Meta‐Analysis of PQ Grass 27600 SU Efficacy and Quality of Life From Phase III Trials

Allergy, Journal Year: 2025, Volume and Issue: unknown

Published: March 31, 2025

PQ Grass 27600 SU (PQ Grass) is a modified broad spectrum grass allergen subcutaneous immunotherapy (SCIT) product using MicroCrystalline Tyrosine and Monophosphoryl Lipid-A as an adjuvant system (Supporting Information; Table S1). Two highly comparable randomized double-blind, placebo-controlled field studies with (G309—EudraCT2020-000408-13 [1]; G306—EudraCT2019-001517-16 [2]) have been completed in the US Europe Information 2) positive results support marketing authorisation application. Here, we report EAACI recommended combined symptom medication score (CSMS0-6) [3] primary endpoint key secondary standardized rhinoconjunctivitis quality of life questionnaire (RQLQ[S]) meta-analysis approach for Grass. These were compared to integrated analyses adult Phase III two registered sublingual (SLIT) products (Table S1) Biologics License Applications (BLA) [4, 5] recently published data [6]. This complied European Medicine Agency (EMA) guidance recommendations [7]. G309 [1] was exploratory II/III study G306 pivotal [2], only performed SU. The selection criteria essentially equal; both used same averaged over peak pollen season (GPS). For meta-analysis, individual single combined, common effects integration performed, weights determined by size [8, 9]. SLIT studies, total treatment effect 95% CIs derived from summary statistics provided respective BLA reviews, analysis strategy, weighing based on size. Although different CSMS definitions applied Grass, it assumed that calculated % change placebo would enable comparison studies. In 674 subjects allergic rhinitis and/or included this meta-analysis. It confirmed outcomes between sufficiently homogeneous (x2 = 1.55, p 0.21). showed clinically relevant statistically significant improvement −22.5% (95% CI: −31.8% −13.2%, < 0.00004) CSMS0-6 (peak GPS) (Figure 1A). single-grass-extract-SLIT enrolling adults [5] calculations, resulting relative −23.7% 1B). However, when considering all supporting tablet (i.e., including pediatric studies), −19.8% reported [5]. 5-grass-mix −22.9% trials 1C) [4]. addition, [1, 2] RQLQ[S] −0.51 points −0.72 −0.29), corresponding −28.9% −40.4% −17.3%; 0.00001), whereas average RQLQ −0.20 −0.34 5-grass-mix, respectively 6] 2). While designs similar, should be noted there are known limitations regarding I-squared value Chi-Square Statistic setting few these interpreted cautiously. Furthermore, long-term started (EUCT number 2023-508520-36-00) 1-year will soon expand conclusion, innovative short-course allergen-specific SCIT applying potent system, showing meaningful strong efficacy response demonstrated after products. tendency towards more pronounced improvements SLIT. Stefan Zielen, Fiona Sellwood, Matthias F. Kramer, Murray Skinner, Pieter-Jan de Kam: idea conceptualisation analysis. Jonathan A. Bernstein, Oliver Pfaar, Lawrence DuBuske, Ralph Mösges, Sven Becker, contextualisation results. manuscript drafting. editing. All authors critically revised approved submission final version. acknowledge active contribution investigators project teams herein analyzed participating patients. grateful Graessel S. Starchenka their writing, editing, formatting, publishing manuscript. S.Z. has received personal fees lectures Engelhard GmbH, Böhringer Ingelheim, Allergy Therapeutics, AstraZeneca, SanofiAventis, EryDel SpA, Lofarma during last 3 years. J.A.B. acting consultant PI forAllergy Stallergens, ALK, Eli Lilly, Novartis, Genentech, Sanofi Regeneron, A.Z., G.S.K., Amgen. O.P. reports grants his institution clinical trial unit RESONATE Therapeutics PLC, UK; he travel AEDA, Alfried Krupp Krankenhaus, ALK-Abelló, Allergopharma, Almirall, Altamira ASIT Biotech, Bencard Allergie GmbH/Allergy Blueprint, Cliantha, Deutsche AllergieLiga e.V., Forschungsgemeinschaft, Dustri-Verlag, ECM Expro&Conference Management GmBH, Forum für Medizinische Fortbildung, Georg-Thieme-Verlag, GSK, HAL Holding B.V./HAL Immunotek, Ingress Health, Institut Disease (Essen, Germany), IQVIA Commercial, Japanese Society Allergology, Königlich Dänisches Generalkonsulat, Laboratorios LETI/LETI Pharma, Lofarma, Hochschule Hannover, med update europe Meinhardt Congress Paul-Ehrlich-Institut, Paul-Martini-Stiftung, PneumoLive, Pohl-Boskamp, Procter & Gamble, Red Maple Trials Inc., R.G. Aerztefortbildung, ROXALL Medizin, Aventis, Genzyme, Springer Publisher, Stallergenes Greer, streamedup! Technical University Dresden, Wiley Publishers, Wort Bild Verlag, Verlag ME, outside submitted work. Vice President Academy Clinical Immunology (EAACI), member Excom, well external board directors German (DGAKI); coordinator, main- or co-author position papers guidelines rhinology, allergology, allergen-immunotherapy; Editor-in-Chief Translational Associate Editor Allergy. LDB acts Consultant Speakers Bureau Sanofi, Astra Zeneca, ALK-Abello, Amgen, Bryn Pharm, Areteia. JALreports via Biomedical Research Funding (Imperial College BRC), R.M. Ltd. conduct study; biotech, Bencard, Leti, grants, fees, non-financial Roxall, Stallergenes, Optima, Friulchem, Hexal, Servier, Klosterfrau, Atmos, Bayer, Bionorica, FAES, MSD, Johnson&Johnson, Meda, Otonomy, Stada, UCB, Ferrero, Hulka, Nuvo, Ursapharm, Menarini, Mundipharma, Inmunotek, Cassella-med GmbH Co. KG, Laboratoire la Mer, Sidroga, BV, Lek, PRO-AdWise, Angelini JGL, bitop, Probelte Diater, Worg Pharmaceuticals, S.B. about advisor Allergie, Brain, Karl Storz, Altamira, Allergy, ALK Abelló, Viatris, Ambu, Stryker, Federal Ministry Education Research. F.S., M.F.K., M.S., P.J.d.K. employees (UK) Plc., P.J.d.K., M.S. named inventors patents related findings available author upon reasonable request. Data S1. Please note: publisher not responsible content functionality any information supplied authors. Any queries (other than missing content) directed article.

Language: Английский

Evolving Paradigms Of Treatment Of Allergic And Non-Allergic Rhinitis

Annals of Allergy Asthma & Immunology, Journal Year: 2025, Volume and Issue: unknown

Published: April 1, 2025

Language: Английский