Multicenter, randomized, double-blind, placebo-controlled clinical trial of vital wheat gluten oral immunotherapy - 07/02/19
Abstract |
Background |
Wheat is a common food allergen that can cause anaphylaxis.
Objective |
We sought to determine the efficacy and safety of vital wheat gluten (VWG) oral immunotherapy (OIT).
Methods |
After baseline double-blind, placebo-controlled food challenge (DBPCFC), 46 patients with wheat allergy (median age, 8.7 years; range, 4.2-22.3 years) were randomized 1:1 to low-dose VWG OIT or placebo, with biweekly escalation to 1445 mg of wheat protein (WP). After a year 1 DBPCFC, active subjects continued low-dose VWG OIT for another year and underwent a year 2 DBPCFC and, if passed, a subsequent off-therapy DBPCFC. Placebo-treated subjects crossed over to high-dose VWG OIT (maximum, 2748 mg of WP).
Results |
The median baseline successfully consumed dose (SCD) was 43 mg of WP in both groups. At year 1, 12 (52.2%) of 23 low-dose VWG OIT–treated and 0 (0%) of 23 placebo-treated subjects achieved the primary end point of an SCD of 4443 mg of WP or greater (P < .0001); median SCDs were 4443 and 143 mg, respectively. At year 2, 7 (30.4%) of 23 low-dose VWG OIT–treated subjects were desensitized to an SCD of 7443 mg of WP; 3 (13%) achieved sustained unresponsiveness 8 to 10 weeks off therapy. Among placebo-treated subjects who crossed over to high-dose VWG OIT, 12 (57.1%) of 21 were desensitized after 1 year (median SCD, 7443 mg of WP; nonsignificant vs low-dose VWG OIT). At year 1, skin prick test responses and wheat- and omega-5 gliadin–specific IgE levels did not differ between groups; the low-dose VWG OIT median specific IgG4 level was greater than placebo (wheat, P = .0005; omega-5 gliadin, P = .0001). Year 1 SCDs correlated with wheat-specific (rho = 0.55, P = .0003) and omega-5 gliadin–specific (rho = 0.51, P = .001) IgG4 levels in all subjects. Among 7822 low-dose VWG OIT doses in year 1, 15.4% were associated with adverse reactions: 0.04% were severe, and 0.08% subjects received epinephrine. Among 7921 placebo doses, 5.8% were associated with adverse reactions; none were severe.
Conclusions |
Low- and high-dose VWG OIT induced desensitization in about one half of the subjects after 1 year of treatment. Two years of low-dose VWG OIT resulted in 30% desensitization, and 13% had sustained unresponsiveness.
Il testo completo di questo articolo è disponibile in PDF.Graphical abstract |
Key words : Wheat allergy, food allergy, oral immunotherapy, sustained unresponsiveness, desensitization, oral tolerance, gluten
Abbreviations used : DBPCFC, EoE, kUA, mgA, OIT, pHC, SCD, sIgE, sIgG4, SPT, SU, VWG, WP
Mappa
| This project was supported by Linda and Bill Friend and the Harris Family Foundation, Food Allergy Research & Education, Inc (FARE), and Thermo Fisher Scientific. |
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| Disclosure of potential conflict of interest: A. Nowak-Węgrzyn is employed by the Icahn School of Medicine; receives grants from DBV Technologies, Astellas Pharma, Nutricia, and Nestle; receives royalties from UpToDate; serves on advisory boards for the Gerber Institute, Merck, ALK-Abelló, and Sanofi Aventis; and is the deputy editor for the Annals of Allergy Asthma and Immunology. R. A. Wood is employed by the Johns Hopkins University School of Medicine; receives grants from the National Institute of Allergy and Infectious Diseases, DBV, Aimmune, Astellas, Sanofi, and HAL Allergy; and receives royalties from UpToDate. K. C. Nadeau is employed by the Stanford University School of Medicine and receives grants from the National Institute of Allergy and Infectious Diseases. J. A. Pongracic is employed by the Ann & Robert H Lurie Children's Hospital of Chicago; receives grants from Food Allergy Research & Education (FARE); serves on the board of FARE; and is on a Speakers' bureau for Aimmune Therapeutics. A. K. Henning is employed by the Emmes Corporation and receives grants from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and the Icahn School of Medicine. R. W. Lindblad is employed by the Emmes Corporation and receives grants from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and the Icahn School of Medicine. K. Beyer is employed by the Charité Universitätsmedizin; receives grants from Aimmune, Danone, DBV, DST Diagnostic, Hipp, Hycor, and Thermo Fisher; and receives speakers' fees or honoraria for advisory boards from Aimmune, ALK-Abelló, Allergo Pharma, Bausch & Lomb, Danone, HAL Allergy, Meda Pharma, MedUpdate, Nestlé, Novartis, and Unilever. H. A. Sampson is a part-time employee of DBV Technologies and the Icahn School of Medicine; receives grants from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, and FARE; receives consultant fees from N-Fold, UCB SA, and Hycor Biomedical; received royalties from UpToDate and Elsevier; and holds stock options in DBV Technologies and N-FOLD. |
Vol 143 - N° 2
P. 651 - febbraio 2019 Ritorno al numero
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