SOLSTICE Study Design^1,2

Abbreviations: ACR 20/50/70, ≥ 20%/50%/70% improvement in American College of Rheumatology response criteria; AE, adverse event; AS, ankylosing spondylitis; CASPAR, Classification Criteria for Psoriatic Arthritis; CO, placebo crossover; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTCAE, Common Terminology Criteria for Adverse Events; DBL, database lock; EE, early escape; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; GUS, guselkumab; HAQ-DI, Health Assessment Questionnaire-Disability Index; IGA, Investigator’s Global Assessment; JAK, Janus kinase; MDA, minimal disease activity; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index; PBO, placebo; PK pharmacokinetics; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; R, randomization; RA, rheumatoid arthritis; SAE, serious adverse event; SC, subcutaneous; SF-36 PCS, 36-item Short Form Healthy Survey physical component summary score; TNFi, tumor necrosis factor inhibitor; VLDA, very low disease activity.
^aEarly escape: At week 16, all participants in 3 groups with <20% improvement from baseline in both tender and swollen joint counts will qualify for early escape and will be allowed to initiate or increase the dose of 1 of the permitted concomitant medications up to the maximum allowed dose, as selected by the investigator.
^bThe first DBL will occur when all randomized participants have either completed the week 24 assessments or terminated study participation prior to the week 24 visit.
^cThe second DBL will occur when all randomized participants have either completed the week 52 assessments or terminated study participation prior to the week 52 visit.
^dThe third DBL will occur when all participants have either completed their final safety visit or have terminated study participation.
^eAmong patients with ≥3% body surface area affected with psoriasis involvement and an IGA score ≥2 at baseline.
^fSerum samples are to be collected at the final visit from patients who discontinue study intervention or who withdraw from the study. Samples will be collected before study intervention administration at visits when study intervention administration is scheduled.