Session Information
Session Type: Late-Breaking Abstracts
Background/Purpose: Enthesitis related arthritis (ERA) is a Juvenile Idiopathic Arthritis category, clinically related to the syndrome of undifferentiated spondyloarthropathy in adults. This study is intended to generate first evidence from a placebo controlled study that treatment with etanercept is safe and effective in patients diagnosed with ERA-JIA, and to analyze stability of remission off medication.
Methods: This is a multi-center, open-labeled uncontrolled study of 24 weeks, followed by randomized, double-blind, placebo-controlled, withdrawal, parallel group treatment phase of further 24 weeks. In phase 1, patients with ERA-JIA were treated with etanercept (ETA) for 24 weeks. Patients who demonstrated at least a PedACR30 response in phase 2 will be randomised to two groups. Group 1 will continue treatment with ETA for a maximum of further 24 weeks. Group 2 will receive placebo (PLC) and will be followed up to observe the duration of a remission without therapy. The study phase 2 is terminated in case of a disease flare or at week 48, whichever occurs earlier.
Results: 44 patients (71% male) were screened and 41 were admitted to the trial to receive ETA (0.8mg/Kg up to a max of 50 mg sc per week) for 24 weeks. Two patients discontinues prematurely, one due to intolerance, the other due to protocol deviation. At week 24, marked reduction of the JADAS10 was achieved from 17.4+/-6.2 to 1.9+/-2.9 (p<0,001). A total of 59% of patients reached JADAS-Remission and 60% reached JADAS-Minimal-Disease-Activity. 38/39 (97%) patients demonstrated at least a PedACR30 response and were randomised. In phase 2, 10 flares occurred, 4 at week 28 (2 ETA, 2 PLC) and 4 at week 32 (all PLC) and 2 at week 48 (all PLC). 28 patients reached week 48 without a flare, 18 patients on ETA (90%) compared to 10 patients on PLC (56%). Thus, significantly more patients set on PLC after week 24 flared compared to those who continued treatment with ETA (Odd‘s ratio for flare PLC vs. ETA 7.2 [1.3 - 40.7], p= 0,016 (c2-Test). At week 48, JADAS 10 had decreased to a mean of 3.4 (median 0) in patients continuously treated with ETA (n=20). 12 (60%) had reached JADAS-MDA and 11 (55%) had JADAS remission.
166 adverse events occurred in 39 patients. 3 meet the criteria for serious adverse events, one bone fracture, one psotraumatic renal hemorrhage and one upper respiratory tract infection. All were considered unrelated and resolved without sequelae.
Conclusion: In this first placebo-controlled randomized study on ERA-JIA patients, ETA proved to be highly effective with a high rate of patients reaching JADAS remission after 24 weeks of treatment. Patients who continued treatment with ETA had significantly less ACR 30 flares than those who received PLC. However, about half of patents set on PLC did not experience a flare in between 24 weeks of the study. Based on this a despite continuous treatment, treatment pause may be also discussed in patients with ERA-JIA
Disclosure:
I. Foeldvari,
Novartis Pharma AG, Abbott, Chugai, Genzyme,
5;
G. Horneff,
AbbVie, Pfizer, and Roche ,
2,
AbbVie, Novartis, Pfizer, and Roche,
8;
K. Minden,
None;
R. Trauzeddel,
None;
J. B. Kuemmerle-Deschner,
Novartis Pharmaceutical Corporation,
2,
SOBI,
8;
K. Tenbrock,
None;
G. Ganser,
Pfizer Inc,
9,
Abbvie,
9;
H. I. Huppertz,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/remission-induction-by-etanercept-in-enthesitis-related-arthritis-jia-patients-juvenile-undifferentiated-spondylarthropathy/