気管支喘息を合併した難病指定好酸球性副鼻腔炎再発例に対する生物学的製剤と経鼻呼出法による治療
重症気管支喘息を合併した難病指定好酸球性副鼻腔炎（ECRS）術後再発例16例に対して吸入ステロイド（ICS）経鼻呼出法を行った後，mepolizumabをICS経鼻呼出に加えて投与し，更にmepolizumabからdupilumabに変更して投与を行った。これらの症例のECRSに対する効果を後方視的に検証した。結果は，ICS経鼻呼出法で3例，mepolizumabの追加で5例において，副鼻腔CTのLund-Mackay Score（LMS）が改善し，残りの8例はdupilumabへの変更によってLMSの改善が初めて認められた。全例で喘息の増悪は見られなかった。Dupilumabの投与を必要とし...
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| Published in | 日本鼻科学会会誌 Vol. 60; no. 4; pp. 538 - 545 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
日本鼻科学会
2021
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0910-9153 1883-7077 |
| DOI | 10.7248/jjrhi.60.538 |
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| Abstract | 重症気管支喘息を合併した難病指定好酸球性副鼻腔炎（ECRS）術後再発例16例に対して吸入ステロイド（ICS）経鼻呼出法を行った後，mepolizumabをICS経鼻呼出に加えて投与し，更にmepolizumabからdupilumabに変更して投与を行った。これらの症例のECRSに対する効果を後方視的に検証した。結果は，ICS経鼻呼出法で3例，mepolizumabの追加で5例において，副鼻腔CTのLund-Mackay Score（LMS）が改善し，残りの8例はdupilumabへの変更によってLMSの改善が初めて認められた。全例で喘息の増悪は見られなかった。Dupilumabの投与を必要とした8例では，それ以外の8例と比較して，治療開始前のLMS，呼気一酸化窒素濃度（FeNO），末梢血好酸球比率，非特異的IgE値に統計学的有意差を認めなかったが，血清TARCの最高値はdupilumab投与群で有意に高値であり，400 pg/ml以上の症例が有意に多かった。喘息を合併したECRSの治療にはdupilumabが有効であるが，好酸球増多疾患がマスクされている可能性も考えると，今回のような順に治療を行っていくことが有用である。また，TARCのようなIL-4/13のマーカーが治療法の選択に役立つかもしれない。 |
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| AbstractList | 重症気管支喘息を合併した難病指定好酸球性副鼻腔炎（ECRS）術後再発例16例に対して吸入ステロイド（ICS）経鼻呼出法を行った後，mepolizumabをICS経鼻呼出に加えて投与し，更にmepolizumabからdupilumabに変更して投与を行った。これらの症例のECRSに対する効果を後方視的に検証した。結果は，ICS経鼻呼出法で3例，mepolizumabの追加で5例において，副鼻腔CTのLund-Mackay Score（LMS）が改善し，残りの8例はdupilumabへの変更によってLMSの改善が初めて認められた。全例で喘息の増悪は見られなかった。Dupilumabの投与を必要とした8例では，それ以外の8例と比較して，治療開始前のLMS，呼気一酸化窒素濃度（FeNO），末梢血好酸球比率，非特異的IgE値に統計学的有意差を認めなかったが，血清TARCの最高値はdupilumab投与群で有意に高値であり，400 pg/ml以上の症例が有意に多かった。喘息を合併したECRSの治療にはdupilumabが有効であるが，好酸球増多疾患がマスクされている可能性も考えると，今回のような順に治療を行っていくことが有用である。また，TARCのようなIL-4/13のマーカーが治療法の選択に役立つかもしれない。 |
| Author | 荻野, 枝里子 安場, 広高 |
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| References | 14) Hamada S, Ogino E, Yasuba H: Cycling therapy with benralizumab and dupilumab for severe eosinophilic asthma with eosinophilic chronic rhinosinusitis and eosinophilic otitis media. Allergol Int 2021; 70: 389–391. 24) Cui XY, Miao JL, Lu HQ, et al: Serum levels of specific IgE to Staphylococcus aureus enterotoxins in patients with chronic rhinosinusitis. Exp Ther Med 2015; 9: 1523–1527. 13) Menzella F, Montanari G, Patricelli G, et al: A case of chronic eosinophilic pneumonia in a patient treated with dupilumab. Ther Clin Risk Manag 2019; 15: 869–875. 25) Meier EC, Grendelmeier PS, Steiner US, et al: Real-life experience of monoclonal antibody treatments in chronic rhinosinusitis with nasal polyposis. Int Arch Allergy Immunol 2021; 182: 736–743. 