Background Since the approval of Adalimumab (ADA) for treatment of juvenile idiopathic arthritis (JIA), it has become a valuable option, which significantly improved the outcome of patients.
Objectives To report efficacy (as observed) and safety of ADA in clinical practice.
Methods Data from the German BiKeR register from 2011 to 2016 are reported. Baseline patient characteristics, treatment response and safety data were compared. Treatment response was analyzed using JIA-ACR criteria, JADAS score and improvement of functional status (Childhood Health Assessment Questionnaire disability index, CHAQ), JIA-ACR-scores, JADAS10-minimal disease activity (MDA), JADAS-remission and ACR-inactive disease criteria were analysed.
Results 589 non-systemic JIA patients exposed to Adalimumab with at least one follow-up report were identified in the German BIKER registry, representing 1143.9 patient years (PY) of exposure to ADA and 1206.5 observation years including 90 days after discontinuation. At Baseline, 58.2% received combination with methotrexate (MTX). Patients on combination treatment had more frequently ANA, less frequently HLA-B27, had higher JADAS 10 and more often received systemic steroids (9.9% vs. 22.2%, p=0.0002). ADA dosage was 0.8mg/kg in both cohorts.
At month 12 JIA-ACR 30/50/70/90 and JADAS-MDA/-remission/ACR-inactive disease was reached by 66/63/49/33/50/24/27% on monotherapy with ADA and 68/63/45/28%/50/28/27 on combination of ADA and MTX (not significant). Response rates at month 24 were 67/66/54/35/65/32/29% on ADA monotherapy and 67/61/46/31/57/35/30% on ADA+MTX combination cohort (not significant).
The rate (/100PY) of all adverse events (AE)/serious AE/infections/serious infections/uveitis events was 52.3/2.2/16.4/4.6 upon monotherapy and 65.3/5.1/2.3/16.4/6.2 upon combination. Only rates for any AE were significantly higher upon combination (p=0.008) as well as rate of elevated transaminase (p=0.01). Rate of patients with an uveitis event was higher upon combination (9.6% vs. 5.3%, p=0.007)
Conclusions Adalimumab demonstrated high response rates and an acceptable risk profile. Efficacy and safety of monotherapy was not inferior to combination therapy with MTX.
Disclosure of Interest A. Klein: None declared, K. Minden Speakers bureau: Abbvie, Pfizer,Roche,Genzyme,Pharm-Allergan, I. Foeldvari: None declared, G. Ganser: None declared, J. Haas: None declared, R. Trauzeddel: None declared, A. Hospach: None declared, F. Weller-Heinemann: None declared, G. Horneff Grant/research support from: Abbvie, Chugai, Novartis, Pfizer,Roche