Guidance on the use of canakinumab in patients with cryopyrin-associated periodic syndrome in Japan

Abstract Cryopyrin-associated periodic syndrome (CAPS) is an orphan disease with incidence of about one in 1,000,000 persons. This autoinflammatory disease develops in the neonatal period or early childhood, with various inflammatory symptoms occurring repeatedly throughout the patient's lifeti...

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Bibliographic Details
Published in:Modern rheumatology 2013-05, Vol.23 (3), p.425-429
Main Authors: Yokota, Shumpei, Nishikomori, Ryuta, Takada, Hidetoshi, Kikuchi, Masako, Nozawa, Tomo, Kanetaka, Taichi, Kizawa, Toshitaka, Miyamae, Takako, Mori, Masaaki, Heike, Toshio, Hara, Toshiro, Imagawa, Tomoyuki
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal - therapeutic use
Canakinumab
Child development
Cryopyrin-associated periodic syndrome
Cryopyrin-Associated Periodic Syndromes - drug therapy
Genetic disorders
Human anti-human IL-1β monoclonal antibody
Humans
Immunologic Factors - therapeutic use
Inflammatory diseases
Interleukin-1beta - antagonists & inhibitors
Interleukin-1β
Japan
Monoclonal antibodies
Patients
Proteins
Signal transduction
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Summary:Abstract Cryopyrin-associated periodic syndrome (CAPS) is an orphan disease with incidence of about one in 1,000,000 persons. This autoinflammatory disease develops in the neonatal period or early childhood, with various inflammatory symptoms occurring repeatedly throughout the patient's lifetime. It is caused by abnormality of the NLRP3 protein which mediates the intracellular signal transduction mechanism of inflammatory processes, resulting in continuous overproduction of interleukin (IL)-1β, which induces chronic inflammation and progressive tissue damage. Definitive diagnosis of CAPS is difficult, and treatment has also been difficult because of a lack of effective medications in Japan. Clinical studies of human anti-human IL-1β monoclonal antibody (canakinumab) treatment were conducted in Japan, and approval was granted for therapeutic use of canakinumab for CAPS in September 2011. Similar to other biological drugs, canakinumab is clinically highly effective. However, sufficient attention to the method of use and adverse drug reactions is necessary. This guidance describes the use of canakinumab in Japan for CAPS in relation to exclusion criteria, method of use, evaluation criteria, and adverse drug reactions.
ISSN:1439-7595
1439-7609
DOI:10.3109/s10165-012-0769-8