Abstract

Patient management in Psoriatic Arthritis (PsA) varies in the real-world clinical practice, especially concerning biologic therapies initiation and switch. This may be a source of considerable variation in treatment costs and due outcomes. We aimed to develop an outcomes measurement tool to evaluate the quality of biologic switch in PsA patients. We performed a modified-Delphi consensus with an expert panel composed of seven experienced rheumatologists, which followed a four-step procedure: 1) literature search and experts’ opinion about quality indicators; 2) Delphi design to address the development of a measurement tool; 3) three Delphi questionnaire rounds; 4) Consensus meeting. The literature search and experts’ opinion resulted on the identification of 45 domains for disease management, which were distributed according to three perspectives: physician (n=19), patient (n=20) and society (n=6). During the Delphi process, experts agreed that biologics switch should be classified into three quality levels: “Good”, based on treat-to-target thresholds; “Moderate”, based on baseline improvement thresholds; and the remaining as “Insufficient”. At the Consensus Meeting 6 domains were selected: disease activity, dactylitis, enthesis, physical function, quality of life, skin and nail manifestations. A “Good” switch was defined as comprising a majority of domains with “Good” outcome, including disease activity, and up 2 domains with “Moderate” outcome; while a “Moderate” was defined as comprising a majority of domains with “Good” or “Moderate” outcomes, also including disease activity, and up to 2 domains with “Insufficient” outcome. The proposed outcomes measurement tool is a first attempt to address the quality of treatment decisions regarding biologics switch in PsA. Validation of this tool in the clinical practice will soon be performed and then it can be used to evaluate the quality of biologic switch in real-world research and to support decision making for oriented patient management.

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