Comparing Guselkumab and Golimumab for Psoriatic Arthritis Patients

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)

This study is testing whether switching to a new medication called guselkumab works better than switching to golimumab for people with psoriatic arthritis who haven't gotten better with other treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Pennsylvania (other)
• Drugs / interventions: golimumab, methotrexate, guselkumab
• Locations: 14 sites (Loxahatchee Groves, Florida and 13 other locations)
• Trial ID: NCT05669833 on ClinicalTrials.gov

What this trial studies

This open-label randomized trial aims to evaluate the effectiveness of switching to guselkumab, a selective IL23 inhibitor, compared to switching to golimumab, a second TNF inhibitor, in patients with psoriatic arthritis who have not adequately responded to TNF inhibitors. The study will include patients who meet the CASPAR criteria for psoriatic arthritis and have active disease as defined by specific clinical measures. By investigating a new mechanism of action, this trial seeks to provide insights into more effective treatment options for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with psoriatic arthritis who have had an inadequate response to a TNF inhibitor.

Not a fit: Patients who have not previously used a TNF inhibitor or those with conditions that complicate the assessment of psoriatic arthritis symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with psoriatic arthritis who have not responded to previous TNF inhibitors.

How similar studies have performed: This approach of switching to a different mechanism of action in patients with inadequate response to TNF inhibitors is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Psoriatic arthritis meeting CASPAR criteria;
2. Active psoriatic arthritis defined by at least 1 swollen joint;
3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be \> 14 in patients without psoriasis.
4. Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy;
5. If using an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Use of up to two OSM/csDMARDs is allowed.
6. If using NSAIDs, glucocorticoids (\<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to Screening/Baseline 1 and remain on a stable dose during the study;
7. Age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA).

Exclusion Criteria:

1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); prior exposure to a TYK2i is acceptable, but cannot be used during course of the study;
2. An adverse event that precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi;
3. Use of moderate to high dose glucocorticoids (\>10 mg);
4. Already meets the primary endpoint at Baseline; \[cDAPSA low disease activity ≤ 14; IGA of psoriasis 0/1\] In patients with psoriasis, cDAPSA can be 10-14 IF the Investigator Global Assessment of Psoriasis ≥ 2.

   In patients without psoriasis, cDAPSA must be \> 14 to meet eligibility requirements.
5. Currently pregnant or actively trying to conceive.

Where this trial is running

Loxahatchee Groves, Florida and 13 other locations

• Family Arthritis Center — Loxahatchee Groves, Florida, United States (RECRUITING)
• Healing Rheumatology — Plant City, Florida, United States (RECRUITING)
• Southwest Florida Rheumatology — Riverview, Florida, United States (RECRUITING)
• Parris and Associates — Lilburn, Georgia, United States (RECRUITING)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (RECRUITING)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
• New York University — New York, New York, United States (RECRUITING)
• Cincy Arthritis — Blue Ash, Ohio, United States (RECRUITING)
• Southern Ohio Rheumatology — Wheelersburg, Ohio, United States (RECRUITING)
• Hospital at the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• Cumberland Rheumatology — Crossville, Tennessee, United States (RECRUITING)
• Heritage Rheumatology and Arthritis Care — Colleyville, Texas, United States (RECRUITING)
• Texas Arthritis Center — El Paso, Texas, United States (RECRUITING)
• University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Alexis Ogdie-Beatty, MD, MSCE — University of Pennsylvania
• Study coordinator: Sarah Gillespie

Conditions: Psoriatic Arthritis, PsA