Enhanced early skin treatment for atopic dermatitis in infants reduces food allergy - 05/07/23
Doi : 10.1016/j.jaci.2023.03.008
Kiwako Yamamoto-Hanada, MD, PhD a, Tohru Kobayashi, MD, PhD a, Masashi Mikami, MS a, Hywel C. Williams, DS, FMedSci b, Hirohisa Saito, MD, PhD a, Mayako Saito-Abe, MD, PhD a, Miori Sato, MD a, Makoto Irahara, MD, PhD a, Yumiko Miyaji, MD, PhD a, Fumi Ishikawa, MD a, Kunihiko Tsuchiya, MD, PhD c, Risa Tamagawa-Mineoka, MD, PhD c, Yuri Takaoka, MD, PhD d, Yutaka Takemura, MD, PhD e, Sakura Sato, MD f, Hiroyuki Wakiguchi, MD, PhD g, Miyuki Hoshi, MD h, Osamu Natsume, MD, PhD i, Fumiya Yamaide, MD, PhD j, Miwako Seike, RN a, Yukihiro Ohya, MD, PhD a, ⁎ 
on the behalf of
on the behalf of
PACI Study Collaborators∗
Kumiko Morita, MD, Eisuke Inoue, PhD, Tatsuki Fukuie, MD, PhD, Shigenori Kabashima, MD, PhD, Yusuke Inuzuka, MD, Koji Nishimura, MD, Kenji Toyokuni, MD, Hiroya Ogita, MD, Tomoyuki Kiguchi, MD, Kazue Yoshida, MD, PhD, Jumpei Saito, PhD, Hajime Hosoi, MD, PhD, Norito Katoh, MD, PhD, Mariko Morimoto, MD, Koji Masuda, MD, PhD, Makoto Kameda, MD, Amane Shigekawa, MD, Koji Yamasaki, MD, PhD, Megumi Nagai, MD, PhD, Motohiro Ebisawa, MD, PhD, Tomoyuki Asaumi, MD, Takaaki Itonaga, MD, Shunji Hasegawa, MD, PhD, Hiroki Yasudo, MD, PhD, Mizuho Nagao, MD, PhD, Takao Fujisawa, MD, PhD, Ryuhei Yasuoka, MD, PhD, Toshiharu Fujiyama, MD, PhD, Naoki Shimojo, MD, PhD, Taiji Nakano, MD, PhD, Yasuto Kondo, MD, PhD, Yuji Mori, MD, PhD, Takahiro Kawaguchi, MD, Masaki Futamura, MD, PhD, Kazumitsu Sugiura, MD, PhD, Akiyo Nagai, MD, PhD, Sachiko Kaburagi, MD, Hiroshi Kitazawa, MD, PhD, Hiroshi Kido, MD, PhD, Shoji F. Nakayama, MD, PhD
a National Center for Child Health and Development, Tokyo, Japan
b Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, United Kingdom
c Kyoto Prefectural University of Medicine, Kyoto, Japan
d Osaka Habikino Medical Center, Osaka, Japan
e Kindai University Faculty of Medicine, Osaka, Japan
f National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan
g Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan
h National Hospital Organization Mie National Hospital, Mie, Japan
i Hamamatsu University School of Medicine, Shizuoka, Japan
j Chiba University Graduate School of Medicine, Chiba, Japan
∗Corresponding author: Yukihiro Ohya, MD, PhD, Director, Allergy Center, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan.Allergy CenterNational Center for Child Health and Development2-10-1 OkuraSetagaya-kuTokyo157-8535Japan
Graphical abstract |
Abstract |
Background |
Early-onset atopic dermatitis is a strong risk factor for food allergy, suggesting that early effective treatment may prevent transcutaneous sensitization.
Objectives |
This study tested whether enhanced treatment of atopic dermatitis to clinically affected and unaffected skin is more effective in preventing hen’s egg allergy than reactive treatment to clinically affected skin only.
Methods |
This was a multicenter, parallel-group, open-label, assessor-blind, randomized controlled trial (PACI [Prevention of Allergy via Cutaneous Intervention] study). This study enrolled infants 7-13 weeks old with atopic dermatitis and randomly assigned infants in a 1:1 ratio to enhanced early skin treatment or conventional reactive treatment using topical corticosteroids (TCSs). The primary outcome was the proportion of immediate hen’s egg allergy confirmed by oral food challenge at 28 weeks of age.
Results |
This study enrolled 650 infants and analyzed 640 infants (enhanced [n = 318] or conventional [n = 322] treatment). Enhanced treatment significantly reduced hen’s egg allergy compared with the conventional treatment (31.4% vs 41.9%, P = .0028; risk difference: –10.5%, upper bound of a 1-sided CI: –3.0%), while it lowered body weight (mean difference: –422 g, 95% CI: –553 to –292 g) and height (mean difference: –0.8 cm, 95% CI: –1.22 to –0.33 cm) at 28 weeks of age.
Conclusions |
This study highlighted the potential of well-controlled atopic dermatitis management as a component of a hen’s egg allergy prevention strategy. The enhanced treatment protocol of this trial should be modified before it can be considered as an approach to prevent hen’s egg allergy in daily practice to avoid the adverse effects of TCSs. After remission induction by TCSs, maintenance therapy with lower potency TCSs or other topical therapies might be considered as alternative proactive treatments to overcome the safety concerns of TCSs.
Le texte complet de cet article est disponible en PDF.Key words : Atopic dermatitis, food allergy, prevention, randomized controlled trial, proactive therapy
Abbreviations used : EASI, FAS, FTU, OFC, POEM, PPS, RCT, RD, TCS
Plan
| Supported by the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003). The Japan Agency for Medical Research and Development had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. |
|
| Disclosure of potential conflict of interest: K. Yamamoto-Hanada received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study. She received grants from the Japan Agency for Medical Research and Development (grant JP22he0422021j0001), Japan Society for the Promotion of Science (JSPS) KAKENHI (grants 22K10545, 20H05678, 19H03569, 18H03101, and 17K13214), National Center for Child Health and Development (grants 2019B-1 and 2021B-12), Japanese Society of Allergology, Environmental Restoration and Conservation Agency, National Science, and Takano Medical; consulting fees from bcase, Abbvie, and KAO; and lecture fees from Abbvie, KAO, Torii Pharmaceutical, Maruho, Pfizer, and Otsuka Pharmaceutical outside of the submitted work. She was a member of the Committee for Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021 (the Japanese Society of Allergology, the Japanese Dermatology Association), a collaborator and systematic review team member of the Japanese Guidelines for Food Allergy 2021 (the Japanese Society of Pediatric Allergy and Clinical Immunology), a member of the allergy prevention committee (World Allergy Organization), and a board member of the Japan Society of Health Science for Children outside of the submitted work. T. Kobayashi received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study. M. Mikami received grants from the Japan Agency for Medical Research and Development (Grant Number J.P. 18ek0410027h0003 and J.P. 20ek0410054h0002) related to this study. H. Saito received grants from the Japan Agency for Medical Research and Development (grants JP18ek0410027h0003 and JP20ek0410054h0002) related to this study. He obtained grants from Bit genomix, JSPS KAKENHI (grant 18H02850), and Health Labour Sciences Research Grant (grants 201913001B and 201913007B), and lecture fees from Novartis, Santen Pharmaceutical, Shionogi Pharma, and Astellas Pharma, and is an auditor of the Japanese Society of Pediatric Allergy and Clinical Immunology outside of the submitted work. M. Saito-Abe received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study and a grant from JSPS KAKENHI (grant 22K17791) outside of the submitted work. She received a lecture fee from Sato Pharmaceutical outside of the submitted work. M. Sato received grants from the Japan Agency for Medical Research and Development (grant JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study and grants from JSPS KAKENHI (grants 18H03101 and 22K08537) outside of the submitted work. M. Irahara received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study. He obtained a grant from JSPS KAKENHI (grant 20K17457) and lecture fees from Kyorin Pharmaceutical and Tokushima Medical Association outside of the submitted work. He was a member of the systematic review team for the Japanese Guidelines for Food Allergy 2021 (the Japanese Society of Pediatric Allergy and Clinical Immunology) outside of the submitted work. Y. Miyaji received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study and a grant from JSPS KAKENHI (grants 22K17791) outside of the submitted work. F. Ishikawa received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study and a grant from the National Center for Child Health and Development (grant 2020B-13) outside of the submitted work. K. Tsuchiya received grants from the Japan Agency for Medical Research and Development (grants JP19ek0410054h0001 and JP20ek0410054h0002) related to this study. He received grants from Health Labour Sciences Research Grant (grant 202013001A) and Sanofi; and lecture fees from Mylan, Maruho, and Torii Pharmaceutical outside of the submitted work. R. Tamagawa-Mineoka received grants from the Japan Agency for Medical Research and Development (grants JP19ek0410054h0001 and JP20ek0410054h0002) related to this study. She received grants from JSPS KAKENHI (grant 21K08330), Mitsubishi Tanabe Pharma Corporation, Teikoku Seiyaku, Maruho, and Sanofi; and lecture fees from Mitsubishi Tanabe Pharma, Sanofi, Maruho, Sato Pharmaceutical, Otsuka Pharmaceutical, Eisai, and Taiho Pharmaceutical outside of the submitted work. Y. Takaoka received a grant from the Japan Agency for Medical Research and Development (grant JP20ek0410054h0002) related to this study. She was a member of the systematic review team and collaborator for the Japanese Guidelines for Food Allergy 2021 (the Japanese Society of Pediatric Allergy and Clinical Immunology) outside of the submitted work. Y. Takemura received a grant from Environmental Restoration and Conservation Agency; and lecture fees from Abbvie, Maruho, and Torii Pharmaceutical outside of the submitted work. S. Sato received grants from the Japan Agency for Medical Research and Development (grants JP17ek0410027h0002, JP19ek0410054h001, and JP20ek0410054h0002) related to this study. She received grants from the Japan Agency for Medical Research and Development (grant JP22ek0410096h0001) and JSPS KAKENHI (grant 17K00909); and lecture fees from Viatris, Torii Pharmaceutical, and Thermo Fisher Diagnostic outside of the submitted work. She was a member of the Committee for Japanese Guidelines for Food Allergy 2021 (the Japanese Society of Pediatric Allergy and Clinical Immunology) and is a board member of the Japanese Society of Pediatric Allergy and Clinical Immunology and the Asia Pacific Academy of Pediatric Allergy, Respirology, and Immunology outside of the submitted work. H. Wakiguchi received a grant from the Japan Agency for Medical Research and Development (grants JP19ek0410054h0001 and JP20ek0410054h0002) related to this study. M. Hoshi received grants from the Japan Agency for Medical Research and Development (grants JP17ek0410027h0002, JP19ek0410054h001, and JP20ek0410054h0002) related to this study. O. Natsume received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study; and JSPS KAKENHI (grant 22K08520) and lecture fees from Maruho, Torii Pharmaceutical, Abbvie, and Sanofi outside of the submitted work. F. Yamaide received a grant from the Japan Agency for Medical Research and Development (grant JP20ek0410054h0002) related to this study. He received grants from Mitsubishi Gas Chemical Company and JSPS KAKENHI (grant 21K07815); and lecture fees from Kyorin Pharmaceutical and Sanofi outside of the submitted work. M. Seike received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study. Y. Ohya received grants from the Japan Agency for Medical Research and Development (grants JP16ek0410027h0001, JP17ek0410027h0002, JP18ek0410027h0003, JP19ek0410054h001, JP20ek0410054h0002, and JP21ek0410054h0003) related to this study. He obtained grants from the Japan Agency for Medical Research and Development (grants JP21ek0410067h0002 and JP19ek0410037h0003), Health Labour Sciences Research Grant (grants 202111023A, 201913001B, 201911035B, and 201913007B), JSPS KAKENHI (grants 18H03101, 19H03569, and 20H01622), National Center for Child Health and Development (2019E-1), Alcare, Fam's Baby, Kao, Yakult, Duskin, Maruho, Novartis, Torii Pharmaceutical, and Natural Science; and consulting fees from bcase, Abbvie, Kao, Maruho, Otsuka Pharmaceutical, Sanofi/Regeneron, Torii/Japan Tabacco, and Pfizer outside of the submitted work. He received lecture fees from Abbvie, Eli Lilly, Kyorin, Maruho, Mitsubishi Tanabe Pharma, Pola Pharma, Sanofi, Shino-test, Sysmex, Shiseido, Thermo Fisher Diagnostic, Torii Pharmaceutical, Towa Pharmaceutical, Otsuka Pharmaceutical, and Pfizer outside of the submitted work. He participated on the advisory board of Abbvie and Sanofi outside of the submitted work. He was the vice chairman of the Committee for Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021 (the Japanese Society of Allergology, the Japanese Dermatology Association, and the member of the Committee for Japanese Guidelines for Food Allergy 2021 [the Japanese Society of Pediatric Allergy and Clinical Immunology]) outside of the submitted work. He is a board member of the Japanese Society of Allergology and Japanese Society of Behavioral Medicine, the vice chairman of the Japanese Society of Pediatric Dermatology, and the president of the Japan Society of Health Science for Children outside of the submitted work. H.C. Williams declares that he has no relevant conflicts of interest. |
|
| UMIN Clinical Trial Registry Identifier: UMIN000028043. |
© 2023
American Academy of Allergy, Asthma & Immunology. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 152 - N° 1
P. 126-135 - juillet 2023 Retour au numéro
Article précédent
- Stratification of asthma by lipidomic profiling of induced sputum supernatant
- Joost Brandsma, James P.R. Schofield, Xian Yang, Fabio Strazzeri, Clair Barber, Victoria M. Goss, Grielof Koster, Per S. Bakke, Massimo Caruso, Pascal Chanez, Sven-Erik Dahlén, Stephen J. Fowler, Ildikó Horváth, Norbert Krug, Paolo Montuschi, Marek Sanak, Thomas Sandström, Dominick E. Shaw, Kian Fan Chung, Florian Singer, Louise J. Fleming, Ian M. Adcock, Ioannis Pandis, Aruna T. Bansal, Julie Corfield, Ana R. Sousa, Peter J. Sterk, Rubén J. Sánchez-García, Paul J. Skipp, Anthony D. Postle, Ratko Djukanović, the U-BIOPRED Study Group
- Local type 2 immunity in eosinophilic gastritis
- Netali Ben-Baruch Morgenstern, Tetsuo Shoda, Yrina Rochman, Julie M. Caldwell, Margaret H. Collins, Vincent Mukkada, Philip E. Putnam, Scott M. Bolton, Jennifer M. Felton, Mark Rochman, Cristin Murray-Petzold, Kara L. Kliewer, Marc E. Rothenberg
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?