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Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen

L. Klimek, A. Chaker, T. Deitmer, S. K. Plontke, B. Wollenberg, Julie Bousquet and Claus Bachert (UGent)
(2021) HNO. 69(11). p.868-877
Author
Organization
Abstract
Background For patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) which cannot be controlled by continuous therapy with intranasal corticosteroids (INCS) and systemic corticosteroids and/or surgical treatment, there were no approved curative options for a long time. For CRSwNP treatment with T2-addressing biologics is possible. On October 24, 2019, the European Commission granted extended approval for dupilumab as the first biological agent for treatment of insufficiently controlled severe CRSwNP. The Federal Joint Committee (G-BA) evaluates the benefits of reimbursable drugs with new active ingredients. This includes assessment of the additional benefit and its therapeutic relevance. Methods A meta-analysis was performed using individual patient data based on two phase III studies. Both studies examined the safety and efficacy of dupilumab as an add-on therapy to INCS for treatment of CRSwNP in adults inadequately controlled with systemic corticosteroids and/or surgery compared to INCS alone. Results Based on the present data, the G-BA decided that there is an indication of a considerable additional benefit of dupilumab compared to mometasone furoate. Conclusion For patients with severe CRSwNP inadequately controlled with INCS and systemic corticosteroids and/or surgery, there is an indication of a considerable additional benefit for the administration of dupilumab as an add-on therapy to INCS compared to mometasone furoate alone.
Keywords
Type-2-inflammation, AMNOG procedure, CRSwNP, Biologics, Dupilumab, Additional approval

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MLA
Klimek, L., et al. “Dupilumab Besitzt Einen Zusatznutzen Für Die Behandlung Der Chronischen Rhinosinusitis Mit Nasenpolypen.” HNO, vol. 69, no. 11, 2021, pp. 868–77, doi:10.1007/s00106-021-01018-z.
APA
Klimek, L., Chaker, A., Deitmer, T., Plontke, S. K., Wollenberg, B., Bousquet, J., & Bachert, C. (2021). Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen. HNO, 69(11), 868–877. https://doi.org/10.1007/s00106-021-01018-z
Chicago author-date
Klimek, L., A. Chaker, T. Deitmer, S. K. Plontke, B. Wollenberg, Julie Bousquet, and Claus Bachert. 2021. “Dupilumab Besitzt Einen Zusatznutzen Für Die Behandlung Der Chronischen Rhinosinusitis Mit Nasenpolypen.” HNO 69 (11): 868–77. https://doi.org/10.1007/s00106-021-01018-z.
Chicago author-date (all authors)
Klimek, L., A. Chaker, T. Deitmer, S. K. Plontke, B. Wollenberg, Julie Bousquet, and Claus Bachert. 2021. “Dupilumab Besitzt Einen Zusatznutzen Für Die Behandlung Der Chronischen Rhinosinusitis Mit Nasenpolypen.” HNO 69 (11): 868–877. doi:10.1007/s00106-021-01018-z.
Vancouver
1.
Klimek L, Chaker A, Deitmer T, Plontke SK, Wollenberg B, Bousquet J, et al. Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen. HNO. 2021;69(11):868–77.
IEEE
[1]
L. Klimek et al., “Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen,” HNO, vol. 69, no. 11, pp. 868–877, 2021.
@article{8706286,
  abstract     = {{Background For patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) which cannot be controlled by continuous therapy with intranasal corticosteroids (INCS) and systemic corticosteroids and/or surgical treatment, there were no approved curative options for a long time. For CRSwNP treatment with T2-addressing biologics is possible. On October 24, 2019, the European Commission granted extended approval for dupilumab as the first biological agent for treatment of insufficiently controlled severe CRSwNP. The Federal Joint Committee (G-BA) evaluates the benefits of reimbursable drugs with new active ingredients. This includes assessment of the additional benefit and its therapeutic relevance. Methods A meta-analysis was performed using individual patient data based on two phase III studies. Both studies examined the safety and efficacy of dupilumab as an add-on therapy to INCS for treatment of CRSwNP in adults inadequately controlled with systemic corticosteroids and/or surgery compared to INCS alone. Results Based on the present data, the G-BA decided that there is an indication of a considerable additional benefit of dupilumab compared to mometasone furoate. Conclusion For patients with severe CRSwNP inadequately controlled with INCS and systemic corticosteroids and/or surgery, there is an indication of a considerable additional benefit for the administration of dupilumab as an add-on therapy to INCS compared to mometasone furoate alone.}},
  author       = {{Klimek, L. and Chaker, A. and Deitmer, T. and Plontke, S. K. and Wollenberg, B. and Bousquet, Julie and Bachert, Claus}},
  issn         = {{0017-6192}},
  journal      = {{HNO}},
  keywords     = {{Type-2-inflammation,AMNOG procedure,CRSwNP,Biologics,Dupilumab,Additional approval}},
  language     = {{ger}},
  number       = {{11}},
  pages        = {{868--877}},
  title        = {{Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen}},
  url          = {{http://doi.org/10.1007/s00106-021-01018-z}},
  volume       = {{69}},
  year         = {{2021}},
}
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