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

Journal of Clinical Medicine

Ulrike Leiter¹  Claus Garbe¹  Franz Heppt²  MarkusV. Heppt²  EliasA. T. Koch²  Carola Berking²  Anja Wessely²  Theresa Steeb²  Matthias Harlaß³  Oliver Schöffski⁴ 

[1] Department of Dermatology, Eberhard Karls University of Tübingen, 72076 Tübingen, Germany;Department of Dermatology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), 91054 Erlangen, Germany;Faculty of Health, Medicine and Life Sciences, Maastricht University, 6211 LK Maastricht, The Netherlands;School of Business, Economics and Society, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), 90403 Nürnberg, Germany;

关键词: actinic keratosis;    phase IV trial;    post-marketing surveillance trial;    real-world evidence;    long-term results;    diclofenac;   

DOI  :  10.3390/jcm9072253

来源: DOAJ

【 摘 要 】

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 of n = 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.

【 授权许可】

Unknown