Systematic Literature Review and Network Meta-Analysis to Assess the Comparative Efficacy of Topical Fixed-Dose Combinations for Moderate to Severe Acne Vulgaris as Measured By Lesion Counts
Author(s)
Harper J1, Baldwin H2, Ghosh B3, Paul Choudhury S3, Rai D3, Aman MS3, Choudhury AR3, Dey D3, Dutta S3, Bhattacharyya S3, Lin T4, Dashputre AA4, Jospeh G4, Tan J5
1The Dermatology and Skin Care Center of Birmingham, Birmingham, AL, USA, 2Rutgers Robert Wood Johnson Medical Center, New Brunswick, NJ, USA, 3PharmaQuant Insights Pvt. Ltd., Kolkata, WB, India, 4Bausch Health, Bridgewater, NJ, USA, 5University of Western Ontario, Windsor, ON, Canada
Presentation Documents
OBJECTIVES: Several topical and oral monotherapies/combination treatments are available for treating moderate to severe acne vulgaris with few currently under review with the United States (US) Food and Drug Administration (FDA), of which topical fixed-dose combinations (FDCs) are widely prescribed in the US. The objective of this study is to conduct a systematic literature review (SLR) and network meta-analysis (NMA) to compare the efficacy of topical FDCs for reducing inflammatory lesion (ILs) and non-inflammatory lesion (NILs) count among patients with moderate to severe acne. METHODS: A search was conducted (May 2022) to identify randomized controlled trials (RCTs), that included at least one topical FDC (currently approved/under review with FDA) arm, in academic and non-academic databases, conference websites, and trial registries. RCTs included in the analysis evaluated acne severity (inclusion criteria) using Investigator’s Global Assessment or equivalent (Evaluator's Global Severity Score, or Investigator’s Static Global Assessment) scales. A Bayesian network meta-regression was conducted on the absolute mean changes in facial ILs and NILs from baseline to week 12, using the proportion of patients with moderate acne at baseline as a covariate to account for acne severity. RESULTS: Twelve Phase II and Phase III RCTs were identified from 5,159 citations comprising 10,313 patients across 8 treatment groups. The mean difference (MD) for IDP-126 gel (clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15%) was estimated to be −8.0 vs. Vehicle for ILs [95% Credible Interval (CrI): −11.6 to −4.5] with surface under cumulative ranking (SUCRA) of 87% and -13.2 vs. Vehicle for NILs [95% CrI: −17.2 to −9.1] with SUCRA of 97%. CONCLUSIONS: Based on the findings from this SLR/NMA, IDP-126 topical gel (currently under FDA review; PDUFA date 20 October 2023), was clinically superior to all other topical FDC treatments in reducing acne lesions in the patients with moderate to severe acne vulgaris.
Conference/Value in Health Info
2023-11, ISPOR Europe 2023, Copenhagen, Denmark
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
CO110
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Literature Review & Synthesis, Meta-Analysis & Indirect Comparisons
Disease
Drugs, Sensory System Disorders (Ear, Eye, Dental, Skin)