Background Since the approval of first biologics for JIA, such treatments in Germany are monitored prospectively by the BiKER registry.
Methods sJIA pts documented in BIKER exposed to Etanercept (ETA), Tocilizumab (TOC) or IL-1inhibitors were identified. A 6-month therapy period was chosen as a meaningful time for early efficacy judgement. Intention to treat analysis (ITT) of JADAS10 was performed. Discontinuation due to inefficacy/intolerance was calculated as non-response.
Results 205 sJIA patients (51% male) received 269 treatment courses with biologics (TOC 71, Anakina 36, Canakinumab 19, ETA 143). Median age and disease duration (ETA 3.3;TOC 3.3;IL-1i 3.0) were comparable. The choice of drug was influenced by the availability. ETA was started in 80% of pts before 2008 while in the TOC cohort all pts and in the IL-1i cohort 74% started therapy after 2008. Pre-treatment consisted of steroids in all pts, MTX in the ETA/TOC/IL-1i cohort in 88%/83%/76% and biologics preexposure was used in 2%/66%/86%. Concomitant treatment with systemic steroids was significantly less frequent with TOC (44%, p<0,001) and IL-1i (44%, p<0.001) compared to 83% with ETA. Concomitant MTX was used with ETA in 81% but significantly less frequent with TOC (64%; p=0.004) or IL-1i (44%; p<0.0001). Also other DMARDs were used less frequently with TOC (9%) and IL-1i (4%) compared to ETA (24%).
Systemic manifestations were present at baseline in: 8% ETA, 96% TOC and 38% IL-1i cohort. The mean±SD baseline JADAS was higher in the ETA cohort (20.7±9.1) than in the TOC cohort (16.2±10.6) or IL-1i cohort (7.8±8.9).
At month 6, a marked decrease of the JADAS was noted in all cohorts. ITT analysis revealed a significant advantage of TOC and Il-1i over ETA (table). Significantly more pts reached a JADAS-Remission (JADAS≤1) upon TOC (OR/95CI 3.85/1.68–8.83/p<0.001) or upon IL-1i (OR/95CI 4.55/1.92–10.77/p=0.003) than with ETA. Significantly more pts reached a JADAS-MDA (JADAS≤3.8) upon TOC (OR 3.55/1.49–8.46/p=0.003) or upon IL-1i (OR 4.5/1.87–10.84/p<0.0001) than with ETA. ETA was more often discontinued due to inefficacy before month 6 than TOC or IL-1i.
Conclusions A high proportion of pts showed a significant response to treatment especially with TOC or with IL-1i. After 6 months on treatment JADAS remission criteria were reached by up to 50% of patients while 60% to 65% reached JADAS minimal disease activity desoite much less steroids and DMARD used with TOC or IL-1i. ETA has been used in earlier times but it is less effective and it's use in sJIA has markedly decreased in Germany.
Disclosure of Interest None declared