Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

University of Pennsylvania

Status and phase: Enrolling; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Guselkumab; Drug: Golimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05669833

CNTO1959PSA3006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Guselkumab 100mg q4w

Experimental group

Description:

Guselkumab (GUS) 100mg every 4 weeks

Treatment:

Drug: Guselkumab

Guselkumab 100mg q8w

Experimental group

Description:

Guselkumab (GUS) 100mg every 8 weeks

Treatment:

Drug: Guselkumab

Golimumab 50mg q4w

Active Comparator group

Description:

Golimumab (GOL) 50mg every 4 weeks

Treatment:

Drug: Golimumab