OP0125 TOFACITINIB IN RHEUMATOID ARTHRITIS-ASSOCIATED INTERSTITIAL LUNG DISEASE: EFFICACY AND SAFETY ANALYSIS FROM TREASURE REAL-LIFE DATA
Authors: U. Kalyoncu, E. Bilgin, A. Erden, H. Satiş, A. Tufan, E. Tekgoz, A. Ateş, B. N. Coşkun, B. Yağiz, O. Küçükşahin, V. Yazisiz, G. Kimyon, C. Bes, A. İ. Ertenli, S. Kiraz
Journal: Annals of the Rheumatic Diseases (2021)

Background: Beyond the joints, rheumatoid arthritis (RA) may affect lungs. Especially the involvement of the paranchyme, RA-associated interstitial lung disease (RA-ILD), is a major cause of mortality and morbidity. Tofacitinib, an oral JAK 1/3 inhibitor, has been used increasingly in the management of rheumatoid arthritis (RA) in recent years. Recently, a couple of animal and human studies reported promising results (1). Objectives: To assess the real-life efficacy and safety of tofacitinib in patients with RA-ILD in TReasure registry. Methods: This is a multicenter, observational study included RA patients with ILD diagnosis based on the HRCT images of the lungs, and were followed in 8 different centers participated in the TReasure database. Demographic data and patients’ characteristics regarding RA and RA-ILD at the visit in which tofacitinib was initiated and for the last follow-up visit under tofacitinib were recorded. Using the present study cohort, the RA patients with ILD receiving tofacitinib were compared with those without ILD receiving tofacitinib (controls) in terms of the general and disease-related characteristics and data of concomitant DMARD use. To evaluate retention rates of tofacitinib and reasons for discontinuation, data of the patients with RA-ILD in this study cohort were compared with the data of RA patients without ILD who were followed in Hacettepe University (major contributor of the TReasure registry). This research was funded by Pfizer. Results: A total of 47 RA patients with RA-ILD and a control group of 387 patients without ILD were included. The RA patients with ILD receiving tofacitinib were mostly male, older, and had higher baseline disease activity as compared with those without ILD (Table). The ILD pattern was known in 44 (93.6%) of 47 RA-ILD: 16 (36.3%) had UIP, 24 (54.5%) had NSIP, and 4 (9.1%) had airway disease. While 15 (31.9%) of the patients was asymptomatic, most common initial symptom was shortness of breath (in 14 (29.7%) patients). 18 patients had pre- and post-treatment FVC% and FEV1% values (with a median of 12 (9-19) months). Mean FEV1%; 82.1 vs. 82.8 (pre and post-treatment, respectively, p=0.079), mean FVC%; 79.8 vs. 82.8 (pre and post-treatment, respectively, p=0.014). To evaluate retention rates and reasons for discontinuation, 47 RA-ILD and 239 RA patients without ILD were analyzed. Retention rates were similar (p=0.21, log-rank) (Figure). Most common cause of tofacitinib discontinuation in RA-ILD group was infections (5 (25%) patients). Follow-up durations under tofacitinib were 15 (7-32) and 11 (4-24) months in ILD + and – groups, respectively. The rate of drug discontinuation due to infection in the RA patients with and without ILD was 6.3 per 100 patient-years and 2.4 per 100 patient-years, respectively. Table 1. Characteristics of the RA patients with and without ILD under tofacitinib Variables RA-ILD(+) n=47 RA-ILD(-) n=387 p Male sex 20 (42.6) 69 (17.8) &lt;0.001 Age, years 64 (57-69) 56 (46-64) &lt;0.001 Disease duration for RA, months 128 (78-212) 110 (64-183) 0.171 Smoking status Never smoker 26 (55.3) 211 (56.4) 0.259 Current&amp;Ex-smoker 19 (44.7) 163 (43.6) RF (+) 36 (78.3) 249 (68.8) 0.187 Anti-CCP (+) 30 (65.2) 196 (61.6) 0.640 RF positive or CCP (+) 41 (87.2) 242 (76.3) 0.094 Presence of comorbidity 33 (70.2) 203 (52.5) 0.021 DAS-28 before tofacitinib 5.4 (4.6-6.22) 4.36 (3.22-5.58) &lt;0.001 ESR before tofacitinib, mm/h 38 (19-73) 29 (17-45) 0.029 CRP before tofacitinib 6.75 (1.63-24) 9.95 (4.18-25.1) 0.065 Follow-up duration under tofacitinib 15 (7-32) 7 (3-12) &lt;0.001 Figure 1. Tofacitinib retention rates in the RA patients with and without ILD Conclusion: In majority of patients, pulmonary functions remained stable during follow-up. Tofacitinib seems as a promising option for RA-ILD. High rate of discontinuation due infections was observed in RA-ILD patients under tofacitinib; however, it should be kept in mind that RA-ILD patients were older than RA patients without ILD. References: [1]Bejarano M, et al AB0418 ILD in Patients with RA Treated with tofacitinib. ARD;78:1672. Disclosure of Interests: Umut Kalyoncu Speakers bureau: Pfizer, Abbvie, UCB, Amgen, Emre Bilgin: None declared, Abdulsamet Erden: None declared, Hasan Satiş: None declared, abdurrahman tufan: None declared, Emre Tekgoz: None declared, Aşkin Ateş: None declared, Belkis Nihan Coşkun: None declared, Burcu Yağiz: None declared, Orhan Küçükşahin: None declared, Veli yazisiz: None declared, Gezmiş Kimyon: None declared, Cemal Bes: None declared, Ali İhsan Ertenli: None declared, Sedat Kiraz: None declared