Background/Purpose: The Patient (Pt) Reported Outcomes Measurement Information System (PROMIS [P]) questionnaires developed by the NIH have been validated and are a feasible assessment tool for rheumatoid arthritis (RA) patients (pts) (Bartlett 2015). AWARE (Comparative and Pragmatic Study of Golimumab Intravenous [IV] Versus Infliximab in RA) is a large, pragmatic multi-center United States based, real-world evidence study of golimumab IV (GLM) vs. infliximab (IFX) in RA, and is using PROMIS assessments as one measure of pt response to therapy. Here we report interim results of the responsiveness of multiple PROMIS short forms and profiles with treatment of RA using GLM or IFX.

Methods: AWARE is a prospective, noninterventional study in which 1,200 adult pts will be enrolled upon initiation of treatment with GLM or IFX. PRO assessments of pt response to treatment include use of PROMIS-29 Profile v2.0 (P29v2), P Pain Interference Short Form-6b (SF6b) and P Fatigue Short Form-7a (SF7a), 36-Item Short Form Health Survey (SF-36v2) and the Clinical Disease Activity Index (CDAI). We report results of an interim analysis of pt response to PROMIS questionnaires. PROMIS questionnaire results are normalized to the US population and reported as a “T-score” (mean of 50 and standard deviation (SD) of 10). Data shown are mean ± standard deviation baseline score (month 0) and change from baseline (months 2 and 5), and interpreted as an effect size.

Results: GLM pts were 61.0 ± 13.0 years and IFX pts were 57.2 ± 13.0 years. RA disease duration of GLM pts was 9.0 ± 9.3 years and IFX pts was 6.8 ± 9.7 years. Mean baseline CDAI score for GLM pts was 31.1 ± 14.6 and for IFX pts was 34.3 ±16.2. with most starting in high (71.4% GLM/72.0% IFX) or moderate disease activity (21.8% GLM/23.4% IFX). A total of 573-586 pts contributed data at the 2 month time point, and 169-173 pts at the 5 month time point. PROMIS domain T-scores of GLM and IFX pts at baseline and mean change from baseline are shown (Table). The mean changes in PROMIS T-scores were generally in the 1-4 unit range, consistent with a small to moderate size effect, with all mean changes in the expected direction that reflected clinical improvement.

Conclusion: These interim data support the use of PROMIS questionnaires to evaluate RA pts in trials and to measure improvement across a range of domains. As additional pts reach later time points (future interim analyses and primary endpoint assessment), the magnitude of change will become more apparent. Analyses using the fully enrolled AWARE study evaluated over 3 years and analysis of PROMIS changes relative to other outcome measures will further define the practical utilization of PROMIS in RA pts.