AB0331 EFFICACY, RETENTION RATE AND PREDICTORS OF TOFACITINIB EFFICACY AND RETENTION IN RHEUMATOID ARTHRITIS PATIENTS: HUR-BIO REAL-LIFE EXPERIENCE
Authors: E. Bilgin, F. Ceylan, E. C. Bolek, E. Duran, B. Farisoğullari, G. K. Yardimci, L. Kiliç, A. Akdoğan, O. Karadag, Ş. A. Bilgen, S. Kiraz, A. İ. Ertenli, U. Kalyoncu
Journal: Annals of the Rheumatic Diseases (2020)

Background: Tofacitinib (TOF) is an oral Janus Kinase (JAK) inhibitor and is indicated in the treatment of rheumatoid arthritis (RA). Several interventional or observational studies demonstrated its safety and efficacy, however, its real-life retention rate and related factors need to be elucidated further and its efficacy needs to be approved in real-life. Objectives: To assess the real-life efficacy, retention rate and related factors of both parameter in rheumatoid arthritis patients under tofacitinib. Methods: We analyzed all RA patients registered to HURBIO database who received at least 1 dose of tofacitinib ( for drug retention ) and who had at least 1 control visit under tofacitinib ( for efficacy ). Drug retention rates were calculated using the Kaplan-Meier method and predictors of drug retention were determined by Cox proportional hazard model. Patients were grouped as ‘’responder’’ or ‘’non-responders according’’ to DAS28 at last control visit: DAS28-CRP≤3.2: ‘’Responders’’; DAS28-CRP&gt;3.2: ‘’Non-responders’’. Predictors of response (DAS28-CRP≤3.2 at last visit) were determined by logistic regression analysis. Reasons for switching and discontinuation were also determined. Results: For drug retention; a total of 247 (210 (85%) female) patients were recruited. Mean age was 53.1±12.6 years. Mean disease duration was 11.3±8.0 years. Rheumatoid factor and anti-CCP antibodies were positive in 160/240 (66.7%) and 135/207 (65.2%) patients, respectively. Combination with DMARDs was used in 83.3% of patients. 55.5% of patients was biologic-naive. Median follow-up while receiving tofacitinib was 10.2 (IQR:4.0-24.2) months. One-year crude retention rate was 64%. Median duration of drug retention was 24.8 months. Predictors of good tofacitinib retention were (in multivariate analysis): living in Ankara (where our center is located ) (HR 1.43 (0.96-2.14); 95% CI) and BMI&gt; 25 (HR 1.46 (0.97-2.29); 95% CI). For efficacy; a total of 204 (174 (85.4%) female) patients were recruited. Mean age was 53.2±12.5 years. Mean disease duration was 11.5±8.1 years. Rheumatoid factor and anti-CCP antibodies were positive in 135/198 (68.1%) and 115/171 (67.2%) patients, respectively. Detailed demographic and clinical characteristics of participants were given in table 1. Median follow-up while receiving tofacitinib was 11.6 (IQR:5.2-26.2) months. DAS28-CRP levels at baseline and last visit were 4.8 (IQR:3.9-5.4) and 3.3 (IQR:2.5-4.6), respectively (p&lt;0.001). At last visit, 19.6% of patients was in low-disease activity (2.6≤DAS28-CRP≤3.2), 26.0% of patients was in remission (DAS28-CRP&lt;2.6) Predictors of good response to tofacitinib were (in multivariate analysis, adjusted for follow-up duration under tofacitinib): biologic-navie (aOR 2.38 (1.30-4.34); 95% CI) and RF negativity (aOR 2.12 (1.13-3.95); 95% CI). The most common cause of drug discontinuation was primary failure (in 36/108 patients, 33.4%). Conclusion: Tofacitinib seems an effective treatment option for rheumatoid arthritis. Relationship between seronegativity and good response to tofacitinib needs to be elucidated. Also, Clinicians should keep in their mind that in addition to patient characteristics, socioeconomic factors may influence the adherence to the treatment. Disclosure of Interests: Emre Bilgin: None declared, Furkan Ceylan: None declared, Ertugrul Cagri Bolek: None declared, Emine Duran: None declared, Bayram Farisoğullari: None declared, Gözde Kübra Yardimci: None declared, Levent Kiliç: None declared, Ali Akdoğan: None declared, Omer Karadag: None declared, Şule Apraş Bilgen: None declared, Sedat Kiraz: None declared, Ali İhsan Ertenli: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB