Efficacy of 2 months of allergen-specific immunotherapy with Bet v 1-derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: Results of a phase IIb study.
- Spertini F Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Electronic address: francois.spertini@chuv.ch.
- DellaCorte G Anergis SA, Epalinges, Switzerland.
- Kettner A Anergis SA, Epalinges, Switzerland.
- de Blay F Chest Diseases Department, Strasbourg University Hospital, Federation of Translational medicine, Strasbourg University, Strasbourg, France.
- Jacobsen L Allergy Learning and Consulting, Copenhagen, Denmark.
- Jutel M "ALL-MED" Medical Research Institute, Department of Clinical Immunology, Silesian Piasts University of Medicine, Wroclaw, Poland.
- Worm M Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Universitätsmedizin Berlin, Berlin, Germany.
- Charlon V Anergis SA, Epalinges, Switzerland.
- Reymond C Anergis SA, Epalinges, Switzerland.
- 2016-07-05
Published in:
- The Journal of allergy and clinical immunology. - 2016
Allergen-specific immunotherapy
Bet v 1
IgE
IgG(4)
aluminum hydroxide
birch pollen allergy
clinical trial
contiguous overlapping peptides
desensitization
synthetic peptides
Adolescent
Adult
Allergens
Antigens, Plant
Conjunctivitis, Allergic
Desensitization, Immunologic
Female
Humans
Immunoglobulin E
Immunoglobulin G
Male
Middle Aged
Peptides
Respiratory Function Tests
Rhinitis, Allergic
Treatment Outcome
Young Adult
English
BACKGROUND
An immunotherapy formulation consisting of 3 contiguous overlapping peptides (COPs) derived from Bet v 1, the major birch pollen allergen, showed good clinical tolerability in a previous phase I/IIa clinical trial.
OBJECTIVES
We sought to evaluate the efficacy and safety of allergen-specific immunotherapy using 2 dose regimens of Bet v 1 COPs versus placebo in subjects with birch pollen-induced allergic rhinoconjunctivitis.
METHODS
A randomized, double-blind, placebo-controlled phase IIb clinical trial was performed to assess the efficacy of Bet v 1 COP immunotherapy during the 2013 birch pollen season. Before the season, Bet v 1 COPs (50 and 100 μg in aluminum hydroxide) or placebo (saline and aluminum hydroxide) were administered as 5 subcutaneous injections to 239 adults with allergic rhinoconjunctivitis to birch pollen. Bet v 1 COPs at 25 or 50 μg were administered on day 1, and 50 or 100 μg was administered on days 8, 15, 29, and 57, respectively. Patients were monitored for adverse events during the treatment period and assessed for combined rhinoconjunctivitis symptom and medication scores, as well as quality of life.
RESULTS
Rhinoconjunctivitis symptom and medication scores improved in both Bet v 1 COP-treated groups, reaching statistical significance over placebo in the 50-μg group (least squares mean, -0.23; 26% improvement; P = .015). Both active groups showed significant improvement in quality of life and nighttime nasal symptom scores, supporting the primary end point findings. Bet v 1 COP injections were well tolerated, with a higher frequency of systemic adverse events in the 100-μg group.
CONCLUSION
Two months of preseasonal immunotherapy with 3 COPs derived from Bet v 1 at a 50-μg dose showed promising efficacy, small risk for systemic reactions, and immunomodulatory changes in this single-season, dose-finding, phase IIb trial in patients allergic to birch pollen.
An immunotherapy formulation consisting of 3 contiguous overlapping peptides (COPs) derived from Bet v 1, the major birch pollen allergen, showed good clinical tolerability in a previous phase I/IIa clinical trial.
OBJECTIVES
We sought to evaluate the efficacy and safety of allergen-specific immunotherapy using 2 dose regimens of Bet v 1 COPs versus placebo in subjects with birch pollen-induced allergic rhinoconjunctivitis.
METHODS
A randomized, double-blind, placebo-controlled phase IIb clinical trial was performed to assess the efficacy of Bet v 1 COP immunotherapy during the 2013 birch pollen season. Before the season, Bet v 1 COPs (50 and 100 μg in aluminum hydroxide) or placebo (saline and aluminum hydroxide) were administered as 5 subcutaneous injections to 239 adults with allergic rhinoconjunctivitis to birch pollen. Bet v 1 COPs at 25 or 50 μg were administered on day 1, and 50 or 100 μg was administered on days 8, 15, 29, and 57, respectively. Patients were monitored for adverse events during the treatment period and assessed for combined rhinoconjunctivitis symptom and medication scores, as well as quality of life.
RESULTS
Rhinoconjunctivitis symptom and medication scores improved in both Bet v 1 COP-treated groups, reaching statistical significance over placebo in the 50-μg group (least squares mean, -0.23; 26% improvement; P = .015). Both active groups showed significant improvement in quality of life and nighttime nasal symptom scores, supporting the primary end point findings. Bet v 1 COP injections were well tolerated, with a higher frequency of systemic adverse events in the 100-μg group.
CONCLUSION
Two months of preseasonal immunotherapy with 3 COPs derived from Bet v 1 at a 50-μg dose showed promising efficacy, small risk for systemic reactions, and immunomodulatory changes in this single-season, dose-finding, phase IIb trial in patients allergic to birch pollen.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jaci.2016.02.044
- PMID 27373329
- Persistent URL
- https://folia.unifr.ch/global/documents/78756
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