Sleep improvement in patients with rheumatoid arthritis treated with upadacitinib in real-world practice: results from the SLEERA study

Abstract Background Sleep impairment is common in rheumatoid arthritis (RA) but has not been extensively studied with wearables and self-observation following treatment. This study investigates the impact of upadacitinib (UPA) on subjective (self-reported) and objective (actigraphy-based) sleep quality in RA patients. Methods SLEERA is a sub-study of UPHOLD, an international observational cohort study (NCT04497597) that assessed sleep quality in RA patients after UPA treatment. Subjective sleep quality was measured using Pittsburgh Sleep Quality Index (PSQI) at baseline and post-treatment months 3, 6, 12 and 24. Objective sleep quality was assessed by actigraphy at baseline and post-treatment month 3. Results Among 39 patients, 76% had impaired subjective sleep quality at baseline (total PSQI: 7.84). Actigraphy sleep efficiency was 85.1%, 85.6% and 82.1% in patients with good (PSQI ≤ 5), moderate (PSQI > 5 and ≤ 8) and poor (PSQI > 8) sleep quality. After 3 months of UPA treatment, the total PSQI significantly improved (-2.42, p < 0.001), while actigraphy outcomes remained unchanged across the whole cohort. Of 19 patients with impaired sleep quality at baseline, 8 achieved good sleep quality, accompanied by improvements in actigraphy-based sleep efficiency (+ 1.5%), total wake time (-7.3 min) and movement index (-0.7%). Shifts from objectively impaired to good sleep efficiency were only observed in patients achieving remission or normative values of pain and fatigue. Conclusions Sleep impairment in RA patients can improve with treatment. Actigraphy showed improvements, particularly in patients with high subjective sleep impairment who achieve remission. Trial registration NCT04497597.