2) Hamada S, Kobayashi Y, Yasuba H: Role of eosinophilic chronic rhinosinusitis in switching to benralizumab treatment in mepolizumab responders. Int J Clin Pharmacol Ther 2020; 58: 703–708. 26) Peters AJ, Han JK, Hellings P, et al: Indirect treatment comparison of biologics in chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract 2021; 9: 2461–2471. 15) Takabayashi T, Asaka D, Okamoto Y, et al: A phase II, multicenter, randomized, placebo-controlled study of benralizumab, a humanized anti-IL-5R alpha monoclonal antibody, in patients with eosinophilic chronic rhinosinusitis. Am J Rhinol Allergy 2021; 35: 861–870. 1) Joseph KH, Bachert C, Fokkens W, et al: Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2021; 9: 1141–1153. 4) Hamada S, Hira D, Kobayashi Y, et al: Effect of nasally exhaling budesonide/formoterol dry powder inhaled at “fast” inspiratory flow on eosinophilic chronic rhinosinusitis. Int J Clin Pharmacol Ther 2018; 56: 539–543. 9) 関 博之，板垣英二，高橋和人，他：カリニ肺炎を併発したステロイド含有点鼻薬によるCushing症候群の一例．日内分泌会誌 2003; 79: 90–94. 17) Wenzel S, Ford L, Pearlman D, et al: Dupilumab in persistent asthma with elevated eosinophil levels. N Eng J Med 2013; 368: 2455–2466. 19) Tsybikov NN, Egorova EV, Kuznik B, et al: Biomarker assessment in chronic rhinitis and chronic rhinosinusitis: Endothelin-1, TARC/CCL17, neopterin and α-defensins. Allergy Asthma Proc 2016; 37: 35–42. 23) Tomassen P, Vandeplas G, Van Zele T, et al: Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol 2016; 137: 1449–1456. 10) 好酸球性副鼻腔炎（指定難病306）：指定難病ペディア2019（日本医師会生涯教育シリーズ96） 日本医師会雑誌；148特別号（1）：S296–S297．診断と治療社，東京；2019. 27) Harrison TW, Chanez P, Frances CO, et al: Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): A randomized, controlled, phase 3b trial. Lancet Respir Med 2021; 9: 260–274. 6) Sullivan PW, Ghushchyan VH, Globe G, et al: Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol 2018; 141: 110–116. 21) Mustafa SS, Vadamalai K, Scott B, et al: Dupilumab as add-on therapy for chronic rhinosinusitis with nasal polyposis in aspirin exacerbated respiratory disease. Am J Rhinol Allergy 2021; 35: 399–407. 22) 安場広高：気管支喘息における好酸球性副鼻腔炎（ECRS）の合併～合併率，肺機能，微生物の特異IgE抗体について．三菱京都病医誌 2019; 26: 45–48. 11) 安場広高：好酸球性副鼻腔炎と喘息～吸入ステロイド経鼻呼出法の有用性とAirway Medicineの考え方．Medical Practice 2019; 36: 1847–1852. 8) 平澤一浩，大塚康司，伊藤博之，他：嗅覚障害に対するステロイド点鼻により生じた副腎機能不全例．耳鼻臨床 2014; 107: 529–533. 16) Tversky J, Lane AP, Azar A: Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial. Clin Exp Allergy 2021; 51: 836–844. 5) Tokunaga T, Sakashita M, Haruna T, et al: Novel scoring system and algorithm for classifying chronic rhinosinusitis: The JESREC study. Allergy 2015; 70: 995–1003. 3) Kobayashi Y, Yasuba H, Asako M, et al: HFA-BDP metered-dose inhaler exhaled through the nose improves eosinophilic chronic rhinosinusitis with bronchial asthma: A blinded, placebo-controlled study. Front Immunol 2018; 9: 2192. 