Ab1101 therapeutic Effects of Apremilast on Enthesitis and Dactylitis in Real Clinical Setting: An Italian Multicenter Study

Abstract

BackgroundTo date only few real-world setting studies evaluated apremilast efficacy in psoriatic arthritis (PsA). Enthesitis and dactylitis are difficult-to-treat features of PsA leading to disability and affecting quality of life.ObjectivesThe aims of this study is to evaluate the leed enthesitis index (LEI) and dactlitis index (DAI) at 6 and 12 month in patients on treatment with apremilast.MethodsAll PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA), LEI, DAI at baseline (T0), 6 month (T1) and 12 months (T2) were recorded. The Mann-Whitney test and chi-squared tests assessed the differences between independent group, whereas the Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value<0.05 was considered statistically significant.Resultsthe total cohort consisted of 209 patients (M/F 94/105) of whom 72 (34.4%) (M/F 29:43) patients had an enthesitis with a median LEI of 3 and 65 patients (31.1%) had dactylitis with a median of DAI of 1; DAPSA at base line was 24.1 in the enthesitis group, and 27.2 in the dactylitis group(Table 1). Prior DMARDs use and concomitant DMARDs drugs were more common in LEI groups with respect to DAI group. Compared to base line, Apremilast 30 mg two times per day demonstrated at 6 and 12 months a significantly improvements in LEI(Figure 1a; p<0.001 for both T1 vs T0, T2 vs T1), DAI (Figure 1b;p<0.001 for both T1 vs T0, T2 vs T1) and DAPSA (Figure 1c; p<0.001 for both T1 vs T0, T2 vs T1). In the LEI group, 29 patients (28.7%) reached a remission with LEI=0 at six months and 40 (44%) patients had a sustained improvement with LEI=0 at 12 months. In the DAI group 45 patients (52.9%) had a remission of dactylitis at 6 months and 43 patients (56.6%) had no dactylitis at T1.ConclusionApremilast demonstrated significant and sustained efficacy in real-life Psa patients, including improvements in enthesitis and dactylitis for up to 12 months.References[1]Ariani A, Parisi S, Del Medico P et al. Apremilast retention rate in clinical practice: observations from an Italian multi-center study. Clin Rheumatol 2022 Oct;41(10):3219-3225.[2]de Vlam K, Toukap AN, Kaiser MJ. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study Adv Ther. 2022 Feb;39(2):1055-1067.Table 1.Baseline CharacteristicTotal CohortDactylitis subgroupEnthesitic subgroupN2096572M:F94:10530:3529:43Age, median [IQR] yrs60[53-67]59[53-65]59[52-65]Smokers, n (%)YesFormerNoUnknown36 (17,2)27 (12,9)144 (68,9)2 (1,0)13 (20,0)10 (15,4)42 (64,6)011 (15,3)14 (19,4)47 (65,3)0Body Mass Index, median [IQR] kg/m^226,5[23,8-29,6] (*)27,1[23,7-29,9] (**)26,1[23,2-29,9] (***)PsA Duration, median [IQR], months50[19-97]42[15-85]51[15-85]PsO Duration, median [IQR], months72[28-140]84[21-141]67[17-142]SJC, median [IQR]3[2-4]3[2-4]3[2-4]TJC, median [IQR]5[3-8]5[3-7]6[4-12]LEI, median [IQR],--3[1-4]Dactylitis, median [IQR], fingers-1[1-2]-CRP, median [IQR], mg/dl1,8[0,7-4,8]2,3[1,0-5,0]3,6[0,9-6,7]PGA Patient (0-10), median [IQR]7[6-8]7[6-8]7[5-8]VAS pain (0-10), median [IQR]7[6-8]7[6-8]7[6-8]DAPSA, median [IQR]24,1[19,4-31,5]24,2[19,5-31,2]27,2[22,9-35,6]Concomitant csDMARDs use, n (%)49 (23,4)22 (33,8)19 (26,3)Prior bDMARDs use, n (%)69 (33,1)34 (52,3)20 (27,8)Concomitant relevant disease, n (%)94 (44,8)37 (56,9)31 (43,1)Figure 1.Acknowledgements:NIL.Disclosure of InterestsAlberto Lo Gullo Grant/research support from: BAYER, GALAPAGOS, NOVARTIS, Andrea Becciolini: None declared, Simone Parisi: None declared, Patrizia Del Medico: None declared, antonella farina: None declared, elisa visalli: None declared, Aldo Molica Colella: None declared, Federica Lumetti: None declared, rosalba caccavale: None declared, Palma Scolieri: None declared, Romina Andracco: None declared, Francesco Girelli: None declared, Elena Bravi: None declared, Matteo Colina: None declared, Alessandro Volpe: None declared, Aurora Ianniello: None declared, Maria Chiara Ditto: None declared, Valeria Nucera: None declared, Veronica Franchina: None declared, Ilaria Platé: None declared, eleonora Di Donato: None declared, Giorgio Amato: None declared, Carlo Salvarani: None declared, Lucia Gardelli: None declared, Gianluca Lucchini: None declared, Francesco De Lucia: None declared, Francesco Molica Colella: None declared, Daniele Santilli: None declared, Natalia Mansueto: None declared, Giulio Ferrero: None declared, Antonio Marchetta: None declared, eugenio arrigoni: None declared, Rosario Foti: None declared, Gilda Sandri: None declared, Vincenzo Bruzzese: None declared, Marino Paroli: None declared, Enrico Fusaro: None declared, ALARICO ARIANI: None declared.