ABSTRACT
INTRODUCTION: Tralokinumab and dupilumab are biological agents licensed for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic treatment. However, no head-to-head studies of their efficacy have been conducted. This study indirectly compared the efficacy of tralokinumab and dupilumab, both in combination with topical corticosteroids (TCS), at week 32. METHODS: An unanchored matching-adjusted indirect comparison was conducted using individual patient data (IPD) from the ECZTRA 3 tralokinumab trial and aggregate data from the LIBERTY AD CHRONOS dupilumab trial. IPD were selected by applying inclusion criteria from LIBERTY AD CHRONOS and weighting to match summary baseline characteristics-age, sex, race, body mass index, disease duration, Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis index-of patients treated with dupilumab. Week 32 outcomes of interest were 50%, 75% or 90% improvements in EASI (EASI-50, EASI-75 and EASI-90), IGA scores of 0 or 1 (IGA 0/1), ≥ 4-point improvement in worst daily pruritus numerical rating scale (NRS) score, and mean improvements in DLQI and the Patient Oriented Eczema Measure (POEM). RESULTS: After matching, tralokinumab and dupilumab, both in combination with TCS, showed similar efficacy across clinical response endpoints at week 32 (IGA 0/1, tralokinumab 49.9% vs dupilumab 39.3%; EASI-50, 78.9% vs 77.5%; EASI-75, 71.5% vs 71.9%; EASI-90, 53.3% vs 56.2%). The mean change from baseline in DLQI was statistically significantly larger in the matched tralokinumab plus TCS population than in the dupilumab plus TCS arm (- 12.1 vs - 10.4, p = 0.005). Changes in POEM and worst daily pruritus NRS were similar in the two groups. CONCLUSION: The results of this analysis demonstrate that, in combination with TCS, tralokinumab and dupilumab have similar efficacy in the treatment of moderate-to-severe AD at 32 weeks of therapy.
ABSTRACT
BACKGROUND/AIMS: Sebum excreted from the seborrheic glands keeps the skin surface subtle and moist. Before determining the activity of seborrheic glands, the skin surface must be degreased to remove contamination but without provoking sebum excretion. The purpose of this study was to set up a standardised degreasing procedure for various seborrheic areas in different skin types. The method will take day-to-day variations into account with respect to the kinetics of refatting. METHODS: The Sebumeter(R) from Courage+Khazaka is used to quantify the sebum excretion. Day-to-day variations were measured on the forehead in groups of 12 volunteers on 2 consecutive days. The degreasing procedure was investigated by individual cleaning with alcohol compared to washing with a mild detergent followed by wipes with alcohol on the forehead. The degree of refatting was monitored until 3 h after defatting on seborrheic areas: the forehead, cheek, nose, chin and upper back. RESULTS: There was no statistical significant difference in the variation from day to day (P<0.05), although a change in the individual skin types was observed. An individual difference in the number of alcoholic wipes needed to degrease the forehead was seen. Washing followed by several repetitions of alcoholic wipes was not sufficient for the forehead, chin and nose (P>0.05). For the cheek and upper back, it was sufficient to wash with soap (P<0.05). The time from degreasing the skin until the sebum output reached the casual level was 2 h (P>0.05). The area under the curve (AUC) indicates that individual skin types return to casual level after defatting. CONCLUSION: There was no statistically significant day-to-day variation using the Sebumeter(R). We ended up with different degreasing procedures in different seborrheic areas. Washing gently with a detergent solution and then performing three wipes with alcohol was optimal for degreasing the forehead, nose and chin. For the cheek and upper back, it was sufficient to use a mild soap. Casual level was reached after 2 h in all seborrheic areas, irrespective of level of oiliness.
