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Objectives To define a fit-for-purpose clinical outcome assessment, and thresholds for entry and improvement, for the serositis domain of a multi-domain outcome measure for clinical trials in systemic lupus erythematosus (SLE), the Treatment Response Measure for SLE (TRM-SLE).Methods A multi-step consensus process was carried out by a 12-member expert working group including lupus clinicians and SLE patients with lived experience of lupus serositis. First, the domain definition and scope in the SLE clinical trial context were defined. Potentially suitable measures were nominated, discussed and shortlisted for evaluation in a systematic literature review (SLR) guided by COSMIN methodology to evaluate instrument measurement properties and clinical trial utility. Nominal group technique (NGT) was then employed to reach consensus on a clinical outcome assessment and with thresholds for entry and improvement.Results Serositis was defined with 100% consensus as ‘active serositis attributed to lupus that impacts the patient and is modifiable by therapy to reduce or control disease activity’, with the scope of the domain limited to pericarditis and pleurisy. Structured discussion resolved to use a single serositis domain to determine treatment response in patients with pericarditis, pleurisy, or both. A total of 71 candidate measures were nominated for consideration. Ten measures were shortlisted for evaluation in the SLR. After review of SLR results, consensus was reached via NGT for serositis response to be measured by an 11-point Numerical Rating Scale (NRS) rating the worst chest pain attributable to pericarditis/pleurisy over the preceding 24 hours, measured via daily pain diary for one week and averaged over 7 days. The entry threshold was next defined as a chest pain NRS of ≥4, with inclusion additionally requiring pericarditis (ECG changes, pericardial rub or new/worsening pericardial effusion), and/or pleurisy (pleural rub, pleural effusion or thickening). The minimum clinically meaningful improvement threshold was defined as ≥50% reduction in pain NRS from baseline, while complete response was defined as pain NRS ≤2 ( figure 1).Abstract PO:05:139 Figure 1Conclusions Consensus was achieved to use the chest pain NRS as the measure of response in pleurisy and/or pericarditis, with defined thresholds for entry and improvement, in the serositis domain of TRM-SLE in SLE clinical trials.