Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Korábbi kezelés

• 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;

Más betegség

• 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;
• 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.

Egyéb

• Use of moderate to high dose glucocorticoids (>10 mg);
• Currently pregnant or actively trying to conceive.

• Psoriatic arthritis meeting CASPAR criteria;
• Active psoriatic arthritis defined by at least 1 swollen joint;
• cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
• 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 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.
• 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;
• 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).