ArticleRheumatology (Oxford, England)2026
Responsiveness of patient-reported outcomes by disease trajectory in SLE.
Article in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
objectivesSLE is a heterogeneous autoimmune disease with persistent symptoms that profoundly impair quality of life yet are often under-recognized by clinician-assessed instruments. Patient-reported outcomes (PROs) are increasingly incorporated in clinical trials to capture treatment benefit from the patient perspective. However, the responsiveness of PRO instruments and their alignment with clinician-assessed disease activity across distinct SLE trajectories remain incompletely defined. We evaluated the longitudinal responsiveness and convergent validity of PRO measures across predefined disease trajectory classes.
methodsSecondary analysis of pooled patient-level data from two phase III randomized clinical trials of belimumab in adults with active SLE (n = 1908), stratified into four previously derived trajectory classes defined by baseline disease activity and treatment response. PROs included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS), EuroQol 5-Dimension 3-level (EQ-5D-3L) and EuroQol Visual Analogue Scale (EQ-VAS). Responsiveness was quantified using standardized response means (SRMs). Convergent validity was evaluated using repeated-measures correlations between within-person changes in PROs and clinician-assessed disease activity measures (SLEDAI-2K, BILAG and Physician's Global Assessment [PGA]), with sensitivity analyses performed to assess the robustness of findings.
resultsFACIT-F and SF-36 PCS generally demonstrated the greatest responsiveness, while EQ-5D-3L showed smaller changes and less consistent responsiveness across classes and timepoints. FACIT-F demonstrated early responsiveness, whereas SF-36 PCS showed sustained responsiveness over later follow-up. PRO changes were most consistently associated with PGA. Sensitivity analyses showed broadly similar patterns.
conclusionFACIT-F and SF-36 PCS demonstrated the greatest responsiveness and alignment with clinician-assessed disease activity. EQ-5D-3L showed less consistent responsiveness, suggesting domain-specific PROs may better capture treatment benefit in SLE trials and health technology assessments.
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