关键词: 痒疹, 结节性痒疹, 度普利尤单抗, 治疗结果, 焦虑, 抑郁, 真实世界研究

Abstract: 【Abstract】 Objective To evaluate the efficacy and safety of dupilumab in the treatment of prurigo nodularis （PN） in the real world. Methods PN patients who were subcutaneously injected with dupilumab for over 12 weeks were collected from the China Type Ⅱ Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project Database from June 2021 to October 2022. Their clinical data were retrospectively analyzed, which included demographic data, and changes in pruritus numeric rating scale （NRS）, investigator global assessment for PN-Stage （IGA PN-S）, dermatology life quality index （DLQI） and hospital anxiety and depression scale （HADS） scores before and after treatment. Differences in scores before and after treatment, as well as in efficacy between patients with and without a history of atopic diseases, were analyzed using Wilcoxon signed-rank test, paired t-test or chi-square test. Results A total of 66 PN patients were collected, including 42 males and 24 females, and they were aged 8 to 89 （44.12 ± 24.17） years. Thirty-six patients had a history of atopic diseases, and 27 had a family history of atopic diseases. After 12-week treatment with dupilumab, the pruritus NRS, IGA PN-S and DLQI scores in the 66 patients significantly decreased from the baseline scores （7.00 ［5.00, 8.00］, 3.00 ［3.00，4.00］, 12.00 ［7.75, 20.25］, respectively） to 3.00 ［2.00, 4.25］, 2.00 ［2.00, 3.00］, 5.00 ［1.75, 8.25］, respectively （all P < 0.001）. Among the 66 patients, 39 continued the regular treatment with dupilumab after 12 weeks and were followed up to 16 weeks; their pruritus NRS and IGA PN-S scores at week 16 further decreased compared with those at week 12 （both P < 0.05）. There were no significant differences in the proportion of patients showing an improvement of ≥ 4 points in the NRS score or the proportion of patients achieving IGA 0/1 at week 12 between the patients with history of atopic diseases and those without （both P > 0.05）. Before treatment, 32 PN patients were accompanied by mild to severe anxiety and/or depression; after 12-week treatment, the HADS-A scores in the 28 patients with anxiety （HADS-A scores > 7 points） and the HADS-D scores in the 20 patients with depression （HADS-D scores > 7 points） significantly decreased compared with their baseline scores （both P < 0.001）; 18 （56.52%） patients achieved remission in anxiety and depression （both HADS-A and HADS-D scores < 7 points）. Among the 66 PN patients, there were 13 minor patients, including 7 males and 6 females, and they were aged 8 to 17 （13.77 ± 3.09） years; after 12-week treatment, their pruritus NRS, IGA PN-S, and DLQI scores significantly decreased compared with the corresponding baseline scores （all P < 0.05）; 8 minor patients continued dupilumab treatment for 16 weeks, with a further decrease in the IGA PN-S score compared with that at week 12 （P < 0.05）, but without significant differences between the pruritus NRS and DLQI scores at week 16 and those at week 12 （both P > 0.05）. Adverse reactions were observed in 7 adult patients, including eye pruritus, local injection reactions, and systemic erythema accompanied by pruritus on the day of injection. No adverse reactions were reported in minor patients. Conclusion In the real world, dupilumab could markedly alleviate pruritus, skin lesions, anxiety and depression symptoms in PN, improve the quality of life, and exhibited a good safety profile.

Key words: Prurigo, Prurigo nodularis, Dupilumab, Treatment outcome, Anxiety, Depression, Real-world study