Hoefnagel J J, Thio H B, Willemze R, Bouwes Bavinck J N
Department of Dermatology, B1-Q, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.
Br J Dermatol. 2003 Aug;149(2):363-9. doi: 10.1046/j.1365-2133.2003.05433.x.
Therapy with fumaric acid esters (FAE) has been shown to be safe and effective in patients with severe psoriasis in several clinical studies with limited follow-up periods. In view of the chronic character of psoriasis, long-term safety aspects are of major importance in determining the suitability of a drug during prolonged periods of treatment.
To investigate adverse events of therapy with systemic FAE with follow-up periods of up to 14 years, in order to determine safety aspects of their long-term use in patients with severe psoriasis.
Current and/or past therapeutic use of FAE was reviewed in 66 patients with severe psoriasis.
Forty-one of 66 patients had received FAE for at least 1 year, and 12 of these 41 patients had received FAE for between 10 and 14 years. Adverse events were reported in 73% of the patients. These were usually mild and mainly consisting of flushing (55%), diarrhoea (42%), nausea (14%), tiredness (14%) and stomach complaints (12%). A relative lymphocytopenia was observed in 76% of patients during therapy with FAE, resulting in a permanent discontinuation of therapy with FAE in four patients. A transient eosinophilia and moderate liver enzyme elevations were observed in 14% and 25% of patients, respectively.
The present study indicates that FAE can be considered as a safe long-term treatment in patients with severe psoriasis.
在几项随访期有限的临床研究中，已证明富马酸酯（FAE）治疗对重度银屑病患者安全有效。鉴于银屑病的慢性特征，在长期治疗期间确定药物适用性时，长期安全性至关重要。
调查系统性FAE治疗长达14年的不良事件，以确定其在重度银屑病患者中长期使用的安全性。
对66例重度银屑病患者目前和/或过去使用FAE的治疗情况进行了回顾。
66例患者中有41例接受FAE治疗至少1年，这41例患者中有12例接受FAE治疗10至14年。73%的患者报告了不良事件。这些事件通常较轻，主要包括潮红（55%）、腹泻（42%）、恶心（14%）、疲劳（14%）和胃部不适（12%）。76%的患者在接受FAE治疗期间出现相对淋巴细胞减少，导致4例患者永久停用FAE治疗。分别有14%和25%的患者出现短暂嗜酸性粒细胞增多和中度肝酶升高。
本研究表明，FAE可被视为重度银屑病患者的一种安全的长期治疗方法。
