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

Table 2 Study objectives and selected endpoints

Objectives	Endpoints
Primary
To evaluate the efficacy of guselkumab treatment in patients with active PsA and inadequate efficacy and/or intolerance to a prior TNFi by assessing reduction in signs and symptoms of PsA	Proportion of patients achieving an ACR20 response at Week 24
Major Secondary
To evaluate the efficacy of guselkumab on additional measures of signs and symptoms of PsA, psoriasis, and patient well-being in TNFi-IR patients with active PsA	At Week 16, proportion of patients achieving: • ACR20/50 responses At Week 24, proportion of patients achieving: • IGA 0/1 response and ≥ 2-grade reduction from baseline^a • PASI 90 response^a • ACR50/70 responses At Week 24, change from baseline in: • HAQ-DI score • SF-36 PCS score • FACIT-Fatigue score Over time, the proportion of patients achieving: • MDA • VLDA
Other Secondary
To evaluate the safety of guselkumab in TNFi-IR patients with active PsA	For the duration of the study, through Week 112: • Frequency and type of AEs, SAEs, AEs leading to discontinuation of study intervention, infections, and injection-site reactions • Frequency of laboratory abnormalities (chemistry, hematology) maximum toxicity (Common Terminology Criteria for Adverse Events [5.0]) grades
To evaluate the PK and immunogenicity of guselkumab in TNFi-IR patients with active PsA	Through Week 112^b: • Mean/median serum guselkumab concentrations over time • Summary of incidence of antibodies to guselkumab

ACR20/50/70 ≥ 20%/50%/70% improvement in American College of Rheumatology response criteria, AE adverse event, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, IGA Investigator’s Global Assessment, MDA minimal disease activity, PASI 90 ≥ 90% improvement in Psoriasis Area and Severity Index, PsA psoriatic arthritis, SAE serious adverse event, SF-36 PCS 36-item Short Form Healthy Survey physical component summary score, TNFi-IR tumor necrosis factor inhibitor-inadequate responder, VLDA very low disease activity
^aAmong patients with ≥ 3% body surface area affected with psoriasis involvement and an IGA score ≥ 2 at baseline
^bSerum 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

ISSN: 2520-1026