Assessment
Chronic Illness, fatigue, Spondyloarthritis, Psoriatic Arthritis, low disease activity, criteria)/very low disease, enthesitis
ENTHESITIS, CHRONIC ILLNESS, DISEASE, REMISSION, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, DISEASE, ENTHESITIS
In OPAL Broaden and Beyond, presence of enthesitis in patients was determined at baseline, and at months 1, 3, and 6, by a blinded, qualified assessor using the Leeds Enthesitis Index (LEI) [Enthesitis sites evaluated by LEI or SPARCC. LEI, Leeds Enthesitis Index; SPARCC, Spondyloarthritis Research Consortium of Canada Enthesitis Index. Adapted from Mease PJ, et al. J Rheumatol. 2017;44:599–608. Reproduced with permissionPatients were categorized based on the presence (LEI > 0 or SPARCC > 0) or absence (LEI = 0 and SPARCC = 0) of enthesitis at baseline. Patients with enthesitis were further stratified by enthesitis location and severity at baseline. Enthesitis location was determined as the individual sites assessed for LEI (Fig. Data at baseline and months 1, 3, and 6, from OPAL Broaden and Beyond, were included in this analysis. Individual patient-level data across the two studies were pooled, and data-handling conventions that were utilized in each study, including the handling of missing data, were also applied across the pooled data.The following endpoints were assessed in patients with LEI > 0 or SPARCC > 0 at baseline: change from baseline in LEI or SPARCC, and the proportions of patients with enthesitis or with relapsed enthesitis (assessed at months 3 and 6 only) after resolution at months 1 or 3. The development of de novo enthesitis in patients with LEI = 0 and SPARCC = 0 at baseline was also assessed.Disease activity measures assessed were: the proportion of patients achieving low disease activity (LDA) and remission, based on minimal disease activity (MDA; ≥ 5/7 criteria)/very low disease activity (7/7 MDA criteria), Psoriatic Arthritis Disease Activity Score (PASDAS; > 1.9– < 3.2/ ≤ 1.9 [near remission]), Disease Activity Index for Psoriatic Arthritis (DAPSA; > 4– ≤ 14/ ≤ 4), and Composite Psoriatic Disease Activity in Psoriatic Arthritis (CPDAI; > 2– ≤ 4/ ≤ 2). Detailed descriptions of the disease activity measures are presented in Supplementary Table 1 (see Additional file PROs included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score (range 0–52; higher scores indicate less fatigue) [