Danese S, et al. · Lancet Gastroenterol Hepatol · 2026 · Derived
    PubMed: PMID 41544637 · NCT05528510 (ASTRO) · Colitis, Ulcerative
  2. Multiomic characterisation of the clinical efficacy of guselkumab induction therapy in ulcerative colitis.
    Hart A, Sridhar S, Venkat S, et al. · BMJ Open Gastroenterol · 2026 · Derived
    PubMed: PMID 41871904 · NCT04033445 (QUASAR) · Colitis, Ulcerative
  3. Guselkumab Improves Patient-Reported Outcomes Among Participants with Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors in the COSMOS Study.
    Gossec L, Baraliakos X, Galloway J, et al. · Rheumatol Ther · 2026 · Derived
    PubMed: PMID 41575731 · NCT03796858 (COSMOS) · Arthritis, Psoriatic
  4. Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials.
    Gladman DD, Eder L, Selmi C, et al. · Rheumatol Ther · 2026 · Derived
    PubMed: PMID 41396391 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  5. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data.
    Crauwels H, Ringold S, Howard S, et al. · Paediatr Drugs · 2026 · Derived
    PubMed: PMID 41152645 · NCT03451851 (PROTOSTAR) · Psoriasis
  6. The Impact of Post-inflammatory Pigment Alteration After Psoriasis: Novel Data from the VISIBLE Study.
    Alexis A, McMichael A, Vashi N, et al. · Dermatol Ther (Heidelb) · 2026 · Derived
    PubMed: PMID 41770445 · NCT05272150 (VISIBLE)
  7. Five-year efficacy and safety of guselkumab for moderately to severely active Crohn's disease: Results from the phase 2 GALAXI 1 trial.
    Afzali A, Danese S, Panaccione R, et al. · Inflamm Bowel Dis · 2026 · Derived
    PubMed: PMID 42065683 · NCT03466411 (GALAXI) · Crohn Disease

2025 (15 papers)

  1. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study.
    Hart A, Panaccione R, Steinwurz F, et al. · Gastroenterology · 2025 · Trial result
    PubMed: PMID 40113101 · NCT07246460 (UPGRADE) · Constriction, Pathologic
  2. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies.
    Rubin DT, Allegretti JR, Panés J, et al. · Lancet · 2025 · Derived
    PubMed: PMID 39706209 · NCT04033445 (QUASAR) · Colitis, Ulcerative
  3. Guselkumab Efficacy in Biologic-Naïve Participants with Psoriatic Arthritis and Severe Disease Activity: Post Hoc Analysis of a Phase 3 Study.
    Ritchlin CT, Lubrano E, Chimenti MS, et al. · Rheumatol Ther · 2025 · Derived
    PubMed: PMID 40690163 · NCT03158285 · Arthritis, Psoriatic
  4. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study.
    Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. · Br J Dermatol · 2025 · Derived
    PubMed: PMID 39708367 · NCT03451851 (PROTOSTAR) · Psoriasis
  5. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
    Panaccione R, Feagan BG, Afzali A, et al. · Lancet · 2025 · Derived
    PubMed: PMID 40684778 · NCT03466411 (GALAXI) · Crohn Disease
  6. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial.
    Ogdie A, Reddy SM, Gillespie SH, et al. · Trials · 2025 · Derived
    PubMed: PMID 40102973 · NCT05669833 (EVOLUTION) · Arthritis, Psoriatic
  7. Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones: Cohort B of the VISIBLE Randomized Clinical Trial.
    McMichael A, Shahriari M, Stein Gold L, et al. · JAMA Dermatol · 2025 · Derived
    PubMed: PMID 40560554 · NCT05272150 (VISIBLE)
  8. Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial.
    Huang K, Geng S, Tao X, et al. · Chin Med J (Engl) · 2025 · Derived
    PubMed: PMID 40921728 · NCT04914429 · Psoriasis
  9. 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
    PubMed: PMID 40357993 · NCT03466411 (GALAXI) · Crohn Disease
  10. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials.
    Egeberg A, Conrad C, Gorecki P, et al. · Dermatol Ther (Heidelb) · 2025 · Derived
    PubMed: PMID 38485863 · NCT02207231 (VOYAGE 1) · Psoriasis
  11. Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.
    Curtis JR, Deodhar A, Soriano ER, et al. · Rheumatol Ther · 2025 · Derived
    PubMed: PMID 39261446 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  12. Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies.
    Chen B, Ye BD, Cao Q, et al. · J Gastroenterol Hepatol · 2025 · Derived
    PubMed: PMID 40574492 · NCT04033445 (QUASAR) · Colitis, Ulcerative
  13. Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study.
    Anders HJ, Chan TM, Sanchez-Guerrero J, et al. · Rheumatology (Oxford) · 2025 · Derived
    PubMed: PMID 39673415 · NCT04376827 (ORCHID-LN) · Lupus Nephritis
  14. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement.
    Alexis A, McMichael A, Vashi N, et al. · JAMA Dermatol · 2025 · Derived
    PubMed: PMID 39661358 · NCT05272150 (VISIBLE)
  15. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial.
    Alexis A, McMichael A, Soung J, et al. · JAMA Dermatol · 2025 · Derived
    PubMed: PMID 40560559 · NCT05272150 (VISIBLE)

