Reformulations of well-known active ingredients in the topical treatment of psoriasis vulgaris can improve clinical outcomes for patients

L. Iversen*, E. Dauden, S. Segaert, K. Freeman, S. Magina, D. Rigopoulos, D. Thaci

*Corresponding author for this work
9 Citations (Scopus)

Abstract

Although the majority of patients with psoriasis vulgaris are treated exclusively with topical therapies, research to develop more effective topical therapies that are associated with higher patient satisfaction has lagged behind the development of systemic agents. The aim of this literature review was to determine whether there is documented evidence that applying an innovative approach to improving the formulation of active ingredients commonly used in the topical treatment of psoriasis can have a positive effect on clinical outcomes and patient-reported outcomes (PROs). The Embase and PubMed databases were searched for articles published between 2001 and 2016 that made direct head-to-head comparisons of different formulations of an active pharmaceutical ingredient (API), focusing on clinical outcomes and PROs. In total, 22 publications on APIs or API combinations met the eligibility criteria (19 head-to-head clinical trials, one pooled analysis, one health-economic modelling study and one systematic review). Significant clinical benefit associated with the use of a reformulated API over an older formulation was reported in three trials of clobetasol propionate, one trial of calcipotriol, three trials of betamethasone and five trials/pooled analyses of calcipotriol/calcipotriene + betamethasone dipropionate (Cal/BD) formulations. Significantly improved PROs associated with the use of a reformulated API over an older formulation were reported in three trials of clobetasol propionate, one trial of betamethasone valerate and two trials of Cal/BD formulations. These results demonstrate that the innovative reformulation of APIs used in the treatment of psoriasis can produce therapies that attain significantly improved clinical outcomes and PROs. This suggests that improvement in topical therapy for psoriasis need not only to be achieved by the identification of new targets and the development of new APIs, but that improvement in the vehicle used to deliver existing APIs has the potential to result in significant clinical and patient benefits.

Original languageEnglish
JournalJournal of the European Academy of Dermatology and Venereology
Volume31
Issue number8
Pages (from-to)1271-1284
Number of pages14
ISSN0926-9959
DOIs
Publication statusPublished - 08.2017

Funding

L. Iversen has been a paid speaker, consultant, expert/advisory board member, investigator and/or received research and educational grants from MSD, Pfizer, AbbVie, Almirall, Amgen, Janssen-Cilag, Eli Lilly, Novartis and/or LEO Pharma. E. Dauden has been a board member, consultant, received grants and research support, participated in clinical trials and/or received honorarium for speaking and research support from AbbVie, Amgen, Galderma, GSK, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, MSD, Celgene and/or Lilly. S. Segaert has served as a paid advisory board member, consultant or speaker for AbbVie, Amgen, Celgene, Galederma, Janssen-Cilag, LEO Pharma, Eli Lilly, MSD, Novartis, Pierre Fabre and/or Pfizer. K. Freeman has received honoraria for participating in advisory boards and for delivering lectures and been reimbursed for attendance at international conferences by LEO Pharma. S. Magina has been a paid speaker, consultant, expert/advisory board member and/or investigator for MSD, Pfizer, AbbVie, Amgen, Janssen-Cilag, Eli Lilly, Novartis and/or LEO Pharma. D. Rigopoulos has been an advisory board member, consultant, received grants, participated in clinical trials and received honorarium for lectures from AbbVie, Amgen, Galderma, GSK, Janssen-Cilag, LEO Pharma, Novartis and Pfizer. D. Thaci has served as a consultant, advisory board member and/or received honoraria for lecturing for AbbVie, Amgen, Almirall, Biogen, Celgene, Dignity, Eli Lilly, Galapagos, GSK, Janssen-Cilag, LEO Pharma, Maruho, Mitsubishi, MSD, Novartis, Pfizer, Regeneron, Sanofi, UCB and XenoPort. This study was sponsored by LEO Pharma. Medical writing and editorial support was provided by Patrick Crowley, PhD, on behalf of Excerpta Medica B.V, funded by LEO Pharma.

Research Areas and Centers

  • Academic Focus: Center for Infection and Inflammation Research (ZIEL)

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