Lauren Stevens1, Kyra Mulder2, Zhaohui Su2, Pam Kumparatana2, Jessica Paulus2 and Stefan Weiss3, 1OM1, Inc., Lexington, KY, 2OM1, Inc., Boston, MA, 3OM1, Inc., Chapel Hill, NC
Background/Purpose: Patient-reported outcomes (PROs) are being increasingly utilized in clinical trials to assess the impact of treatment on symptom control and patient quality of life. However, evidence is lacking surrounding the impact of PRO monitoring in routine clinical practice. The objective of this study is to examine the role of PROs as assessed by the RAPID3 in guiding therapy in rheumatoid arthritis (RA) in routine clinical practice.
Methods: The OM1 platform collects, links, and leverages structured and unstructured data from electronic medical records (EMR) and other sources in a continuously updating manner. The OM1 PremiOM-RA dataset includes data on more than 200,000 patients. This analysis included all patients who were treated by a rheumatologist and received a disease-modifying antirheumatic drug (DMARD) at any time from January 2013 through May 2022, where the index date was defined as the date of first observed DMARD. Changes in DMARD therapy were identified and RAPID3 scores assessed within 30 days prior to a change in DMARD; utilizing a linear mixed model, these scores were compared to RAPID3 scores assessed at 90 days, 180 days, and 365 days following a change in DMARD. The RAPID3 is scored 0-10, where higher scores correspond to higher disease activity. To adjust for varying availability of patient data, follow-up was censored at 24 months after the index date.
Results: This analysis includes 111,605 patients treated with a DMARD during the observation period; 77.6% female, 22.4% male, with the mean (SD) age of 58.4 (13.5) years. Overall, 49.6% of patients who were treated with DMARDs reported at least one RAPID3. Patients with ≥ 2 RAPID3 measurements (n=26,581, 23.8%) were more likely to have a DMARD class change than patients with ≤ 1 measurement (n=85,024; 26.1% vs. 18.0%, p< 0.001 by Chi- square test). In a linear regression model with time in months as a covariate, patients with changes in DMARD therapy had worse RAPID3 scores than those who did not have changes in DMARD (4.7 v. 4.0, p< 0.001). During the study period, there were 34,109 changes in DMARD among 22,256 patients. Among these 22,256 patients, RAPID3 scores reported in the 30 days prior to a change in DMARD therapy (mean±SD=4.5±2.2) were worse than scores reported at 3 months (3.9±2.3, p< 0.001), 6 months (3.9±2.3, p< 0.001) and 12 months (3.9±2.3, p< 0.001) post therapy change.
Conclusion: Rheumatologists that routinely monitor PROs (e.g., RAPID3) in clinical practice appear to use that information to guide DMARD therapy in patients with RA. Patients reported worse RAPID3 prior to changing DMARD therapies. Further research is needed to assess the impact of specific DMARDs on improvement in RAPID3 post-treatment switch.
Disclosures: L. Stevens, OM1, Inc.; K. Mulder, OM1, Inc; Z. Su, OM1, Inc.; P. Kumparatana, OM1; J. Paulus, None; S. Weiss, OM1.