BASIC/CLINICAL SCIENCE ISA247: Quality of Life Results from a Phase II, Randomized, Placebo-Controlled Study Aditya K. Gupta, Richard G. Langley, Charles Lynde, Kirk Barber, Wayne Gulliver, Gilles Lauzon, Launa J. Aspeslet, Robert T. Foster, Robert B. Huizinga, and Randall W. Yatscoff Background: Psoriasis is a chronic skin condition that can negatively affect a patient’s quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. Objective: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. Methods: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d (n 5 77) or 1.5 mg/kg/d (n 5 83) compared with placebo (n 5 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. Results: ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo (p , .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group (p , .05). Conclusions: ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque- type psoriasis. Ante´ce´ dents: Affection cutane´ e chronique, le psoriasis peut avoir des effets ne´ gatifs sur la qualite´ de vie des patients, entravant souvent leur fonctionnement social. ISA247, un nouvel agent de lutte contre le psoriasis, a montre´ une efficacite´ clinique dans le traitement du psoriasis mode´re´a` se´ve` re. Son effet sur la qualite´ de vie n’a pas e´te´ rapporte´. Objectif: E ´ valuer l’effet de ISA247 sur la qualite´ de vie des patients souffrant de psoriasis en plaque stable. Me´ thodes: Les participants a` une e´ tude multicentrique de phase II, randomise´e, a` double insu contre placebo, avec groupes paralle` les, ont rec¸ u, pendant 12 semaines, des doses de ISA247 de 0,5 mg/kg/j (n 5 77) ou de 1,5 mg/kg/j (n 5 83) et ont e´te´ compare´s a` un groupe placebo (n 5 41). La qualite´ de vie a e´te´e´ value´ e au moyen de l’Indice dermatologique de qualite´ de vie (DLQI) et de l’Indice d’invalidite´ due au psoriasis (PDI). Re´ sultats: L’e´ tude a montre´ que le traitement au ISA247 (groupes mis en commun) a conside´ rablement augmente´ le score de la qualite´ de vie tel que re´ve´le´ par les deux e´ chelles, DLQI et PDI, par rapport au groupe recevant le placebo (p , ,05). Le groupe qui a rec¸ u la dose la plus forte du ISA247 a affiche´ de meilleurs re´sultats de qualite´ de vie que le groupe qui a rec¸u la dose la moins forte (p , ,05). Conclusions: ISA247 semble ame´ liorer la qualite´ de vie tout en constituant un traitement efficace contre le psoriasis en plaque chronique, mode´re´a` se´ve` re. S KIN DISORDERS are considered by many to be merely a cosmetic concern. However, many skin diseases not otherwise considered ‘‘serious’’ have in recent decades been recognized by physicians as having psychosocial impacts not previously appreciated. These impacts may reduce the quality of life (QoL) experienced by the patient and in some cases are related to clinically significant depression and From the Division of Dermatology, Department of Medicine, Sunnybrook and Women’s College Health Sciences Centre (Sunnybrook Site) and the University of Toronto, Toronto, ON; Mediprobe Research Inc., London, ON; Division of Dermatology, Department of Medicine, Dalhousie University, Halifax, NS; Lynderm Research Inc., Markham, ON; The Dermatology Centre, Calgary, AB; NewLab Clinical Research Inc., St. John’s, NF; University Dermatology Center, University of Alberta, Edmonton, AB; Isotechnika Inc., Edmonton, AB. Supported by a grant from Isotechnika. Drs. Gupta, Langley, Lynde, Barber, Gulliver, and Lauzon were principal investigators in this study. Drs. Langley, Lauzon, Lynde, and Gulliver have acted as a consultant for Isotechnika. Drs. Yatscoff and Foster are employees of and hold shares in Isotechnika and have applied for patents for ISA247. Dr. Aspeslet is an employee of and holds shares in Isotechnika. Mr. Huizinga is an employee of Isotechnika. Address reprint requests to: Aditya K. Gupta, MD, PhD, FRCPC, 645 Windermere Road, London, ON N5X 2P1; e-mail: agupta@ execulink.com. DOI 10.2310/7750.2008.07060 # 2008 Canadian Dermatology Association 268 Journal of Cutaneous Medicine and Surgery, Vol 12, No 6 (November/December), 2008: pp 268–275