Rhinitis, sinusitis, and upper airway disease
Fel d 1–derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study

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Background

Allergic rhinoconjunctivitis is an increasingly common source of morbidity, with sensitivity to cats accounting for 10% to 15% of disease burden. Allergy to cats is also a major risk factor for the development of asthma.

Objectives

We sought to probe the persistence of the treatment effect of a novel Fel d 1–derived peptide antigen desensitization (Cat-PAD) 1 year after the start of treatment in subjects with cat allergy–induced rhinoconjunctivitis after standardized allergen challenge.

Methods

In a randomized, double-blind, placebo-controlled, parallel-group clinical trial, subjects attended an environmental exposure chamber in which they were exposed to cat allergen before and after treatment with 2 different regimens of Cat-PAD over a 3-month period. Clinical efficacy was assessed as a change in total rhinoconjunctivitis symptom scores 18 to 22 weeks and 50 to 54 weeks after the start of treatment.

Results

Treatment with Cat-PAD showed greater efficacy with 4 administrations of a 6-nmol dose 4 weeks apart than with 8 administrations of a 3-nmol dose 2 weeks apart. The treatment effect of 6 nmol persisted 1 year after the start of treatment and was significantly different from that of 3 nmol (P = .0342) and placebo (P = .0104). The treatment effect was apparent on both nasal and ocular symptoms at 1 year.

Conclusions

A short course of Cat-PAD improves the ocular and nasal components of rhinoconjunctivitis symptoms in subjects with cat allergy, with the treatment effect persisting 1 year after the start of treatment.

Key words

Allergic rhinitis
allergic rhinoconjunctivitis
cat allergy
environmental exposure chamber
Fel d 1 peptide immunotherapy
T-cell epitope
immune tolerance
persistence

Abbreviations used

AE
Adverse event
EEC
Environmental exposure chamber
PAD
Peptide antigen desensitization
PTC
Posttreatment challenge
TEAE
Treatment-emergent adverse events
TNSS
Total nasal symptom score
TOSS
Total ocular symptom score
TRSS
Total rhinoconjunctivitis symptom score

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Supported by Adiga Life Sciences and Circassia. M.L. is supported by the Canada Research Chairs program, the Canadian Foundation for Innovation, and the McMaster University/GlaxoSmithKline Chair in Lung Immunology at St Joseph’s Healthcare.

Disclosure of potential conflict of interest: D. Patel and P. Couroux are employed by Cetero Research. P. Hickey, P. Laidler, and R. P. Hafner are employed by Circassia Limited. A. M. Salapatek was employed by Cetero Research and has received research support from Circassia Research. M. Larché is founder, consultant, and stockholder of Circassia Limited; is scientific founder of Adiga Life Sciences; has consultant arrangements with Boehringer Ingelheim; has received one or more honoraria from MedImmune; has received research support from Adiga Life Sciences, the Canadian Institutes for Health Research, the Canadian Lung Association, the Canada Research Chairs program, and the McMaster University/GlaxoSmithKline Chair in Lung Immunology at St Joseph's Healthcare; and is a member of the American Academy of Allergy, Asthma & Immunology Genetics, Molecular Biology, and Epidemiology Committee.

Drs Patel and Couroux are currently affiliated with Topstone Research, Toronto, Ontario, Canada.

Dr Salapatek is currently affiliated with Adiga Life Sciences, Hamilton, Ontario, Canada.