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IL-6 blockade in systemic juvenile idiopathic arthritis – achievement of inactive disease and remission (data from the German AID-registry).

IL-6 blockade in systemic juvenile idiopathic arthritis – achievement of inactive disease and remission (data from the German AID-registry).
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Bielak M, Husmann E, Weyandt N, Haas JP, Hügle B, Horneff G, Neudorf U, Lutz T, Lilienthal E, Kallinich T, Tenbrock K, Berendes R, Niehues T, Wittkowski H, Weißbarth-Riedel E, Heubner G, Oommen P, Klotsche J, Foell D, Lainka E,


Bielak M, Husmann E, Weyandt N, Haas JP, Hügle B, Horneff G, Neudorf U, Lutz T, Lilienthal E, Kallinich T, Tenbrock K, Berendes R, Niehues T, Wittkowski H, Weißbarth-Riedel E, Heubner G, Oommen P, Klotsche J, Foell D, Lainka E, (click to view)

Bielak M, Husmann E, Weyandt N, Haas JP, Hügle B, Horneff G, Neudorf U, Lutz T, Lilienthal E, Kallinich T, Tenbrock K, Berendes R, Niehues T, Wittkowski H, Weißbarth-Riedel E, Heubner G, Oommen P, Klotsche J, Foell D, Lainka E,

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Pediatric rheumatology online journal 2018 04 0516(1) 22 doi 10.1186/s12969-018-0236-y

Abstract
BACKGROUND
Systemic juvenile idiopathic arthritis (sJIA) is a complex disease with an autoinflammatory component of unknown etiology related to the innate immune system. A major role in the pathogenesis has been ascribed to proinflammatory cytokines like interleukin-6 (IL-6), and effective drugs inhibiting their signaling are being developed. This study evaluates sJIA patients treated with the IL-6 inhibitor tocilizumab (TCZ) concerning clinical response rate, disease course and adverse effects in a real-life clinical setting.

METHODS
In 2009 a clinical and research consortium was established, including an online registry for autoinflammatory diseases (AID) ( https://aid-register.de ). Data for this retrospective TCZ study were documented by 13 centers.

RESULTS
From 7/2009 to 4/2014, 200 patients with sJIA were recorded in the AID-registry. Out of these, 46 (19 m, 27 f, age 1-18 years) received therapy with TCZ. Long term treatment (median 23 months) has been documented in 24/46 patients who were evaluated according to Wallace criteria (active disease 6/24, inactive disease 5/24, remission 13/24 cases). Under observation co-medication were used in 40/46 cases. Adverse events were reported in 11/46 patients. The clinical response rate (no clinical manifestation, no increased inflammation parameters) within the first 12 weeks of treatment was calculated to be 35%.

CONCLUSION
Out of 200 sJIA children reported in the German AID-registry, 46 were treated with TCZ, showing a clinical response rate of 35% during the first 12 weeks, and inactive disease and/or remission under medication in 75% after one year. Adverse events were seen in 24% and severe adverse events in 4%.

TRIAL REGISTRATION
The AID-Registry is funded by the BMBF (01GM08104, 01GM1112D, 01GM1512D).

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