AB0537 PSORIATIC ARTHRITIS BURDEN, QUALITY OF LIFE AND FUNCTIONAL ABILITY IMPAIRMENTS IN PATIENTS INITIATED ON APREMILAST IN THE ROUTINE CARE IN GREECE: INTERIM RESULTS FROM THE MULTICENTER PROSPECTIVE STUDY “APROACH”
Authors: P. Katsimpri, D. Vassilopoulos, G. Katsifis, G. Vosvotekas, D. Bogdanos, P. Sidiropoulos, P. Vounotrypidis, A. Georgountzos, A. Bounas, A. Garyfallos, S. Gazi, P. Georgiou, E. Kataxaki, C. Papagoras, A. Elezoglou, S. N. Liossis, A. Tzioufas, P. Voulgari, F. Satra Tzoufra, Z. Anagnostopoulos, N. Antonakopoulos, P. Sfikakis
Journal: Annals of the Rheumatic Diseases (2021)

Background: Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with substantial psychosocial burden and health-related quality of life (HRQoL) and functional ability impairments. Objectives: To characterize the profile of patients with PsA initiating therapy with apremilast in routine care settings, in terms of the physician-assessed clinical disease burden and the patient-reported generic and disease-related HRQoL and functional disability. Methods: This is an ongoing 52-week multicenter, prospective study conducted in the Greek healthcare environment. Eligible patients are bio-naïve adults with active peripheral PsA, inadequate (within the first 12 months of treatment) response/intolerance to a prior conventional synthetic disease-modifying antirheumatic drug (csDMARD), and no prior use of tofacitinib, initiating apremilast as per the approved label. Data are being collected by physician assessments, as performed in routine clinical practice, and by patient-reported outcomes. 170 patients enrolled in the study; data at apremilast initiation (baseline) from the first 100 eligible consenting patients are presented in this interim analysis as per protocol. Results: 99 evaluable patients were consecutively enrolled in 19 rheumatology departments between 15-Apr-2019 and 13-Jan-2020. At baseline (Table 1) [mean (SD) age: 53.8 (11.7) years], 43.4% of the patients had at least one (30.3% had ≥2) ongoing comorbidity other than PsA/PSO. The median [interquartile range (IQR)] PsA and psoriasis duration were 1.9 (1.0-3.5) and 7.5 (3.9-16.8) years, respectively. All subjects were on csDMARD while 24.2% received combination therapy, oral non-steroid anti-inflammatory drugs (32.3%), topical treatments (20.2%) and systemic steroids (11.1%). Based on the Clinical Disease Activity in PsA (cDAPSA) score, 58.6% of the patients had moderate, and 29.3% high disease activity. In the EuroQol (EQ) 5-Dimensions (5D) 5-Levels questionnaire, 93.9, 82.8, 82.8, 73.7, and 51.5% of the patients reported problems in ‘pain/discomfort’, ‘anxiety/depression’, ‘usual activities’, ‘mobility’, and ‘self-care’, respectively. The median (IQR) baseline UK-weighted EQ-5D index and EQ-Visual Analogue Scale scores were 0.55 (0.44-0.70) and 50.0 (40.0-70.0), respectively. The median (IQR) Health Assessment Questionnaire-Disability Index (HAQ-DI) and mean (SD) PsA Impact of Disease 12-item (PsAID12) scores were 1.0 (0.5-1.4) and 4.6 (2.0), respectively. Conclusion: More than 8 out of 10 bio-naïve patients initiated on apremilast in the routine clinical care in Greece have at least moderate disease activity, active psoriasis, and problems with pain/discomfort, anxiety/depression, and performance of usual activities at a median of 2 years post-diagnosis. HAQ-DI and PsAID12 scores indicate moderate impairment of physical functionality and PsA-related HRQoL. The findings underscore considerable disease