Date: Sunday, October 21, 2018
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Tofacitinib is an oral JAK inhibitor approved for the treatment of RA. Efficacy and safety of tofacitinib have been shown in several randomized clinical trials. Aim of the study presented here was to assess the clinical tolerability and effectiveness of tofacitinib among RA patients in real life.
Methods: Consecutive patients between June 2013 and April 2017 with RA who fulfilled the ACR/EULAR 2010 criteria were included in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5mg bid. The primary objective was to analyze the 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, hemoglobin, and creatinine. The secondary outcome was to analyze the frequency of and time to achieve low disease activity (LDA) and remission as defined by DAS28. Patients were stratified according to previous treatment with biologic agents (bio-naïve versus bio-experienced).
Overall, 144 patients were treated with tofacitinib. 83.9% of patients were pre-exposed to at least one biologic agent. The average DAS28 at the initiation of tofacitinib was 4.42. 50.4% were rheumatoid factor and 49.0% were ACPA positive. The mean follow up was 1.22 years (range 4d – 3.7 years). 89 (61.8%) patients remained on tofacitinib during follow-up. The median time to stop tofacitinib was 95 days (range 4-1106). Reasons to stop tofacitinib were: insufficient response (n=23), gastrointestinal symptoms (n=18), infection (n=5), myalgia (n=2), remission (n=2), headache (n=2), cough, blue finger syndrome, intolerance, heartburn, psoriasis, and increased liver enzymes (all n=1). Increased ALAT or ASAT > 2x ULN were detected in 3.3% and 4.4%, respectively. These elevated transaminase levels were transient in 50 and 60% of the cases, respectively. Hemoglobin decrease of >10% was detected in 15.1% of the patients and decreased lymphocytes < 500/μl in 3.4%. An increase of creatinine >20% was detected in 9.4%.
58.2% and 49.5% of all patients achieved LDA or remission after a median survival time of 319 and 645 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 mean 92d, pre-exposed 34.8% after 434d, p <0.001; remission: naïve 83.3% after 132d, pre-exposed 44.9% after 692d, p=0.001).
Conclusion: 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 point to benefits of an early use of tofacitinib in the therapeutic strategy.
To cite this abstract in AMA style:Mueller R, Hasler C, Popp F, Mattow F, Durmisi M, Rubbert-Roth A, Souza A, Graf N, Schulze-Koops H, Hasler P, von Kempis J. Effectiveness, Tolerability, and Safety of Tofacitinib in Rheumatoid Arthritis: A Retrospective Analysis of Real-World DATA from the ST. Gallen and-Aarau RA-Cohort [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/effectiveness-tolerability-and-safety-of-tofacitinib-in-rheumatoid-arthritis-a-retrospective-analysis-of-real-world-data-from-the-st-gallen-and-aarau-ra-cohort/. Accessed August 7, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-tolerability-and-safety-of-tofacitinib-in-rheumatoid-arthritis-a-retrospective-analysis-of-real-world-data-from-the-st-gallen-and-aarau-ra-cohort/