Extracorporal photopheresis as an interventional therapy for the treatment of severe, refractory atopic dermatitis - Preliminary results

Financial Disclosure All authors hereby disclose any commercial associations which might pose or create a conflict of interest with information presented in this manuscript. Ethics This study is to be conducted in conformance with applicable local requirements regarding ethical and investigational committee review, informed consent, and other statutes or regulations regarding the protection of the rights and welfare of human subjects participating in medical research. Introduction: Atopic dermatitis (AD) is a complex disease with a variety of possible treatement regimen. The study objective was to demonstrate that methoxsalen (UVADEXI Sterile Solution formulation, Therakos Inc.,Exton, PA, USA) used in conjunction with the UVAR' XTSTM Photopheresis System (Therakos Inc.,Exton, PA, USA) is safe and can have a clinical effect on the skin manifestations of severe, refractory atopic dermatitis and on the patients quality of life. Methods: Single-arm, open-label treatment using UVARI XTSTM Photopheresis System. Treatment consisted of two photopheresis treatments on successive days every 2 weeks for a minimum of 12 weeks to a maximum of 20 weeks. Quality of Life assessment was performed with SF 36 Health Survey, the Functional Assessment of Chronic Illness Therapy FACT-G Survey. Clinical improvement was documented with SCORAD assessment. Results: SF36 Health Survey showed significant improvement in the emotional well-being subscores (p < 0.05). The functional well-being subscored showed no significant improvement (p > 0.05). Before therapy subjects had a mean total FACT-G score of 64.8 +/- 12.4 SD. After therapy the mean FACT-G score, significantly improved to 72.9 +/- 14.4 SD (p < 0.05). Conclusions: This is the first study showing that extracoporal photopheresis can have a significant effect on quality of life improvement among patients with severe atopic dermatitis who are refractory to conventional forms of therapy.