奥马珠单抗对食物过敏成人的疗效——一项回顾性分析。
Efficacy of omalizumab in food allergic adults - A retrospective analysis.
作者信息
Alexiou Aikaterina, Carreras-Kàtcheff Sofia, Hartmann Karin, Treudler Regina, Tassinari Paolo, Cardona Victoria, Worm Margitta
机构信息
Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin, Germany.
Department of Allergy, Hospital Vall d'Hebron, Barcelona, Spain.
出版信息
World Allergy Organ J. 2025 Apr 3;18(4):101048. doi: 10.1016/j.waojou.2025.101048. eCollection 2025 Apr.
BACKGROUND
IgE-mediated food allergy poses a significant public health concern, currently with no approved therapies for adults in Europe. Omalizumab (OMA) used as monotherapy or in conjunction with oral immunotherapy (OIT) has been suggested as an efficacious treatment for severe food allergy. The aim of this study was to analyze real-world data from food-allergic patients treated with OMA.
METHODS
We included food-allergic patients treated with OMA between 2002 and 2022 throughout Europe. Treatment responders (TR) were identified based on the unresponsiveness to related food allergens (determined by food challenge), reduction in the severity of food allergy and absence of anaphylactic reactions.
RESULTS
Sixty-two patients (female n = 39/62, 62.9%; mean age 30.6 years) were included into this analysis, most of whom were polysensitized to more than 2 food allergens (n = 40/62, 64.5%); 45/62 patients (72.6%) received OMA in conjunction with OIT, while the remaining patients underwent OMA monotherapy. The eliciting food allergens were tree nuts (n = 27/62, 43.5%), cow's milk (n = 26/62, 41.9%), and vegetables (n = 25/62, 40.3%). In most cases, OMA was initiated with 300 mg q4w (n = 51/62, 82.3%) dosing. Treatment was tolerated exceptionally well.Fifty-two (52/62) patients (83.9%) were classified as treatment responders. Six (6/62) patients (9.7%) developed unresponsiveness, 6/62 (9.7%) had a reduction of the severity of food allergy, and 40/62 (64.5%) had no further anaphylactic reactions during treatment. One (1/62) patient (1.6%) undergoing monotherapy was a non-responder, exhibiting repeated anaphylactic reactions to accidental exposures, and 10/62 patients (16.1%) reported anaphylactic reactions during treatment. In most of these cases, cofactors (n = 5/10, 50%) were present.
CONCLUSION
Our real-world evidence data indicate efficacy and tolerability of OMA for the treatment of IgE-mediated food allergy with and without OIT. As the onset of food related reactions upon treatment was frequently linked to the presence of cofactors, these should be identified and considered in patients with food allergy-not only for diagnosis, but also in treatment settings.
背景
IgE介导的食物过敏引起了重大的公共卫生关注，目前在欧洲尚无获批用于成人的治疗方法。有人提出，奥马珠单抗（OMA）作为单一疗法或与口服免疫疗法（OIT）联合使用，是治疗严重食物过敏的有效方法。本研究的目的是分析接受OMA治疗的食物过敏患者的真实世界数据。
方法
我们纳入了2002年至2022年期间在欧洲各地接受OMA治疗的食物过敏患者。根据对相关食物过敏原无反应（通过食物激发试验确定）、食物过敏严重程度降低以及无过敏反应来确定治疗反应者（TR）。
结果
62例患者（女性n = 39/62，62.9%；平均年龄30.6岁）纳入本分析，其中大多数对2种以上食物过敏原多敏（n = 40/62，64.5%）；45/62例患者（72.6%）接受OMA联合OIT治疗，其余患者接受OMA单一疗法。引发过敏的食物过敏原为坚果（n = 27/62，43.5%）、牛奶（n = 26/62，41.9%）和蔬菜（n = 25/62，40.3%）。在大多数情况下，OMA起始剂量为300 mg，每4周一次（n = 51/62，82.3%）。治疗耐受性非常好。52例（52/62）患者（83.9%）被归类为治疗反应者。6例（6/62）患者（9.7%）出现无反应，6/62例（9.7%）食物过敏严重程度降低，40/62例（64.5%）在治疗期间无进一步过敏反应。1例（1/62）接受单一疗法的患者无反应，对意外接触反复出现过敏反应，10/62例患者（16.1%）在治疗期间报告有过敏反应。在大多数这些病例中，存在辅助因素（n = 5/10，50%）。
结论
我们的真实世界证据数据表明，OMA在联合或不联合OIT治疗IgE介导的食物过敏方面具有疗效和耐受性。由于治疗期间与食物相关反应的发生通常与辅助因素的存在有关，因此在食物过敏患者中应识别并考虑这些因素——不仅用于诊断，也用于治疗环境中。
Zotero 插件