Guselkumab vs Golimumab for Psoriatic Arthritis
(EVOLUTION Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Pennsylvania
Must be taking: TNFi, OSM/csDMARDs
Must not be taking: Golimumab, IL12/23i, IL17i, IL23i
Disqualifiers: Pregnancy, Heart failure, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of any oral small molecule drugs, NSAIDs, glucocorticoids (less than 10 mg daily), or topical medications for psoriasis that you are currently using. You must have been on this stable dose for at least 4 weeks before starting the trial and continue it during the study.
What data supports the effectiveness of the drugs Guselkumab and Golimumab for treating psoriatic arthritis?
Research shows that Golimumab is effective for psoriatic arthritis, especially for patients who did not respond to other similar treatments. Guselkumab has also shown positive results in improving symptoms in psoriatic arthritis and has been effective in treating plaque psoriasis, which is related to psoriatic arthritis.12345
Is Guselkumab or Golimumab safe for humans?
How does the drug Guselkumab differ from other treatments for psoriatic arthritis?
Research Team
Alexis Ogdie-Beatty, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for adults aged 18-80 with active psoriatic arthritis who have not responded well to TNF inhibitors. Participants must have at least one active psoriasis plaque and meet specific criteria for joint swelling or tenderness. They should be on a stable dose of certain medications if used, but cannot be pregnant, trying to conceive, or have had serious reactions to similar drugs.Inclusion Criteria
I am on a stable dose of one specific oral medication for my condition.
I have at least one active psoriasis plaque.
I have been diagnosed with psoriatic arthritis according to CASPAR criteria.
See 4 more
Exclusion Criteria
I have previously been treated with golimumab or similar medications.
I am taking more than 10 mg of steroids daily.
Currently pregnant or actively trying to conceive
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either guselkumab or golimumab based on randomization to assess effectiveness in PsA patients with inadequate response to TNFi
12 months
Visits every 4 or 8 weeks depending on treatment group
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Treatment Details
Interventions
- Golimumab (Monoclonal Antibodies)
- Guselkumab (Monoclonal Antibodies)
- Placebo (Other)
Trial OverviewThe study compares the effectiveness of two treatments in patients with PsA who haven't done well on TNF inhibitors: Guselkumab (an IL23 inhibitor) versus Golimumab (a second TNFi). It's a randomized double-blind trial where participants won't know which treatment they're getting.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Guselkumab 100mg q8wExperimental Treatment1 Intervention
Guselkumab (GUS) 100mg every 8 weeks
Group II: Guselkumab 100mg q4wExperimental Treatment1 Intervention
Guselkumab (GUS) 100mg every 4 weeks
Group III: Golimumab 50mg q4wActive Control1 Intervention
Golimumab (GOL) 50mg every 4 weeks
Golimumab is already approved in Canada for the following indications:
Approved in Canada as Simponi for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Family Arthritis CenterLoxahatchee Groves, FL
Southwest Florida RheumatologyRiverview, FL
Parris and AssociatesLilburn, GA
Healing RheumatologyPlant City, FL
More Trial Locations
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Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Trials
2118
Patients Recruited
45,270,000+
Janssen Scientific Affairs, LLC
Industry Sponsor
Trials
165
Patients Recruited
579,000+
Findings from Research
In a pooled analysis of 712 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), second-line treatment with golimumab (GLM) achieved low disease activity in 58.3% of RA patients and around 45% in PsA and axSpA patients after 6 months, indicating its effectiveness as a treatment option.
The treatment was well-tolerated, with a 12-month persistence rate of 67.8% and no new safety concerns reported, suggesting that GLM is a safe and viable second-line therapy for patients who did not respond to first-line TNFα inhibitors.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie.Govoni, M., Batalov, A., Boumpas, DT., et al.[2023]
In a study of 410 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), golimumab demonstrated a two-year retention rate of 47.3% for RA, 48% for PsA, and 62.8% for AS, indicating better long-term use in AS patients.
Patients with RA who received golimumab alongside conventional synthetic disease-modifying antirheumatic drugs (sDMARDs) had a lower discontinuation rate compared to those on golimumab alone, suggesting that combination therapy may enhance treatment retention.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry.Manara, M., Caporali, R., Favalli, EG., et al.[2017]
Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.
Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis.Al-Salama, ZT., Scott, LJ.[2019]
In a real-world study of 1454 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), golimumab (GLM) showed significant effectiveness as a treatment regardless of whether it was used as a first, second, or third-line biologic agent.
After 24 months of treatment, remission rates for RA patients were 45.3% for first-line, 50.0% for second-line, and 33.3% for third-line users, while PsA patients had a response rate of 76.4% for first-line use, demonstrating GLM's efficacy across different treatment lines.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany.Krüger, K., Burmester, GR., Wassenberg, S., et al.[2021]
In a study of 1318 patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, GP2017 (Hyrimoz) showed a lower risk of withdrawal compared to SB5 (Imraldi), with a hazard ratio of 0.60, indicating better retention of treatment.
Patients using GP2017 also had a higher remission rate at 6 months (OR 1.72) compared to those on SB5, suggesting that GP2017 may be more effective in routine care for these conditions.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial.Nabi, H., Georgiadis, S., Loft, AG., et al.[2021]
In a study of 603 patients with rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis, over 93% successfully transitioned from the reference drug adalimumab (ADA) to the biosimilar Amgevita® (ADAbio) without significant changes in disease activity or safety, supporting the bioequivalence of the two medications.
Only 6.6% of patients switched back to ADA, indicating that the majority tolerated the switch well, and any reported symptoms likely stemmed from nocebo effects rather than actual disease flare-ups.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Non-medical Switch from Reference Adalimumab to Biosimilar Adalimumab is Highly Successful in a Large Cohort of Patients with Stable Inflammatory Rheumatic Joint Diseases: A Real-Life Observational Study.van Adrichem, RCS., Voorneveld, HJE., Waverijn, GJ., et al.[2022]
Tofacitinib has a consistent safety profile in psoriatic arthritis (PsA) similar to that observed in rheumatoid arthritis (RA), based on a review of 73,525 adverse event reports, with 5,394 cases related to PsA.
The analysis showed that the reporting rates for adverse events were higher for the modified release formulation compared to the immediate release, indicating potential differences in safety profiles based on the formulation used.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis.Burmester, GR., Coates, LC., Cohen, SB., et al.[2023]
References
Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie. [2023]
Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry. [2017]
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]
Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. [2021]
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. [2023]
Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review. [2022]
Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial. [2021]
The Non-medical Switch from Reference Adalimumab to Biosimilar Adalimumab is Highly Successful in a Large Cohort of Patients with Stable Inflammatory Rheumatic Joint Diseases: A Real-Life Observational Study. [2022]
Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis. [2023]
Guselkumab: First Global Approval. [2019]
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. [2023]
Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. [2020]
Guselkumab for the treatment of adults with moderate to severe plaque psoriasis. [2020]