2024 (23 papers)

  1. Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab: A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA).
    Reich K, Bianchi L, Khemis A, et al. · Dermatol Ther (Heidelb) · 2024 · Trial result
    PubMed: PMID 38300408 · NCT04533737 (COBRA) · Psoriasis
  2. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.
    Warren RB, McInnes IB, Nash P, et al. · Rheumatol Ther · 2024 · Derived
    PubMed: PMID 38488975 · NCT03158285 · Arthritis, Psoriatic
  3. Guselkumab for Pityriasis Rubra Pilaris and Dysregulation of IL-23/IL-17 and NFkB Signaling: A Nonrandomized Trial.
    Velasco RC, Shao C, Cutler B, et al. · JAMA Dermatol · 2024 · Derived
    PubMed: PMID 38598229 · NCT03975153 · Pityriasis Rubra Pilaris
  4. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis.
    Strober B, Coates LC, Lebwohl MG, et al. · Drug Saf · 2024 · Derived
    PubMed: PMID 37906417 · NCT02203032 (NAVIGATE) · Psoriasis
  5. Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: results from a phase III randomized controlled trial.
    Siebert S, Schett G, Raychaudhuri SP, et al. · Ther Adv Musculoskelet Dis · 2024 · Derived
    PubMed: PMID 39493888 · NCT03158285 · Arthritis, Psoriatic
  6. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions.
    Shao J, Vetter M, Vermeulen A, et al. · Clin Pharmacol Ther · 2024 · Derived
    PubMed: PMID 38488354 · NCT03662542 (VEGA) · Colitis, Ulcerative
  7. Guselkumab treatment normalizes the stratum corneum ceramide profile and alleviates barrier dysfunction in psoriasis: results of a randomized controlled trial.
    Rousel J, Mergen C, Bergmans ME, et al. · J Lipid Res · 2024 · Derived
    PubMed: PMID 38992724 · NCT04394936 · Psoriasis
  8. Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study.
    Ritchlin CT, Mease PJ, Boehncke WH, et al. · Clin Rheumatol · 2024 · Derived
    PubMed: PMID 38844682 · NCT03158285 · Arthritis, Psoriatic
  9. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis.
    Rahman P, McInnes IB, Deodhar A, et al. · Clin Rheumatol · 2024 · Derived
    PubMed: PMID 38472528 · NCT03158285 · Arthritis, Psoriatic
  10. Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial.
    Puig L, Costanzo A, de Jong EMGJ, et al. · Dermatol Ther (Heidelb) · 2024 · Derived
    PubMed: PMID 39153060 · NCT02207231 (VOYAGE 1) · Psoriasis
  11. Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial.
    Puig L, Costanzo A, de Jong EMGJ, et al. · Am J Clin Dermatol · 2024 · Derived
    PubMed: PMID 37804472 · NCT02207231 (VOYAGE 1) · Psoriasis
  12. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study.
    Ogdie A, Merola JF, Mease PJ, et al. · BMC Rheumatol · 2024 · Derived
    PubMed: PMID 38773563 · NCT04936308 (SOLSTICE) · Arthritis, Psoriatic
  13. Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study.
    Mease PJ, Gladman DD, Poddubnyy D, et al. · Rheumatol Ther · 2024 · Derived
    PubMed: PMID 37819505 · NCT03158285 · Arthritis, Psoriatic
  14. Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.
    Mease P, Korotaeva T, Shesternya P, et al. · Rheumatol Ther · 2024 · Derived
    PubMed: PMID 39320583 · NCT03158285 · Arthritis, Psoriatic
  15. Speed and Cumulative Responses According to Body Regions in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Ixekizumab (Interleukin-17A Antagonist) versus Guselkumab (Interleukin-23p19 Inhibitor).
    Gooderham M, Vender R, Crowley J, et al. · Dermatol Ther (Heidelb) · 2024 · Derived
    PubMed: PMID 38332436 · NCT03573323 (IXORA-R)
  16. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial.
    Eyerich K, Asadullah K, Pinter A, et al. · JAMA Dermatol · 2024 · Derived
    PubMed: PMID 39083288 · NCT03818035 (GUIDE) · Psoriasis
  17. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial.
    Danese S, Panaccione R, Feagan BG, et al. · Lancet Gastroenterol Hepatol · 2024 · Derived
    PubMed: PMID 38104569 · NCT03466411 (GALAXI) · Crohn Disease
  18. Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis.
    Curtis JR, McInnes IB, Rahman P, et al. · Rheumatol Ther · 2024 · Derived
    PubMed: PMID 38386178 · NCT03158285 · Arthritis, Psoriatic
  19. Continuous improvement through differential trajectories of individual minimal disease activity criteria with guselkumab in active psoriatic arthritis: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study.
    Coates LC, Rahman P, Mease PJ, et al. · BMC Rheumatol · 2024 · Derived
    PubMed: PMID 38310261 · NCT03158285 · Arthritis, Psoriatic
  20. Guselkumab Reduces Disease- and Mechanism-Related Biomarkers More Than Adalimumab in Patients with Psoriasis: A VOYAGE 1 Substudy.
    Blauvelt A, Langley RG, Branigan PJ, et al. · JID Innov · 2024 · Derived
    PubMed: PMID 39114670 · NCT02207231 (VOYAGE 1) · Psoriasis
  21. Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy.
    Blauvelt A, Chen Y, Branigan PJ, et al. · JID Innov · 2024 · Derived
    PubMed: PMID 39224116 · NCT03090100 (ECLIPSE) · Psoriasis
  22. BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies.
    Baraliakos X, Gladman DD, Chakravarty SD, et al. · Rheumatol Adv Pract · 2024 · Derived
    PubMed: PMID 38765190 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  23. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies.
    Armstrong A, González-Cantero A, Khattri S, et al. · Dermatol Ther (Heidelb) · 2024 · Derived
    PubMed: PMID 38521874 · NCT03573323 (IXORA-R)

