gms | German Medical Science

Introduction: Sleep impairment is a clinically significant burden in rheumatoid arthritis (RA) [1]. Upadacitinib (UPA), a selective JAK inhibitor, has previously shown a positive impact on subjective sleep measures [2]. However, objective sleep quality using wearables has not been widely investigated. This analysis presents the findings on actigraphy sleep measures in patients with RA treated with UPA.

Methods: SLEERA is a multicenter, prospective and observational cohort study that assesses sleep quality in a real-world population of adult Swiss patients with RA, initiating treatment with UPA 15 mg once daily. The primary endpoint was the change in the Pittsburgh Sleep Quality Index (PSQI) total score after 3 months of treatment. Results of actigraphy measures with the GT9x wearable are presented using descriptive measures at baseline and for follow-up visit at month 3. All data were analyzed as observed, with no imputation of missing data. Normative values for sleep and patient-reported outcomes are defined as follows: impaired sleep quality (PSQI>5); good sleep efficiency (≥85%); absence (NRS≤1) and tolerable (NRS≤4) pain; normal fatigue (FACIT-F≥43.6).

Results: Of the 39 patients (87% female, mean age of 59.5 years) included in this study, 35 completed the follow-up visit at month 3. At baseline, 76% of patients had an impaired sleep quality. Mean sleep efficiency was 85.1%, 86.4% and 82.2% in patients with, good (PSQI≤5), moderate (PSQI>5 and ≤8) and poor (PSQI>8) sleep quality, respectively (Table 1 [Tab. 1]). After 3 months of UPA treatment, 39% (7/18) of patients with impaired sleep quality at baseline achieved good sleep quality. This were associated with improvement in actigraphy sleep measures including sleep efficiency (+2.7%), total wake time (-11.9 minutes) and movement index (-1.0%) (Table 2 [Tab. 2]). In addition, shifts from impaired (<85%) sleep efficiency to good sleep efficiency (>85%) were only observed in patients achieving remission or normative values of pain and fatigue (Figure 1 [Fig. 1]).

Conclusion: A high proportion of RA patients exhibited subjective sleep impairment in this Swiss cohort. UPA treatment was associated with improved PSQI sleep quality. Only patients achieving remission also achieve good actigraphy sleep efficiency. These findings underscore the importance and benefit of achieving stringent disease control in RA.

Disclosures: AbbVie and the authors thank the patients, study sites, investigators who participated in this study, Dr. Francesca Siclari and Jacinthe Cataldi from the Center for Investigation and Research in Sleep, and Dr. Imma Fischer from Biostatistik Tübingen. AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data. No honoraria or payments were made for authorship.

Thomas Hügle received research grants, consultation and/or speaker honoraria from Abbvie, Eli Lilly, Fresenius Kabi, MSD and Pfizer. Heino Prillwitz received research grants, consultation and/or speaker honoraria from AbbVie, Amgen, Boehringer, Celgene, Grünenthal, Novartis, Pfizer, Roche, Sanofi-Genzyme, and UCB. Godehard Scholz received research grants, consultation and/or speaker honoraria from AbbVie. Diego Kyburz received research grants, consultation and/or speaker honoraria from AbbVie, Janssen, Eli Lilly, Novartis, Takeda and Pfizer. Jean Dudler received research grants, consultation and/or speaker honoraria from AbbVie, Janssen, Eli Lilly and Novartis. Kristin Schmiedeberg has no conflicts of interest/financial disclosures. Melanie D. Harrer Kuster and Pascal S. Roulin are employees of AbbVie and may hold stock or options. Andrea Rubbert-Roth received honoraria for lectures and consulting AbbVie, Amgen, BMS, Galapagos, Lilly, MSD, Pfizer, Roche, Sanofi, and UCB.