THU0311
WHAT HAPPENS WHEN ETANERCEPT IS DISCONTINUED IN “REMISSION” IN PATIENTS WITH JUVENILE IDIOPATHIC ARTHRITIS?
G. Horneff 1,*H. I. Hupppertz 2I. Foeldvari 3K. Minden 4
1Paediatrics, Asklepios Clinic, Sankt Augustin, 2private, Bremen, 3Hamburger Zentrum, Kinderrheumatologie, Hamburg, 4Epidemiology, Charite, Berlin, Germany
Background: Etanercept turned out to be highly effective in juvenile idiopathic arthritis. The aim of this study was to use the German Biker Registry data base to analyse the performance after discontinuation of Etanercept because of remission.
Methods: Requested reasons for discontinuation were inefficacy, intolerance, remission or other reasons. Judgement about decision for discontinuation or restart of treatment was not influenced by the registry. The course during follow up was analysed until restart of Etanercept treatment.
Results: 1499 patients (pts) recruited into the registry have been identified. 208 (13.9%) pts discontinued treatment with etanercept due to “remission” of their disease including patients of all JIA categories: enthesitis related arthritis 17/79 (17%), extended oligoarthritis 40/275 (14.5%), systemic JIA 18/130 (13.8%), RF - polyarthritis 62/472 (13.1%) but significantly less frequently patients with RF+ polyarthritis (9/154 (5.8%) ; p=0.003, c2-test). Data of 476 follow ups were available in 166 pts for a median of 17 months (0-110 months). 100 (46%) were followed for at least 12 months, 47(22%) for at least 24 months, 31 (14%) for at least 36 months. 71 (34%) Patients restarted treatment with Etanercept due to a relapse. Treatment was restarted in 5 pts in the first month, 18 in the first 3 months, 31 in the first 6 months and 47 in the first 12 months after discontinuation of Etanercept. Kaplan Meier analysis revealed a median Etanercept free survival time of 38.2 months. Etanercept free survival time is significantly influenced by the total treatment time with etanercept and ongoing treatment with methotrexate. Treatment with corticosteroids at the time of discontinuation of etanercept or disease duration before initiation of Etanercept were without significant input. At the time when Etanercept has been first discontinued due to “remission” 118 (62%) patients fulfilled the “Wallace” criteria for inactive disease. However, this had no effect on the median survival time until retreatment.
JIA category/treatment allocation |
Median drug free survival time |
p-value; |
hazard ratio |
|
All JIA patients, n=205 |
35 months |
|
|
|
Treatment without (n=123) vs. with methotrexate (n=82) |
16.6 vs. 61.4 months |
0.006 |
0.49 |
|
Treatment without (n=183) vs. with corticosteroids (n=22) |
28.4 months vs. ∞ |
0.085 |
0.51 |
|
Treatment time on ETA < 2 (n=95) vs. > 2 years (n=110) |
50.9 vs. 18.2 months |
0.068 |
0.62 |
|
Disease duration before ETA < 2 (n=75)vs. > 2 y (n=129) |
34 vs. 39.5 months |
Not significant |
1,51 |
|
Wallace criteria* fulfilled (n=118)vs. not fulfilled (n=72) |
35.3 vs. 28.5 months |
Not significant |
1,31 |
*Proposed criteria for inactive disease, Wallace CA, Ruperto N, Giannini EH. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol 2004; 31: 2290-4
Conclusions: Discontinuation of a successful treatment with Etanercept occurred frequently in JIA patients. Compared to the total cohort, patients with enthesitis related arthritis more frequently and patients with RF+ polyarthritis less frequently discontinued due to “remission”. The median drug free survival time was influenced positively by treatment with methotrexate and negatively by a longer period of time to reach “remission”. Further observation of these pts will demonstrate the total rate of permanently discontinuation of antirheumatic drugs.
Disclosure of Interest: G. Horneff Grant / Research support from: Pfizer, AbbottH. Hupppertz: None DeclaredI. Foeldvari: None DeclaredK. Minden: None Declared