Abstract
Background: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years. Objective: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy. Methods: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated. Results: At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2–specific IgG4 observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose. Conclusions: Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 992-1003.e5 |
| Journal | Journal of Allergy and Clinical Immunology |
| Volume | 147 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 2021 |
Keywords
- IgE
- IgG
- Peanut allergy
- desensitization
- epicutaneous immunotherapy
- follow-up
- food allergy
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
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In: Journal of Allergy and Clinical Immunology, Vol. 147, No. 3, 03.2021, p. 992-1003.e5.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Epicutaneous immunotherapy for treatment of peanut allergy
T2 - Follow-up from the Consortium for Food Allergy Research
AU - Consortium for Food Allergy Research (CoFAR)
AU - Scurlock, Amy M.
AU - Burks, A. Wesley
AU - Sicherer, Scott H.
AU - Leung, Donald Y.M.
AU - Kim, Edwin H.
AU - Henning, Alice K.
AU - Dawson, Peter
AU - Lindblad, Robert W.
AU - Berin, M. Cecilia
AU - Cho, Christine B.
AU - Davidson, Wendy F.
AU - Plaut, Marshall
AU - Sampson, Hugh A.
AU - Wood, Robert A.
AU - Jones, Stacie M.
N1 - Funding Information: Disclosure of potential conflict of interest: A. M. Scurlock reports grant support to her institution from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and Food Allergy Research and Education (FARE) and clinical medical advisory board membership with DBV Technologies. A. W. Burks reports being a minority stock holder in Allertein and Mastcell pharmaceuticals; scientific advisory board membership with Aimmune Therapeutics, Consortia TX, Inc, Intrommune Therapeutics, and Prota Therapeutics; consultancy for DBV Technologies, N-fold LLC, Aravax, Genentech, and Hycor Biomedical; grant support to his institution from the NIH/NIAID, NIH/National Center for Complementary and Integrative Health, Johns Hopkins/NIH, FARE, and the Wallace Research Foundation, in addition to royalty payments from UpToDate and royalties paid from the following US patents: #7879977, #6835824, #6486311, #6441142, #5973121, and #5558869. S. H. Sicherer reports grants from NIH/NIAID and royalty payments from UpToDate, the American Academy of Allergy, Asthma & Immunology, and Johns Hopkins University Press. D. Y. M. Leung receives grant support to his institution from the NIH/NIAID and serves on the Data Safety Monitoring Committee for Aimmune Therapeutics. E. H. Kim reports clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and grant support to his institution from the NIH/NIAID, NIH/NCCIH, FARE, and the Wallace Research Foundation. A. K. Henning, P. Dawson, and R. W. Lindblad are employed by Emmes, which received grant support from the Division of Allergy, Immunology and Transplantation (DAIT)/NIH/NIAID. M. C. Berin reports scientific advisory board membership with Prota Therapeutics. H. A. Sampson reports being a part-time employee of DBV Technologies; receiving consultant fees from N-Fold Therapeutics, and royalties for various textbooks; holding stock options in DBV Technologies and N-FOLD; receives grant support to his institution from the Immune Tolerance Network and NIH/NIAID; and serves as an unpaid Board of Directors member and advisor to AllerGenis. R. A. Wood reports royalty payments from UpToDate and grant support to his institution from the NIH/NIAID, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, HAL-Allergy, and Sanofi. S. M. Jones reports research advisory board membership with FARE and consultancy and scientific advisory board membership with Aimmune Therapeutics; received grant support to her institution from the NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE; and has performed CSR review/preparation for DBV Technologies on behalf of Emmes. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: This study is registered with ClinicalTrials.gov with ID NCT01904604 and was supported by the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) (grant nos. U19AI066738, U01AI066560, and UM2AI130836). The project was also supported by the University of Arkansas for Medical Sciences (grant no. UM1AI130781), the University of North Carolina (grant no. UM1AI30936), the Mount Sinai University (grant no. UM1AI130570), National Jewish Health (grant no. UM1AI130780), and Johns Hopkins University School of Medicine (grant no. UM1AI30838), which were supported by the NIH-NIAID, and by the University of Arkansas for Medical Sciences (grant no. UL1TR003107), the University of North Carolina (grant no. UL1TR001111), the Mount Sinai University (grant no. UL1TR000067), National Jewish Health (grant no. UL1TR002535), and Johns Hopkins University School of Medicine (grant no. UL1TR000424), which were supported by the National Center for Research Resources (NCRR), a component of the NIH. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or the NIH. Support for this trial was also provided by DBV Technologies, Inc (Montrouge, France), through funds provided to the Consortium for Food Allergy Research. Protocol development, study conduct, data analysis, and manuscript development were conducted independently of DBV. Disclosure of potential conflict of interest: A. M. Scurlock reports grant support to her institution from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and Food Allergy Research and Education (FARE) and clinical medical advisory board membership with DBV Technologies. A. W. Burks reports being a minority stock holder in Allertein and Mastcell pharmaceuticals; scientific advisory board membership with Aimmune Therapeutics, Consortia TX, Inc, Intrommune Therapeutics, and Prota Therapeutics; consultancy for DBV Technologies, N-fold LLC, Aravax, Genentech, and Hycor Biomedical; grant support