Data collected in the German BIKER registry were analyzed in patients with polyJIA who started treatment with approved biologics,
adalimumab,
etanercept or
tocilizumab, from 2011 to 2015. Baseline patient characteristics, treatment response, safety and
drug survival were compared.
RESULTS: Two hundred thirty-six patient started
adalimumab, 419
etanercept and 74
tocilizumab, with differences in baseline patient characteristics. Baseline Juvenile Disease Activity Score (JADAS)10 (mean ± SD) in the
adalimumab/
etanercept/
tocilizumab cohorts was 12.1+/-7.6, 13.8 ± 7.1 and 15.1 ± 7.4, respectively (
adalimumab vs
etanercept, p = 0.01), and Childhood Health Assessment Questionnaire (CHAQ)-disability index scores was 0.43 ± 0.58, 0.59 ± 0.6 and 0.63 ± 0.55, respectively (
adalimumab vs
etanercept, p < 0.001).
Uveitis history was more frequent in the
adalimumab cohort (OR 5.73; p < 0.001). Balanced patients' samples were obtained by a generalized propensity score to adjust for baseline differences. Pediatric ACR30/50/70/90 criterion improvement after 3 months treatment was achieved by 68%/60%/42%/24% in the
etanercept cohort, 67%/59%/43%/27% in the
adalimumab cohort and 61%/52%/35%/26% in the
tocilizumab cohort. At 24 months, JADAS minimal disease activity was achieved in 52.4%/61.3%/52.4% and JADAS remission in 27.9%/34.8%/27.9% patients in the
adalimumab/
etanercept/
tocilizumab cohorts, respectively.
Etanercept was used in 95.5% of patients as a first
biologic,
adalimumab in 50.8% and
tocilizumab in 20.2%. There were no important differences in efficacy between first-line and second-line use of biologics. In total 60.4%/49.4%/31.1% patients discontinued
adalimumab/
etanercept/
tocilizumab, respectively (HR for
adalimumab 1.67; p < 0.001; HR for
tocilizumab 0.35; p = 0.001).
Drug survival rates did not differ significantly in patients on
biologic monotherapy compared with combination
therapy with
methotrexate. Over 4 years observation under
etanercept/
adalimumab/
tocilizumab, 996/386/103 adverse events, and 148/119/26 serious adverse events, respectively, were reported.
CONCLUSIONS: In clinical practice,
etanercept is most frequently used as first-line
biologic.
Adalimumab/
etanercept/
tocilizumab showed comparable efficacy toward polyJIA. Overall, tolerance was acceptable. Interestingly, compliance was highest with
tocilizumab and lowest with
adalimumab. This study provides the first indication for the comparison of different
biologic agents in polyarticular JIA based on observational study data with all their weaknesses and demonstrates the need for well-controlled head-to-head studies for confirmation.