期刊
ANNALS OF THE RHEUMATIC DISEASES
卷 72, 期 10, 页码 1634-1638出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/annrheumdis-2012-202192
关键词
Cytokines; Disease Activity; Fever Syndromes; Inflammation
类别
资金
- Radboud University Nijmegen Medical Centre
- VIDI grant of The Netherlands Organisation for Scientific Research
- Novartis
Objectives Schnitzler's syndrome is a chronic disabling autoinflammatory disorder, characterised by chronic urticaria, paraproteinemia and systemic inflammation. The interleukin (IL) 1 receptor antagonist anakinra is a very effective treatment, but requires daily injection and blocks both IL-1 and IL-1. Canakinumab is a selective human monoclonal anti-IL-1 antibody with a long half-life. We investigated the long-term efficacy and safety of canakinumab in Schnitzler's syndrome. Methods In an open-label, single-treatment arm trial, eight patients with Schnitzler's syndrome received monthly injections with 150mg canakinumab subcutaneously for 6months, followed by a 3-month observation period. Primary outcome was complete or clinical remission at day 14. Secondary outcome measures included inflammatory markers, quality of life, time to relapse, safety and tolerability. Results After stopping anakinra, patients developed moderate to severe clinical symptoms. Canakinumab induced complete or clinical remission at day 14 in all eight patients. Median C-reactive protein concentrations decreased from 169mg/l at baseline to less than 10mg/l on day 14 and remained low or undetectable. One patient discontinued participation on day 39 because of return of symptoms while all others remained in complete or clinical remission during the 6-month treatment period. Relapse after last canakinumab dose occurred within 3months in four patients. For two patients, remission continued several months post-study. Five patients reported at least one adverse event, predominantly mild upper respiratory tract infections. One patient died in a traffic accident. Conclusions In this 9-month study, monthly 150mg canakinumab injection was an effective and well-tolerated treatment for Schnitzler's syndrome. Our data demonstrate that IL-1 plays a pivotal role in this disease. ClinicalTrials.gov NCT01276522.
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