Therapeutic Maintenance of Baricitinib and Tofacitinib in Real Life

Abstract

Background: Janus kinase inhibitors (JAKis) represent a new alternative to treat rheumatoid arthritis (RA). The objective of this study was to evaluate the effectiveness, tolerance profile, and maintenance of these treatments (tofacitinib and baricitinib) in real life. Methods: All patients in the rheumatology department of Amiens University Hospital treated by JAKis for RA were included from 1 October 2017 to 20 May 2020. Clinical and biological data were provided retrospectively in this observational and single-center study. We aimed to study the JAKi maintenance rate at 12 months and their clinical and biological safety profiles. Results: Fifty-five patients were included. Drug maintenance at 12 months was 67.6%. Factors associated with poorer maintenance were a higher Charlson comorbidity index (HR 1.311 (1.089–1.579); p = 0.0042), a higher age (HR 1.055 (1.015–1.096); p = 0.0067), and corticosteroids therapy at initiation (HR 2.722 (1.006–7.365); p = 0.0487). The clinical and biological safety profile was generally good. Conclusions: Our study found that a higher Charlson index, age, and corticosteroids appeared to be associated with the earlier discontinuation of treatment. JAKis had a response and tolerance profile in real life at least equivalent to that of biological disease-modifying antirheumatic drugs (bDMARDs).

Effectiveness and safety profile of tofacitinib and baricitinib in rheumatoid arthritis patients: results from a 24-month real-life prospective study in Southern-Italy

“…Efficacy was observed despite the disease being active, persistent, and treatment-resistant at baseline. Despite the small sample size, the results of this study are consistent with those reported in the literature from RCTs and other realworld cohorts demonstrating an improvement in all clinimetric scores and activity indexes in both bDMARD-naïve and failure RA patients (13)(14)(15)(16)(17)(18).…”

“…Extensive observational research on JAKinhibs in RA is expanding, and a substantial amount of data from real-world clinical settings is now accessible. Several of these data are limited to a 12-month follow-up period (13)(14)(15)(16)(17)(18). Consequently, the primary objectives of the present study were to assess the efficacy, as measured by DAS-28 and SDAI, and safety of tofacitinib and baricitinib during a of follow-up up to 24 months in patients with RA treated in a real-world setting in Southern Italy.…”

A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience

“…Below is a comprehensive descriptive review of the literature regarding RWE for baricitinib that has been reported to date; data were sourced from registries, monocentric and multicentric clinical practice studies, administrative or insurance claim databases, or prospective observational studies. At the time of writing, 41 published sources for RWE of baricitinib in the treatment of RA were identified [ 29 , 33 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 ].…”

“…Supplementary Table S1 summarises available baseline characteristics of baricitinib-treated patients in real-world settings [ 29 , 33 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 ]. The typical patient in the various RWE sources is aged about 60 years (which is older than the mean age of patients in baricitinib RCTs).…”

“…Understanding the risk factors associated with early discontinuation of drug treatment, should it be for poor tolerance, lack of efficacy or other reasons, allows us to take a step closer to personalised medicine. Several studies discussed below investigated factors associated with a higher risk of JAKi treatment discontinuation; most studies investigated baricitinib [ 60 , 62 , 74 , 82 , 85 ] and two considered baricitinib and tofacitinib [ 71 , 84 ].…”