AB0200 IMPROVEMENT OF SLEEP IMPAIRMENT IN PATIENTS WITH RHEUMATOID ARTHRITIS ACHIEVING REMISSION OR PAIN RELIEVE WITH UPADACITINIB: RESULTS FROM THE POST-MARKETING OBSERVATIONAL SLEERA STUDY

Abstract

BackgroundSleep impairment is a common clinical condition in the rheumatoid arthritis (RA) population, which has been reported in over 60% of patients[1]. Although few longitudinal studies demonstrated change from baseline on sleep quality with advanced therapies[2,3], none of them described the clinical meaningfulness of these changes by subjective and objective measures.ObjectivesThe SLEERA study aims to investigate the impact of upadacitinib (UPA), a selective and reversible JAK inhibitor, on sleep quality in a real-world RA population in Switzerland, by using a validated patient-reported measure, the Pittsburgh Sleep Quality Index (PSQI)[4], and an actigraphy-based objective measure with the GT9x wearable.MethodsSLEERA is a sub-study of UPHOLD, an international, multicenter, prospective, non-interventional, open-label, observational cohort study (NCT04497597) that assesses sleep quality in a real-world population of adult Swiss patients with moderate-to-severe active RA, initiating treatment with UPA 15 mg once daily according to the product label and with the treatment decision made prior to study participation. This primary interim analysis reports data for all enrolled patients up to 3 months after treatment start. Results are presented for the total sample using descriptive measures reflecting sample size (N), average values (standard deviation) for each visit and average change scores (standard deviation) for follow-up visit at month 3. All data were analyzed as observed, with no imputation of missing data.ResultsOf the 39 patients (87% female) included in this study, 35 completed the follow-up visit at month 3. The mean age and disease duration were 59.5 (13.9) years and 7.0 (8.3) years, respectively. The mean initial DAS28-CRP was 4.1 (1.0). At baseline, 76% of patients showed subjective sleep impairment (defined by PSQI >5) and 51% had objective poor sleep efficiency (defined by actigraphy sleep efficiency <85%) (Table 1). At month 3, upadacitinib showed significant improvement in the PSQI total score with a decrease of 2.26 (2.92, p value <0.001), as well as other subjective outcomes. The proportion of objective poor sleepers decreased to 38%, while sleep efficiency and physical activity outcomes in total remained unchanged. However, patients achieving DAS28-CRP remission or absence of pain after 3 months of treatment showed higher improvements in both subjective and objective measures compared to those who did not achieve DAS28-CRP remission or have residual pain (Figure 1).Table 1.PSQIBL Visit N = 37Visit at Month 3 N = 33Change from BL N = 31Sleep impairment (PSQI >5), n (%)28 (76%)18 (55%)PSQI total score7.84 (3.12)6.06 (4.26)-2.26 (2.92)PSQI sleep efficiency (%)78.5% (18.5%)84.2% (16.0%)5.0% (17.7%)PSQI sleep duration (hours)6.8 (1.0)6.9 (1.2)0.2 (0.9)ActigraphyN = 39N = 26N = 26Poor sleep efficiency (SE <85%), n (%)20 (51%)10 (38%)Sleep efficiency (%)84.2% (6.8%)84.5% (7.9%)0.5% (3.9%)Total sleep time (hours)6.7 (0.9)6.8 (1.0)-0.1 (1.4)Total awake time (minutes)74 (37)73 (49)-7 (36)Physical ActivityN = 32N = 17N = 17Steps count4,272 (2,270)4,509 (2721)-68 (1157)MVPA (minutes)177 (98)181 (95)-2 (37)ConclusionIn this Swiss cohort, a high proportion of RA patients exhibited sleep impairment as shown by subjective and objective measures. Patients treated with upadacitinib significantly improved their subjective sleep quality after 3 months. Higher improvements for both subjective and objective sleep measures were observed in patients achieving remission or absence of pain. This research provides evidence of sleep impairment in RA patients which can be improved following a treatment, and further supports the importance of remission when assessing disease treatment goals.