title: Japanese guidance for use of biologics for psoriasis (the 2013 version).
abstract: The clinical use of adalimumab and infliximab, human anti-tumor necrosis factor (TNF)-α monoclonal antibodies, for psoriasis began in January 2010. In January 2011, ustekinumab, a human anti-interleukin-12/23p40 (IL-12/23p40) monoclonal antibody, was newly approved as the third biologic with an indication for psoriasis. While all of these biologics are expected to exhibit excellent therapeutic effect for psoriasis and to contribute to the improvement of quality of life in patients, these drugs require careful safety measures to prevent adverse drug reactions, such as serious infections. The new guidance, an English version prepared by revising the Japanese Guidance/Safety Manual for Use of Biologics for Psoriasis 2011 (in Japanese), is intended to provide up-to-date, evidence-based recommendations and safety measures on the use of biologics, and describes the optimal use of the three biologics, medical requirements for facilities for using biologics, details of safety measures against reactivation of tuberculosis and hepatitis B virus infection, and recommendable combination therapies with biologics.
authors.affiliation: Department of Dermatology, Jichi Medical University, Shimotsuke.
authors.forename: Mamitaro
authors.initials: M
authors.lastname: Ohtsuki
authors.forename: Tadashi
authors.initials: T
authors.lastname: Terui
authors.forename: Akira
authors.initials: A
authors.lastname: Ozawa
authors.forename: Akimichi
authors.initials: A
authors.lastname: Morita
authors.forename: Shigetoshi
authors.initials: S
authors.lastname: Sano
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Mayumi
authors.initials: M
authors.lastname: Komine
authors.forename: Takafumi
authors.initials: T
authors.lastname: Etoh
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Igarashi
authors.forename: Hideshi
authors.initials: H
authors.lastname: Torii
authors.forename: Akihiko
authors.initials: A
authors.lastname: Asahina
authors.forename: Osamu
authors.initials: O
authors.lastname: Nemoto
authors.forename: Hidemi
authors.initials: H
authors.lastname: Nakagawa
mesh_terms: D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000075202:Contraindications; D004359:Drug Therapy, Combination; D006801:Humans; D061214:Patient Safety; D018579:Patient Selection; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized
keywords: adalimumab; biologics; guidance; infliximab; psoriasis; ustekinumab