Nopp A, Johansson S G O, Ankerst J, Palmqvist M, Oman H
Department of Medicine, Clinical Immunology and Allergy Unit, Karolinska Institute, Stockholm, Sweden.
Allergy. 2007 Oct;62(10):1175-81. doi: 10.1111/j.1398-9995.2007.01476.x.
Many clinical trials with omalizumab, Xolair, have been reported but the treatment period has always been short, i.e. <12 months. After withdrawal, the clinical symptoms tend to return. A group of patients who stopped treatment after approx. 6 years allowed studies of the long-term effects of Xolair.
The patient's cat or mite allergen sensitivity was quantitated as basophil allergen threshold sensitivity, CD-sens, and immunoglobulin E (IgE) and IgE- and IgG4-antibodies were determined before start and during treatment withdrawal. Asthma severity was evaluated from forced expiratory volume (FEV), peak expiratory flow (PEF) and a questionnaire.
At 6-14 months without Xolair 13 of the 18 cat and mite allergic asthmatics had either improved or remained the same as on treatment. Most of the patients were in a stable clinical condition reporting high quality of life, no increased nightly asthma attacks, no emergency visits as well as little or no increase in medication. The CD-sens to cat showed a peak 4 months after withdrawal but then decreased to levels below those of untreated patients with allergic asthma and at 12 months six of 14 had nonreactive basophils. Cat IgG4 antibody levels were higher than in cat allergics in general.
Most of the patients 12-14 months had, after closing of 6-year Xolair treatment, a surprisingly mild asthma. Interestingly, and probably contributing to the clinical results, a downregulation of basophil, and presumably also mast cell, reactivity, was seen.
已有许多关于奥马珠单抗（商品名：Xolair）的临床试验报道，但治疗期一直较短，即<12个月。停药后，临床症状往往会复发。一组在约6年后停药的患者使得对Xolair的长期影响的研究成为可能。
通过嗜碱性粒细胞过敏原阈值敏感性（CD敏感性）对患者的猫或螨过敏原敏感性进行定量，并在开始治疗前和停药期间测定免疫球蛋白E（IgE）以及IgE和IgG4抗体。根据用力呼气量（FEV）、呼气峰值流速（PEF）和一份问卷对哮喘严重程度进行评估。
在停用Xolair 6 - 14个月后，18名猫和螨过敏性哮喘患者中有13名病情有所改善或与治疗期间相同。大多数患者临床状况稳定，报告生活质量高，夜间哮喘发作未增加，无急诊就诊情况，并且药物用量很少增加或未增加。对猫的CD敏感性在停药后4个月达到峰值，但随后降至低于未治疗的过敏性哮喘患者的水平，在12个月时，14名患者中有6名嗜碱性粒细胞无反应。猫IgG4抗体水平总体上高于猫过敏患者。
在6年的Xolair治疗结束后，大多数患者在12 - 14个月时患有令人惊讶的轻度哮喘。有趣的是，可能促成临床结果的是，观察到嗜碱性粒细胞以及可能还有肥大细胞反应性的下调。
