Outcomes
PsA, peripheral joint pain, gastrointestinal (GI) perforations, axial disease, Deaths, low disease activity, Cancer
ADVERSE EVENT, ANKYLOSING SPONDYLITIS, ADVERSE EVENTS, DISEASE, EVENTS, DISEASE, CANCER
Efficacy outcomes that describe axial disease activity in the two PsA patient sub-groups with axial involvement (ie, axial involvement defined by investigator judgement alone or investigator judgement and PRO-based criteria) were evaluated at weeks 12, 24, and 56 for both studies. Efficacy endpoints included change from baseline in the overall BASDAI score, modified BASDAI score (excluding question 3 related to peripheral joint pain), and the Ankylosing Spondylitis Disease Activity Score (ASDAS [CRP], hereafter referred to as ASDAS). In addition, change from baseline in individual BASDAI components (questions 1 to 6) were evaluated. The proportion of patients achieving BASDAI50 (≥ 50% improvement from baseline in BASDAI), as well as ASDAS inactive disease (ID, defined as score < 1.3), ASDAS low disease activity (LDA, defined as score < 2.1), ASDAS major improvement (MI, defined as ≥ 2.0 decrease from baseline), and ASDAS clinically important improvement (CII, defined as ≥ 1.1 decrease from baseline) were also assessed.For this post-analysis, safety data from both SELECT-PsA trials were summarized for all patients who received ≥ 1 dose of study drug through week 56. Treatment-emergent adverse events (TEAEs) were coded per the Medical Dictionary for Regulatory Activities (MedDRA; v 22.0) and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; v 5.0). Deaths and cardiovascular events were adjudicated by a blinded, independent, external committee using definitions that were pre-specified. Reported gastrointestinal (GI) perforations were adjudicated by a blinded committee of sponsor-employed experts.