2023 (19 papers)

  1. Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial.
    Tillett W, Egeberg A, Sonkoly E, et al. · Arthritis Res Ther · 2023 · Derived
    PubMed: PMID 37715294 · NCT02207244 (VOYAGE 2) · Psoriasis
  2. Endoscopic and chemopreventive management of familial adenomatous polyposis syndrome.
    Stone JK, Mehta NA, Singh H, et al. · Fam Cancer · 2023 · Derived
    PubMed: PMID 37119510 · NCT03649971 · Adenomatous Polyposis Coli
  3. PsABIOnd Study and eDaily Substudy Design: Long-Term Effectiveness and Safety of Guselkumab and IL-17 Inhibitors in Routine Clinical Practice in Patients with Psoriatic Arthritis.
    Siebert S, Behrens F, Lubrano E, et al. · Rheumatol Ther · 2023 · Derived
    PubMed: PMID 36585602 · NCT05049798 (PsABIOnd) · Arthritis, Psoriatic
  4. Collagen Turnover Biomarkers Associate with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase 3 Clinical Trial (DISCOVER-2).
    Schett G, Loza MJ, Palanichamy A, et al. · Rheumatol Ther · 2023 · Derived
    PubMed: PMID 35352313 · NCT03158285 · Arthritis, Psoriatic
  5. Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study.
    Schett G, Chen W, Gao S, et al. · Arthritis Res Ther · 2023 · Derived
    PubMed: PMID 37587493 · NCT03796858 (COSMOS) · Arthritis, Psoriatic
  6. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial.
    Ritchlin CT, Coates LC, Mease PJ, et al. · Trials · 2023 · Derived
    PubMed: PMID 36627711 · NCT04882098 (APEX) · Arthritis, Psoriatic
  7. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis.
    Rahman P, Boehncke WH, Mease PJ, et al. · J Rheumatol · 2023 · Derived
    PubMed: PMID 36642439 · NCT02319759 · Arthritis, Psoriatic
  8. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study.
    Peyrin-Biroulet L, Allegretti JR, Rubin DT, et al. · Gastroenterology · 2023 · Derived
    PubMed: PMID 37659673 · NCT04033445 (QUASAR) · Colitis, Ulcerative
  9. Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis.
    Orbai AM, Chakravarty SD, You Y, et al. · Dermatol Ther (Heidelb) · 2023 · Derived
    PubMed: PMID 37713133 · NCT02207244 (VOYAGE 2) · Psoriasis
  10. Guselkumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa: A phase 2 randomized study.
    Kimball AB, Podda M, Alavi A, et al. · J Eur Acad Dermatol Venereol · 2023 · Derived
    PubMed: PMID 37317022 · NCT03628924 (NOVA) · Hidradenitis Suppurativa
  11. Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2.
    Kim BS, Jo SJ, Youn S, et al. · Dermatol Ther (Heidelb) · 2023 · Derived
    PubMed: PMID 37750995 · NCT02207244 (VOYAGE 2) · Psoriasis
  12. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials.
    Kavanaugh A, Baraliakos X, Gao S, et al. · Adv Ther · 2023 · Derived
    PubMed: PMID 36995469 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  13. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis.
    Gottlieb AB, McInnes IB, Rahman P, et al. · RMD Open · 2023 · Derived
    PubMed: PMID 36828643 · NCT03158285 · Arthritis, Psoriatic
  14. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial.
    Feagan BG, Sands BE, Sandborn WJ, et al. · Lancet Gastroenterol Hepatol · 2023 · Derived
    PubMed: PMID 36738762 · NCT03662542 (VEGA) · Colitis, Ulcerative
  15. Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis.
    Coates LC, Ritchlin CT, Gossec L, et al. · Rheumatology (Oxford) · 2023 · Derived
    PubMed: PMID 35766811 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  16. Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab.
    Campbell K, Li K, Yang F, et al. · Immunohorizons · 2023 · Derived
    PubMed: PMID 37071038 · NCT02203032 (NAVIGATE) · Psoriasis
