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

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.

• Authors: Linda Stein Gold, Gale Harding, Danellys Borroto, Saswata Paul Choudhury, Sekhar Kumar Dutta, Tina Lin PharmD, May Kamleh, George Joseph, Ankur A Dashputre
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 22 Issue 10 Pg. 1033-1039 (Oct 01 2023) ISSN: 1545-9616 [Print] United States
• PMID: 37801539 (Publication Type: Journal Article)

Chemical References

• Gels

Topics

• Adolescent
• Humans
• Acne Vulgaris (diagnosis, drug therapy, pathology)
• Quality of Life
• Severity of Illness Index
• Treatment Outcome
• Clinical Trials, Phase III as Topic
• Gels