TY - JOUR
T1 - Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis
T2 - Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials
AU - Simpson, Eric L.
N1 - Funding Information:
The study and article processing charges were funded by Sanofi and Regeneron Pharmaceuticals, Inc. The author would like to thank Abhijit Gadkari and Andreas Kuznik of Regeneron Pharmaceuticals, Inc. and Laurent Eckert and Gaëlle Bégo-Le Bagousse of Sanofi for their review and comments on this article. Medical writing support was provided by E. Jay Bienen, funded by Sanofi and Regeneron Pharmaceuticals, Inc. The author meets the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, takes responsibility for the integrity of the work as a whole, and has given final approval for the version to be published. In addition, the author is responsible for all content and editorial decisions and received no honoraria related to the development of this publication. The author had full access to all the data in this study and takes complete responsibility for the integrity of the data and accuracy of the data analysis.
Publisher Copyright:
© 2017, The Author(s).
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Introduction: Patients with moderate-to-severe atopic dermatitis (AD) report a multidimensional disease burden that includes impaired health-related quality-of-life (HRQoL). Changes in overall health status and specific dimensions that contribute to HRQoL were evaluated in adults with moderate-to-severe AD who participated in phase 3 clinical trials of dupilumab, which is a fully human monoclonal antibody that inhibits signaling of cytokines IL-4 and IL-13. Methods: Two dupilumab phase 3 clinical trials of identical design included the 5-dimension 3-level EuroQol (EQ-5D) as a measure of HRQoL. EQ-5D data from the two trials were pooled in an analysis that, using analysis of covariance, compared subcutaneous dupilumab 300 mg once weekly (qw) or every 2 weeks (q2w) versus placebo for EQ-5D utility score change from baseline overall and for clinical responders. The proportions of patients who reported different levels of problems on the individual dimension of the EQ-5D were also compared by treatment group. Results: Patients (n = 1379) were 57.9% male with a mean (SD) age of 38.3 (14.3) years; baseline EQ-5D utility scores ranged from 0.611 to 0.629 across treatment groups. EQ-5D least squares mean change from baseline at week 16 was 0.031 with placebo, and was significantly greater with dupilumab qw (0.207) and q2w (0.210) (both P < 0.0001), which exceeded the minimal clinically important difference and resulted in scores that approached population norms. Changes from baseline among patients who achieved AD clinical response were greater than changes among the total population. Improvements were driven by the individual EQ-5D dimensions with the greatest burden at baseline (i.e., pain/discomfort, anxiety/depression and usual activities). Conclusion: In adults with moderate-to-severe AD, dupilumab resulted in improvements in HRQoL that were statistically significant relative to placebo and were clinically meaningful. Funding: Sanofi and Regeneron Pharmaceuticals, Inc. Trial registration: ClinicalTrials.gov identifiers, NCT02277743 and NCT02277769, EudraCT Numbers 2014-001198-15 and 2014-002619-40.
AB - Introduction: Patients with moderate-to-severe atopic dermatitis (AD) report a multidimensional disease burden that includes impaired health-related quality-of-life (HRQoL). Changes in overall health status and specific dimensions that contribute to HRQoL were evaluated in adults with moderate-to-severe AD who participated in phase 3 clinical trials of dupilumab, which is a fully human monoclonal antibody that inhibits signaling of cytokines IL-4 and IL-13. Methods: Two dupilumab phase 3 clinical trials of identical design included the 5-dimension 3-level EuroQol (EQ-5D) as a measure of HRQoL. EQ-5D data from the two trials were pooled in an analysis that, using analysis of covariance, compared subcutaneous dupilumab 300 mg once weekly (qw) or every 2 weeks (q2w) versus placebo for EQ-5D utility score change from baseline overall and for clinical responders. The proportions of patients who reported different levels of problems on the individual dimension of the EQ-5D were also compared by treatment group. Results: Patients (n = 1379) were 57.9% male with a mean (SD) age of 38.3 (14.3) years; baseline EQ-5D utility scores ranged from 0.611 to 0.629 across treatment groups. EQ-5D least squares mean change from baseline at week 16 was 0.031 with placebo, and was significantly greater with dupilumab qw (0.207) and q2w (0.210) (both P < 0.0001), which exceeded the minimal clinically important difference and resulted in scores that approached population norms. Changes from baseline among patients who achieved AD clinical response were greater than changes among the total population. Improvements were driven by the individual EQ-5D dimensions with the greatest burden at baseline (i.e., pain/discomfort, anxiety/depression and usual activities). Conclusion: In adults with moderate-to-severe AD, dupilumab resulted in improvements in HRQoL that were statistically significant relative to placebo and were clinically meaningful. Funding: Sanofi and Regeneron Pharmaceuticals, Inc. Trial registration: ClinicalTrials.gov identifiers, NCT02277743 and NCT02277769, EudraCT Numbers 2014-001198-15 and 2014-002619-40.
KW - Atopic dermatitis
KW - Dupilumab
KW - EQ-5D
KW - Health-related quality-of-life
KW - Minimal clinically important difference
KW - Treatment responders
KW - Utility scores
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U2 - 10.1007/s13555-017-0181-6
DO - 10.1007/s13555-017-0181-6
M3 - Article
AN - SCOPUS:85019988455
SN - 2190-9172
VL - 7
SP - 243
EP - 248
JO - Dermatology and Therapy
JF - Dermatology and Therapy
IS - 2
ER -