AB0497 Effectiveness, tolerability, and safety of tofacitinib in rheumatoid arthritis: a retrospective analysis of real-world data from the st. gallen and aarau cohort
Authors: R. Mueller, F. Popp, F. Mattow, M. Durmisi, A. Souza, H. Schulze-Koops, P. Hasler, J. von Kempis
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Tofacitinib is an oral JAK inhibitor indicated for the treatment of RA. Efficacy and safety of tofacitinib have been shown in several randomised clinical studies. <h3>Objectives</h3> The study presented here aimed to assess the clinical tolerability and effectiveness of tofacitinib among patients with RA in real life. <h3>Methods</h3> Consecutive patients between June 2013 and April 2017 with RA who fulfilled the American College of Rheumatology/EULAR 2010 criteria were analysed in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5 mg bid. The primary objective was to analyse safety of tofacitinib in a real life cohort. Safety was assessed by the reasons to stop tofacitinib during follow up and changes of liver enzymes, haemoglobin, and creatinine. The secondary outcome was to analyse the frequency of and time to achieve low disease activity (LDA) and remission as defined by DAS28. <h3>Results</h3> Overall, 144 patients were treated with tofacitinib. 84.9% of the patients were pre-exposed to at least one biological agent. The average DAS 28 at initiation of tofacitinib was 4.43. 50.0% were rheumatoid factor and 49.0% ACPA positive. The mean follow up was 1.22 years (range 10d – 3.7a) after initiation of tofacitinib treatment. 94 (64.4%) patients remained on tofacitinib during follow up. The average time to stop tofacitinib was 190.0 days. Reasons to stop tofacitinib were: insufficient response (n=23), gastrointestinal symptoms (n=18), infection (n=5), myalgia (n=2), remission (n=2), headache,<sup>2</sup> cough, blue toe syndrome, intolerance, heart burn, psoriasis, and increased liver enzymes (all n=1). Increased ALAT or ASAT &gt;2 x ULN were detected in 3.3% and 4.4%, respectively. These elevated transaminase levels were transient in 50% and 60% of the cases, respectively. Haemoglobin decrease of &gt;10% was detected in 15.1% of the patients and decreased lymphocytes&lt;500/μl in 3.4%. An increase of creatinine &gt;20% was detected in 9.4%. 62.9% and 50.0% of the patients achieved LDA or remission after a median 260 and 616 days, respectively. These rates were significantly higher in patients naïve to biologic agents as compared to patients pre-exposed to biologics (LDA: naïve 100% after median 100d, pre-exposed 57.0% after 359d; remission: naïve 86.7% after 132d, pre-exposed 44.1% after 720) <h3>Conclusions</h3> Tofacitinib is a safe and effective treatment option for patients with RA. Tofacitinib may induce high rates of LDA and remission in patients with active disease, even after use of one or more biologics, though the rate is significantly higher in patients naïve to biologics. Tofacitinib may be a valuable option in a treat to target approach. Our data justify an early use of tofacitinib in the therapeutic strategy. <h3>Disclosure of Interest</h3> None declared