FRI0567 CONSTRUCT VALIDATION OF PROMIS SHORT FORM AND PROFILE-29 T-SCORES WITH SF-36 IN RHEUMATOID ARTHRITIS PATIENTS TREATED FOR 1 YEAR: RESULTS FROM A REAL‑WORLD EVIDENCE-BASED STUDY IN THE UNITED STATES

Background: Use of patient-reported outcomes (PROs) to assess health-related quality of life in clinical practice, research studies, and clinical trials in rheumatoid arthritis (RA) remains an ongoing area of research. SF-36 is commonly used in RA trials but is not feasible for routine use in clinical practice settings. The Patient Reported Outcomes Measurement Information System (PROMIS) may address this gap but has not been widely assessed in RA patients starting therapy in a real-world comparative effectiveness study, nor examined in that setting in relation to the SF36 and Clinical Disease Activity Index (CDAI). Objectives: To assess validity of PROMIS based on Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in Rheumatoid Arthritis (AWARE), an ongoing Phase 4 study providing real-world assessment of IV tumor necrosis factor inhibitor (TNFi) medications in RA patients. Methods: AWARE is a prospective, non-interventional, 3-year study conducted at 88 US sites. RA patients were enrolled when initiating TNFi treatment. Treatment decisions were made by treating rheumatologists. We report baseline PROMIS-29 (7 domains and pain intensity), PROMIS Pain Interference (PI) Short Form (SF) 6b (PI6b) and PROMIS Fatigue (F) Short Form 7a (F7a), domain T-Scores, and SF-36 subdomain and Component Scores (CS) in AWARE patients. Here we report baseline data obtained from the final 1-year AWARE dataset. Correlations between PROMIS measures and comparable SF-36 component scores were calculated using Pearson correlations. Data is shown as mean ± standard deviation (SD). Results: At baseline, mean CDAI of all patients (n=1262) was 32.3±15.6, with 70.4% in high disease activity (HDA, CDAI>22), 22.8% in moderate disease activity (MDA, CDAI: >10 and ≤22), 6.1% in low disease activity (LDA, CDAI: >2.8 and ≤10), and 0.7% in remission (CDAI ≤2.8). Mean PROMIS scores were >0.5 SD worse than population means for Physical Function (PF, 38.1±6.84), PI (63.4±7.68), F (58.8±9.95), Sleep Disturbance (55.1±8.68); and Ability to Participate in Social Roles/Activities (PSRA, 43.4±8.58). Baseline Depression and Anxiety were within 0.5 SD of population T-scores. PI6b, F7a, and P29 domain T-scores correlated with the comparable SF-36 subdomain and component scores (r’s >0.58), except sleep for which no comparable SF-36 element was applicable. Examples include: P6b (r=-0.80) and P29-PI (0.81) with SF-36 Bodily Pain; F7a (-0.77) and P29-F (-0.77) with SF-36 Vitality; P29-PF with SF-36 PF (0.77), Role-Physical (0.69), and Physical CS (0.73); P29 Anxiety with SF-36 Mental Health (-0.72), Role-Emotional (-0.56), Mental CS (-0.70); and P29-PRSA with SF-36-Social Functioning (0.71). Mean PROMIS-29 T-scores (except Anxiety and Sleep Disturbance) among patients with HDA were significantly different from patients with MDA, LDA or remission (p Conclusion: Analysis of baseline results from a large cohort of RA patients indicates high correlations between individual P29 domain T-scores and SF-36 component scores, as well as categorical CDAI, providing strong evidence of PROMIS construct validity in a real-world population of RA patients. Disclosure of Interests: Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB