ISA247: quality of life results from a phase II, randomized, placebo-controlled study

J Cutan Med Surg. 2008 Nov-Dec;12(6):268-75. doi: 10.2310/7750.2008.07060.

Abstract

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 = 77) or 1.5 mg/kg/d (n = 83) compared with placebo (n = 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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Cyclosporine / administration & dosage
  • Cyclosporine / therapeutic use*
  • Dermatologic Agents / therapeutic use*
  • Disability Evaluation
  • Female
  • Humans
  • Leisure Activities
  • Male
  • Middle Aged
  • Psoriasis / drug therapy*
  • Psoriasis / psychology*
  • Quality of Life* / psychology
  • Surveys and Questionnaires

Substances

  • Dermatologic Agents
  • voclosporin
  • Cyclosporine