Real-world single centre use of JAK inhibitors across the rheumatoid arthritis pathway

Abstract Objectives To evaluate real world efficacy of approved JAK inhibitors (JAKi) tofacitinib and baricitinib in a large, single-centre cohort of RA patients across the treatment pathway, including those refractory to multiple biologic drugs. Methods All RA patients, treated with tofacitinib (from time of compassionate access scheme) or baricitinib since approval in 2017 had DAS28-CRP scores and components recorded at baseline, 3 and 6 months (with retrospective data for compassionate access scheme). Efficacy was evaluated in the total cohort, each treatment group, and subgroups of number of prior biologic classes failed. Results One hundred and fifteen patients were treated with a JAKi (tofacitinib 54, baricitinib 69, 8 both); 76.4% female; mean (SD) age 57.3 (14.3) years. On average patients had received 3 previous bDMARDs; 11 (9.6%) were bDMARD naïve. Combined group baseline DAS28-CRP (SD) 5.62(1.14) improved by 1.49(1.44) and 1.67(1.61) at 3 and 6 months respectively, comparable in individual JAKi groups; with 24% in at least low disease activity at 3 months. The biggest improvement was observed in the biologic-naïve group (mean DAS28-CRP improved from 5.16–2.14 after 6 months); whilst those with prior exposure to minimum 3 bDMARD classes had DAS28-CRP improvement of > 1.2. 5/8 patients treated with both JAKi sequentially responded. Twelve patients previously unresponsive to IL-6 blockade responded to JAKi. No unexpected safety events were recorded. Two cases of venous thrombo-embolism were observed. Conclusion JAK inhibition is effective in a real world population of RA patients, including in a subset of patients refractory to multiple previous bDMARDs.

Download Full-text

Comment on: Real-world single centre use of JAK inhibitors across the rheumatoid arthritis pathway

Rheumatology ◽

10.1093/rheumatology/keab195 ◽

2021 ◽

Author(s):

Francesca Romana Spinelli ◽

Cristina Garufi ◽

Silvia Mancuso ◽

Fulvia Ceccarelli ◽

Fabrizio Conti

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Jak Inhibitors ◽

Single Centre

Download Full-text

Real-world Effectiveness and Safety of JAK Inhibitors in Rheumatoid Arthritis: A Single-centre Study

Reumatología Clínica ◽

10.1016/j.reuma.2021.08.001 ◽

2021 ◽

Author(s):

Roxana González Mazarío ◽

Jorge Juan Fragío Gil ◽

José Ivorra Cortés ◽

Elena Grau García ◽

Antonio José Cañada Martínez ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Jak Inhibitors ◽

Single Centre ◽

Centre Study ◽

Single Centre Study

Download Full-text

POS0674 DIRECT COMPARISON OF EFFECTIVENESS AND SAFETY OF TOFACITINIB AND BARICITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-WORLD SETTINGS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3469 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 581.3-581

Author(s):

