Introduction: Tofacitinib is an oral JAK inhibitor indicated for the treatment of rheumatoid arthritis (RA). The efficacy and safety of tofacitinib have been shown in several randomized clinical trials. The study presented here aimed to assess the clinical tolerability and effectiveness of tofacitinib among RA patients in real life. Methods: Consecutive patients between January 2015 and April 2017 with RA who fulfilled the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria were included in a prospectively designed analysis of retrospective data. Patients were initiated on tofacitinib 5 mg 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 28 joint count disease activity score (DAS28). Results: A total of 144 patients were treated with tofacitinib. A total of 84.9% of patients were pre-exposed to at least one biological agent. The average DAS28 at the initiation of tofacitinib was 4.43. A total of 50.0% of patients were positive for rheumatoid factor and 49.0% for ACPA. The mean follow up was 1.22 years (range 10d–3.7a) after initiation of tofacitinib treatment. A total of 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 (n = 2), cough, blue finger syndrome, intolerance, heartburn, psoriasis, and increased liver enzymes (all n = 1). Increased alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) > 2× upper limit of normal (ULN) were detected in 3.3% and 4.4% of patients, 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% of patients. A total of 62.9% and 50.0% of the patients achieved low disease activity (LDA) or remission after a median 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% 92 d, pre-exposed 57.0% 434 d, p ≤ 0.001; remission: naïve 86.7% 132 d, pre-exposed 44.1%, 692 d, p = 0.001). Conclusions: 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 the use of one or more biologics, though the rate appeared higher in patients naïve to biologics. Tofacitinib may be a valuable option in a treat-to-target approach. Our data demonstrate that Janus kinase (JAK) inhibitors are safe and efficacious in real life patients.

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BackgroundTofacitinib is an oral JAK inhibitor indicated for the treatment of RA. Efficacy and safety of tofacitinib have been shown in several randomised clinical studies.ObjectivesThe study presented here aimed to assess the clinical tolerability and effectiveness of tofacitinib among patients with RA in real life.MethodsConsecutive 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.ResultsOverall, 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,2 cough, blue toe syndrome, intolerance, heart burn, psoriasis, and increased liver enzymes (all n=1). Increased ALAT or ASAT >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 >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%.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)ConclusionsTofacitinib 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.Disclosure of InterestNone declared

Die Digitalisierung in der Medizin steht seit der SARS-CoV-2-Pandemie im Mittelpunkt des Interesses. Der Beitrag versucht die Veränderungen und technischen Lösungen in Bezug auf die unterschiedlichen Teile der „patient journey“ darzustellen. Symptom-Checkers, neue Gesundheitsapplikationen, digitale Terminverwaltung etc. werden beschrieben. Abgesehen von den technischen und digitalen Möglichkeiten muss ergänzend die Veränderung der Qualität in der Kommunikation beachtet werden. Es besteht die dringende Notwendigkeit der weiteren technischen Standardisierung einschließlich der Schnittstellen. Weitere Studien müssen die Gleichwertigkeit der digitalen Anwendungen im Vergleich zur analogen Technik in vielen Fällen erst noch belegen.

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