Randomized Controlled Trial

. 2023 Oct;78(10):2756-2766.

doi: 10.1111/all.15788. Epub 2023 Jun 27.

Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

P J de Kam¹, S Zielen², J A Bernstein³, U Berger⁴, M Berger⁵, M Cuevas⁶, D Cypcar⁷, A Fuhr-Horst⁸, W A Greisner⁹, M Jandl¹⁰, S Laßmann¹¹, M Worm¹², J Matz¹³, E Sher¹⁴, C Smith¹⁵, G C Steven¹⁶, R Mösges^{17

18}, M H Shamji^{19

20}, L DuBuske²¹, F Borghese¹, K Oluwayi¹, T Zwingers¹, M Seybold¹, O Armfield¹, M D Heath¹, S J Hewings¹, M F Kramer¹, M A Skinner¹

Affiliations

¹ Allergy Therapeutics PLC, Worthing, UK.
² Children and Adolescents Department, Allergology, Pulmonology & Cystic Fibrosis, Goethe University, Frankfurt, Germany.
³ Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, USA.
⁴ Aerobiology and Pollen Research Unit, Department of Oto-Rhino-Laryngology, Medical University Vienna, Vienna, Austria.
⁵ Department of Otorhinolaryngology, Wiener Gesundheitsverbund, Hospital Hietzing, Vienna, Austria.
⁶ Clinic and Polyclinic of Otorhinolaryngology, University Clinic Carl Gustav Carus, Dresden, Germany.
⁷ Allergy Partners of Western North Carolina, Asheville, North Carolina, USA.
⁸ ENT Research- Institut für klinische Studien, Essen, Germany.
⁹ Bluegrass Allergy Research, Lexington, Kentucky, USA.
¹⁰ Hamburger Institut für Therapieforschung GmbH, Hamburg, Germany.
¹¹ Studienzentrum Dr. Sabine Laßmann, Saalfeld, Germany.
¹² Department of Dermatology and Allergy-Charite Campus Mitte, Universitätsmedizin Berlin, Berlin, Germany.
¹³ Chesapeake Clinical Research, Inc, White Marsh, Maryland, USA.
¹⁴ Allergy Partners of New Jersey, Ocean Township, New Jersey, USA.
¹⁵ Certified Research Associates, Cortland, New York, USA.
¹⁶ Allergy Asthma & Sinus Center, S.C., Greenfield, Wisconsin, USA.
¹⁷ IMSB (Institute of Computational Biology and Medical Statistics), University at Cologne, Cologne, Germany.
¹⁸ ClinCompetence, Cologne, Germany.
¹⁹ Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Department of National Heart and Lung Institute, Imperial College London, London, UK.
²⁰ Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, UK.
²¹ Division of Allergy and Immunology, Department of Internal Medicine, George Washington University Hospital, Washington, DC, USA.

PMID: 37366581
DOI: 10.1111/all.15788

Randomized Controlled Trial

Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

P J de Kam et al. Allergy. 2023 Oct.

. 2023 Oct;78(10):2756-2766.

doi: 10.1111/all.15788. Epub 2023 Jun 27.

Authors

Affiliations

¹ Allergy Therapeutics PLC, Worthing, UK.
² Children and Adolescents Department, Allergology, Pulmonology & Cystic Fibrosis, Goethe University, Frankfurt, Germany.
³ Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, USA.
⁴ Aerobiology and Pollen Research Unit, Department of Oto-Rhino-Laryngology, Medical University Vienna, Vienna, Austria.
⁵ Department of Otorhinolaryngology, Wiener Gesundheitsverbund, Hospital Hietzing, Vienna, Austria.
⁶ Clinic and Polyclinic of Otorhinolaryngology, University Clinic Carl Gustav Carus, Dresden, Germany.
⁷ Allergy Partners of Western North Carolina, Asheville, North Carolina, USA.
⁸ ENT Research- Institut für klinische Studien, Essen, Germany.
⁹ Bluegrass Allergy Research, Lexington, Kentucky, USA.
¹⁰ Hamburger Institut für Therapieforschung GmbH, Hamburg, Germany.
¹¹ Studienzentrum Dr. Sabine Laßmann, Saalfeld, Germany.
¹² Department of Dermatology and Allergy-Charite Campus Mitte, Universitätsmedizin Berlin, Berlin, Germany.
¹³ Chesapeake Clinical Research, Inc, White Marsh, Maryland, USA.
¹⁴ Allergy Partners of New Jersey, Ocean Township, New Jersey, USA.
¹⁵ Certified Research Associates, Cortland, New York, USA.
¹⁶ Allergy Asthma & Sinus Center, S.C., Greenfield, Wisconsin, USA.
¹⁷ IMSB (Institute of Computational Biology and Medical Statistics), University at Cologne, Cologne, Germany.
¹⁸ ClinCompetence, Cologne, Germany.
¹⁹ Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Department of National Heart and Lung Institute, Imperial College London, London, UK.
²⁰ Asthma UK Centre in Allergic Mechanisms of Asthma, Imperial College London, London, UK.
²¹ Division of Allergy and Immunology, Department of Internal Medicine, George Washington University Hospital, Washington, DC, USA.

PMID: 37366581
DOI: 10.1111/all.15788

Abstract

Background: A modified grass allergen subcutaneous immunotherapy (SCIT) product with MicroCrystalline Tyrosine and monophosphoryl lipid-A as an adjuvant system (Grass MATA MPL [PQ Grass]) is being developed as short-course treatment of grass-pollen allergic rhinitis (SAR) and/or rhinoconjunctivitis. We sought to evaluate the combined symptom and medication score (CSMS) of the optimized cumulative dose of 27,600 standardized units (SU) PQ Grass in a field setting prior to embarking on a pivotal Phase III trial.

Methods: In this exploratory, randomized, double-blind, placebo-controlled trial subjects were enrolled across 14 sites (Germany and the United States of America). Six pre-seasonal subcutaneous injections of PQ Grass (using conventional or extended regimens) or placebo were administered to 119 subjects (aged 18-65 years) with moderate-to-severe SAR with or without asthma that was well-controlled. The primary efficacy endpoint was CSMS during peak grass pollen season (GPS). Secondary endpoints included Rhinoconjunctivitis Quality of Life Questionnaire standardized (RQLQ-S) and allergen-specific IgG4 response.

Results: The mean CSMS compared to placebo was 33.1% (p = .0325) and 39.5% (p = .0112) for the conventional and extended regimens, respectively. An increase in IgG4 was shown for both regimens (p < .01) as well as an improvement in total RQLQ-S for the extended regimen (mean change -0.72, p = .02). Both regimens were well-tolerated.

Conclusions: This trial demonstrated a clinically relevant and statistically significant efficacy response to PQ Grass. Unprecedented effect sizes were reached for grass allergy of up to ≈40% compared to placebo for CSMS after only six PQ Grass injections. Both PQ Grass regimens were considered equally safe and well-tolerated. Based on enhanced efficacy profile extended regime will be progressed to the pivotal Phase III trial.

Keywords: allergic rhinoconjunctivitis; grass pollen allergy; short-course treatment; subcutaneous immunotherapy.

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Comment in

Correspondence to "Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy¹".
Cheng IH, Yii CY, Shih LC, Yong SB. Cheng IH, et al. Allergy. 2024 Jun;79(6):1635-1636. doi: 10.1111/all.16020. Epub 2024 Jan 16. Allergy. 2024. PMID: 38226721 No abstract available.

References

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Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

Affiliations

Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy

Authors

Affiliations

Abstract

Comment in

References

REFERENCES

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous