POS0607 PROMIS ASSESSMENT OF RESPONSE TO TREATMENT WITH GOLIMUMAB IV OR INFLIXIMAB IN RHEUMATOID ARTHRITIS PATIENTS: RESULTS FROM THE PHASE-4 AWARE STUDY
Authors: C. Bingham, S. Kafka, S. Black, S. Xu, W. Langholff, J. Curtis
Journal: Annals of the Rheumatic Diseases (2021)

Background: AWARE is a phase-4 observational study designed to provide real-world assessment of Golimumab (GLM) IV &amp; infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA). Objectives: To assess patient-reported aspects of social, mental, &amp; physical health through the 8 th infusion (≈1 year of treatment) using Patient Reported Outcomes Measurement Information System (PROMIS), a validated, disease-agnostic set of health assessment instruments. Methods: AWARE enrolled 1270 RA pts initiating treatment with GLM/IFX. The 52 week analysis set included pts with ≥1-year treatment or those discontinued and, while enrolled, completed PROMIS-29 or PROMIS short form (SF) questionnaires. PROMIS instruments were administered at baseline &amp; prior to infusions 2, 5, &amp; 8. The raw score was converted into a standardized T-score with a mean of 50 and SD of 10. Results: At baseline, treatment groups were balanced on demographics &amp; medical characteristics. Most pts were white (87.0% GLM, 86.2% IFX) &amp; female (83.4% GLM, 82.4% IFX). Mean ages were 58.5 ±12.96 years for GLM &amp; 59.6 ±13.24 years for IFX. Overall, 35.3% GLM &amp; 42.9% IFX pts were bio-naïve. The proportion of GLM &amp; IFX pts with prior exposure to 1 or 2 biologics was similar; however, 20.1% GLM pts vs 10.8% IFX pts had exposure to ≥3 biologics. Methotrexate use was similar between GLM (76.4%) &amp; IFX pts (75.0%). Based on mean PROMIS T-scores at baseline (Table 1), Fatigue, Pain Interference, &amp; Physical Function domains approached or exceeded 1 SD worse than those of general US population. Through the 8 th infusion, GLM- &amp; IFX-treated pts achieved meaningful improvement based on mean changes from baseline in most PROMIS-29 domains &amp; respective SFs with no significant difference between GLM and IFX. The percentage of GLM or IFX pts with improvements of ≥3, ≥5, or ≥10 units change in T-scores increased from infusion 2 through infusion 8. Conclusion: RA pts treated with GLM or IFX achieved comparable improvements across PROMIS-assessed social, mental, &amp; physical health. PROMIS-29 was able to detect change to subsequent anti-tumor necrosis factor-α therapies. Table 1. Mean (SD) Change from Baseline PROMIS-29 Domain and Short Form T-Scores: 52 Week Analysis Set GLM IFX LSM difference (95% CI)* Anxiety (4-item ) N=6 N=570 Baseline 53.4 (10.13) 54.6 (10.53) Change from baseline at infusion 8 N=223 -2.6 (8.10) N=286 -3.7 (7.86) -0.29 (-1.54, 0.97) Depression (4-item ) Baseline N=674 51.9 (9.83) N=574 52.5 (10.21) Change from baseline at infusion 8 N=225 -2.1 (7.56) N=287 -2.3 (7.89) 0.49 (-0.72, 1.70) Fatigue (4-item ) Baseline N=671 58.4 (9.91) N=574 59.4 (9.99) Change from baseline at infusion 8 N=225 -3.4 (8.72) N=281 -3.1 (7.77) 0.69 (-0.64, 2.03) Short form Fatigue 7a Baseline N=681 59.1 (8.51) N=576 59.7 (8.25) Change from baseline at infusion 8 N=228 -3.2 (7.40) N=287 -2.4 (6.35) 1.01 (-0.11, 2.14) Pain interference (4-item ) Baseline N=679 63.0 (7.56) N=574 63.9 (7.80) Change from baseline at infusion 8 N=227 -4.2 (8.23) N=284 -3.1 (7.77) 1.84 (0.55, 3.13) Short form Pain interference 6b Baseline N=680 61.9 (7.45) N=576 62.8 (7.54) Change from baseline at infusion 8 N=228 -3.8 (7.88) N=287 -3.2 (6.67) 1.31 (0.15, 2.48) Physical function (4-item ) Baseline N=678 38.2 (6.79) N=571 38.0 (6.90) Change from baseline at infusion 8 N=224 2.2 (5.64) N=283 1.9 (5.85) -0.76 (-1.73, 0.21) Sleep disturbance (4-item ) Baseline N=671 54.6 (8.72) N=569 N=55.5 (8.61) Change from baseline at infusion 8 N=221 -1.4 (7.45) N=281 -1.7 (7.61) 0.23 (-0.96, 1.42) Social participation (4-item ) Baseline N=673 43.7 (8.40) N=574 42.9 (8.77) Change from baseline at infusion 8 N=225 3.2 (8.15) N=283 3.4 (7.48) -0.10 (-1.36, 1.16) * Least squares mean (LSM) difference &amp; confidence interval (CI) are based on analysis of covariance controlling for baseline PROMIS score using inverse probability of treatment weighted propensity score. Disclosure of Interests: Clifton Bingham Consultant of: AbbVie, BMS, Eli Lilly, Gilead, Janssen, Pfizer, Regeneron/Sanofi, Grant/research support from: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Research &amp; Development, LLC, Shawn Black Employee of: Janssen Research &amp; Development, LLC, Stephen Xu Employee of: Janssen Research &amp; Development, LLC, Wayne Langholff Employee of: Janssen Research &amp; Development, LLC, Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB