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Kei Hosoya,1 Taro Komachi,2,* Katsunori Masaki,3,* Isao Suzaki,4 Hidehisa Saeki,5 Naoko Kanda,6 Makoto Nozaki,7 Yosuke Kamide,8 Yoshinori Matsuwaki,9 Yoshiki Kobayashi,10 Eriko Ogino,11 Shin-Ichi Osada,12 Norihiro Usukura,13 Toshikazu Kurumagawa,14 Junya Ninomia,15 Mikiya Asako,16 Keitaro Nakamoto,17 Hidenori Yokoi,18 Manabu Ohyama,19 Keiji Tanese,3 Sho Kanzaki,3 Koichi Fukunaga,3 Motohiro Ebisawa,8 Kimihiro Okubo13 1Nippon Medical School, Musashi Kosugi Hospital, Kanagawa, Japan; 2Department of Otolaryngology, Nippon Medical School, Chiba Hokusoh Hospital, Inzai, Chiba, Japan; 3Keio Allergy Center, Keio University Hospital, Tokyo, Japan; 4Department of Otorhinolaryngology, Head and Neck Surgery, Showa University, School of Medicine, Tokyo, Japan; 5Department of Dermatology, Nihon Medical School, Tokyo, Japan; 6Department of Dermatology, Nippon Medical School, Chiba Hokusoh Hospital, Inzai, Chiba, Japan; 7Wakaba-Hifuka Clinic, Tokyo, Japan; 8National Hospital Organization Sagamihara National Hospital, Clinical Research Center for Allergy and Rheumatology, Kanagawa, Japan; 9Matsuwaki Clinic Shinagawa, Tokyo, Japan; 10Allergy Center, Kansai Medical University, Hirakata, Japan; 11Kyoto Nose and Allergy Clinic, Kyoto, Japan; 12Department of Dermatology, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan; 13Department of Otolaryngology, Head and Neck Surgery, Nippon Medical School Hospital, Tokyo, Japan; 14Minamiosawa Medical Plaza, Tokyo, Japan; 15Nagase Clinic of Dermatology, Tokyo, Japan; 16Department of Otolaryngology, Head and Neck Surgery, Kansai Medical University, Osaka, Japan; 17Department of Respiratory Medicine, Kyorin University Faculty of Medicine, Tokyo, Japan; 18Department of Otolaryngology, Head and Neck Surgery, Kyorin University Faculty of Medicine, Tokyo, Japan; 19Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan*These authors contributed equally to this workCorrespondence: Kei Hosoya, Nippon Medical School, Musashi Kosugi Hospital, 1-383 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa, 211-8533, Japan, Tel +81-44-733-5181, Fax +81-44-711-8713, Email s00-073@nms.ac.jpPurpose: The status of dupilumab self-injection at home is not well understood. We therefore aimed to identify the barriers to adherence to dupilumab self-injection.Patients and Methods: This non-interventional open-label study was conducted between March 2021 and July 2021. Patients with atopic dermatitis, bronchial asthma, and chronic rhinosinusitis with nasal polyps receiving dupilumab, from 15 sites, were requested to complete a self-administered questionnaire regarding the frequency and effectiveness of dosing as well as their use and satisfaction with dupilumab. Barriers to adherence were assessed using the Adherence Starts with Knowledge-12.Results: We included 331 patients who used dupilumab for atopic dermatitis (n = 164), chronic rhinosinusitis with nasal polyps (n = 102), and bronchial asthma (n = 65). The median efficacy of dupilumab scored 9.3 on the visual analog scale. Overall, 85.5% of the patients self-injected dupilumab, and 70.7% perfectly complied with the established injection dates. The pre-filled pen was significantly superior to the conventional syringe in terms of usability, operability, ease of pushing the plunger, and patient satisfaction. However, the pre-filled pen caused more pain during self-injection than did the syringe. Multivariate logistic regression analysis showed that adherence decreased with longer dupilumab treatment duration (p = 0.017) and was not associated with age, sex, underlying disease, or device type. There was a difference in responses related to “inconvenience/forgetfulness” between the good and poor adherence groups.Conclusion: The pre-filled dupilumab pen was superior to the syringe in terms of usability, operability, ease of pushing the plunger, and satisfaction. Repetitive instructions are recommended for preventing poor adherence to dupilumab self-injection.Keywords: atopic dermatitis, biologics, bronchial asthma, chronic rhinosinusitis