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Background: Chronic spontaneous urticaria (CSU) is a relatively common skin disease associated with hives and angio-oedema. Eosinophils play a role in CSU pathogenesis. Benralizumab, an anti-interleukin-5 receptor-α monoclonal antibody, has been shown to induce nearly complete depletion of eosinophils., Objectives: To determine the clinical efficacy and safety of benralizumab in patients with CSU who were symptomatic despite H1 antihistamine treatment., Methods: The 24-week, randomized, double-blind, placebo-controlled, phase IIb portion of the ARROYO trial enrolled adult patients with CSU who were currently on H1 antihistamine treatment. Patients were randomized to one of five treatment groups according to benralizumab dose and regimen for a 24-week treatment period. The primary endpoint was change from baseline in Itch Severity Score (ISS)7 at week 12. The key secondary endpoint was change from baseline in Urticaria Activity Score (UAS)7 at week 12. Additional secondary endpoints included other metrics to assess CSU at week 24, blood eosinophil levels, and pharmacokinetics and immunogenicity assessments. Exploratory subgroup analyses were conducted to explore responses according to demographics, clinical features and biomarkers. Safety was assessed in all treatment groups., Results: Of 155 patients, 59 were randomized to benralizumab 30 mg, 56 to benralizumab 60 mg and 40 to placebo. Baseline and disease characteristics were consistent with what was expected for patients with CSU. There were no significant differences in change from baseline in ISS7 score at week 12 between benralizumab and placebo [benralizumab 30 mg vs. placebo, least-squares mean difference -1.01, 95% confidence interval (CI) -3.28 to 1.26; benralizumab 60 mg vs. placebo, least-squares mean difference -1.79, 95% CI -4.09 to 0.50] nor in change from baseline in UAS7 score at week 12 between benralizumab and placebo (benralizumab 30 mg vs. placebo, P = 0.407; benralizumab 60 mg vs. placebo, P = 0.082). Depletion of blood eosinophil levels was observed at week 24 in patients treated with benralizumab. All other secondary endpoints and exploratory/subgroup analyses indicated no significant differences between benralizumab and placebo. Safety results were consistent with the known profile of benralizumab., Conclusions: Although benralizumab resulted in near-complete depletion of blood eosinophils, there was no clinical benefit over placebo., Competing Interests: Conflicts of interest S.A. is or recently was a speaker and/or advisor for and/or has received research funding from AstraZeneca, BioCryst, Blueprint, CSL Behring, LEO Pharma, Moxie, Novartis, Pfizer, Pharvaris, Sanofi-Regeneron, Takeda and Thermo Fisher Scientific. A.M.G.-A. is or recently was a speaker and/or advisor for and/or has received research funding from Almirall, Amgen, AstraZeneca, Avene, Celldex, Escient Pharmaceuticals, Genentech, GlaxoSmithKline, Instituto Carlos III-FEDER, LEO Pharma, Menarini, Mitsubishi Tanabe Pharma, Novartis, Sanofi-Regeneron, Servier, Thermo Fisher Scientific and Uriach Pharma/Neucor. J.A.B. has been a consultant for Escient Pharmaceuticals, Jasper Therapeutics and Ono Pharmaceutical, and has been a principal investigator and consultant for Amgen, AstraZeneca, Celldex Therapeutics, Genentech, Novartis and Sanofi-Regeneron. M.M. has received honoraria as a speaker and/or consultant for AbbVie, Amgen, argenx, AstraZeneca, Bayer, Beiersdorf, Celldex, Escient Pharmaceuticals, Galderma, GlaxoSmithKline, Incyte, Jasper Therapeutics, Novartis, Pfizer, Pharvaris, Sanofi, Teva, Third Harmonic Bio and Vifor. L. Bahadori, M.B., L.Brooks, C.N.H., P.J., P.B.L., E.R.-S., C.W. and C.J.D. are or were employees of AstraZeneca at the time of the study and may own stock or stock options., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Plasma rich in growth factors (PRGF®-Endoret®) is an autologous technology that contains a set of proteins specifically addressed to wound healing and tissue regeneration. The scaffold formed by using this technology is a clot mainly composed of fibrin protein, forming a three-dimensional (3D) macroscopic network. This biomaterial is easily obtained by biotechnological means from blood and can be used in a range of situations to help wound healing and tissue regeneration. Although the main constituent of this clot is the fibrin scaffold, little is known about other proteins interacting in this clot that may act as adjuvants in the healing process. The aim of this study was to characterize the proteins enclosed by PRGF-Endoret scaffold, using a double-proteomic approach that combines 1D-SDS-PAGE approach followed by LC-MS/MS, and 2-DE followed by MALDI-TOF/TOF. The results presented here provide a description of the catalogue of key proteins in close contact with the fibrin scaffold. The obtained lists of proteins were grouped into families and networks according to gene ontology. Taken together, an enrichment of both proteins and protein families specifically involved in tissue regeneration and wound healing has been found., (Copyright © 2013 John Wiley & Sons, Ltd.)