SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.  
• EVOLUTION (NCT05669833) is an ongoing phase 3b, pragmatic, randomized, open-label, multicenter, active-comparator study evaluating the efficacy and safety of TREMFYA subcutaneous (SC) compared with golimumab SC in tumor necrosis factor inhibitor-inadequate response (TNFi-IR) adult patients with active psoriatic arthritis (PsA).^1,2  
• Efficacy and safety results are not currently available. Details regarding the study status and study design of EVOLUTION can be found on clinicaltrials.gov.² 

CLINICAL DATA

Phase 3b Study - EVOLUTION

Ogdie et al (2025)¹ designed the study protocol of a phase 3b, pragmatic, randomized, open-label, multicenter, active-comparator trial to assess efficacy and safety in switching to TREMFYA 100 mg SC every 4 weeks (Q4W) and every 8 weeks (Q8W) compared with a second tumor necrosis factor inhibitor (TNFi), golimumab 50 mg SC Q4W in TNFi-IR adult patients with active PsA. 

Study Design/Methods 

• Eligible inclusion criteria are as follows:^1,2 
  • Adult patients (18 to 80 years of age)
  • Diagnosis of PsA and meet the ClASsification criteria for Psoriatic ARthritis (CASPAR)
  • Active PsA: ≥1 swollen joint
  • clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) ≥10 (patients with psoriasis [PsO] and Investigator’s Global Assessment of psoriasis [IGA] ≥2 may have a cDAPSA score of 10-14; patients without PsO must have a cDAPSA score >14)
  • Currently receiving or previously received a TNFi and experienced inadequate response (TNFi-IR: primary, lack of response to TNFi; secondary, loss of TNFi response) and planning to switch to a new biologic therapy.
  • If using oral glucocorticoids (≤10 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs), topical therapies for PsO, or ≤2 oral small molecule therapies (conventional synthetic disease-modifying antirheumatic drug [csDMARD], or apremilast) must be on a stable dose for ≥4 weeks before study enrollment and throughout the study participation.
• Key exclusion criteria include as follows: 
  • Prior exposure to golimumab intravenous (IV) or SC, biologics other than TNFi
    (interleukin [IL]-12/23i, IL-17i, or IL-23i), or Janus kinase inhibitor (JAKi)
  • An adverse event that precludes use of another TNFi (development of drug-induced systemic lupus erythematosus [SLE], allergic reaction, serious infection, heart failure symptoms, demyelination due to the use of TNFi) or any other contraindication or substantial intolerance to a TNFi
  • Receiving oral glucocorticoids >10 mg per day
  • Already meet the primary endpoint criteria at screening or baseline (cDAPSA ≤13 and IGA 0/1) 
• The study design is summarized in Figure: EVOLUTION Study Design.³ 

• The primary efficacy endpoint will be assessed through month 12, and secondary endpoints through month 6 and month 12, respectively. The safety endpoint will be evaluated through week 60. Please see Table: Efficacy and Safety Endpoints.^1,2

• In the primary endpoint analysis, patients who discontinue study treatment, initiate, or increase the use of other PsA medications will be classified as nonresponders. Using multiple imputation, other missing data will be imputed.¹ 
• Safety analyses will include all patients who received ≥1 dose of study intervention.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, DERWENT^® (and other resources, including internal/external databases) was conducted on 22 August 2025.