Post-Hoc Exploratory Pooled Analysis of the Impact of IDP-126 Gel on QoL in Moderate-to-Severe Acne

October 2023 | Volume 22 | Issue 10 | 1033 | Copyright © October 2023


Published online September 30, 2023

doi:10.36849/JDD.7812

Linda Stein Gold MDa, Gale Harding MAb, Danellys Borroto PharmD MSc, Saswata Paul Choudhury MScd, Sekhar Kumar Dutta MScd, Tina Lin PharmDe, May Kamleh PhDb, George Joseph PhDc,f, Ankur A. Dashputre PhD

aHenry Ford Medical Center - Farmington, West Bloomfield, MI
bEvidera, Bethesda, MD
cHealth Economics & Outcomes Research (HEOR), Clinical & Medical Affairs, Bausch Health, Bridgewater, NJ 
dPharmaQuant Insights Pvt. Ltd., Kolkata, India 
eOrtho Dermatologics, Bridgewater, NJ
fBioNTech US, Inc, Cambridge, MA

Abstract
Background: Acne has psychosocial effects on patient's quality of life (QoL). This post hoc exploratory analysis of pooled phase 3 data assessed the impact of investigational IDP-126 gel (for moderate to severe acne) on the Acne-Specific Quality of Life Questionnaire (Acne-QoL; exploratory endpoint in the trials). 
Methods: A post hoc exploratory analysis using pooled data (N=309; age ≥13 years) was conducted to assess if 1) changes from baseline to week 12 in Acne-QoL domain scores significantly differ by treatment; 2) differences were clinically meaningful, and 3) relative importance of acne severity as measured by the Evaluator's Global Severity Score (EGSS) or lesion counts explains the changes in QoL (Acne-QoL). 
Results: Acne-QoL domain scores significantly (P<0.001, each) improved for patients treated with IDP-126 Gel vs vehicle in all four domains (role-emotional [least squares mean difference {LSMean} 4.1], self-perception [LSMean 3.8], acne symptoms [LSMean 2.6], and role-social [LSMean 2.0]). The proportion of responders was significantly higher (P<0.05, each) in the IDP-126 Gel group vs vehicle across Acne-QoL domains, self-perception (odds ratio [OR]: 4.32), acne symptoms (OR: 3.90), role-social (OR: 3.59), and role-emotional (OR: 2.50). Across all Acne QoL domains, the improvement on the EGSS endpoint (53.8-63.3%) was more likely to influence QoL improvements than the inflammatory (20.1-33.4%) and non-inflammatory lesion (9.5-18.7%) counts. 
Conclusions: This post hoc exploratory analysis of pooled phase 3 data (moderate to severe acne) suggests that treatment with IDP 126 Gel led to statistically significant and clinically meaningful improvements in QoL and improvement in QoL was primarily influenced by EGSS.

J Drugs Dermatol. 2023;22(10):1033-1039      doi:10.36849/JDD.7812

INTRODUCTION

Acne vulgaris is a common inflammatory cutaneous disorder of the pilosebaceous unit of the skin (comprising the hair follicle, hair shaft, and sebaceous gland), leading to the development of whiteheads, blackheads, papules, pustules, nodules, and cystic lesions.1 It is the most commonly diagnosed skin condition in the US,1 and is most common among adolescents and young adults in their twenties.2 The estimated age-standardized prevalence rate of acne vulgaris is 30.4 per 1,000 people, with more than 8 million physician-diagnosed cases estimated in the United States (US).3,4

Potential sequelae of acne, such as scarring, dyspigmentation, and low self-esteem, may result in significant morbidity. Acne may be classified as mild, moderate, or severe, based on the number and type of skin lesions.5 Studies have demonstrated that acne may negatively impact the patient’s quality of life psychologically, socially, and functionally; for example, by negatively influencing school and work performance.3,5

The Acne-Specific Quality of Life Questionnaire (Acne-QoL) was developed to measure the impact of facial acne across four domains including self-perception, role-social, role-emotional, and acne symptoms.6,7 The Acne-QoL is a responsive, internally consistent, and valid instrument to measure the impact of facial acne.8 This study initially confirmed that the Acne-QoL is appropriate and sensitive to treatment differences in clinical trials, based on results of two randomized, double-blind, placebo-controlled studies of the efficacy of Estrostep (norethindrone acetate/ethinyl estradiol). More recently, the Acne-QoL was used in two phase 3 clinical trials of treatment with tazarotene 0.045% lotion among patients with moderate-to-severe acne, with results of pooled data (N=1,614) indicating