12) Maspero JF, Katelaris CH, Busse WW, et al: Dupilumab efficacy in uncontrolled, moderate-to-severe asthma with self-reported chronic rhinosinusitis. J Allergy Clin Immunol Pract 2020; 8: 527–539. 7) 池袋宗博，角田美佳子，土井 賢，他：過剰ステロイド点鼻薬によって二次性副腎不全になった1例．ACTH RELATED PEPTIDES 2003; 14: 211–215. 20) Stevens WW, Ocampo CJ, Berdnikovs S, et al: Cytokines in chronic rhinosinusitis: Role in eosinophilia and aspirin-exacerbated respiratory disease. Am J Resp Critic Care Med 2015; 19: 682–694. 18) Nonaka M, Ogihara N, Fukumoto A, et al: Combined stimulation with Poly(I:C), TNF-alpha and Th2 cytokines induces TARC production by human fibroblasts from the nose, bronchioles and lungs. Int Arch Allergy Immunol 2010; 152: 327–341. |
| References_xml | – reference: 7) 池袋宗博，角田美佳子，土井 賢，他：過剰ステロイド点鼻薬によって二次性副腎不全になった1例．ACTH RELATED PEPTIDES 2003; 14: 211–215. – reference: 21) Mustafa SS, Vadamalai K, Scott B, et al: Dupilumab as add-on therapy for chronic rhinosinusitis with nasal polyposis in aspirin exacerbated respiratory disease. Am J Rhinol Allergy 2021; 35: 399–407. – reference: 26) Peters AJ, Han JK, Hellings P, et al: Indirect treatment comparison of biologics in chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract 2021; 9: 2461–2471. – reference: 12) Maspero JF, Katelaris CH, Busse WW, et al: Dupilumab efficacy in uncontrolled, moderate-to-severe asthma with self-reported chronic rhinosinusitis. J Allergy Clin Immunol Pract 2020; 8: 527–539. – reference: 14) Hamada S, Ogino E, Yasuba H: Cycling therapy with benralizumab and dupilumab for severe eosinophilic asthma with eosinophilic chronic rhinosinusitis and eosinophilic otitis media. Allergol Int 2021; 70: 389–391. – reference: 17) Wenzel S, Ford L, Pearlman D, et al: Dupilumab in persistent asthma with elevated eosinophil levels. N Eng J Med 2013; 368: 2455–2466. – reference: 20) Stevens WW, Ocampo CJ, Berdnikovs S, et al: Cytokines in chronic rhinosinusitis: Role in eosinophilia and aspirin-exacerbated respiratory disease. Am J Resp Critic Care Med 2015; 19: 682–694. – reference: 18) Nonaka M, Ogihara N, Fukumoto A, et al: Combined stimulation with Poly(I:C), TNF-alpha and Th2 cytokines induces TARC production by human fibroblasts from the nose, bronchioles and lungs. Int Arch Allergy Immunol 2010; 152: 327–341. – reference: 2) Hamada S, Kobayashi Y, Yasuba H: Role of eosinophilic chronic rhinosinusitis in switching to benralizumab treatment in mepolizumab responders. Int J Clin Pharmacol Ther 2020; 58: 703–708. – reference: 27) Harrison TW, Chanez P, Frances CO, et al: Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): A randomized, controlled, phase 3b trial. Lancet Respir Med 2021; 9: 260–274. – reference: 1) Joseph KH, Bachert C, Fokkens W, et al: Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2021; 9: 