  17. Management of Lupus Nephritis: New Treatments and Updated Guidelines.
    Avasare R, Drexler Y, Caster DJ, et al. · Kidney360 · 2023 · Derived
    PubMed: PMID 37528520 · NCT04376827 (ORCHID-LN) · Lupus Nephritis
  18. 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
    PubMed: PMID 35129472 · NCT07352566 · Psoriasis
  19. 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
    PubMed: PMID 37672566 · NCT07352566 · Psoriasis

2022 (15 papers)

  1. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease.
    Kucharzik T, Wilkens R, D'Agostino MA, et al. · Clin Gastroenterol Hepatol · 2022 · Trial result
    PubMed: PMID 35842121 · NCT07246460 (UPGRADE) · Constriction, Pathologic
  2. Efficacy and Safety of Guselkumab in Japanese Patients With Palmoplantar Pustulosis: A Phase 3 Randomized Clinical Trial.
    Terui T, Kobayashi S, Okubo Y, et al. · JAMA Dermatol · 2022 · Derived
    PubMed: PMID 31268476 · NCT02641730 · Psoriasis
  3. Guselkumab for the Treatment of Crohn's Disease: Induction Results From the Phase 2 GALAXI-1 Study.
    Sandborn WJ, D'Haens GR, Reinisch W, et al. · Gastroenterology · 2022 · Derived
    PubMed: PMID 35134323 · NCT03466411 (GALAXI) · Crohn Disease
  4. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies.
    Ritchlin CT, Mease PJ, Boehncke WH, et al. · RMD Open · 2022 · Derived
    PubMed: PMID 35296534 · NCT03158285 · Arthritis, Psoriatic
  5. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2.
    Reich K, Gordon KB, Strober BE, et al. · Br J Dermatol · 2022 · Derived
    PubMed: PMID 34105767 · NCT02207244 (VOYAGE 2) · Psoriasis
  6. Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis.
    Rahman P, Ritchlin CT, Helliwell PS, et al. · J Rheumatol · 2022 · Derived
    PubMed: PMID 33934076 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  7. Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study.
    Orbai AM, Coates LC, Deodhar A, et al. · Patient · 2022 · Derived
    PubMed: PMID 35768650 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  8. Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a randomised, double-blind, placebo controlled multicentre trial.
    Haberman RH, MacFarlane KA, Catron S, et al. · BMJ Open · 2022 · Derived
    PubMed: PMID 36564123 · NCT05004727 (PAMPA) · Psoriasis
  9. Efficacy and safety of guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial.
    Gladman DD, Mease PJ, Bird P, et al. · Trials · 2022 · Derived
    PubMed: PMID 36064592 · NCT04929210 (STAR) · Arthritis, Psoriatic
  10. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
    Elewski BE, Blauvelt A, Gallo G, et al. · Dermatol Ther (Heidelb) · 2022 · Derived
    PubMed: PMID 35279805 · NCT03573323 (IXORA-R)
  11. The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial.
    Curtis JR, McInnes IB, Rahman P, et al. · Adv Ther · 2022 · Derived
    PubMed: PMID 35947348 · NCT03158285 · Arthritis, Psoriatic
  12. The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial.
    Curtis JR, McInnes IB, Rahman P, et al. · Adv Ther · 2022 · Derived
    PubMed: PMID 35947349 · NCT03158285 · Arthritis, Psoriatic
  13. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS).
    Coates LC, Gossec L, Theander E, et al. · Ann Rheum Dis · 2022 · Derived
    PubMed: PMID 34819273 · NCT03796858 (COSMOS) · Arthritis, Psoriatic
  14. 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
    PubMed: PMID 35788566 · NCT07352566 · Psoriasis
  15. Modified dose of guselkumab for treatment of pyoderma gangrenosum.
    Reese AM, Erickson K, Reed KB, et al. · JAAD Case Rep · 2022 · Background
    PubMed: PMID 35146098 · NCT06563323 (GEORGE) · Skin Diseases

