[Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis].

To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.探讨度普利尤单抗对中重度特应性皮炎（AD）患者的疗效和安全性。本研究采取小样本治疗前后自身对照研究的方法，回顾性分析2020年7月至2022年3月在重庆医科大学附属第一医院皮肤科就诊使用度普利尤单抗的中重度AD患者，于第0周给予度普利尤单抗600 mg皮下注射，之后每2周给予300 mg皮下注射，通过特应性皮炎评分（severity scoring of atopic dermatitis，SCORAD）、数字评分分级法（numerical rating scale，NRS）、皮肤病生活质量指数（dermatology life quality index，DLQI）、患者湿疹自我监测（patient-oriented eczema measure，POEM）对病情进行评估。采用配对t检验，非参数秩和检验分析SCORAD、NRS、DLQI、POEM的改善情况。结果显示，共有67例中重度AD患者接受度普利尤单抗治疗，其中41例患者疗程大于6周治疗后皮损的严重程度降低、生活质量改善、瘙痒减轻，有23例患者完成16周度普利尤单抗治疗，在第4、8、12、16周时的SCORAD、NRS、DLQI、POEM分别较基线降低，差异具有统计学意义，第0周SCORAD（50.13±15.19）分，第4周SCORAD（36.08±11.96）分（t=6.049，P<0.001），第8周SCORAD（28.04±11.10）分（t=10.471，P<0.001），第12周SCORAD（22.93±9.72）分（t=12.428，P<0.001），第16周SCORAD（16.84±7.82）分（t=14.609，P<0.001），第0周NRS 7（6，8）分，第4周NRS 4（3，5）分（Z=-3.861，P<0.001），第8周NRS 2（1，4）分（Z=-4.088，P<0.001），第12周NRS 1（0，2）分（Z=-4.206，P<0.001），第16周NRS 2（0，2）分（Z=-4.222，P<0.001）。第0周DLQI（13.83±5.71）分，第4周DLQI（8.00±4.02）分（t=6.325，P<0.001），第8周DLQI（5.61±3.50）分（t=8.060，P<0.001），第12周DLQI（3.96±1.99）分（t=8.717，P<0.001），第16周DLQI（2.70±1.89）分（t=10.355，P<0.001）。第0周POEM（18.04±6.41）分，第4周POEM（9.70±4.70）分（t=7.031，P<0.001），第8周POEM（7.74±3.48）分（t=8.806，P<0.001），第12周POEM（6.35±3.33）分（t=10.474，P<0.001），第16周POEM（4.26±2.51）分（t=11.996，P<0.001）；16周时23例患者中100%（23例）、91.3%（21例）、34.8%（8例）和8.7%（2例）的患者分别达到SCORAD30、SCORAD50、SCORAD70和SCORAD90，有82.6%（19例）、95.7%（22例）、95.7%（22例）的患者NRS、DLQI、POEM均较基线改善≥4分；16周后继续接受度普利尤单抗治疗的AD患者（12例），皮损可进一步改善。出现的不良反应有结膜炎、注射部位反应。综上，度普利尤单抗用于中重度AD患者疗效肯定，安全性良好，但还需扩大样本量及延长随访时间以进一步研究更长期的疗效、安全性。.