Dermatology and therapy · 2016
Superior Efficacy with Ivermectin 1% Cream Compared to Metronidazole 0.75% Cream Contributes to a Better Quality of Life in Patients with Severe Papulopustular Rosacea: A Subanalysis of the Randomized, Investigator-Blinded ATTRACT Study.
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Schaller Martin, Dirschka Thomas, Kemény Lajos, Briantais Philippe, Jacovella Jean
Аннотация
INTRODUCTION: Ivermectin 1% cream (IVM 1%) is indicated for the treatment of inflammatory lesions of rosacea. The objective of this subanalysis was to compare IVM 1% vs. metronidazole 0.75% cream (MTZ 0.75%) in the treatment of severe inflammatory lesions of rosacea.
METHODS: A subanalysis of the investigator-assessed severe subjects from a Phase 3, investigator-blinded, randomized study comparing IVM 1% once daily (QD) with MTZ 0.75% twice daily (BID) over 16 weeks followed by a 36-week extension period was performed. Efficacy assessments were Dermatology Life Quality Index (DLQI) and EuroQol-5 Dimension (EQ-5D) questionnaires, investigator's global assessment (IGA), subject assessment of rosacea improvement, and inflammatory lesion counts. Adverse events (AEs) were monitored throughout the study.
RESULTS: A total of 161 subjects (16.7% of overall study population; 80 IVM 1% and 81 MTZ 0.75%) had an IGA score of 4 at baseline representing severe papulopustular rosacea. Significantly more IVM 1% subjects had a minimal clinically important difference (MCID, defined as a decrease from baseline of ≥4 points) in DLQI score than MTZ 0.75% subjects at week 16 (65.4% vs. 39.2%; P = 0.001) and week 52 (68.8% vs. 40.4%; P = 0.003). At week 16, the mean EQ-5D score for the IVM 1% subjects was higher (better quality of life) than for MTZ 0.75% subjects (0.941 vs. 0.896). Significantly more IVM 1% subjects were IGA "clear" or "almost clear" at week 16 compared to MTZ 0.75% (82.5% vs. 63.0%; P = 0.005). Incidence of AEs was comparable between groups.
CONCLUSION: Better efficacy with IVM 1% cream (QD) compared to MTZ 0.75% cream (BID) contributes to an improved quality of life with significantly more patients achieving an MCID in DLQI score at week 16 and higher mean EQ-5D score. IVM 1% cream is thus a better alternative than MTZ 0.75% cream for severe papulopustular rosacea patients.
TRIAL REGISTRATION: EUDRACT number: 2011-004791-11.
FUNDING: Galderma R&D.
METHODS: A subanalysis of the investigator-assessed severe subjects from a Phase 3, investigator-blinded, randomized study comparing IVM 1% once daily (QD) with MTZ 0.75% twice daily (BID) over 16 weeks followed by a 36-week extension period was performed. Efficacy assessments were Dermatology Life Quality Index (DLQI) and EuroQol-5 Dimension (EQ-5D) questionnaires, investigator's global assessment (IGA), subject assessment of rosacea improvement, and inflammatory lesion counts. Adverse events (AEs) were monitored throughout the study.
RESULTS: A total of 161 subjects (16.7% of overall study population; 80 IVM 1% and 81 MTZ 0.75%) had an IGA score of 4 at baseline representing severe papulopustular rosacea. Significantly more IVM 1% subjects had a minimal clinically important difference (MCID, defined as a decrease from baseline of ≥4 points) in DLQI score than MTZ 0.75% subjects at week 16 (65.4% vs. 39.2%; P = 0.001) and week 52 (68.8% vs. 40.4%; P = 0.003). At week 16, the mean EQ-5D score for the IVM 1% subjects was higher (better quality of life) than for MTZ 0.75% subjects (0.941 vs. 0.896). Significantly more IVM 1% subjects were IGA "clear" or "almost clear" at week 16 compared to MTZ 0.75% (82.5% vs. 63.0%; P = 0.005). Incidence of AEs was comparable between groups.
CONCLUSION: Better efficacy with IVM 1% cream (QD) compared to MTZ 0.75% cream (BID) contributes to an improved quality of life with significantly more patients achieving an MCID in DLQI score at week 16 and higher mean EQ-5D score. IVM 1% cream is thus a better alternative than MTZ 0.75% cream for severe papulopustular rosacea patients.
TRIAL REGISTRATION: EUDRACT number: 2011-004791-11.
FUNDING: Galderma R&D.