2021 (13 papers)

  1. Evaluating Potential Disease-Mediated Protein-Drug Interactions in Patients With Moderate-to-Severe Plaque Psoriasis Receiving Subcutaneous Guselkumab.
    Zhu Y, Xu Y, Zhuang Y, et al. · Clin Transl Sci · 2021 · Derived
    PubMed: PMID 32407591 · NCT02397382 · Psoriasis
  2. 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
    PubMed: PMID 34656148 · NCT04340076 (BeNeBio) · Psoriasis
  3. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials.
    Sweet K, Song Q, Loza MJ, et al. · RMD Open · 2021 · Derived
    PubMed: PMID 34011674 · NCT03158285 · Arthritis, Psoriatic
  4. Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study.
    Reich K, Armstrong AW, Foley P, et al. · Am J Clin Dermatol · 2021 · Derived
    PubMed: PMID 32910434 · NCT02207244 (VOYAGE 2) · Psoriasis
  5. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response-results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis.
    Rahman P, Mease PJ, Helliwell PS, et al. · Arthritis Res Ther · 2021 · Derived
    PubMed: PMID 34261541 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  6. Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study.
    Mease PJ, Gladman DD, Deodhar A, et al. · RMD Open · 2021 · Derived
    PubMed: PMID 32665433 · NCT02319759 · Arthritis, Psoriatic
  7. Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis.
    McInnes IB, Rahman P, Gottlieb AB, et al. · Arthritis Rheumatol · 2021 · Derived
    PubMed: PMID 33043600 · NCT03158285 · Arthritis, Psoriatic
  8. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies.
    McGonagle D, McInnes IB, Deodhar A, et al. · Rheumatology (Oxford) · 2021 · Derived
    PubMed: PMID 33822898 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  9. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE).
    Eyerich K, Weisenseel P, Pinter A, et al. · BMJ Open · 2021 · Derived
    PubMed: PMID 34518264 · NCT03818035 (GUIDE) · Psoriasis
  10. A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.
    Blauvelt A, Leonardi C, Elewski B, et al. · Br J Dermatol · 2021 · Derived
    PubMed: PMID 32880909 · NCT03573323 (IXORA-R)
  11. Ustekinumab for Extra-intestinal Manifestations of Inflammatory Bowel Disease: A Systematic Literature Review.
    Guillo L, D'Amico F, Danese S, et al. · J Crohns Colitis · 2021 · Background
    PubMed: PMID 33367674 · NCT06563323 (GEORGE) · Skin Diseases
  12. Successful treatment of a refractory pyoderma gangrenosum with risankizumab.
    Burgdorf B, Schlott S, Ivanov IH, et al. · Int Wound J · 2021 · Background
    PubMed: PMID 32266771 · NCT06563323 (GEORGE) · Skin Diseases
  13. Guselkumab as a treatment option for recalcitrant pyoderma gangrenosum.
    Baier C, Barak O · JAAD Case Rep · 2021 · Background
    PubMed: PMID 33490346 · NCT06563323 (GEORGE) · Skin Diseases

