阿达木单抗治疗重度银屑病14例临床疗效及安全性观察

Clinical efficacy and safety of adalimumab for the treatment of 14 cases of severe psoriasis

目的 观察阿达木单抗治疗重度银屑病的临床疗效及安全性。方法 在2015 年12月至2017年8月就诊于南京医科大学附属无锡第二医院的重度银屑病患者中选择传统治疗无效的患者14例，给予阿达木单抗单药皮下注射治疗，初始剂量80 mg，1周时给予40 mg，以后每2周给予40 mg，分别于第4、8、12周时记录患者银屑病皮损面积和严重度指数（PASI）及疾病严重程度评分（PGA）改善情况，观察临床疗效及药物不良反应。合并关节病性银屑病患者的关节改善采用美国风湿病协会（ACR）有关类风湿关节炎改善的ACR20作为评价指标。结果 14 例患者均接受至少12 周疗程的药物治疗。4 周时，8 例达PASI 50；8周时，8例达PASI 75，其中2例达PASI 90；12周时，14例达PASI 75，其中7例达PASI 90，3例达PASI 100。治疗前14例患者PGA为（4.92 ± 0.02）分，12周时下降至（1.21 ± 0.02）分。3 例合并关节病性银屑病患者，关节症状改善明显，8周时2例达ACR20，12周时3例达ACR20。所有患者均未出现严重感染或恶性肿瘤等严重的药物不良反应。3例患者出现荨麻疹，给予抗组胺药后症状缓解。结论 阿达木单抗隔周皮下注射治疗重度银屑病疗效显著，不良反应较少，为传统治疗无效的重度银屑病患者的治疗提供了新选择。

Objective To evaluate the clinical efficacy and safety of adalimumab for the treatment of severe psoriasis. Methods Between December 2015 and August 2017, 14 patients with severe psoriasis who showed no response to traditional therapy were enrolled into this study. All the patients received subcutaneous injection of adalimumab at an initial dose of 80 mg, which decreased to a dose of 40 mg once every 2 weeks after 1-week treatment. At week 4, 8 and 12, the psoriasis area severity index（PASI）and physician′s global assessment （PGA） scores were recorded, and clinical efficacy and adverse drug reactions were observed. In patients with psoriatic arthritis, the improvement of arthritis was evaluated according to the American College of Rheumatology 20% response criteria （ACR20）. Results All the 14 patients received the drug treatment for at least 12 weeks. At week 4, 8 patients achieved 50% reduction in PASI （PASI 50）. At week 8, 8 patients achieved PASI 75, and 2 of the 8 patients achieved PASI 90. At week 12, 14 patients achieved PASI 75, 7 of them achieved PASI 90, and 3 of them achieved PASI 100. Before the treatment, the average PGA score of the 14 patients were 4.92 ± 0.02, and decreased to 1.21 ± 0.02 at week 12. The arthritis symptom was markedly improved in the 3 patients with psoriatic arthritis. At week 8, 2 patients achieved ACR20, and 3 achieved ACR20 at week 12. There were no serious adverse drug reactions such as serious infections and malignant tumors in any of the patients. Urticaria occurred in 3 patients, and was relieved after antihistamine treatment. Conclusion Subcutaneous injection of adalimumab every other week is markedly effective and safe for the treatment of severe psoriasis with few adverse drug reactions, and it provides a new treatment choice for patients with severe psoriasis who show no response to traditional therapy.