Conjunctivitis in dupilumab clinical trials

B. Akinlade, E. Guttman-Yassky, M. de Bruin-Weller, Eric Simpson, A. Blauvelt, M. J. Cork, E. Prens, P. Asbell, E. Akpek, J. Corren, C. Bachert, I. Hirano, J. Weyne, A. Korotzer, Z. Chen, T. Hultsch, X. Zhu, J. D. Davis, L. Mannent, J. D. Hamilton & 8 others A. Teper, H. Staudinger, E. Rizova, G. Pirozzi, N. M.H. Graham, B. Shumel, M. Ardeleanu, A. Wollenberg

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: Dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo. Objectives: To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials. Methods: We evaluated randomized placebo-controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47). Results: In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis. Conclusions: Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study.

Original languageEnglish (US)
JournalBritish Journal of Dermatology
DOIs
StatePublished - Jan 1 2019

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Conjunctivitis
Atopic Dermatitis
Clinical Trials
Placebos
Incidence
Eosinophilic Esophagitis
Nasal Polyps
Asthma
SAR231893
Type II Interleukin-4 Receptors
Therapeutics
Keratitis
Histamine Antagonists
Mast Cells
Prescriptions

ASJC Scopus subject areas

  • Dermatology

Cite this

Akinlade, B., Guttman-Yassky, E., de Bruin-Weller, M., Simpson, E., Blauvelt, A., Cork, M. J., ... Wollenberg, A. (2019). Conjunctivitis in dupilumab clinical trials. British Journal of Dermatology. https://doi.org/10.1111/bjd.17869

Conjunctivitis in dupilumab clinical trials. / Akinlade, B.; Guttman-Yassky, E.; de Bruin-Weller, M.; Simpson, Eric; Blauvelt, A.; Cork, M. J.; Prens, E.; Asbell, P.; Akpek, E.; Corren, J.; Bachert, C.; Hirano, I.; Weyne, J.; Korotzer, A.; Chen, Z.; Hultsch, T.; Zhu, X.; Davis, J. D.; Mannent, L.; Hamilton, J. D.; Teper, A.; Staudinger, H.; Rizova, E.; Pirozzi, G.; Graham, N. M.H.; Shumel, B.; Ardeleanu, M.; Wollenberg, A.

In: British Journal of Dermatology, 01.01.2019.

Research output: Contribution to journalArticle

Akinlade, B, Guttman-Yassky, E, de Bruin-Weller, M, Simpson, E, Blauvelt, A, Cork, MJ, Prens, E, Asbell, P, Akpek, E, Corren, J, Bachert, C, Hirano, I, Weyne, J, Korotzer, A, Chen, Z, Hultsch, T, Zhu, X, Davis, JD, Mannent, L, Hamilton, JD, Teper, A, Staudinger, H, Rizova, E, Pirozzi, G, Graham, NMH, Shumel, B, Ardeleanu, M & Wollenberg, A 2019, 'Conjunctivitis in dupilumab clinical trials', British Journal of Dermatology. https://doi.org/10.1111/bjd.17869
Akinlade B, Guttman-Yassky E, de Bruin-Weller M, Simpson E, Blauvelt A, Cork MJ et al. Conjunctivitis in dupilumab clinical trials. British Journal of Dermatology. 2019 Jan 1. https://doi.org/10.1111/bjd.17869
Akinlade, B. ; Guttman-Yassky, E. ; de Bruin-Weller, M. ; Simpson, Eric ; Blauvelt, A. ; Cork, M. J. ; Prens, E. ; Asbell, P. ; Akpek, E. ; Corren, J. ; Bachert, C. ; Hirano, I. ; Weyne, J. ; Korotzer, A. ; Chen, Z. ; Hultsch, T. ; Zhu, X. ; Davis, J. D. ; Mannent, L. ; Hamilton, J. D. ; Teper, A. ; Staudinger, H. ; Rizova, E. ; Pirozzi, G. ; Graham, N. M.H. ; Shumel, B. ; Ardeleanu, M. ; Wollenberg, A. / Conjunctivitis in dupilumab clinical trials. In: British Journal of Dermatology. 2019.
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abstract = "Background: Dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo. Objectives: To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials. Methods: We evaluated randomized placebo-controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47). Results: In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis. Conclusions: Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study.",
author = "B. Akinlade and E. Guttman-Yassky and {de Bruin-Weller}, M. and Eric Simpson and A. Blauvelt and Cork, {M. J.} and E. Prens and P. Asbell and E. Akpek and J. Corren and C. Bachert and I. Hirano and J. Weyne and A. Korotzer and Z. Chen and T. Hultsch and X. Zhu and Davis, {J. D.} and L. Mannent and Hamilton, {J. D.} and A. Teper and H. Staudinger and E. Rizova and G. Pirozzi and Graham, {N. M.H.} and B. Shumel and M. Ardeleanu and A. Wollenberg",
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T1 - Conjunctivitis in dupilumab clinical trials

AU - Akinlade, B.

AU - Guttman-Yassky, E.

AU - de Bruin-Weller, M.

AU - Simpson, Eric

AU - Blauvelt, A.

AU - Cork, M. J.

AU - Prens, E.

AU - Asbell, P.

AU - Akpek, E.

AU - Corren, J.

AU - Bachert, C.

AU - Hirano, I.

AU - Weyne, J.

AU - Korotzer, A.

AU - Chen, Z.

AU - Hultsch, T.

AU - Zhu, X.

AU - Davis, J. D.

AU - Mannent, L.

AU - Hamilton, J. D.

AU - Teper, A.

AU - Staudinger, H.

AU - Rizova, E.

AU - Pirozzi, G.

AU - Graham, N. M.H.

AU - Shumel, B.

AU - Ardeleanu, M.

AU - Wollenberg, A.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo. Objectives: To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials. Methods: We evaluated randomized placebo-controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47). Results: In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis. Conclusions: Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study.

AB - Background: Dupilumab blocks the shared receptor component for interleukin (IL)-4 and IL-13. It is approved in the U.S.A. for patients aged ≥ 12 years with moderate-to-severe atopic dermatitis (AD) uncontrolled by topical prescription medicines or who cannot use topical medicines, for patients in Japan whose AD is uncontrolled with existing therapies, for patients with moderate-to-severe AD in Europe who are candidates for systemic therapy and for patients aged ≥ 12 years for maintenance treatment of moderate-to-severe asthma uncontrolled with their current medicines. AD trials have reported increased incidence of conjunctivitis for dupilumab vs. placebo. Objectives: To characterize further the occurrence and risk factors of conjunctivitis in dupilumab clinical trials. Methods: We evaluated randomized placebo-controlled trials of dupilumab in AD (n = 2629), asthma (n = 2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n = 60) and eosinophilic oesophagitis (EoE) (n = 47). Results: In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous history of conjunctivitis were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered or resolved during the treatment period; two patients permanently discontinued dupilumab due to conjunctivitis or keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and antihistamines or mast cell stabilizers. Most cases were diagnosed by the investigators. In asthma and CRSwNP trials, the incidence of conjunctivitis was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase the incidence compared with placebo. In the EoE trial, no patients had conjunctivitis. Conclusions: Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study.

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