N. Iwamoto ◽

T. Suzuki ◽

A. Okada ◽

K. Fujikawa ◽

T. Aramaki ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Propensity Score ◽

Disease Activity ◽

Clinical Response ◽

Treatment Response ◽

Real World ◽

Jak Inhibitors ◽

Low Disease Activity ◽

Real World Setting ◽

Significant Difference

Background:Tofacitinib is a non-selective first-generation JAK inhibitor and baricitinib was approved for the treatment of Rheumatoid arthritis several years after approve of tofacitinib. Randomized controlled trials have shown good treatment response for RA in these two drugs. However, the evaluation of these two drugs in real-world setting have been rarely reported, moreover, until now, no published data of a direct comparison among JAK inhibitors in RA have been available.Objectives:To compare the efficacy and safety of the JAK inhibitors tofacitinib and baricitinib in patients with rheumatoid arthritis (RA) by using propensity score matching in a real-world setting.Methods:A total of 242 patients with RA who were treated with tofacitinib (n=161) or baricitinib (n=81) were enrolled. To avoid confounding, we performed propensity score matching based on multiple baseline characteristic variables, and then 80 baricitinib-treated patients and 57 tofacitinib-treated patients were extracted for the direct comparison. A mixed effect model with a repeated measures analysis of variance (ANOVA) was performed to ascertain whether there were significant differences in clinical efficacy between the two treatment groups during the treatment period.Finally, We evaluated the predictive factor of clinical responses by performing univariate and multivariable logistic regression analyses.Results:The mean delta disease activity scores (DAS)28-ESR from baseline to 6 months were −1.60 (tofacitinib) and −1.46 (baricitinib). The remission rate defined by the DAS28-ESR at 24 weeks were 21.1% (tofacitinib) and 25.0% (baricitinib). There was no significant difference in the clinical response between the baricitinib-treated and tofacitinib-treated groups. Although there was no significant difference, the concomitant use of methotrexate (MTX) showed better clinical efficacy in the cases of baricitinib treatment as compared with in the case of tofacitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response differed. The concomitant use of oral steroid was independently associated with the achievement of DAS-low disease activity in both groups, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used and the DAS28-ESR at the time of initiation were associated with DAS-low disease activity.Conclusion:This study indicate that tofacitinib and baricitinib had comparable efficacies and safety profiles in a real-world setting. However, the influence of clinical characteristics on the treatment response differed between these two drugs. Direct comparison between two JAK inhibitors provide useful information to optimal use of JAK inhibitors in real-world settings.Disclosure of Interests:None declared

Download Full-text

Sensor-controlled scalp cooling: a safe and effective method to prevent chemotherapy-induced alopecia in a real-world population of patients with breast or female genital tract cancer

10.26226/morressier.5770e29ed462b80290b4c52d ◽

2016 ◽

Author(s):

Christian Martin Kurbacher

Keyword(s):

Real World ◽

Genital Tract ◽

Female Genital Tract ◽

World Population ◽

Scalp Cooling ◽

Tract Cancer ◽

Female Genital

Download Full-text

Real World Performance Evaluation of Transcatheter Aortic Valve Implantation

Journal of Clinical Medicine ◽

10.3390/jcm10091890 ◽

2021 ◽

Vol 10 (9) ◽

pp. 1890

Author(s):

Gabriele Pesarini ◽

Gabriele Venturi ◽

Domenico Tavella ◽

Leonardo Gottin ◽

Mattia Lunardi ◽

...

Keyword(s):

Aortic Valve ◽

Real World ◽

Baseline Risk ◽

Risk Scores ◽

World Population ◽

Control Analysis ◽

Transcatheter Aortic Valve ◽

Procedural Control ◽

Risk Patients ◽

Over Time

Background: The aim of this research is to describe the performance over time of transcatheter aortic valve implantations (TAVIs) in a high-volume center with a contemporary, real-world population. Methods: Patients referred for TAVIs at the University Hospital of Verona were prospectively enrolled. By cumulative sum failures analysis (CUSUM), procedural-control curves for standardized combined endpoints—as defined by the Valve Academic Research Consortium-2 (VARC-2)—were calculated and analyzed over time. Acceptable and unacceptable limits were derived from recent studies on TAVI in intermediate and low-risk patients to fit the higher required standards for current indications. Results: A total of 910 patients were included. Baseline risk scores significantly reduced over time. Complete procedural control was obtained after approximately 125 and 190 cases for device success and early safety standardized combined endpoints, respectively. High risk patients (STS ≥ 8) had poorer outcomes, especially in terms of VARC-2 clinical efficacy, and required a higher case load to maintain in-control and proficient procedures. Clinically relevant single endpoints were all influenced by operator’s experience as well. Conclusions: Quality-control analysis for contemporary TAVI interventions based on standardized endpoints suggests the need for relevant operator’s experience to achieve and maintain optimal clinical results, especially in higher-risk subjects.

Download Full-text