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Responders at week 104 demonstrated more significant changes from baseline and achieved normative values in PROs compared with non-responders.
Results of a post hoc analysis revealed patients with psoriatic arthritis (PsA)who achieve clinical disease control are more likely to see significant improvements in patient-reported outcomes (PROs) and quality of life (QoL) measures, according to data published in ACR Open Rheumatology.1
As PsA is a heterogeneous disease with a high disease burden, the primary goal is to enhance QoL by reducing disease activity, managing symptoms, and ideally, preventing any irreversible joint damage or disability.2
“Owing to the substantial impact of PsA manifestations, such as enthesitis, dactylitis, tender and swollen joints, and skin and nail psoriasis, on patients’ QoL, PROs are an important part of clinical assessment,” wrote a team of investigators led by Arthur Kavanaugh, MD, rheumatologist and professor of medicine at the University of California San Diego.
Investigators used 104-week data from the SELECT-PsA 1 and SELECT-PsA 2 trials to assess the connection between achievement of clinical disease control and normative values for and improvements in PROs and QoL. The trials enrolled adult patients with PsA who had inadequate response to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD; SELECT-PsA1) or biologic DMARD (bDMARD; SELECT-PsA 2). Patients in both studies were randomized to receive oral upadacitinib 15 mg once daily (QD), upadacitinib 30 mg QD, or placebo. In the SELECT-PsA 1 trial, an additional group of patients were randomized to receive subcutaneous adalimumab 40 mg every other week (EOW). At week 24, patients in the placebo cohort were blindly switched (1:1) to initiate upadacitinib 15 mg or 30 mg QD.
Measures used to evaluate clinical disease control included minimal disease activity (MDA), low disease activity (LDA), very low disease activity (VLDA), remission as characterized by Disease Activity in Psoriatic Arthritis (DAPSA), Routine Assessment of Patient Index Data 3 (RAPID3), and the Psoriatic Arthritis Disease Activity Score (PASDAS). Investigators used these findings to assess their associations with improvements and normative values for a number of PROs. These included the Health Assessment Questionnaire-Disability Index (HAQ-DI), the 36-item short-form quality of life questionnaire (SF-36) mental component summary (MCS) and physical component summary (PCS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), patients’ global assessment of disease activity (PtGA), 5-Level EuroQol 5-Dimension (EQ-5D-5L) index, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
In total, 1069 patients in SELECT-PsA 1 and 317 patients in SELECT-PsA 2 were analyzed. Responders were defined as those who achieved MDA or VLDA, and PASDAS, DAPSA, and RAPID3 LDA or remission. Disease control was obtained by similar proportions of patients in the upadacitinib 15 mg QD cohort, placebo to upadacitinib 15 mg QD cohort, and adalimumab 40 mg EOW cohort.
In both studies, responders at week 104 demonstrated more marked changes from baseline and achieved normative values in PROs compared with non-responders (P <.0001). Additionally, more responders obtained minimal clinically important differences among PROs compared with non-responders. Those who achieved MDA or VLDA were more likely to achieve PASDAS, DAPSA, and RAPID3 LDA or remission (P <.0001) for upadacitinib 15 mg QD and for pooled treatment arms.
Investigators noted limitations including the post hoc study design, missing data and loss to follow-up, and the limited generalizability of results.
“These results further suggest that clinical disease activity control measures are key to the treatment of PsA and are closely tied to the achievement of outcomes that are important to patients,” investigators concluded.
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