背景:奥马珠单抗在英国被批准为慢性自发性荨麻疹(CSU)患者的附加治疗H1-抗组胺药反应不足。Ciclosporin是CSU的既定但未经许可的第三线选项。进行了两项平行的回顾性观察研究,以描述使用奥马珠单抗或环孢素治疗CSU的治疗结果和不良事件。
方法:从CSU患者中使用奥马珠单抗(5个中心)或环孢素(3个中心)的英国专科中心的数据由临床工作人员从医院记录中收集并汇总分析。
结果:纳入46例服用奥马珠单抗的患者和72例服用环孢素的患者。22例(48%)接受奥马珠单抗治疗的患者出现配对荨麻疹活动评分(UAS7),显示治疗期间25.4点改善(P<0.0001)。配对皮肤病生活质量指数(DLQI)在28例(61%)奥马珠单抗治疗和17例(24%)环孢素治疗的患者中可用。在79%的奥马珠单抗治疗的患者和41%的环孢素治疗的患者中,DLQI评分至少改善了75%,65%的奥马珠单抗治疗患者的生活质量损害(DLQI0-1)完全缓解,而21%的环孢素治疗患者的生活质量损害得到完全缓解.临床医生的评论报告了15/36(42%)奥马珠单抗治疗和10/60(17%)环孢素治疗的患者的症状清除。不良事件患者的比例相似,但奥马珠单抗患者的症状类似于CSU,使因果关系分配变得困难,而环孢素的不良反应与其已知的不良反应特征一致.
结论:CSU管理中应常规使用经验证的患者报告的疾病严重程度和生活质量指标。根据临床医生的意见和DLQI评分,与环孢素治疗组相比,奥马珠单抗治疗组的症状和生活质量改善更大.
BACKGROUND: Omalizumab is approved in the UK as add-on treatment for chronic spontaneous urticaria (CSU) in patients with inadequate response to H1-antihistamines.
Ciclosporin is an established but unlicensed 3rd line option for CSU. Two parallel retrospective observational studies were conducted to describe outcomes of treatment and adverse events with omalizumab or
ciclosporin for CSU treatment.
METHODS: Data from UK specialist centres prescribing omalizumab (five centres) or
ciclosporin (three centres) in CSU patients were collected from hospital records by clinical staff and pooled for analysis.
RESULTS: Forty-six patients prescribed omalizumab and 72 patients prescribed
ciclosporin were included. Twenty-two (48%) omalizumab-treated patients had paired Urticaria Activity Scores (UAS7), showing a 25.4 point improvement during treatment (P < 0.0001). Paired Dermatology Life Quality Index (DLQI) was available in 28 (61%) omalizumab-treated and 17 (24%) ciclosporin-treated patients. At least a 75% improvement in DLQI score was observed in 79% of omalizumab-treated and 41% of
ciclosporin-treated patients, and 65% of omalizumab-treated patients had complete resolution of their quality-of-life impairment (DLQI 0-1) versus 21% of ciclosporin-treated patients. Clinician comments reported symptom clearance in 15/36 (42%) omalizumab-treated and 10/60 (17%) ciclosporin-treated patients. Proportions of patients with adverse events were similar but those for omalizumab resembled CSU symptoms, making causality assignment difficult, whereas those for ciclosporin were consistent with its known adverse effect profile.
CONCLUSIONS: Validated patient-reported measures of disease severity and quality of life should be used routinely in CSU management. Based on clinician comments and DLQI scores, symptoms and quality of life showed a greater improvement in the omalizumab-treated cohort than in the ciclosporin-treated cohort.