POS0436 PATIENT CHARACTERISTICS AND OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH UPADACITINIB: THE OM1 RA REGISTRY

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Background:Upadacitinib (UPA) has demonstrated efficacy in the treatment of rheumatoid arthritis (RA) in randomized controlled trials,1-6 but there are limited data available on its real-world use and effectiveness in patients with RA.Objectives:To describe the characteristics and clinical outcomes at 3 months among real-world patients with RA initiating UPA.Methods:The data source for this study was the OM1 RA Registry, a subset of the OM1 Real-World Data Cloud (OM1, Inc, Boston, MA, US), a large, linked clinical and administrative dataset derived from medical and pharmacy claims, electronic medical record data, and death data. This analysis includes data collected in patients who initiated UPA during or after August 2019. Patients had ≥1 prescription for UPA (index date was first UPA prescription), were ≥18 years of age at index date, had ≥6 months of available data in the OM1 RA Registry prior to index date (ie, baseline period), ≥1 baseline disease activity measure, and ≥1 follow-up disease activity measure (3 or 6 months post-index). Disease activity was based on RAPID3 or CDAI. Multivariate analyses were conducted using a mixed-effects linear model adjusting for age, sex, and baseline scores. Outcomes were also assessed by therapy status (monotherapy or combination therapy) and targeted immunomodulator (TIM) use (naïve vs experienced).Results:Inclusion criteria were met by 1,102 patients, of whom 620 were on monotherapy and 482 were on combination therapy at index. Mean age was 57.7 years, 83% were female, 75% had prior treatment with a biologic, and 47% had prior treatment with a Janus kinase inhibitor. Of 651 patients with known disease activity category, 113 (17%) were in low disease activity (LDA)/remission. At baseline, overall mean±SD scores were 19.9±12.3 for CDAI, 4.5±2.4 for RAPID3, 5.7±2.8 for pain, 5.2±3.0 for fatigue, 3.1±2.7 for MDHAQ Physician Global Assessment (PGA), 5.2±2.8 for MDHAQ Patient Global Assessment (PtGA), and 3.1±2.3 for MDHAQ Functional Index. At 3 months post-UPA initiation, mean (95% CI) change in CDAI was –5.1 (–7.5 to –2.7) in the monotherapy group and –5.9 (–8.7 to –3.0) in the combination group. At 3 months, 29% (109/374) of patients were in LDA/remission and 32% (120/374) of patients showed improvement in disease activity. Of 94 patients with moderate disease at baseline, 34 (36%) were in LDA/remission at 3 months. Of 215 patients with high disease at baseline, 30 (14%) were in LDA/remission and 49 (23%) had moderate disease at 3 months. RAPID3 and other outcomes also improved at 3 months in the monotherapy and combination therapy groups (Figure 1). Improvements in disease activity were observed at 3 months and maintained at 6 months post-UPA initiation. Of 1,102 patients, 16% were TIM naïve and 84% TIM experienced. Both TIM-naïve and TIM-experienced patients achieved significant mean changes in CDAI (–5.7 [–10.8 to –0.6] and–5.0 [–7.0 to –3.0], respectively) and RAPID3 (–1.0 [–1.6 to –0.4] and –0.5 [–0.8 to –0.1]) at 3 months (Table 1). Improvements in clinical outcomes were maintained at 6 months in both TIM-naïve and TIM-experienced patients.Conclusion:Significant improvements in disease activity were consistently observed at 3 months and maintained at 6 months post-UPA initiation regardless of monotherapy, combination therapy, or prior TIM use.