Abstract
Many pivotal studies and post-marketing experiences have confirmed the safety and efficacy of biologics in treating psoriasis. However, only limited data are available in Asia-Pacific region. Open label studies of efalizumab and alefacept have been conducted in Taiwan. A phase Ⅱ/Ⅲ randomized controlled study and an open label study of adalimumab have been conducted in Japan and Taiwan. As for infliximab, randomized, double-blind, placebo-controlled multicenter trials of psoriasis have been conducted in Japan and China. For etanercept, retrospective studies have been reported in South Korea and Taiwan in addition to two clinical studies (PRESTA and PRISTINE) which both involved Taiwanese and Korean patients. Three phase 3 randomized placebo-controlled studies for ustekinumab have been conducted, PEARL (in Korea and Taiwan), Jpn-02 (in Japan) and LOTUS (in China). The safety profiles of the above biologics used among Asia-Pacific population were generally consistent with the results published in the pivotal studies except for high incidence of newly onset arthritis and anti-drug antibodies in the efalizumab studies. Besides, a higher incidence of anti-drug antibodies was also found after infliximab use. The therapeutic efficacy of the biologics showed a mixed result in Asia- Pacific region. This review article offers a detail summary on the already published data in Asia-Pacific region, of the six biologics indicated for treating psoriasis, namely alefacept, efalizumab, adalimumab, infliximab, etanercept, and ustekinumab. Currently, secukinumab is already under phase III studies (ERASURE and SCULPTURE) in Japan, Taiwan, and Vietnam. In addition, we have also provided a summary of the current status of individual government reimbursement of the biologics in Asia-Pacific region.
Keywords: Psoriasis, psoriatic arthritis, TNF blocker, alefacept, efalizumab, adalimumab, infliximab, etanercept, ustekinumab, secukinumab, Asian.
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