Session Information
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: 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 used in clinical practice and observational studies in RA (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 will assess infusion reactions, disease activity, and multiple PROs as outcomes.
Methods: AWARE is a prospective, noninterventional, ongoing study in which 1200 adult Pts will be enrolled on initiation of treatment with GLM 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 Clinical Disease Activity Index (CDAI). We report here an interim analysis of 747 pts’ baseline PROMIS questionnaire and CDAI scores, and their inter-relationships. PROMIS questionnaire results are normalized to the US population and reported as a “T-score” (mean of 50 and standard deviation (SD) of 10) with higher scores indicating more of the trait being measured. PROMIS T-scores were compared between HDA with MDA, LDA and remission, respectively. Data shown are mean ± SD. Statistical testing compared T-scores across CDAI categories using ANOVA for this IA of baseline data (before drug administration). Data from GLM and IFX pts are combined.
Results: Overall baseline CDAI score was 32.5 ± 15.4, with 71.7% of pts in high DA (HDA), 22.5% in moderate disease activity (MDA), 5.2% in low disease activity (LDA) and 0.7% in remission. All P29v2 domains, PISF and FSF scores were significantly worse in pts with CDAI>22 vs. CDAI≤22 (p < 0.05), as was true for the 8 SF-36 domains (data not shown). PROMIS T-scores (P29v2 domains, PISF and FSF) were compared to the 4 CDAI disease activity categories. As shown below, PROMIS T-scores correlated with CDAI disease category, with HDA Pt T-scores significantly (*, p<0.05) different from those of MDA, LDA and Remission pts (except between HDA and remission for Anxiety, Depression and Sleep Disturbance domains).
|
Mean ± Standard Deviation of PROMIS T-Score of All Patients in Interim Analysis Dataset and a Comparison of T-Scores of PROMIS-29 Domains, Fatigue Short Form and Pain Interference Short Form to CDAI Disease Activity Category |
|||||
|
All Patients (n=672-682) |
Remission CDAI≤2.8 (n=5) |
LDA 2.8<CDAI≤10 (n=38) |
MDA 10<CDAI≤22 (n=165) |
HDA CDAI>22 (n=526) |
|
|
P29-Physical Function |
37.9 ± 6.6 |
47.5 ± 5.7 |
45.0 ± 7.6 |
40.0 ± 6.7 |
36.6 ± 5.9* |
|
P29-Anxiety |
53.8 ± 10.4 |
45.2 ± 6.7# |
47.7 ± 8.6 |
51.3 ± 10.0 |
55.2 ± 10.3* |
|
P29-Depression |
52.5 ± 10.3 |
42.6 ± 3.6# |
45.9 ± 6.5 |
49.4 ± 9.8 |
54.0 ± 10.3* |
|
P29-Fatigue |
58.8 ± 9.9 |
42.3 ± 5.4 |
49.7 ± 9.7 |
55.6 ± 9.2 |
60.8 ± 9.4* |
|
P29-Sleep Disturbance |
55.5 ± 8.7 |
48.2 ± 13.6# |
51.5 ± 7.9 |
53.2 ± 8.4 |
56.7 ± 8.6* |
|
P-29 Ability to participate in Social Roles and Activities |
43.2 ± 8.6 |
57.3 ± 7.6 |
50.8 ± 8.5 |
45.9± 8.5 |
41.6 ± 8.0* |
|
P29-Pain Interference |
63.5 ± 7.7 |
46.9 ± 7.2 |
53.9 ± 8.4 |
60.1 ± 7.7 |
65.4 ± 6.5* |
|
Fatigue Short Form 7a |
59.3 ± 8.5 |
46.7± 8.8 |
51.6 ± 9.0 |
56.2 ± 7.5 |
61.0 ± 8.1* |
|
Pain Interference Short Form 6b |
62.5 ± 7.6 |
45.9 ± 7.5 |
53.9 ± 9.3 |
59.3 ± 5.6 |
64.3 ± 6.4* |
|
P29 Pain Intensity (scored 0-10 scale) |
6.0 ± 2.2 |
1.6 ± 2.6 |
3.5 ± 2.3 |
5.1 ± 2.2 |
6.6 ± 1.9* |
|
T-scores > 50 indicate worsening of the domain relative to the general population, except “Physical Function” and “Ability to participate in Social Roles and Activities”, where T-scores < 50 indicate worsening of these domains relative to the general population. * = p<0.05 vs respective scores in MDA, LDA and remission DA categories. # = not statistically different from HDA |
|||||
Conclusion: Our interim findings demonstrate the feasibility of using PROMIS short forms and profiles to evaluate RA pts in clinical trials. These results confirm the domain validity of PROMIS measures according to CDAI disease category. PROMIS measures show the range of impact across multiple domains of physical, emotional, and social health experienced by RA pts. With a fully enrolled AWARE trial, evaluation of PROs, their responsiveness over time, and comparison with SF36 will provide important additional validation for their use in clinical trials.
To cite this abstract in AMA style:
Curtis JR, Schwartzman S, Kafka S, Parenti D, Black S, Xu S, Langholff W, Bingham III CO. Real World Clinical Trial Comparing the Patient Reported Outcomes Measurement Information System Short Forms and Profiles to CDAI Disease Classification in Rheumatoid Arthritis Patients [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/real-world-clinical-trial-comparing-the-patient-reported-outcomes-measurement-information-system-short-forms-and-profiles-to-cdai-disease-classification-in-rheumatoid-arthritis-patients/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-clinical-trial-comparing-the-patient-reported-outcomes-measurement-information-system-short-forms-and-profiles-to-cdai-disease-classification-in-rheumatoid-arthritis-patients/