2020 (7 papers)

  1. Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies.
    Reich K, Papp KA, Armstrong AW, et al. · Br J Dermatol · 2020 · Derived
    PubMed: PMID 30485400 · NCT02207244 (VOYAGE 2) · Psoriasis
  2. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.
    Mease PJ, Rahman P, Gottlieb AB, et al. · Lancet · 2020 · Derived
    PubMed: PMID 32178766 · NCT03158285 · Arthritis, Psoriatic
  3. Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial.
    Helliwell PS, Deodhar A, Gottlieb AB, et al. · Arthritis Care Res (Hoboken) · 2020 · Derived
    PubMed: PMID 31421033 · NCT02319759 · Arthritis, Psoriatic
  4. Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study.
    Gordon KB, Armstrong AW, Foley P, et al. · J Invest Dermatol · 2020 · Derived
    PubMed: PMID 31207232 · NCT02207244 (VOYAGE 2) · Psoriasis
  5. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study.
    Ferris LK, Ott E, Jiang J, et al. · J Dermatolog Treat · 2020 · Derived
    PubMed: PMID 30887876 · NCT02905331 · Psoriasis
  6. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial.
    Deodhar A, Helliwell PS, Boehncke WH, et al. · Lancet · 2020 · Derived
    PubMed: PMID 32178765 · NCT03162796 (Discover-1) · Arthritis, Psoriatic
  7. Interleukin 23 and autoimmune diseases: current and possible future therapies.
    Abdo AIK, Tye GJ · Inflamm Res · 2020 · Background
    PubMed: PMID 32215665 · NCT06563323 (GEORGE) · Skin Diseases

2019 (4 papers)

  1. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial.
    Reich K, Armstrong AW, Langley RG, et al. · Lancet · 2019 · Derived
    PubMed: PMID 31402114 · NCT03090100 (ECLIPSE) · Psoriasis
  2. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials.
    Foley P, Gordon K, Griffiths CEM, et al. · JAMA Dermatol · 2019 · Derived
    PubMed: PMID 29799960 · NCT02207231 (VOYAGE 1) · Psoriasis
  3. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies.
    Armstrong AW, Reich K, Foley P, et al. · Am J Clin Dermatol · 2019 · Derived
    PubMed: PMID 30417277 · NCT02207244 (VOYAGE 2) · Psoriasis
  4. Dysregulation of inflammatory gene expression in lesional and nonlesional skin of patients with pyoderma gangrenosum.
    Ortega-Loayza AG, Nugent WH, Lucero OM, et al. · Br J Dermatol · 2019 · Background
    PubMed: PMID 28734003 · NCT06563323 (GEORGE) · Skin Diseases

2018 (1 paper)

  1. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.
    Deodhar A, Gottlieb AB, Boehncke WH, et al. · Lancet · 2018 · Derived
    PubMed: PMID 29893222 · NCT02319759 · Arthritis, Psoriatic

2016 (1 paper)

  1. 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
    PubMed: PMID 25904741 · NCT07352566 · Psoriasis

2015 (1 paper)

  1. Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial.
    Ormerod AD, Thomas KS, Craig FE, et al. · BMJ · 2015 · Background
    PubMed: PMID 26071094 · NCT06563323 (GEORGE) · Skin Diseases

2011 (1 paper)

  1. Interleukin 23 expression in pyoderma gangrenosum and targeted therapy with ustekinumab.
    Guenova E, Teske A, Fehrenbacher B, et al. · Arch Dermatol · 2011 · Background
    PubMed: PMID 21680759 · NCT06563323 (GEORGE) · Skin Diseases

2005 (1 paper)

  1. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation.
    Langrish CL, Chen Y, Blumenschein WM, et al. · J Exp Med · 2005 · Background
    PubMed: PMID 15657292 · NCT06563323 (GEORGE) · Skin Diseases

2003 (1 paper)

  1. What decline in pain intensity is meaningful to patients with acute pain?
    Cepeda MS, Africano JM, Polo R, et al. · Pain · 2003 · Background
    PubMed: PMID 14499431 · NCT06563323 (GEORGE) · Skin Diseases

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).