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Abstract
Background Patient (Pt) reported outcomes (PROs) play a role in overall disease evaluation, therapeutic response assessment and care of rheumatoid arthritis (RA) patients (Pts). The Pt Reported Outcomes Measurement Information System (PROMIS [P]) questionnaires developed by the NIH have been validated and are a feasible assessment tool in RA (Bartlett 2015).
Objectives AWARE (Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in RA) is a real-world study of golimumab IV (G-IV) vs. infliximab (IFX) in RA and will assess infusion reactions, disease activity and multiple PROs as outcomes measures.
Methods AWARE is a prospective, noninterventional, ongoing US-based study in which 1,200 adult Pts will be enrolled on initiation of treatment with G-IV or IFX. Objectives include PRO assessments of Pt response to treatment using the PROMIS-29 Profile v2.0 (P29v2), P Pain Interference Short Form-6b (PISF) and P Fatigue Short Form-7a (FSF), 36-Item Short Form Health Survey (SF-36v2) and the Clinical Disease Activity Index (CDAI). We report an interim analysis from the first 353 Pts of baseline PROMIS questionnaire and CDAI scores, and their inter-relationships. PROMIS questionnaire results are scored on a 0 to 100 scale, normed to the US population and reported as a “T-score” (mean of 50 and standard deviation (SD) of 10). PROMIS T scores were compared across CDAI disease activity (DA) categories.
Results Baseline mean (SD) CDAI score was 33.46 (±15.79), with 73.4% of pts with high DA (HDA), 22.1% with moderate disease activity (MDA), 3.7% with low disease activity (LDA) and 0.8% pts in remission. PROMIS scores are shown below. All P29v2 domains, PISF and FSF scores were significantly worse in pts with CDAI>22 vs. CDAI≤22 (p<0.05). The same was true for SF-36 domains (data not shown). PROMIS scores are shown below for all pts, and also based on CDAI DA category. PROMIS T scores across all domains (P29v2 domains, PISF and FSF) were compared to CDAI disease activity category (below). As shown, PROMIS T scores correlated with CDAI disease category, with HDA Pt T scores significantly (*, p<0.05) greater than those of MDA, LDA and Remission pts (excepting the Sleep Disturbance domain).
Conclusions These interim data further support the viability of using PROMIS questionnaires to evaluate RA pts, and indicate in this predominantly HDA population of RA pts correlations between PROMIS and CDAI disease activity category. Confirmation of the baseline interim analysis findings with the fully enrolled AWARE study, as well as inclusion of longitudinal and subset analyses based on disease activity levels, will further define the role of PROMIS relative to CDAI in RA patients in a real world setting.
Disclosure of Interest J. Curtis Consultant for: Janssen, AbbVie, Roche/Genentech, BMS, UCB, Myriad, Lilly, Amgen, Pfizer, Corrona, S. Kafka Employee of: Janssen Scientific Affairs, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Black Employee of: Janssen Scientific Affairs, LLC, S. Xu Employee of: Janssen Research & Development, LLC, Y. Wang Employee of: Janssen Research & Development, LLC, C. Bingham III Grant/research support from: Janssen, PCORI, NIH, Pfizer, Consultant for: Janssen, AbbVie, Amgen, BMS, Celgene, Genentech/Roche, Lilly, Macrogenics, Meoblast, Novartis, NovoNordisk, Pfizer, Regeneron, UCB