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Safe Psoriasis Control: A New Outcome Measure for the Composite Assessment of the Efficacy and Safety of Psoriasis Treatment

  • Published:
Journal of Cutaneous Medicine and Surgery

Abstract

Background

PASI is an inadequate outcome measure for the assessment of psoriasis treatments. No currently used endpoints provide a benefit: risk assessment of treatment taking into consideration all available efficacy and safety data.

Objective

To propose a new outcome measure called “safe psoriasis control” (SPC), which assesses multiple dimensions of the disease in a clinically meaningful way through the combined use of appropriate efficacy, quality of life, and safety data.

Methods

Data from 3,500 subjects were used for the purpose of derivation and validation of the SPC endpoint. Advanced statistical methodology was used to evaluate and validate important components in the assessment of therapeutic benefit.

Results

SPC was shown to be a simple but meaningful combined endpoint showing the proportion of patients who had treatment benefit without major side effects.

Conclusion

The SPC endpoint may be a step-forward in providing a composite tool for the evaluation of treatments for psoriasis.

Sommaire

Antécédents

Le PASI est un élément de mesure inadéquat pour l’évaluation des traitements du psoriasis. Aucun paramètre utilisé actuellement ne permet d’évaluer le ratio bénéfice/risque d’un traitement en tenant compte de toutes les données concernant l’efficacité et l’innocuité.

Objectif

Proposer une nouvelle mesure, appelée «Contrôle sécuritaire du psoriasis» (CSP), qui évalue plusieurs dimensions de la maladie, de façon significative du point de vue clinique, au moyen de données sur l’efficacité, la qualité de vie et l’innocuité.

Méthodes

Des données sur 3 500 sujets ont été utilisées pour fin de calcul et de validation des paramètres du CSP. Une méthodologie statistique avancée a servi à évaluer et à valider des composantes essentielles à l’évaluation de l’avantage thérapeutique.

Résultats

Le CSP s’est avéré une combinaison simple mais efficace de paramètres qui permet d’obtenir la proportion de patients ayant bénéficié du traitement sans avoir subi des effets secondaires importants.

Conclusion

Le CSP peut être un pas en avant vers la création d’un outil composite de l’évaluation des traitements du psoriasis.

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Author information

Authors and Affiliations

  1. Probity Medical Research, 135 Union Street East, Waterloo, Ontario, N2J 1C4, Canada

    Kim A. Papp

  2. Serono International S.A. 15bis, chemin des Mines Case postale 54, Geneva 20, CH-1211, Switzerland

    Eric Henninger

Authors
  1. Kim A. Papp
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  2. Eric Henninger
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Additional information

Conflicts of Interest:

Kim Papp has acted as a consultant to Serono

Eric Henninger is an employee of Serono

This material was presented as a poster during the EADV 2004 convention

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Papp, K.A., Henninger, E. Safe Psoriasis Control: A New Outcome Measure for the Composite Assessment of the Efficacy and Safety of Psoriasis Treatment. J Cutan Med Surg 9, 276–283 (2005). https://doi.org/10.1007/s10227-005-0121-4

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  • DOI: https://doi.org/10.1007/s10227-005-0121-4

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