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Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results - PubMed

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Observational Study

Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results

Hermine I Brunner et al. Arthritis Care Res (Hoboken). 2020 Oct.

Abstract

Objective: To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (JIA) in the STRIVE registry.

Methods: STRIVE enrolled patients with polyarticular-course JIA into 2 arms based on treatment with methotrexate (MTX) alone or ADA with/without MTX (ADA ± MTX). Adverse events (AEs) per 100 patient-years of observation time were analyzed by registry arm. Patients who entered the registry within 4 weeks of starting MTX or ADA ± MTX, defined as new users, were evaluated for change in disease activity assessed by the 27-joint Juvenile Arthritis Disease Activity Score with the C-reactive protein level (JADAS-27CRP ).

Results: At the 7-year cutoff date (June 1, 2016), data from 838 patients were available (MTX arm n = 301, ADA ± MTX arm n = 537). The most common AEs were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) in the MTX arm and arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis, tonsillitis, and injection site pain (3.0% each) in the ADA ± MTX arm. Rates of serious infection were 1.5 events/100 patient-years in the MTX arm and 2.0 events/100 patient-years in the ADA ± MTX arm. AE and serious AE rates were similar in patients receiving ADA with versus without MTX. No deaths or malignancies were reported. New users in the ADA ± MTX arm showed a trend toward lower mean JADAS-27CRP compared with new users in the MTX arm in the first year of STRIVE.

Conclusion: The STRIVE registry 7-year interim results support the idea that ADA ± MTX is well tolerated by most children. Registry median ADA exposure was 2.47 (interquartile range 1.0-3.6) years, with 42% of patients continuing ADA at the 7-year cutoff date.

© 2019 AbbVie Inc. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

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Figures

Figure 1
Figure 1

Seven‐year interim patient disposition in all‐treated population. ADA = adalimumab; JIA = juvenile idiopathic arthritis; MTX = methotrexate; * = these 39 patients are also included in the 537 patients in the ADA ± MTX arm; † = of the 41 patients, 39 were included in the 537 patients in the ADA ± MTX arm, the remaining 2 patients reported that they would switch to adalimumab but never received a dose of adalimumab; ‡ = if patient and family did not want to continue the registry owing to reasons other than the available options, the reasons were collected under Other; if patient discontinued registry but no reason for discontinuation was available in the database, the reasons were collected under Unknown; § = other reasons for registry discontinuation included lack of treatment effectiveness, protocol deviation, noncompliance, remission, partial remission, and flare of JIA disease. The sum of counts for each reason may exceed the total number of discontinuations because each reason given for discontinuation was counted for patients who discontinued from the registry.

Figure 2
Figure 2

A, Kaplan‐Meier plot of time to change or discontinuation of initial therapy in adalimumab (ADA) – methotrexate (MTX) new users, ADA + MTX new users, and MTX new users at registry enrollment. Change or discontinuation of initial therapy was defined as adding MTX or stopping ADA for ADA – MTX new users, stopping 1 or both drugs for ADA + MTX new users, or adding ADA or any other biologic or stopping MTX for MTX new users, whichever occurred first. B, Mean score for the 27‐joint Juvenile Arthritis Disease Activity Score with the C‐reactive protein level (JADAS‐27CRP) over time. The last observation was carried forward until initial therapy was stopped or changed for ADA – MTX new users, ADA + MTX new users, and MTX new users at registry enrollment, excluding JADAS‐27CRP data as soon as initial therapy was stopped or changed. n = number of patients with nonmissing baseline and nonmissing value after imputation. Error bars represent 95% confidence interval (95% CI).

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