POS1066 DEVELOPMENT OF PHYSICAL AND MENTAL COMPONENT SUMMARY SCORES FROM PROMIS-29 INSTRUMENT IN PATIENTS WITH PSORIATIC ARTHRITIS

Abstract

BackgroundPatients (pts) with psoriatic arthritis (PsA) experience pain, fatigue, anxiety, depression, sleep disturbance, and impaired physical function that can negatively affect health-related quality of life (HRQoL).1 As the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile is a generic instrument assessing 7 health outcome domains, composite scores to summarize these domains into generalized concepts of mental and physical health using physical component summary (PCS) and mental component summary (MCS) scores2,3 will be useful to evaluate overall HRQoL in pts with PsA.ObjectivesCalculate and validate PCS and MCS scores, using PROMIS-29 data from the DISCOVER-1 Phase 3 study, and compare the scores for guselkumab (GUS) vs placebo (PBO).MethodsThe DISCOVER-1 study evaluated 381 pts with active PsA (≥3 swollen & ≥3 tender joints; C-reactive protein ≥0.3 mg/dL; 31% with prior tumor necrosis factor inhibitor exposure) and inadequate response to standard therapies.4 The PROMIS-29 Profile contains 4 items for each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social participation, pain interference; 28 items scored on 5-point Likert scale) and 1 pain intensity item (0-10 visual analog scale). Using standardized scoring coefficients,3 PROMIS-29 PCS/MCS at baseline and Week 24 were calculated based on the 7 domains and pain intensity item. The validity of scores was assessed by Spearman correlation between PROMIS-29 PCS/MCS and 36-item Short-Form (SF-36) PCS/MCS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores. To evaluate the ability of derived PROMIS-29 PCS/MCS scores to distinguish between treatments, responder analyses (employing an improvement of ≥1/2 standard deviation [SD] of baseline scores) by treatment group (GUS 100 mg Q4W, GUS 100 mg Q8W, PBO) were conducted and compared with SF-36 PCS/MCS scores.ResultsAs construct validity analysis, PROMIS-29 PCS/MCS strongly/very strongly correlated with SF-36 PCS/MCS scores at baseline and Week 24 (coefficients 0.66-0.86; Table 1). PROMIS-29 and SF-36 PCS scores showed strong/very strong correlations with HAQ-DI scores, a key component of physical health (coefficients 0.66-0.83), while PROMIS-29 MCS and SF-36 MCS scores showed strong/very strong correlations with FACIT-F scores, a key component of mental health (coefficients 0.63-0.91). The proportions of pts achieving improved PROMIS-29 PCS/MCS scores (≥1/2 SD at baseline) were similar to a comparable degree of improvement in SF-36 PCS/MCS scores (≥1/2 SD at baseline). For both PROMIS-29 PCS/MCS and SF-36 PCS/MCS scores, significantly higher proportions of GUS Q4W/Q8W- vs PBO-treated pts achieved these response thresholds (all p<0.05; Figure 1) with the deltas between both GUS groups vs PBO for PROMIS-29 PCS/MCS responses numerically greater than for SF-36 PCS/MCS responses.Table 1.Mean (SD) PCS and MCS Scores: Construct ValidityInstruments Assessing Physical Aspects of HRQoLInstruments Assessing Mental Aspects of HRQoLSF-36 PCSPROMIS-29 PCSSF-36 MCSPROMIS-29 MCSBaseline, N381381381381Mean (SD)34.6 (8.2)39.4 (7.2)47.4 (10.2)45.3 (7.7)Median34.438.247.845.1Spearman’s correlationPROMIS-29 vs SF-360.760.66Week 24, N380381380381Mean (SD)39.6 (9.3)43.3 (8.3)50.3 (9.7)49.3 (8.5)Median39.342.252.350.0Spearman’s correlationPROMIS-29 vs SF-360.860.71ConclusionPROMIS-29 PCS/MCS scores calculated in DISCOVER-1 showed evidence of validity as summary scores with the ability to efficiently evaluate pt-reported HRQoL outcome in PsA. PROMIS-29 PCS/MCS scores, similar to the commonly employed and validated SF-36 PCS/MCS scores, may reliably be used to assess physical and mental health in pts with PsA.