Op0231 comparative Effectiveness of Jak-Inhibitors, TNF-Inhibitors, Abatacept and Il-6 Inhibitors in an International Collaboration of Registers of Rheumatoid Arthritis Patients (The “Jak-Pot” Study)
Abstract:Background:In many countries, JAK-inhibitors (JAKi) have only recently been approved as treatment for patients with rheumatoid arthritis (RA).Objectives:To evaluate the effectiveness of JAKi compared to bDMARDs in RA patients in the real-world population in an international collaboration of registers (the “JAK-pot” collaboration).Methods:Patients initiating either JAKi, TNFi, IL-6i or abatacept (ABA) during a time period when JAKi were available in each country (19 registers, Table) were included. We compared … Show more
“…During the observation period, the proportions of patients receiving monotherapy were 50.9% and 31.2% for baricitinib-treated patients and patients treated with another tsDMARD or any bDMARD, respectively. This finding is aligned with the findings of the JAK-POT study, which evaluated the effectiveness of JAK inhibitors compared with bDMARDs in patients with RA initiating treatment with these agents in the usual care, using data from 17 international registries [ 32 ]. This study reported that JAK inhibitors were more often initiated as monotherapy than were bDMARDs.…”
Introduction
RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time until discontinuation from any cause (excluding sustained response) of the initial treatment.
Methods
RA-BE-REAL is an ongoing, prospective, observational, 36-month study in patients with RA initiating treatment with baricitinib (cohort A) or any other tsDMARD or any bDMARD (cohort B) for the first time. The primary objective is to assess the time until treatment discontinuation from any cause (excluding sustained response) at 24 months, (i.e., the rate of discontinuation of initial baricitinib or ts/bDMARD). Patient profiles of each cohort are described and compared. Post-baseline data are descriptively analyzed. This manuscript presents baseline and interim (6-month) outcomes for European patients with RA participating in the global RA-BE-REAL study.
Results
Data from 1074 patients (cohort A: 509; cohort B: 565) were analyzed. For cohorts A and B, respectively, the 6-month cumulative incidence (95% confidence interval) of treatment discontinuation was 16.5 (12.9–21.1) and 23.3 (19.1–28.2), and the proportions of patients achieving remission were 25.6% and 18.5%. At baseline, mean patient age was 59.1 and 57.0 years (
p
= 0.010) and mean disease duration was 10.0 and 8.9 years (
p
= 0.047), respectively. The proportions of patients exposed to ts/bDMARDs at any time before study entry were 51.9% and 39.1%, and the proportions of patients initiated on monotherapy were 50.9% and 31.2%, respectively.
Conclusion
In real-world settings, patients with RA initiating treatment with baricitinib were older and had longer disease duration than those initiating treatment with any other tsDMARD or any bDMARD. Initial descriptive data regarding treatment discontinuation (including reasons for discontinuation), effectiveness, and treatment patterns will be enriched as the study progresses.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40744-022-00500-6.
“…During the observation period, the proportions of patients receiving monotherapy were 50.9% and 31.2% for baricitinib-treated patients and patients treated with another tsDMARD or any bDMARD, respectively. This finding is aligned with the findings of the JAK-POT study, which evaluated the effectiveness of JAK inhibitors compared with bDMARDs in patients with RA initiating treatment with these agents in the usual care, using data from 17 international registries [ 32 ]. This study reported that JAK inhibitors were more often initiated as monotherapy than were bDMARDs.…”
Introduction
RA-BE-REAL has the overall aim of defining a profile of patients with rheumatoid arthritis (RA) starting baricitinib or any other targeted synthetic (ts) or any biologic (b) disease-modifying antirheumatic drug (DMARD) for the first time, and the primary objective of estimating time until discontinuation from any cause (excluding sustained response) of the initial treatment.
