Laboratory Safety of Dupilumab, and Its Effect on Inflammatory Biomarkers, in Chinese Adults With Moderate-to-Severe Atopic Dermatitis: An Analysis of a Randomized, Double-Blind Phase III Study

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摘要Objective::Limited information is available on the use of dupilumab for the treatment of atopic dermatitis (AD) in the Chinese population.Methods::We analyzed laboratory data from a previously published randomized, double-blind phase III trial (NCT03912259) to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe AD. The trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 weeks. Hematology, blood chemistry, serum thymus and activation-regulated chemokine (TARC), and total immunoglobulin E (IgE) were evaluated.Results::In total, 82 participants received dupilumab and 83 received placebo. With the exception of eosinophil counts of >0.8 × 10 9/L, which were found less frequently with dupilumab (9.8%) than with placebo (18.7%), the hematology and blood chemistry values were generally stable in both treatment groups. There were no clinically significant differences between the dupilumab and placebo groups, and no participants developed treatment-emergent abnormalities of potential clinical significance. However, compared with placebo, greater decreases in serum lactate dehydrogenase (mean change, ?97.4 vs. ?33.5 IU/L), TARC (median percent change, ?78.6% vs. ?30.8%), and total IgE (median percent change, ?53.4% vs. ?0.2%) were observed with dupilumab than placebo at week 16. Conclusion::Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.

abstractsObjective::Limited information is available on the use of dupilumab for the treatment of atopic dermatitis (AD) in the Chinese population.Methods::We analyzed laboratory data from a previously published randomized, double-blind phase III trial (NCT03912259) to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe AD. The trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 weeks. Hematology, blood chemistry, serum thymus and activation-regulated chemokine (TARC), and total immunoglobulin E (IgE) were evaluated.Results::In total, 82 participants received dupilumab and 83 received placebo. With the exception of eosinophil counts of >0.8 × 10 9/L, which were found less frequently with dupilumab (9.8%) than with placebo (18.7%), the hematology and blood chemistry values were generally stable in both treatment groups. There were no clinically significant differences between the dupilumab and placebo groups, and no participants developed treatment-emergent abnormalities of potential clinical significance. However, compared with placebo, greater decreases in serum lactate dehydrogenase (mean change, ?97.4 vs. ?33.5 IU/L), TARC (median percent change, ?78.6% vs. ?30.8%), and total IgE (median percent change, ?53.4% vs. ?0.2%) were observed with dupilumab than placebo at week 16. Conclusion::Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.

作者 Zhao Yan ^[1] Wu Li-Ming ^[2] Lu Qian-Jin ^[3] Gao Xing-Hua ^[4] Zhu Xiao-Hong ^[5] Yao Xu ^[6] Li Lin-Feng ^[7] Li Wei ^[8] Ding Yang-Feng ^[9] Song Zhi-Qiang ^[10] Liu Ling-Ling ^[11] Dang Ning-Ning ^[12] Zhang Chun-Lei ^[13] Liu Xiao-Ming ^[14] Gu Jun ^[15] Wang Jin-Yan ^[16] Geng Song-Mei ^[17] Liu Quan-Zhong ^[18] Guo Yi-Feng ^[19] Dong Li ^[20] Li Shelley ^[20] Xu Christine ^[20] O’Malley John T. ^[20] Laws Elizabeth ^[20] Amin Nikhil ^[21] Bansal Ashish ^[21] Wang Min ^[22] Zhang Jian-Zhong ^[1] 学术成果认领

作者单位 Department of Dermatology, Peking University People’s Hospital, Beijing 100044, China ^[1] Hangzhou First People’s Hospital, Hangzhou, Zhejiang 310006, China ^[2] The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China ^[3] The First Hospital of China Medical University, Shenyang, Liaoning 110001, China ^[4] Wuxi Second People’s Hospital, Wuxi, Jiangsu 214002, China ^[5] Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, Jiangsu 210042, China ^[6] Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China ^[7] Huashan Hospital, Fudan University, Shanghai 200040, China ^[8] Shanghai Skin Disease Hospital, Shanghai 200040, China ^[9] The Southwest Hospital of AMU, Chongqing 400038, China ^[10] Peking University First Hospital, Beijing 100034, China ^[11] Jinan Central Hospital, Jinan, Shandong 250013, China ^[12] Peking University Third Hospital, Beijing 100191, China ^[13] University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong 518040, China ^[14] Changhai Hospital of Shanghai, Shanghai 200433, China ^[15] Ningbo No. 2 Hospital, Ningbo, Zhejiang 315099, China ^[16] The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi 710004, China ^[17] Tianjin Medical University General Hospital, Tianjin 300052, China ^[18] Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, China ^[19] Research amp; Development, Sanofi, Bridgewater, NJ 08807, USA ^[20] Research amp; Development, Regeneron, Tarrytown, NY 10591, USA ^[21] Medical, Sanofi China, Shanghai 200040, China ^[22]

关键词 atopic dermatitis dupilumab laboratory safety Chinese atopic dermatitis dupilumab laboratory safety Chinese

栏目名称 Original Article

DOI 10.1097/JD9.0000000000000264

发布时间 2025-02-25