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Background: Some sleep-promoting medications are associated with cognitive impairment, making treatment of comorbid obstructive-sleep-apnea (OSA) and insomnia (COMISA) challenging. Lemborexant is a dual-orexin-receptor-antagonist approved for insomnia treatment. This post-hoc analysis evaluated cognition in the subgroup of subjects with mild-OSA (apnea-hypopnea-index ≥5–<15 events/h-of-sleep). Methods: Study E2006-G000-304 was a 1-month, randomized, double-blind, placebo (PBO)- and active-comparator (zolpidem-ER 6.25mg [ZOL])-controlled study of lemborexant 5/10mg (LEM5/LEM10). Subjects ≥55y with insomnia disorder/sleep maintenance problems were enrolled (N=1006). A cognitive-performance assessment battery (CPAB) was performed at morning waketime of Days(D)2/3 and D30/31. Change-from-baseline (CFB) for mean power-of-attention (PoA), continuity-of-attention (CoA), quality-of-memory (QoM), and speed-of-memory-retrieval (SoMR) for CPAB tasks was analyzed. Results: The mild-OSA subgroup comprised 410 (40.8%) subjects. On D2/3 and D30/31, CFB for PoA, CoA, QoM, and SoMR for LEM5/LEM10 were not significantly different than PBO. On D2/3, PoA and QoM were significantly worse with ZOL vs PBO; QoM was significantly better with LEM5/LEM10 vs ZOL. On D30/31, SoMR was significantly worse with ZOL vs PBO and significantly better with LEM5/LEM10 vs ZOL. LEM safety in the subgroup was consistent with the overall study population. Conclusions: Memory and attention domains in subjects with COMISA characterized by mild-OSA were not impacted by LEM, unlike ZOL.Support: Eisai Inc.

Background:MIDAS study assessed the disease activity in psoriatic arthritis (PsA) patients treated in clinical practice in Spain.Objectives:This sub-analysis compared disease activity between PsA patients with or without axial manifestations.Methods:MIDAS is an observational, non-interventional, cross-sectional, multicenter study conducted in Spain. Patients included were ≥18 years old with ≥6 months since diagnosis, were classified by CASPAR criteria and had initiated treatment ≥3 months. Disease activity was measured by Disease Activity in Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA). Axial involvement was defined according to the presence of inflammatory back pain assessed by rheumatologist.Results:312 evaluable PsA patients were included in this analysis, 12.2% of which presented with axial involvement. PsA patients with axial manifestations reported longer time from onset of symptoms to diagnosis and disease duration, higher presence of concomitant diseases, HLA-B*27+ status, C-reactive protein (CRP) levels, perception of uncontrolled disease and presence of swollen and tender joints compared to patients without axial involvement. A higher proportion of PsA patients with axial manifestations were treated with a biologic compared with those without axial involvement 68.4% vs 57.3% (Table 1). Patients with axial involvement showed a higher impairment of their quality of life compared to those without axial manifestations by a worse higher mean (SD) Psoriatic Arthritis Impact of Disease 12-item questionnaire (PSAID12) score (5.0 [2.4] vs 2.7 [2.2], respectively). In terms of disease control more patients with axial manifestations presented with moderate to high disease activity (DAPSA>14: 65.7% vs 36.8%, respectively) and did not meet the MDA criteria for remission (89.5% vs 42.7%, respectively) (Figure 1).Conclusion:PsA patients with axial manifestations presented with a higher burden of disease and showed a worse disease control compared to those without axial involvement.Table 1.Baseline demographic and clinical characteristicsWith axial manifestations(n=38)Without axial manifestations (n=274)PsA(n=312)Age (years), mean (SD)53.1 (10.4)54.1 (12.4)54.0 (12.2)Sex (male), n (%)17 (44.7%)153 (55.8%)170 (54.5%)Time since diagnosis (years), mean (SD)13.6 (10.1)10.1 (8.8)10.5 (9.0)Time from onset of symptoms to diagnosis (years), mean (SD)4.3 (6.1)2.8 (4.8)3.0 (5.0)Presence of concomitant diseases, mean (SD)26 (68.4%)166 (60.6%)192 (61.5%)Anemia, n (%)3 (7.9%)7 (2.6%)7 (2.2%)Anxiety, n (%)6 (15.8%)9 (3.3%)1 (0.3%)Asthma, n (%)2 (5.3%)7 (2.6%)1 (0.3%)Depression, n (%)6 (15.8%)1 (0.4%)1 (0.3%)Dyslipidemia, n (%)3 (7.9%)8 (2.9%)9 (2.9%)Hypertension, n (%)3 (7.9%)7 (2.6%)9 (2.9%)Others (excluding skin psoriasis, uveitis, or IBD), n (%)3 (7.9%)17 (6.2%)19 (6.1%)Presence of HLA-B*27+, n (%)6 (15.8%)28 (10.2%)34 (10.9%)CRP levels (mg/l), mean (SD)7.3 (11.3)4.6 (6.5)4.9 (7.3)Patient perceived disease control (PASS), n (%)30 (78.9%)228 (83.5%)258 (83.0%)Presence of swollen (SJC≥1), n (%)22 (57.9%)117 (42.7%)139 (44.6%)Presence of tender joints (TJC≥1), n (%)14 (36.8%)74 (27.0%)88 (28.2%)Patients treated with biological26 (68.4%)157 (57.3%)183 (58.7%)COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; HLA-B*27, human leukocyte antigen B27; IBD, inflammatory bowel disease; PASS, patient acceptable symptom state; PsA, psoriatic arthritis; SD, standard deviation; SJC, swollen joint counts; TJC, tender joint counts.Figure 1.Disease status according to clinical phenotype of PSA A) Disease activity according to DAPSA B) Disease activity according to MDA DAPSA, Disease Activity in Psoriatic Arthritis; MDA, Minimal Disease Activity; PsA, psoriatic arthritis.Acknowledgements:We thank to MIDAS group investigators and patients included in the study.Disclosure of Interests:Eugenio de Miguel Speakers bureau: AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi., Paid instructor for: Janssen, Novartis, Roche, Consultant of: AbbVie, Novartis, Pfizer, Galapagos, Grant/research support from: Abbvie, Novartis, Pfizer, Jordi Gratacos-Masmitja Speakers bureau: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Lilly and Amgen., Consultant of: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Lilly and Amgen., Grant/research support from: During the course of the year I have received a private grand from Pfizer.I have not received any private influence in the elaboration of the contents of this talk., Ana Paula Cacheda: None declared, José M. Rodríguez-Heredia Speakers bureau: Amgen, Novartis, Sanofi, Consultant of: Amgen, Biogen, Fresenius, MSD, Janssen, Roche, Novartis, Pfizer, Sanofi, Adela Gallego Speakers bureau: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen, Novartis, Lilly, Amgen and Sanofi.I have not received any private influence in the elaboration of the contents of this talk., Grant/research support from: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen, Novartis, Lilly, Amgen and Sanofi.I have not received any private influence in the elaboration of the contents of this talk., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Beatriz Font Ramos Employee of: Novartis employee, Carlos Sastré Employee of: Novartis employee, Cristina Sanabra Employee of: Novartis employee.