to his institution from the NIH/NIAID, NIH/National Center for Complementary and Integrative Health, Johns Hopkins/NIH, FARE, and the Wallace Research Foundation, in addition to royalty payments from UpToDate and royalties paid from the following US patents: #7879977, #6835824, #6486311, #6441142, #5973121, and #5558869. S. H. Sicherer reports grants from NIH/NIAID and royalty payments from UpToDate, the American Academy of Allergy, Asthma & Immunology, and Johns Hopkins University Press. D. Y. M. Leung receives grant support to his institution from the NIH/NIAID and serves on the Data Safety Monitoring Committee for Aimmune Therapeutics. E. H. Kim reports clinical medical advisory board membership with DBV Technologies; consultancy with Aimmune Therapeutics, DBV Technologies, AllerGenis, Allakos, Ukko, and Vibrant America; and grant support to his institution from the NIH/NIAID, NIH/NCCIH, FARE, and the Wallace Research Foundation. A. K. Henning, P. Dawson, and R. W. Lindblad are employed by Emmes, which received grant support from the Division of Allergy, Immunology and Transplantation (DAIT)/NIH/NIAID. M. C. Berin reports scientific advisory board membership with Prota Therapeutics. H. A. Sampson reports being a part-time employee of DBV Technologies; receiving consultant fees from N-Fold Therapeutics, and royalties for various textbooks; holding stock options in DBV Technologies and N-FOLD; receives grant support to his institution from the Immune Tolerance Network and NIH/NIAID; and serves as an unpaid Board of Directors member and advisor to AllerGenis. R. A. Wood reports royalty payments from UpToDate and grant support to his institution from the NIH/NIAID, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, HAL-Allergy, and Sanofi. S. M. Jones reports research advisory board membership with FARE and consultancy and scientific advisory board membership with Aimmune Therapeutics; received grant support to her institution from the NIH/NIAID, Immune Tolerance Network, Aimmune Therapeutics, DBV Technologies, Astellas, Regeneron, Genentech, and FARE; and has performed CSR review/preparation for DBV Technologies on behalf of Emmes. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: This study is registered with ClinicalTrials.gov with ID NCT01904604 and was supported by the National Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID) (grant nos. U19AI066738 , U01AI066560 , and UM2AI130836 ). The project was also supported by the University of Arkansas for Medical Sciences (grant no. UM1AI130781 ), the University of North Carolina (grant no. UM1AI30936 ), the Mount Sinai University (grant no. UM1AI130570 ), National Jewish Health (grant no. UM1AI130780 ), and Johns Hopkins University School of Medicine (grant no. UM1AI30838 ), which were supported by the NIH-NIAID , and by the University of Arkansas for Medical Sciences (grant no. UL1TR003107 ), the University of North Carolina (grant no. UL1TR001111 ), the Mount Sinai University (grant no. UL1TR000067 ), National Jewish Health (grant no. UL1TR002535 ), and Johns Hopkins University School of Medicine (grant no. UL1TR000424 ), which were supported by the National Center for Research Resources (NCRR), a component of the NIH. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or the NIH. Support for this trial was also provided by DBV Technologies, Inc (Montrouge, France), through funds provided to the Consortium for Food Allergy Research. Protocol development, study conduct, data analysis, and manuscript development were conducted independently of DBV. Publisher Copyright: © 2020 American Academy of Allergy, Asthma & Immunology
PY - 2021/3
Y1 - 2021/3
N2 - Background: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years. Objective: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy. Methods: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated. Results: At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2–specific IgG4 observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose. Conclusions: Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
AB - Background: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years. Objective: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy. Methods: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Efficacy was assessed by double-blind, placebo-controlled food challenge (5044 mg peanut protein), and adherence, safety, and mechanistic parameters were evaluated. Results: At week 130, desensitization success was achieved in 1 of 20 (5%) PLB-VP250, 5 of 24 (20.8%) VP100-VP250, and 9 of 25 (36%) VP250 participants, with median successfully consumed dose change from baseline of 11.5 mg, 141.5 mg, and 400 mg, respectively. Median age (years) for week 130 desensitization success was 6.2 years (interquartile range, 5.2-9.1) versus 9.4 years (interquartile range, 7.6-12.8) for failures (P < .001). Adherence was 96%. Adverse reactions were predominantly local patch-site reactions. Significant increases in peanut- and Ara h2–specific IgG4 observed at week 52 persisted to week 130. By a post hoc analysis, there were no statistically significant increases from week 52 to week 130 in either desensitization success or successfully consumed dose. Conclusions: Extended treatment with VP250 was well tolerated, and desensitization observed at week 52 persisted between weeks 52 and 130. Treatment success was observed predominantly in younger participants, with younger age at initiation of active therapy an important predictor of success.
KW - IgE
KW - IgG
KW - Peanut allergy
KW - desensitization
KW - epicutaneous immunotherapy
KW - follow-up
KW - food allergy
UR - http://www.scopus.com/inward/record.url?scp=85098964100&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85098964100&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2020.11.027
DO - 10.1016/j.jaci.2020.11.027
M3 - Article
C2 - 33290772
AN - SCOPUS:85098964100
SN - 0091-6749
VL - 147
SP - 992-1003.e5
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 3
ER -