Increasingly Stringent Clinical Responses and the Association with Improvements in Pain, HRQoL, and Work Productivity in Patients with Hidradenitis Suppurativa: 16-Week Results from Phase 3 Studies BE HEARD I&II
Author(s)
Gottlieb AB1, Mørup M2, Davis L3, Lukowski B4, Lambert J5, Horvath B6
1The Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2UCB Pharma, Copenhagen S, 84, Denmark, 3UCB Pharma, Raleigh, NC, USA, 4UCB Pharma, Brussels, Belgium, 5UCB Pharma, Colombes, France, 6Faculty of Medical Sciences, University Medical Center Groningen, Groningen, Netherlands
OBJECTIVES: Hidradenitis suppurativa (HS), a chronic inflammatory skin disease, is associated with reduced quality of life (QoL) and work productivity.1,2 The association between increasingly stringent efficacy responses and changes in patient-reported pain, health‑related QoL (HRQoL), and work productivity was examined in patients with moderate to severe HS.
METHODS: This post hoc analysis used pooled data from the phase 3 studies BE HEARD I&II.3,4 Patients were pooled regardless of treatment (placebo, bimekizumab 320mg every 2 or 4 weeks), and grouped by achievement of mutually exclusive HS Clinical Response (HiSCR) levels (<50% improvement from baseline [<HiSCR50]; 50–<75% improvement [HiSCR50–<75]; 75–<90% improvement [HiSCR75–<90]; 90–100% improvement [HiSCR90–100]) at Week 16.
Associations between level of increasingly stringent efficacy response and improvement in patient-reported outcomes (HS Symptom Daily Diary Worst Skin Pain, EQ-5D Utility, HS QOL [HiSQOL] scores, and Work Productivity and Activity Impairment [WPAI] Percent Overall Work Impairment) to Week 16 were assessed. Observed case data are reported.RESULTS: In BE HEARD I&II, 1,014 patients were randomized to placebo or bimekizumab; 915 (90.2%) completed Week 16.
At Week 16, patients achieving increasingly stringent HiSCR responses demonstrated sequentially numerically greater mean (95% confidence intervals) improvements from baseline in Worst Skin Pain score (<HiSCR50: −0.9[−1.2,−0.7]; HiSCR50–<75: −1.6[−2.0,−1.2]; HiSCR75–<90: −2.4[−2.9,−1.9]; HiSCR90–100: −2.8[−3.3,−2.3]). Similar improvements were seen for EQ-5D Utility and HiSQOL scores. Increasingly stringent HiSCR response was associated with numerically greater improvements in WPAI Percent Overall Work Impairment (<HiSCR50: −7.6[−11.1,−4.2]; HiSCR50–<75: −14.3[−19.8,−8.8]; HiSCR75–<90: −17.9[−23.1, −12.6]; HiSCR90–100: −21.3[−26.8,−15.9]).CONCLUSIONS: Patients with HS achieving increasingly stringent clinical response outcomes had greater improvements in pain, HRQoL, and work productivity. Pain and work productivity improvements were up to ~3x greater in HiSCR90–100 responders vs <HiSCR50 responders.
1. Zouboulis CC. Dermatology 2015;231:184–90; 2. Chernyshov PV, et al. J Eur Acad Dermatol Venereol. 2023;37:954–64; 3. BE HEARD I: www.clinicaltrials.gov/study/NCT04242446; 4. BE HEARD II: www.clinicaltrials.gov/study/NCT04242498.Conference/Value in Health Info
Value in Health, Volume 27, Issue 6, S1 (June 2024)
Acceptance Code
P50
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
biologics-biosimilars, sensory-system-disorders-ear-eye-dental-skin