Date: Sunday, November 5, 2017
Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Tofacitinib is an oral JAK inhibitor for the treatment of RA. Efficacy and safety of tofacitinib have been shown in several clinical studies. The study presented here aimed to assess the clinical effectiveness and tolerability of tofacitinib among patients with RA in real life.
Consecutive patients between June 2013 and April 2017 with RA who fulfilled the American College of Rheumatology/EULAR 2010 criteria were analyzed in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5mg bid. The primary objective was to analyze 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 and time to achieve low disease activity (LDA) and remission as defined by DAS28.
Overall, 58 patients were treated with tofacitinib. 86% of the patients were pre-exposed to at least one biological agent. The average DAS 28 at initiation of tofacitinib was 4.5. 65% were rheumatoid factor and 52% ACPA positive. The mean follow up was 1.74 years after initiation of tofacitinib treatment. 32 (57%) patients remained on tofacitinib during follow up. The average time to stop tofacitinib was 112 days. Reasons to stop tofacitinib were: gastrointestinal (n=12), insufficient response (n=5), flare (n=3), pneumonia (n=2), blue toe syndrome (n=1), thoracic pain (n=1), and myalgia (n=1).
Increased of ALAT and ASAT were detected in 4 and 8 patients (>2x ULN: n=1 and n=2). These elevated transaminase levels were transient in 2 and 5 patients, respectively. The average hemoglobin level decreased by 2.6%. A decrease of more than 10% of the hemoglobin level was found in 7 patients during follow up. The average lymphocyte count increased by 6.6%. A decrease below 1000 Lymphocytes/mcl was detected in four patients. Three of them were transient. The mean creatinine level increased by 3.4%. An increase of more than 10% was detected in seven patients (n=1 with pathological creatinine level).
37 (63.8%) and 31(53.4%) of the patients achieved LDA or remission after 62.0 and 65.3 days respectively.
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, over prolonged periods of time. Tofacitinib may be a valuable option in a treat to target approach because the time to determine its efficacy or adverse reaction leading to discontinuation is short, based on the data of our cohort
To cite this abstract in AMA style:Mueller R, Mattow F, Popp F, von Kempis J. Effectiveness, Tolerability, and Safety of Tofacitinib in Rheumatoid Arthritis: A Retrospective Analysis of Real-World Data from the St. Gallen Cohort [abstract]. Arthritis Rheumatol. 2017; 69 (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-cohort/. Accessed March 29, 2023.
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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-cohort/