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Table 1 Selected inclusion and exclusion criteria

From: Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study

Inclusion Criteria

Exclusion Criteria

Aged ≥ 18 years

Diagnosis of PsA for ≥ 6 months prior to first study intervention administration and meet CASPAR criteria at screening

Active PsA: ≥ 3 swollen joints, ≥ 3 tender joints, and CRP ≥ 0.3 mg/dL

Inadequate efficacy and or/ intolerance to TNFi therapy: active PsA despite previous treatment with one prior TNFi

Active plaque psoriasis (≥ 1 plaque of ≥ 2 cm and/or psoriatic nail changes) or documented history of psoriasis

 ≥ 1 of the following PsA subtypes: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis

Other inflammatory diseases (e.g., RA, AS, lupus)

 > 1 prior TNFi

Prior TNFi within 8 weeks (infliximab, intravenous golimumab), within 6 weeks (subcutaneous golimumab, adalimumab, or certolizumab pegol), or within 4 weeks (etanercept) of first study intervention administration

Previous biologic therapy other than one TNFi

Previous JAK inhibitor therapy

Prior therapy with systemic immunosuppressants; epidural, intra-articular, intramuscular, or intravenous corticosteroids, including adrenocorticotropic hormone; or apremilast within 4 weeks of first study intervention administration

Receiving ≥ 2 csDMARDs at baseline

  1. AS ankylosing spondylitis, CASPAR ClASsification criteria for Psoriatic Arthritis, CRP C-reactive protein, csDMARD conventional synthetic disease-modifying antirheumatic drug, JAK Janus kinase, NSAID nonsteroidal anti-inflammatory drug, PsA psoriatic arthritis, RA rheumatoid arthritis, TNFi tumor necrosis factor inhibitor