PReS-FINAL-2161: Safety and effectiveness of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to <4 years or >=4 years weighing <15 kg

Abstract

Background: Adalimumab (ADA) is approved for use in moderate to severe JIA in patients (pts) >4 years old in the US, EU, and Japan. Limited data are available in pts 1 year of ADA therapy in pts aged 2 to <4 years old or >4 years old weighing <15 kg with moderately to severely active polyarticular JIA. Methods: JIA pts were treated with ADA 24 mg/m2 (maximum =20 mg/dose) every other week +/- MTX for 96 weeks in an ongoing international, multicentre, open-label, phase 3 b study until achieving the limit for age (>4 years) and weight (>15 kg). Adverse events (AEs) were summarized for all visits up to 96 weeks. Clinical effectiveness endpoints included American College of Rheumatology pediatric (PedACR) 30/50/70/90 responses through week 60, and JIA outcome parameters (PhGA, PaGA, DICHAQ, AJC73, LOM69, CRP, TJC, SJC, and POM75). Results: 32 pts were randomized; through week 60, two pts withdrew due to AEs (JIA worsening or flare) and 2 withdrew for other reasons. AE incidence rates included: any AEs (91%), serious AEs (16%), infectious AEs (78%), and serious infections (9%). No deaths, malignancies, or opportunistic infections were reported. 90% of pts had achieved PedACR30 at week 60 (Table 1). High PedACR 50/70/90 response rates were achieved at week 24 and maintained through week 60. Statistically significant improvements in other JIA outcomes were also observed. Growth was not adversely impacted by ADA treatment; based on CDC growth standards, at baseline, 50%/53% of pts were in the >33rd percentile for height and BMI, respectively; at week 60, this had increased to 76%/67%. Conclusion: In this very young population with polyarticular JIA, primary clinical trial data revealed that the safety profile and effectiveness of ADA were comparable to that observed in older children with JIA. No adverse effects on growth were observed; however, data did reflect improvement in growth through week 60 of the study. (Table Presented).