Methods
RA-BE-REAL is an ongoing, prospective, observational, 36-month study in patients with RA initiating treatment with baricitinib (cohort A) or any other tsDMARD or any bDMARD (cohort B) for the first time. The primary objective is to assess the time until treatment discontinuation from any cause (excluding sustained response) at 24 months, (i.e., the rate of discontinuation of initial baricitinib or ts/bDMARD). Patient profiles of each cohort are described and compared. Post-baseline data are descriptively analyzed. This manuscript presents baseline and interim (6-month) outcomes for European patients with RA participating in the global RA-BE-REAL study.
Results
Data from 1074 patients (cohort A: 509; cohort B: 565) were analyzed. For cohorts A and B, respectively, the 6-month cumulative incidence (95% confidence interval) of treatment discontinuation was 16.5 (12.9–21.1) and 23.3 (19.1–28.2), and the proportions of patients achieving remission were 25.6% and 18.5%. At baseline, mean patient age was 59.1 and 57.0 years (
p
= 0.010) and mean disease duration was 10.0 and 8.9 years (
p
= 0.047), respectively. The proportions of patients exposed to ts/bDMARDs at any time before study entry were 51.9% and 39.1%, and the proportions of patients initiated on monotherapy were 50.9% and 31.2%, respectively.
Conclusion
In real-world settings, patients with RA initiating treatment with baricitinib were older and had longer disease duration than those initiating treatment with any other tsDMARD or any bDMARD. Initial descriptive data regarding treatment discontinuation (including reasons for discontinuation), effectiveness, and treatment patterns will be enriched as the study progresses.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40744-022-00500-6.
“…Further studies are now required to refine and validate OPEX. For example, future research will enable further comparisons in newer trials, such as the recent RCT comparing a Jak inhibitor to a TNFi-in which the former was found to be more effective but at a higher risk of toxicity [11]. Other notable examples include high risk decisions in which the patient experience is markedly different between two options, such as early rhythm control versus usual care for atrial fibrillation.…”
Objectives
A measure that encompasses both benefits and harms at the individual patient level may facilitate comparisons between treatment options and improve shared decision-making. The objective of this study was to develop a patient reported measure to capture overall experience (including both benefits and harms) of treatment using rheumatoid arthritis (RA) as a case example.
Methods
Hierarchies for treatment benefits are known. Therefore, we developed a hierarchy of adverse events (AEs) using a series of trajectory mapping and paired comparison surveys. We subsequently used these data to construct a paired comparison survey, asking patients to compare options including both a specified level of benefit and an AE. These data were used to generate a hierarchy of overall experience on treatment.
Results
782 participants completed a series of three surveys. The trajectory mapping procedure and a paired comparison survey led to the generation of a hierarchy of AEs with nine levels ranging from No AEs to irreversible serious complications. In a third survey, in which AEs were paired with benefits, participants’ ratings generated a 6-level hierarchy of overall experiences ranging from Major improvement + No, mild or manageable AEs (Level 1) to No improvement + Irreversible AEs (Level 6).
Conclusions
Using a trajectory mapping approach, we developed a patient reported measure representing the distribution of patients’ overall experiences on treatment. The intent of this measure is to enable patients and their physicians to compare the percentage of patients experiencing each level of outcome, from most to least desirable, across treatments.
“…A real-world study of more than 25,000 patients with RA found that the hazard ratio for drug discontinuation tended to be lower for JAK inhibitors than for TNF inhibitors. 13 However, discontinuation rates were comparable for the JAK inhibitors, abatacept, and specific IL-6 inhibitors. 13 Further investigation is needed to determine the key factors influencing drug discontinuation in patients with RA and whether or not the route of treatment administration plays a role.…”
Section: Rheumatoid Arthritismentioning
confidence: 96%
“…13 However, discontinuation rates were comparable for the JAK inhibitors, abatacept, and specific IL-6 inhibitors. 13 Further investigation is needed to determine the key factors influencing drug discontinuation in patients with RA and whether or not the route of treatment administration plays a role. In 3 decades, scientific advancements have led to the evolution of the RA therapeutic landscape from general immunosuppressants to targeted biological and synthetic DMARDs.…”
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