Autor(es): Bernstein, Jonathan A. ; Giménez-Arnau, Ana ; Maurer, Marcus ; Staubach, Petra ; Barbier, Nathalie ; Hua, Eva ; Severin, Thomas ; Laires, Pedro A. ; Balp, Maria Magdalena
Data: 2023
Identificador Persistente: http://hdl.handle.net/10362/155430
Origem: Repositório Institucional da UNL
Assunto(s): chronic spontaneous urticaria; complete response; patient-reported outcomes; quality of life; sleep; Medicine(all)
Funding Information: The authors thank Bharat Suryawanshi of IQVIA India Ltd. and Sandip Acharya of Novartis Hyderabad Pvt Ltd. for their statistical analyses support, as well as Gillian Brodie, MSc and Linda Hassanali, PhD of Novartis Ireland Ltd. and Mohammad Fahad Haroon, PhD of Novartis Hyderabad Pvt. Ltd. for their medical writing and editorial support, which was funded by Novartis Pharma AG, Basel, Switzerland in accordance with the Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 (accessed on 14 May 2023). This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland. Funding Information: This research was funded by Novartis Pharma AG, Switzerland. Publisher Copyright: © 2023 by the authors.
This study investigated the association between urticaria activity and health-related quality of life (HRQoL). Patient evaluations from the ligelizumab Phase 2b clinical trial (N = 382) were pooled (NCT02477332). Daily patient diaries assessed urticaria activity, sleep and activity interference, the dermatology life quality index (DLQI), and work productivity and activity impairment-chronic urticaria (WPAI-CU). The number of DLQI scores, weekly sleep interference scores (SIS7), weekly activity interference scores (AIS7), and overall work impairment (OWI) evaluations with a complete response per weekly urticaria activity score (UAS7) using bands (0, 1–6, 7–15, 16–27, and 28–42) were reported. Over 50% of the patients had a mean DLQI of > 10 at baseline, indicating a significant effect of chronic spontaneous urticaria (CSU) on their HRQoL. Complete response (UAS7 = 0) evaluations corresponded with no impacts on other patient-reported outcomes. In total, 91.1% of UAS7 = 0 evaluations corresponded to DLQI scores of 0–1, 99.7% to SIS7 scores of 0, 99.7% to AIS7 scores of 0, and 85.3% to OWI scores of 0. This was significantly different compared with the UAS7 = 1–6 evaluations (61.9%, 68.5%, 67.7%, and 65.4%, respectively; p < 0.0001). Complete responses to treatment were associated with no impairments on the dermatology-QoL, no interferences with sleep and activity, and significantly improved capacities to work compared to patients who continued to have signs and symptoms, even for those with minimal disease activity.
