Session Information
Date: Sunday, November 13, 2016
Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects I: Juvenile Arthritis
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Treatment response, remission rates and compliance in polyarticular JIA patients treated with adalimumab(ADA), etanercept(ETA), or tocilizumab(TCZ) were analyzed in clinical practice.
Methods: Data from the German BIKER registry were analyzed in all patients with polyarticular JIA who started treatment with ETA, ADA or TCZ from 2011-2015. Baseline patient characteristics, treatment response, safety and drug survival were compared.
Results: : In total 236 patients started ADA, 419 ETA and 74 TCZ, with several differences in baseline patient characteristics (table 1). The baseline JADAS10 scores (mean +/-SD) in the ADA/ETA/TCZ cohorts were 12.1+/-7.6, 13.8+/-7.1 and 15.1+/-7.4, respectively (ADA vs ETA p<0.004), and the CHAQ-disability index scores were 0.43 +/-0.58, 0.59 +/- 0.6 and 0.63+/-0.55 (ADA vs ETA p<0.001). Uveitis history was more frequent in the ADA cohort (OR 5.73; p<0.0001). PedACR30/50/70/90 criterion improvement after 3 months of treatment was achieved by 69%/60%/42%/24% in the ETA cohort, 68%/61%/44%/27% in the ADA cohort and 61%/51%/33%/ 25% in the TCZ cohort. At 12 months, JADAS minimal disease activity was achieved in 57.2%/68.6%/60.5% and JADAS remission in 30.3%/44.4%/21.1% patients in the ADA/ETA/TCZ cohorts, respectively. ETA was used as a first biologic for 374 patients, ADA for 122 patients and TCZ for 13 patients. There were no important differences in efficacy between first and second-line use of the biologics. A total of 60.4%/49.4%/31.1% patients discontinued ADA/ETA/TCZ, respectively (OR for ADA 1.73; p= 0.006; OR for TCZ 0.46; p=0.004). The drug survival rates did not differ significantly for patients on biologic monotherapy compared with combination therapy with methotrexate. Over 4 years of observation in the ETA/ADA/TCZ cohorts 996/386/103 adverse events, and 148/119/26 serious adverse events, were reported.
Conclusion: In clinical practice, ETA is most frequently used as first-line biologic. ADA/ETA/TCZ showed comparable efficacies toward polyarticular JIA. Remission was achieved more frequently with ETA and TOC than with ADA. Overall, tolerance was acceptable. Interestingly, compliance was highest with TCZ and lowest with ADA. Because the patient cohorts differed at baseline, these results are preliminary and demonstrate the need for well-controlled head-to-head studies for confirmation. Table 1 Patient characteristics and response
Etanercept cohort N=419 |
Adalimumab cohort N=236 |
Statistical comparison# |
Tocilizumab cohort N=74 |
Statistical comparison# |
|
Female, n (%) |
332 (79.2%) |
192 (81.4%) |
OR=1.1 (0.7-1.5); p=0.78 |
51 (68.8%) |
OR=0.6 (0.4-0.9); p=0.027 |
Age at baseline,
mean+/- SD |
10.49+/-4.36 |
11.8 +/-4.0 |
p<0.0001 |
13.9+/-3.6 |
p<0.0001 |
|
|
||||
JIA Category, n (%)
RF+PA |
37 (8.8%) |
23 (9.7%) |
n.s. |
9 (12.2%) |
n.s. |
RF-PA |
224 (53.5%) |
128 (54.2%) |
n.s. |
47 (63.5%) |
n.s. |
ExOA |
158 (37.7%) |
85 (36.0%) |
n.s. |
18 (24.3%) |
OR=0.58 (0.4-0.99); p=0.03 |
Uveitis before start of biologic, n (%) |
23 (5.5%) |
59 (25%) |
OR=5.73 (3.4-6.0); p=0.0001 |
0 |
n.a. |
Use as first biologic, n (%) |
400 (95.5%) |
122 (51.7%) |
OR=0.08 (0.05-0.1); p<0.0001 |
15 (20.3%) |
OR=0.02 (0.01-0.03); p<0.0001 |
Co-Med MTX, n (%) |
309 (73.7) |
127 (53.8) |
OR=0.5 (0.4-0.7); p<0.0001 |
34 (45.9) |
OR=0.4 (0.3-0.7); p=0.0004 |
JADAS10 [0-40], mean +/-SD |
13.8+/-7.1 |
12.1+/-7.6 |
p= 0.004 |
15.1+/-7.4 |
n.s |
Median (IQR) |
13.6 (8.8-19.0) |
11.7 (6.1-17.5) |
|
14.8 (9.2-19.8) |
|
JADAS10 MDA at month 12 (ITT-population), n (%) |
68.6% |
57.2% |
OR=0.61 (0.4-0.95); p=0.03 |
60.5% |
n.s. |
|
|
|
|
|
|
JADAS10 remission at month 12 (ITT-population), n (%) |
44.4% |
30.3% |
OR=0.55 (0.35-0.85) p=0.007 |
21.1% |
OR=0.33 (0.15-0.76) p=0.007 |
# Compared with the ETA cohort, n.a. not applicable, n.s. not significant. Table 2: Rates and reasons for discontinuation
Reason for discontinuation |
Etanercept N=419 |
Adalimumab N=236 | Odds ratio # (95% CI); p | Tocilizumab N=74 | Odds ratio # �(95% CI); p |
Discontinuations N (%) |
207 (49.4) |
142 (60.4) | 1.55 (1.12-2.14); 0.008 | 23 (31.1) | 0.46 (0.27-0.78); 0.004 |
Inefficacy N (%) |
50 (11.9) |
52 (22.0) | 2.03 (1.32-3.11); <0.001 | 9 (12.2) | 1.01 (0.47-2.15); n.s. |
Remission N (%) |
54 (12.9) |
22 (9.3) | 0.69 (0.41-1.17); n.s. | 2 (2.7) | 0.19 (0.05-0.79); 0.01 |
Intolerance N (%) |
15 (3.6) |
15 (6.4) | 1.83 (0.88-3.81); n.s. | 2 (2.7) | 0.75 (0.17.3.34); n.s. |
Others* N (%) |
88 (16.0) |
53 (22.4) | n.a. | 10 (13.4) | n.a. |
* Others included patient/parent decision, # Compared with the ETA cohort n.a. not applicable; n.s. not significant
To cite this abstract in AMA style:
Horneff G, Klein A, Minden K, Huppertz HI, Weller-Heinemann F, Kuemmerle-Deschner JB, Haas JP, Hospach T. Comparison of Treatment Response, Remission Rate and Drug Adherence in Polyarticular Juvenile Idiopathic Arthritis Patients Treated with Etanercept, Adalimumab or Tocilizumab [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/comparison-of-treatment-response-remission-rate-and-drug-adherence-in-polyarticular-juvenile-idiopathic-arthritis-patients-treated-with-etanercept-adalimumab-or-tocilizumab/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-treatment-response-remission-rate-and-drug-adherence-in-polyarticular-juvenile-idiopathic-arthritis-patients-treated-with-etanercept-adalimumab-or-tocilizumab/