Session Information
Date: Tuesday, November 10, 2015
Session Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Adalimumab (ADA) has become a valuable option for treatment of juvenile idiopathic arthritis (JIA), which significantly improves the outcome of patients. The aim of the German BIKER registry is surveillance of biologics. The purpose of this interim analysis is to evaluate the efficacy and safety under practical conditions.
Methods: Treatment with ADA was followed prospectively by documentation of pts’ characteristics, pervious/concomitant therapy, disease activity parameters and adverse events. The efficacy was assessed by PedACR criteria and JADAS10. A control cohort not treated with biologics was established in parallel.
Results: 568 JIA pts (67.2% fem.) started ADA. The mean/median age at baseline was 12.6/13.3, disease duration 5.8/4.9 years. The RF-Polyarthritis was the most frequent JIA category (200pts), followed by extended Oligo (143), ERA (74), persistent Oligo (47), RF+Poly (45), PsA (35), systemic JIA (15), and unclass. JIA (9). Pretreatments were performed with steroids 59.3%, methotrexate 91%, sulfasalazine 12.1%, azathioprine 9.9%, leflonomide (7.2%), antimalarials 5.6%, and other DMARDs (n=47) as well as 347 therapies with other biologicals (313 with Etanercept). The initial concomitant treatment was carried out using NSAIDs 57.7%, steroids 31.3%, methotrexate 59.0% and other DMARDs (n=69). A JIAACR30/50/70/90 response was reached by 69%/66%/51%/35% after 12 months. A JADAS remission (JADAS10≤1) at month 3/6/12/18/24 was reached by 29%/34%/29%/37%</36% and a JADAS-MDA by 53%/59%/54%/56%/59%. Response rates according to the JIA categories are given in table 1.
416 adverse events were reported (57.2/100 PY), 32 (4.4/100 PY) were serious. Infections were the most frequent AE (n=133), 6 were SAE. Opportunistic infections including TB did not occur. 142 patients had had a history of uveitis before baseline. There were 30 uveitis flares. A single patient had a first uveitis upon ADA. Rates of adverse events of special interest are shown in table 2. In 168 patients (29.6%) the therapy was discontinued. Reasons reported were (several same time) remission 39 (6.9%), inefficacy 99 (17.4%), patient request 77 (13.6%), intolerance 34 (5.9%) and 21 (3.7%) other. No patients died.
Conclusion: JIA patients achieved high ACR response rates upon treatment with ADA, a JADAS-MDA was frequently reached as well. A JADAS remission was achieved only in part. Overall tolerability was good. Only a small portion discontinues therapy because of intolerance or side effects.
Table 1: JADAS10 at baseline and treatment response at month 12
|
|
sJIA |
RF-PA |
RF+PA |
Pers.OA |
Ext.OA |
ERA |
PsA |
|
JADAS baseline Mean/Median |
8.2/5.0 |
12.7/12.8 |
15.4/14.6 |
6.7/4.4 |
10.4/10.4 |
10.4/9.7 |
10.9/9.4 |
|
JADAS M12 (Mean/Median) |
2.1/0.4 |
5.1/2.9 |
7.8/6.5 |
2.7/1.9 |
5.6/3.0 |
3.8/2.5 |
5.4/4.4 |
|
JADAS MDA M12 |
80% |
57.1% |
10% |
72.2% |
54.5% |
59.3% |
40% |
|
JADAS Remission M12 |
60% |
32.4% |
10% |
38.9% |
30.9% |
33.3% |
10% |
|
JIA-ACR 30 M12 |
100% |
69.3% |
75.0% |
45.5% |
73.8% |
64.5% |
81.8% |
|
JIA-ACR 50 M12 |
100% |
65.9% |
75.0% |
45.5% |
66.2% |
61.3% |
81.8% |
|
JIA-ACR 70 M12 |
80% |
54.5% |
58.3% |
18.2% |
50.8% |
51.6% |
72.7% |
|
JIA-ACR 90 M12 |
60% |
37.5% |
25.0% |
13.6% |
29.2% |
51.6% |
36.4% |
Table 2: Incidence of adverse events of special interest
|
ADA (723 PY) |
MTX (3099 PY) |
RR (95%CI) |
P (Wald-test) |
|
|
SAE, n/rate/100PY |
32/4.43 |
47/1.52 |
2.92(1.86-4.57) |
<0.0001 |
|
SAE-Infection; n/rate/100PY |
18/2.49 |
10/0.32 |
7.72(3.56-16.7) |
<0.0001 |
|
Herpes zoster; n/rate/100PY |
3/0.41 |
6/0.19 |
2.14(0.54-8.57) |
0.28 |
|
Uveitis; n/rate/100PY |
30/4.15 |
49/1.58 |
2.62(1.67-4.13) |
<0.0001 |
|
Psoriasis; n/rate/100PY |
6/0.83 |
0/0.0 |
¥ |
<0.0001 |
|
Malignancy; n/rate/100PY |
2/0.28 |
3/0.10 |
2.86(0.48-17.1) |
0.25 |
To cite this abstract in AMA style:
Horneff G, Ganser G, Foeldvari I, Haas JP, Hospach T, Trauzeddel R, Weller-Heinemann F, Kuemmerle-Deschner JB, Thon A. Experience with Adalimumab for Treatment of 568 Juvenile Idiopathic Arthritis Patients in the German JIA Biologics Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/experience-with-adalimumab-for-treatment-of-568-juvenile-idiopathic-arthritis-patients-in-the-german-jia-biologics-register/. Accessed January 19, 2021.« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/experience-with-adalimumab-for-treatment-of-568-juvenile-idiopathic-arthritis-patients-in-the-german-jia-biologics-register/