A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials

Steeb T, Wessely A, Harla M, Heppt F, Koch E, Leiter U, Garbe C, Schöffski O, Berking C, Heppt M (2020)

Publication Type: Journal article, Review article

Publication year: 2020

Journal

Journal of Clinical Medicine MDPI

Book Volume: 9

Pages Range: 2253

Journal Issue: 7

DOI: 10.3390/jcm9072253

Abstract

Multiple interventions are available for the treatment of actinic keratosis (AK) showing high efficacy in pivotal trials. However, data from post-marketing surveillance studies have received little attention until now. Here, we systematically investigate interventions for AK from post-marketing surveillance trials as a proxy for real-world efficacy and tolerability. A systematic literature search was conducted in Medline, Embase, and CENTRAL. Pertinent trial registers were hand-searched until 25 March 2020. Results were pooled using a random-effects model to calculate pooled proportions and relative risks (RR) or were described qualitatively. Eleven records with a total sample size ofn= 4109 were included. Three of the studies had an active-controlled design, while seven were single-armed. Participant complete clearance ranged from 23.1% for diclofenac sodium 3% gel to 88.9% for ingenol mebutate 0.05% gel. The lesion-specific clearance rate for photodynamic therapy (PDT) was 74% (95% confidence interval (CI) 56-87%). The recurrence rate was significantly higher for diclofenac sodium 3% in comparison to imiquimod 5% cream (RR 1.10, 95% CI 1.02-1.1.8) and ranged from 10.6% for ingenol mebutate 0.015% gel to 23.5% for PDT. Few patients discontinued the trials due to adverse events. The results from the majority of the post-marketing surveillance studies deviated from those of pivotal trials.

Authors with CRIS profile

Franz Heppt Department of Dermatology Elias Koch Department of Dermatology Oliver Schöffski Lehrstuhl für Betriebswirtschaftslehre, insbesondere Gesundheitsmanagement Carola Berking Lehrstuhl für Haut- und Geschlechtskrankheiten Markus Heppt Department of Dermatology

Involved external institutions

Maastricht University NL Netherlands (NL) Eberhard Karls Universität Tübingen DE Germany (DE)

How to cite

APA:

Steeb, T., Wessely, A., Harla, M., Heppt, F., Koch, E., Leiter, U.,... Heppt, M. (2020). A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials. Journal of Clinical Medicine, 9(7), 2253. https://dx.doi.org/10.3390/jcm9072253

MLA:

Steeb, Theresa, et al. "A Systematic Review and Meta-Analysis of Interventions for Actinic Keratosis from Post-Marketing Surveillance Trials." Journal of Clinical Medicine 9.7 (2020): 2253.

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