Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis


Ramanan, AV, Dick, AD, Jones, AP, McKay, A ORCID: 0000-0003-1312-8911, Williamson, PR ORCID: 0000-0001-9802-6636, Compeyrot-Lacassagne, S, Hardwick, B, Hickey, H ORCID: 0000-0003-0467-0362, Hughes, D ORCID: 0000-0001-8247-7459, Woo, P et al (show 4 more authors) (2017) Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. New England Journal of Medicine, 376 (17). pp. 1637-1646.

[img] Text
SYCAMORE Ramanan April 26 2017.pdf - Published version
Download (218kB)

Abstract

BACKGROUND Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis. METHODS In this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either adalimumab (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every 2 weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. They were followed for up to 2 years after randomization. The primary end point was the time to treatment failure, defined according to a multicomponent intraocular inflammation score that was based on the Standardization of Uveitis Nomenclature criteria. RESULTS The prespecified stopping criteria were met after the enrollment of 90 of 114 patients. We observed 16 treatment failures in 60 patients (27%) in the adalimumab group versus 18 treatment failures in 30 patients (60%) in the placebo group (hazard ratio, 0.25; 95% confidence interval [CI], 0.12 to 0.49; P<0.0001 [the prespecified stopping boundary]). Adverse events were reported more frequently in patients receiving adalimumab than in those receiving placebo (10.07 events per patient-year [95% CI, 9.26 to 10.89] vs. 6.51 events per patient-year [95% CI, 5.26 to 7.77]), as were serious adverse events (0.29 events per patient-year [95% CI, 0.15 to 0.43] vs. 0.19 events per patient-year [95% CI, 0.00 to 0.40]). CONCLUSIONS Adalimumab therapy controlled inflammation and was associated with a lower rate of treatment failure than placebo among children and adolescents with active JIA-associated uveitis who were taking a stable dose of methotrexate. Patients who received adalimumab had a much higher incidence of adverse events and serious adverse events than those who received placebo. (Funded by the NIHR Health Technology Assessment Programme and Arthritis Research UK; SYCAMORE EudraCT number, 2010-021141-41. opens in new tab.)

Item Type: Article
Uncontrolled Keywords: SYCAMORE Study Group, Humans, Uveitis, Methotrexate, Anti-Inflammatory Agents, Antirheumatic Agents, Drug Therapy, Combination, Double-Blind Method, Time Factors, Adolescent, Child, Child, Preschool, Female, Male, Intention to Treat Analysis, Arthritis, Juvenile, Adalimumab
Depositing User: Symplectic Admin
Date Deposited: 05 May 2017 11:40
Last Modified: 19 Jan 2023 07:05
DOI: 10.1056/NEJMoa1614160
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3007259
Dimensions
Altmetric
CORE (COnnecting REpositories)