Ab0386 differences Between Jakis-Naive and Jakis-Not Naive Patients in a Real Life Clinical Setting: Data From an Prospective Multicentric Italian Study.

Abstract

BackgroundCurrent and previous EULAR recommendations (1,2) suggest using JAK-inhibitors (JAKis) for treating Rheumatoid Arthritis (RA). However, little is known about differences of patients who are JAK-inhibitors (JAKis) naïve and patients who have already experienced at least one JAKi.ObjectivesTo analyse differences between JAK-naïve and JAKis not naive patients in a real life setting.MethodsAll patients with RA on JAKis were prospectively followed up for 12 months in this multicentric study conducted in 23 centres. For each patient, the following variables were recorded: sex, age, disease duration at JAKi prescription, smoking, BMI, comorbidities, positive RF/ACPA, DAS28-ESR at baseline, 6 and 12 months, cDMARDs and prednisone at baseline, JAKis discontinuation, JAK-naïve. Statistics were performed by R (2022.12.0).Results864 patients were included (Table 1). Among them, 731 (84.60%) were JAKis naïve, whereas 122 (14.12%) were not naïve (missing data in 11-1.27%-patients). 473 (55.22%) patients were treated with baricitinib (JAK-naïve were 412, 87.3%), 213 (24.6%) with tofacitinib (JAKis-naïve 187, 87.79%), 111 (12.84%) with upadacitinib (JAKis-naïve 78.37%) and 62 (7.17%) with filgotinib (JAKis-naïve 72.58%). Significant differences between JAKis-naïve and not naïve were found for hypercholesterolemia (p=0.04), hypertension (p=0.02), previous cancer (p<0.001), disease duration (p<0.001), line of treatment (p<0.001). No difference was found for JAKis discontinuation (p=0.13)(Table 1).ConclusionOur data suggest that line of treatment and disease duration result higher in JAKis not naive compared to naïve ones. Notably, JAKis naïve and not naïve did not differ regarding drug discontinuation, suggesting a similar retention rate irrespective of previous JAKis.References[1] Smolen JS, et al. Ann Rheum Dis 2020.[2] Smolen JS, et al. Ann Rheum Dis 2023.Table 1.Differences between JAKis naïve and not naïve patientsTotalTotal (N=864)JAKis naive (N=731)JAKis not naïve (N=122)P valueN (%)N (%)N(%)Mean age at baseline (SD) (N=852)58.83 (12.87)58.54 (12.92)60.61 (12.45)0.10Females (N=853)668 (78.31)564 (77.15)104 (85.25)0.05Mean BMI (Kg/cm2) (SD) (N=616)25.15 (3.77)25.18 (3.62)25.02 (4.46)0.68Smoking (N=788)0.13 Yes150 (19.03)135 (19.97)15 (13.39) No496 (62.94)425 (62.87)71 (63.39) Former142 (18.02)116 (17.16)26 (23.31)Positive RF (N=800)527 (65.89)444 (64.91)83 (71.55)0.16Positive ACPA (N=787)491 (62.39)411 (61.43)80 (67.80)0.19Diabetes (N=760)68 (8.95)56 (8.78)12 (9.84)0.71Hypertension (N=761)297 (39.03)238 (37.25)59 (48.36)0.02Hypercholesterolemia (N=759)195 (25.36)155 (24.29)40 (33.06)0.04Previous MACE (N=758)47 (6.20)39 (6.13)8 (6.56)0.86Previous cancer (N=760)42 (5.52)39 (6.10)3 (2.48)<0.001Disease duration (months), (median, IQR) (N=844)76 (29-155)71 (24-142.50)142 (69-226)<0.001Mean DAS28-ESR at baseline (SD) (N=736)5.29 (1.06)5.27 (1.09)5.40 (0.89)0.22cDMARDs at baseline (N=771)280 (36.31)235 (36.21)45 (36.89)0.88PDN at baseline (N=438)438 (50.69)368 (57.38)70 (56.79)0.90Median dosage (IQR) of PDN (mg/day) (N= 438)5 (4.00-5.00)2.50 (0.00-5.00)4.00 (0.00-5-00)0.08Line of JAKis treatment (N=853)<0.001 1^244 (28.60)244 (33.38)0 (0.00) 2^211 (24.74)207 (28.32)4 (3.28) 3^175 (20.63)172 (23.53)(3.28) 4^109 (12.78)56 (7.66)53 (3.44) 5^65 (7.62)32 (4.38)33 (27.05) 6^28 (3.28)12 (1.64)6 (13.11) 7^12 (1.41)6 (0.82)6 (4.92) 8^3 (0.35)1 (0.14)2 (1.64) 9^2 0.23)1 (0.14)1 (0.82) 10^3 (0.35)0 (0.00)(2.46)Patients who discontinued JAKis (N=853)192 (22.51)158 (21.61)34 (27.87)0.13SD: standard deviation; BMI: Body Mass Index; RF: Rheumatoid Factor; ACPA: Autoantibodies against citrullinated proteins; MACE: Major cardiovascular events; PDN: prednisone; IQR: interquartile range; DAS28-ESR: Disease Activity Score-28 for Rheumatoid Arthritis with ESR; cDMARDs: conventional Disease-modifying antirheumatic agents; JAKis: JAK inhibitors.Acknowledgements:NIL.Disclosure of InterestsMaddalena Larosa: None declared, Andrea Becciolini: None declared, Elena Bravi: None declared, Dario Camellino Speakers bureau: Abiogen, GSK, Paid instructor for: Mylan, Ilaria Platé: None declared, eugenio arrigoni: None declared, Francesca Ometto: None declared, Eleonora Di Donato: None declared, Giuditta Adorni: None declared, Gianluca Lucchini: None declared, Daniele Santilli: None declared, Alessandra Bezzi: None declared, Maria Cristina Focherini: None declared, Fabio Mascella: None declared, Vincenzo Bruzzese: None declared, Palma Scolieri: None declared, Simone Parisi: None declared, Enrico Fusaro: None declared, Maria Chiara Ditto: None declared, Viviana Ravagnani: None declared, Gilda Sandri: None declared, Carlo Salvarani: None declared, Marta Priora: None declared, Marino Paroli: None declared, rosalba caccavale: None declared, Romina Andracco: None declared, Natalia Mansueto: None declared, Matteo Colina: None declared, Massimo Reta: None declared, Olga Addimanda: None declared, Alberto Lo Gullo: None declared, elisa visalli: None declared, Rosario Foti: None declared, Giorgio Amato: None declared, Francesco De Lucia: None declared, antonella farina: None declared, Francesco Girelli: None declared, Patrizia Del Medico: None declared, Aldo Molica Colella: None declared, Veronica Franchina: None declared, Francesco Molica Colella: None declared, Federica Lumetti: None declared, Aurora Ianniello: None declared, Valeria Nucera: None declared, Rosetta Vitetta: None declared, Alessia Fiorenza: None declared, Guido Rovera: None declared, Alessandro Volpe: None declared, Giulio Ferrero: None declared, Antonio Marchetta: None declared, Simone Bernardi: None declared, Gerolamo Bianchi: None declared, Alarico Ariani: None declared.