burden early in the disease course. Table 1. Baseline characteristics N %/Mean/Median Women, % 57/99 57.6 Peripheral joint involvement only, % 92/99 92.9 Polyarthritis (≥5 joints), % 69/99 69.7 cDAPSA (range: 0-154), median (IQR ) 99 22.0 (16.0-29.0) Number of SJC (0-66) / TJC (0-68), median (IQR) 99 4 (2-8) / 6 (2-10) Active psoriasis (BSA&gt;0%), % 83/99 83.8 BSA score, median (IQR) 77/83 5.0 (2.0-12.0) Nail involvement, % 38/96 39.6 Enthesitis and/or dactylitis, % 30/95 31.6 Dactylitis, % 11/95 11.6 Finger and toe Dactylitis Severity Score (DSS) (range: 0-60), median (IQR) 10/11 2.0 (1.0-6.0) Enthesitis, % 22/95 23.2 LEI score (range: 0-14), median (IQR) 22 2.0 (1.0-2.0) Extra-articular manifestations (mainly fatigue), % 10/99 10.1 Comorbidities in ≥15% of the patients Hypertension, Essential hypertension, % 23/99 23.2 Dyslipidemia, hypercholesterolemia, (type V) hyperlipidemia, % 15/99 15.2 Total PsAID12 score (range: 0-10), mean (SD ) 98 4.6 (2.0) Total HAQ-DI score (range: 0-3), median (IQR ) 99 1.0 (0.5-1.4) Disclosure of Interests: PELAGIA KATSIMPRI Speakers bureau: Janssen, Genesis pharma, Novartis, Abbvie, UCB, Hospital Line, Actelion Pharmaceuticals, Pfizer, Consultant of: Janssen, Genesis pharma, Novartis, Abbvie, UCB, Hospital Line, Actelion Pharmaceuticals, Pfizer, Dimitrios Vassilopoulos Speakers bureau: AbbVie, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, GenesisPharma, Νovartis, Pfizer, Roche, UCB, Janssen, MSD, Gkikas Katsifis Speakers bureau: Abbvie, Aenorasis, Amgen, Genesis Pharma, Bausch Health, BMS, Celgene, Janssen, MSD, Novartis, Roche, Pfizer, UCB, Grant/research support from: Abbvie, Aenorasis, Amgen, Genesis Pharma, Bausch Health, BMS, Celgene, Janssen, MSD, Novartis, Roche, Pfizer, UCB, GEORGIOS VOSVOTEKAS Speakers bureau: MSD, Consultant of: AbbVie, Novartis, Dimitrios Bogdanos Speakers bureau: Menarini, Novartis, Consultant of: Fresenius Kabi Hellas, Novartis, Grant/research support from: Aenorasis, Elpen, Genesis Pharma, GlaxoSmithKline, Boehringer Ingelheim, Lilly, Prodromos Sidiropoulos Grant/research support from: University of Crete Special Account for Research and pharma, Periklis Vounotrypidis Speakers bureau: Genesis Pharma, MSD, Novartis, Grant/research support from: Genesis Pharma, MSD, Novartis, Athanasios Georgountzos Grant/research support from: AbbVie, Genesis Pharma, Janssen, Mylan SAS, Pfizer, Roche, UCB, Andreas Bounas: None declared., Alexandros Garyfallos Speakers bureau: AbbVie, BGP, Roche, Consultant of: Genesis Pharma, UCB, Pfizer, Sousana Gazi: None declared., Panagiotis Georgiou Grant/research support from: Janssen-Cilag, Novartis, UCB, Evaggelia Kataxaki Speakers bureau: Novartis, Charalampos Papagoras Speakers bureau: Abbvie, Novartis, Genesis, Lilly, Biogen, Aenorasis, GSK, Pfizer, ANTONIA ELEZOGLOU: None declared., Stamatis-Nick Liossis: None declared., Athanasios Tzioufas Grant/research support from: AbbVie, Genesis Pharma, GSK, Horizon, Lilly, Novartis, Pfizer, Paraskevi Voulgari Speakers bureau: GlaxoSmithKline, Novartis, UCB, Consultant of: GlaxoSmithKline, Novartis, UCB, FOTEINI SATRA TZOUFRA Employee of: GENESIS PHARMA S.A., ZAFEIRIOS ANAGNOSTOPOULOS Employee of: GENESIS PHARMA S.A., NIKOLAOS ANTONAKOPOULOS Employee of: GENESIS PHARMA S.A., Petros Sfikakis Speakers bureau: AbbVie, Boehringer Ingelheim, GenesisPharma, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, GenesisPharma, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, GenesisPharma, Novartis, Pfizer, UCB.