Cost-Effectiveness of Ivermectin 1% Cream in Adults with Papulopustular Rosacea in the United States

Abstract

This study was sponsored by Galderma Laboratories. The sponsor was involved in the design of the model structure but not in the collection of the data used to populate the model. Manuscript preparation was also funded by Galderma. Taieb is an investigator and advisor for Galderma. Gold is an investigator for Galderma. Feldman is a consultant and speaker for Galderma and has received grants from Galderma. Dansk and Bertranou received a research grant from Galderma to conduct this study. Dansk and Bertranou contributed to the design of the model structure, the sourcing and inputting of the data, and the interpretation of the results. Taieb, Feldman, and Gold contributed to the interpretation of the results. All authors reviewed draft versions of the manuscript and gave permission for the submission of the final version.

Defining treatment success in rosacea as ‘clear’ may provide multiple patient benefits: results of a pooled analysis

“…Representative archive photographs demonstrate a subject who became 'clear' (IGA 0) of papules/pustules and erythema after treatment with IVM 1% cream QD monotherapy ( Figure 6). The impact on global success rate, time to relapse, retreatment duration and time free of treatment are also important from a pharmacoeconomic perspective and further studies are warranted to evaluate the overall economic benefit of achieving 'clear' vs. 'almost clear' (29).…”

Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials

“…Rosacea is a chronic inflammatory cutaneous disorder involving the face that reportedly affects approximately 16 million individuals in the United States. 1,2 It is typically characterized by cutaneous signs such as flushing, central facial erythema, telangiectasia, edema, papules, and pustules. [1][2][3] Currently approved topical therapies include azelaic acid, metronidazole, and ivermectin; each is a topical therapy approved by the US Food and Drug Administration for inflammatory lesions of rosacea.…”

“…1,2 It is typically characterized by cutaneous signs such as flushing, central facial erythema, telangiectasia, edema, papules, and pustules. [1][2][3] Currently approved topical therapies include azelaic acid, metronidazole, and ivermectin; each is a topical therapy approved by the US Food and Drug Administration for inflammatory lesions of rosacea. [2][3][4][5] They are generally well tolerated and, when effective, require continued use to maintain their therapeutic effects.…”

“…[1][2][3] Currently approved topical therapies include azelaic acid, metronidazole, and ivermectin; each is a topical therapy approved by the US Food and Drug Administration for inflammatory lesions of rosacea. [2][3][4][5] They are generally well tolerated and, when effective, require continued use to maintain their therapeutic effects. 5 Oral tetracyclines, specifically doxycycline and minocycline, are also frequently used for the treatment of moderate to severe papulopustular disease but have been associated with systemic adverse effects involving the gastrointestinal tract and other body systems.…”

Pharmacokinetics of Minocycline Foam FMX103 in Subjects With Moderate-to-Severe Facial Papulopustular Rosacea Under Maximum-Use Conditions: Results of a Phase 1 Study

“…• Rosacea is a chronic, inflammatory, facial skin condition affecting approximately 16 million people in the United States 1,2 • Topical therapies such as metronidazole and azelaic acid are considered firstline options for the treatment of papulopustular rosacea [2][3][4][5] • Oral tetracyclines, doxycycline and minocycline, are mainstays of treatment; however, they are associated with significant systemic side effects 2,4 • FMX103 1.5% is a topical minocycline foam that was developed for the treatment of moderate-to-severe papulopustular rosacea. Efficacy and safety have been established in: IGA=Investigator's Global Assessment; TEAE=treatment-emergent adverse event.…”