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

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.

Treatment-Free Interval: A Novel Approach to Assessing Real-World Treatment Effectiveness and Economic Impact Among Patients with Irritable Bowel Syndrome with Diarrhea.

INTRODUCTION: Objective assessment of treatment effectiveness using real-world claims data is challenging. This study assessed treatment-free intervals (TFI) as a proxy for treatment effectiveness, and all-cause healthcare costs among adult patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin or eluxadoline in the USA. METHODS: Adult patients (18-64 years) with IBS-D and ≥ 1 rifaximin or eluxadoline prescription were identified in the IQVIA PharMetrics® Plus database (10/01/2015-12/31/2021) and classified into two mutually exclusive cohorts (i.e., rifaximin and eluxadoline). Index date was the date of rifaximin or eluxadoline initiation. Entropy-balanced baseline characteristics, TFI (periods of ≥ 30 consecutive days without IBS-D treatment), and healthcare costs were reported. Healthcare costs were compared between cohorts using mean cost differences. RESULTS: There were 7094 and 2161 patients in the rifaximin and eluxadoline cohorts, respectively. After balancing, baseline characteristics (mean age 44.1 years; female 72.4%) were similar between cohorts. A higher proportion of patients treated with rifaximin achieved a TFI of ≥ 30 days (76.2% vs. 66.7%), ≥ 60 days (67.0% vs. 47.0%), ≥ 90 days (61.0% vs. 38.7%), ≥ 180 days (51.7% vs. 31.0%), and ≥ 240 days (47.7% vs. 27.9%) compared to eluxadoline. Among patients with a TFI ≥ 30 days, mean TFI durations were 8.3 and 6.0 months for the rifaximin and eluxadoline cohorts. Mean all-cause healthcare costs were lower for rifaximin vs. eluxadoline ($18,316 vs. $23,437; p = 0.008), primarily driven by pharmacy costs ($7348 vs. $10,250; p < 0.001). In a simulated health plan of one million commercially insured lives, initiating 50% of patients on rifaximin instead of eluxadoline resulted in total cost savings of $2.1 million per year or $0.18 per-member-per-month. CONCLUSIONS: This real-world study suggests that TFI is a meaningful surrogate measure of treatment effectiveness in IBS-D. Patients treated with rifaximin had longer treatment-free periods and lower healthcare costs than patients treated with eluxadoline.

Impact of rifaximin use following an initial overt hepatic encephalopathy hospitalization on rehospitalization and costs.

AIM: To assess the impact of rifaximin (± lactulose) use following discharge of an initial overt hepatic encephalopathy (OHE) hospitalization on OHE rehospitalizations and healthcare costs in a real-world setting. METHODS: Adults (18-64 years) with an OHE hospitalization were identified from MarketScan® Commercial claims (Q4'15-Q2'20), classified into two mutually exclusive treatment cohorts (i.e. rifaximin and no rifaximin treatment), and further stratified into four subgroups based on decreasing quality of care (QoC; i.e. Type 1 - rifaximin without delay post-discharge; Type 2 - rifaximin with delay post-discharge; Type 3 - lactulose only post-discharge; Type 4 - no rifaximin/lactulose treatment post-discharge). The impact of rifaximin use on 30-day and annualized OHE hospitalizations and healthcare costs were assessed between cohorts and by the QoC subgroup. RESULTS: Characteristics were similar between the rifaximin (N = 1,452; Type 1: 1,138, Type 2: 314) and no rifaximin (N = 560; Type 3:337, Type 4: 223) treatment cohorts. The 30-day risk of OHE rehospitalization was lower for the rifaximin vs. no rifaximin treatment cohort (odds ratio 0.56, p < .01) and increased with decreasing QoC. The annual rate of OHE hospitalizations was 59% lower for the rifaximin treatment cohort (incidence rate ratio 0.41, p < .01) and increased with decreasing QoC. Compared to the no rifaximin treatment cohort, the rifaximin treatment cohort had higher pharmacy costs, lower medical costs, and no difference in total healthcare costs. LIMITATIONS: This was a claims-based study subject to common data limitations such as billing inaccuracies or omissions in coded claims. Total healthcare costs were reported from a payer's perspective, which do not capture indirect costs associated with patient burden. CONCLUSIONS: Initiation of rifaximin after an OHE hospitalization was associated with reduced OHE hospitalizations both in the 30-days following and annually. Further, reduced medical costs offset increased pharmacy costs, and no annual cost differences were observed between cohorts.