Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults - 29/04/13
, Jennifer Maloney, MD b, David I. Bernstein, MD c, Thomas Casale, MD d, Amarjot Kaur, PhD b, Robert Fisher, MD e, Nancy Liu, PhD b, Kevin Murphy, MD f, Kristóf Nékám, MD g, Hendrik Nolte, MD, PhD b
Corresponding author: Peter S. Creticos, MD, Division of Allergy & Clinical Immunology, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224-6801.Abstract |
Background |
In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration.
Objectives |
This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy.
Methods |
Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration.
Results |
During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (−0.76; P = .22), 19% (−1.58; P = .01), and 24% (−2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (−0.88; P = .09), 18% (−1.28; P = .01), and 27% (−1.92; P < .001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred.
Conclusions |
In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.
Le texte complet de cet article est disponible en PDF.Key words : Allergy immunotherapy tablet, allergic conjunctivitis, allergic rhinitis, allergic rhinoconjunctivitis, specific immunotherapy, ragweed pollen, sublingual immunotherapy
Abbreviations used : AE, AIT, Amb a 1-U, AR/C, DMS, DSS, RS, TCS, VAS
Plan
| Supported by Merck Sharp & Dohme Corp, Whitehouse Station, NJ. |
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| Disclosure of potential conflict of interest: D. I. Bernstein has been supported by one or more grants from the Bernstein Clinical Research Center; has received one or more consulting fees or honoraria and received one or more fees for participation from Merck and ALK-Abelló; has received support for travel from Merck; has consultancy arrangements with Proctor and Gamble and Sanofi Aventis; has provided expert testimony for a number of law firms; and has received one or more grants from or has one or more grants pending with NIOSH/CDC, NIAID, and NIEHS. T. Casale has been supported by one or more grants from Merck, has consultancy arrangements with and has received one or more grants from or has one or more grants pending with Stallergenes, and has received one or more payments for lecturing from or is on the speakers’ bureau for ALK-Abelló. P. S. Creticos has been supported by one or more grants from Johns Hopkins School of Medicine; has consultancy arrangements with Merck, Greer Labs, Stallergenes, and Circassia; and has received one or more grants from or has one or more grants pending with Merck/Schering-Plough, Greer Labs, Stallergenes, Circassia, and UpToDate/AHRQ. A. Kaur, N. Liu, J. Maloney, and H. Nolte are employed by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Whitehouse Station, NJ. K. Murphy is an Advisory Board member for, has consultancy arrangements with, and has received one or more payments for lecturing from or is on the speakers’ bureau for Merck. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 131 - N° 5
P. 1342 - mai 2013 Retour au numéro
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