Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)
Psoriatic Arthritis
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis
Eligibility Criteria
Inclusion Criteria: Psoriatic arthritis meeting CASPAR criteria; Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints (this captures the majority of patients switching therapy in our cohort); At least one active psoriasis plaque; 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; If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Only use of a single OSM/csDMARD is allowed. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks and remain on a stable dose during the study; 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: Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); An adverse event the 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; Use of moderate to high dose glucocorticoids (>10 mg). Already meet the primary outcome at screening or baseline
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
GOL (4 Weeks)
GUS (8 Weeks)
GUS (4 Weeks)
Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks
Guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks
GUS 100 mg every 4 weeks