1141–1153. – reference: 5) Tokunaga T, Sakashita M, Haruna T, et al: Novel scoring system and algorithm for classifying chronic rhinosinusitis: The JESREC study. Allergy 2015; 70: 995–1003. – reference: 24) Cui XY, Miao JL, Lu HQ, et al: Serum levels of specific IgE to Staphylococcus aureus enterotoxins in patients with chronic rhinosinusitis. Exp Ther Med 2015; 9: 1523–1527. – reference: 16) Tversky J, Lane AP, Azar A: Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial. Clin Exp Allergy 2021; 51: 836–844. – reference: 25) Meier EC, Grendelmeier PS, Steiner US, et al: Real-life experience of monoclonal antibody treatments in chronic rhinosinusitis with nasal polyposis. Int Arch Allergy Immunol 2021; 182: 736–743. – reference: 19) Tsybikov NN, Egorova EV, Kuznik B, et al: Biomarker assessment in chronic rhinitis and chronic rhinosinusitis: Endothelin-1, TARC/CCL17, neopterin and α-defensins. Allergy Asthma Proc 2016; 37: 35–42. – reference: 15) Takabayashi T, Asaka D, Okamoto Y, et al: A phase II, multicenter, randomized, placebo-controlled study of benralizumab, a humanized anti-IL-5R alpha monoclonal antibody, in patients with eosinophilic chronic rhinosinusitis. Am J Rhinol Allergy 2021; 35: 861–870. – reference: 11) 安場広高：好酸球性副鼻腔炎と喘息～吸入ステロイド経鼻呼出法の有用性とAirway Medicineの考え方．Medical Practice 2019; 36: 1847–1852. – reference: 6) Sullivan PW, Ghushchyan VH, Globe G, et al: Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol 2018; 141: 110–116. – reference: 10) 好酸球性副鼻腔炎（指定難病306）：指定難病ペディア2019（日本医師会生涯教育シリーズ96） 日本医師会雑誌；148特別号（1）：S296–S297．診断と治療社，東京；2019. – reference: 13) Menzella F, Montanari G, Patricelli G, et al: A case of chronic eosinophilic pneumonia in a patient treated with dupilumab. Ther Clin Risk Manag 2019; 15: 869–875. – reference: 22) 安場広高：気管支喘息における好酸球性副鼻腔炎（ECRS）の合併～合併率，肺機能，微生物の特異IgE抗体について．三菱京都病医誌 2019; 26: 45–48. – reference: 3) Kobayashi Y, Yasuba H, Asako M, et al: HFA-BDP metered-dose inhaler exhaled through the nose improves eosinophilic chronic rhinosinusitis with bronchial asthma: A blinded, placebo-controlled study. Front Immunol 2018; 9: 2192. – reference: 4) Hamada S, Hira D, Kobayashi Y, et al: Effect of nasally exhaling budesonide/formoterol dry powder inhaled at “fast” inspiratory flow on eosinophilic chronic rhinosinusitis. Int J Clin Pharmacol Ther 2018; 56: 539–543. – reference: 8) 平澤一浩，大塚康司，伊藤博之，他：嗅覚障害に対するステロイド点鼻により生じた副腎機能不全例．耳鼻臨床 2014; 107: 529–533. – reference: 23) Tomassen P, Vandeplas G, Van Zele T, et al: Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol 2016; 137: 1449–1456. – reference: 9) 関 博之，板垣英二，高橋和人，他：カリニ肺炎を併発したステロイド含有点鼻薬によるCushing症候群の一例．日内分泌会誌 2003; 79: 90–94. |
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| Title | 気管支喘息を合併した難病指定好酸球性副鼻腔炎再発例に対する生物学的製剤と経鼻呼出法による治療 |
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