Title:An Update of the Published Reports on Biologics Use for Psoriasis and the Reimbursement Status in Asia-Pacific Region
Volume: 8
Issue: 3
Author(s): Tsen-Fang Tsai and Ting-Yu Yeh
Affiliation:
Keywords:
Psoriasis, psoriatic arthritis, TNF blocker, alefacept, efalizumab, adalimumab, infliximab, etanercept, ustekinumab, secukinumab, Asian.
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.
