BARICITINIB IN RHEUMATOID ARTHRITIS-INTERSTITIAL LUNG DISEASE. NATIONAL MULTICENTER STUDY OF 60 PATIENTS

Background: Interstitial lung disease (ILD) is a severe extraarticular manifestation of rheumatoid arthritis (RA) that determines a worse prognosis, leading the cause of mortality in RA patients, second only to cardiovascular disease [1] . Abatacept and rituximab are the preferred drugs for the treatment of RA-ILD, if indicated [2-3]. JAK inhibitors (JAKi) have demonstrated efficacy in patients with RA. The JAKi approved by the Food and Drugs Administration (FDA) and the European Medicines Agency (EMA) for the treatment of RA are baricitinib (BARI), tofacitinib, upadacitinib and filgotinib. Evidence on RA-ILD treatment with JAKi is growing, especially with BARI [4]. Objectives: To assess a ) the effectiveness and b ) the safety of BARI in RA-ILD patients. Methods: National multicenter study of RA-ILD patients from clinical practice on treatment with BARI. We analyzed the following outcomes from baseline to final follow-up: a ) forced vital capacity (FVC), b ) diffusing capacity of the lungs for carbon monoxide (DLCO), c ) chest high resolution computed tomography (HRCT), d ) dyspnea (modified Medical Research Council scale), e ) arthritis activity (DAS28-ESR or clinical records), and f ) sparing corticosteroids effect. Results: We collected a total of 60 patients (44 women/ 16 men; mean age 67±11 years). Baseline demographic and clinical characteristics are shown in Table 1. All patients had received disease-modifying antirheumatic drugs (DMARDs) before BARI [methotrexate (52;87%), leflunomide (41;68%), sulfasalazine (18;30%), abatacept (38;63%), tocilizumab (24;40%), adalimumab (18;30%) and rituximab (15;20%)]. All the patients were refractory to previous therapies. Median ILD duration up to BARI initiation was of 25 [16-62] months. Mean baseline values of FVC and DLCO (% predicted) were 87±27 and 68±19, respectively. Patients were followed-up for a mean of 37±23 months. The evolution of FVC and DLCO remained stable during the first 24 months (Figure 1). At the end of the follow-up, available chest HRCT images improved/ stabilized in 78% of patients. Stabilization or improvement of dyspnea was found in 85% of patients. Most patients showed articular remission or low activity. BARI was withdrawn in 26 (44) patients due to: articular inefficacy (n=18), lung inefficacy (n=5), hypersensitivity pneumonitis (n=1), ocular involvement (n=1) and brain cancer (n=1). After follow-up the relevant adverse event were Zoster virus infection, pneumococcal pneumonia, Pneumoncystis pneumonia and oral candidiasis. Conclusion: BARI might be effective and safe in controlling both pulmonary and joint disease in RA-ILD patients, even in ABA and/or RTX refractory patients. REFERENCES: [1] Manfredi A, Cassone G, Luppi F, Atienza-Mateo B et al. Expert Rev Clin Imm. 2021 May 4;17(5):485–97. [2] Fernández-Díaz C, et al. Rheumatology (Oxford). 2020 Dec 1;59(12):3906-3916. [3] Atienza-Mateo B, et al. J Clin Med. 2020 Sep 23;9(10):3070. [4] Tardella M, et al. Inflammopharmacology. 2022 Jun;30(3):705-712. Table 1. Baseline characteristics of RA-ILD patients treated with BARI. RA-ILD patients with BARI (n=60 ) Age, years mean±SD 67 ± 11 Women, n (%) 44 (73) Smoker ever, n (%) 35 (58) Time since ILD diagnosis, months, median [IQR] 25 [16-62] RF, n (%) 56 (93) ACPA, n (%) 56 (93) Bone erosions, n (%) 31 (52) Prednisone at baseline, mg/day, median [IQR] 5 [3-10] FVC (% of the predicted), mean±SD 87 ± 27 DLCO (% of the predicted), mean±SD 68 ± 19 UIP pattern on HRCT, n (%) 26 (45) NSIP pattern on HRCT, n (%) 21 (36) Joint activity n (%) 54 (92) Previous immunosuppressive therapy, n (% ) Conventional/ biologic DMARD 59(98)/ 51(85) Concomitant immunosuppresive therapy, n (% ) 27 (60) Concomitant antifibrotic therapy, n (% ) 6 (10) ACPA, anti-citrullinated protein antibodies; DLCO, diffusing capacity of the lung for carbon monoxide; DMARD, disease-modifying antirheumatic drug; FVC, forced vital capacity; HRCT, high-resolution computed tomography; ILD, interstitial lung disease; RA, rheumatoid arthritis; RF, rheumatoid factor; UIP, usual interstitial pneumonia. Figure 1. Evolution of pulmonary function tests (mean % of the predicted FVC and DLCO) in RA-ILD patients treated with BARI at baseline and 24 months. Acknowledgements: NIL. Disclosure of Interests: Ana Serrano-Combarro: None declared, Belén Atienza-Mateo: None declared, Jesús Alejandro Valero Jaimes: None declared, Marta Pastor Mena: None declared, Rafael B Melero-González: None declared, David Castro-Corredor: None declared, María Martín López: None declared, Santos Castañeda: None declared, Jesús Loarce-Martos: None declared, Natalia Mena-Vázquez: None declared, Maria del Carmen Carrasco Cubero: None declared, Carolina Díez: None declared, Andrea García-Valle: None declared, Juan María Blanco-Madrigal: None declared, N. Del-Val: None declared, Nuria Vegas-Revenga: None declared, Lorena Pérez Albaladejo: None declared, Rafaela Ortega-Castro: None declared, Deseada Palma Sanchez: None declared, ANA MARIA FERNANDEZ ORTIZ: None declared, Patricia López Viejo: None declared, María América López Lasanta: None declared, Marta Garijo Bufort: None declared, Ivette Casafont-Solé: None declared, Juan Moreno Morales: None declared, Ana Urruticoechea-Arana: None declared, Carolina Pérez-García: None declared, Jose Rosas Gómez de Salazar: None declared, Delia Fernandez-Lozano: None declared, LETICIA DEL OLMO PEREZ: None declared, Jose Ramón Lamúa Riazuelo: None declared, Diego Ferrer: None declared, Ricardo Blanco Abbvie, Pfizer, Roche, lilly, Bristol-Myers, Janssen, Galapagos and MSD., Abbvie, Pfizer, Roche, lilly, Bristol-Myers, Janssen and MSD., Abbvie, MSD, novartis and Roche. DOI: 10.1136/annrheumdis-2024-eular.4182 Keywords: Real-world evidence, Lungs, Disease-modifying Drugs (DMARDs) Citation: , volume 83, supplement 1, year 2024, page 1637Session: Rheumatoid arthritis (Publication Only)

Real-world evidence, Lungs, Disease-modifying Drugs (DMARDs)