Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Официальное название

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

Обзор

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.

Подробное описание

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Вмешательства

• Препарат Guselkumab
  Guselkumab (GUS) subcutaneous injection
• Препарат Golimumab
  Golimumab (GOL) subcutaneous injection

Первичные конечные точки

• Achievement of cDAPSA low disease activity [Срок оценки: 12 Months]
• Investigator Global Assessment of Psoriasis of Clear or Almost Clear [Срок оценки: 12 Months]

Вторичные конечные точки (11)

• Minimal Disease Activity (MDA) using PSAID-12 [Срок оценки: 6 and 12 months]
• Minimal Disease Activity (MDA) using HAQ-DI [Срок оценки: 6 and 12 months]
• Change in PSAID-12 [Срок оценки: 6 and 12 months]
• PSAID-12 < 4 [Срок оценки: 6 and 12 months]
• Change in DLQI [Срок оценки: 6 and 12 months]
• IGA Among Patients with BSA > 3% at Baseline [Срок оценки: 6 and 12 months]
• IGA Among Patients with IGA ≥ 2 at Baseline [Срок оценки: 6 and 12 months]
• Change in Promis Fatigue [Срок оценки: 6 and 12 Months]
• Resolution of Dactylitis [Срок оценки: 6 and 12 Months]
• Resolution of Enthesitis [Срок оценки: 6 and 12 Months]
• Change in BASDAI [Срок оценки: 6 and 12 Months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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;
• 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;
• Use of moderate to high dose glucocorticoids (>10 mg);
• 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.

• Currently pregnant or actively trying to conceive.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Family Arthritis Center — Loxahatchee Groves
• Healing Rheumatology — Plant City
• Southwest Florida Rheumatology — Riverview
• Parris and Associates — Lilburn
• University of Massachusetts Chan Medical School — Worcester
• University of Nebraska Medical Center — Omaha
• New York University — New York
• Cincy Arthritis — Blue Ash
• … и ещё 6 центров

Публикации

• Ogdie A, Reddy SM, Gillespie SH, Husni ME, Scher JU, Salomon-Escoto K, Kay J, Luedders BA, Curtis JR, Shields AJS, Chakravarty SD, Gong C, Walsh JA. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial. PMID 40102973

Идентификаторы

NCT: NCT05669833 · CNTO1959PSA3006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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