Blin Patrick, Demoly Pascal, Drouet Martine, Falissard Bruno, Lignot-Maleyran Séverine, Maizi Hélène, Lorrain Simon, Lassalle Régis, Droz-Perroteau Cécile, Moore Nicholas, Molimard Mathieu
1Bordeaux PharmacoEpi, Université de Bordeaux, 146, rue Léo Saignat, 33076 Bordeaux Cedex, France.
CIC Bordeaux, CIC Bordeaux CIC1401, Bordeaux Cedex, France.
Allergy Asthma Clin Immunol. 2018 Sep 24;14:38. doi: 10.1186/s13223-018-0262-9. eCollection 2018.
Allergic rhinitis affects around one quarter of the Western European population. Prophylactic allergen immunotherapy may be useful to reduce the risk of acute symptomatic attacks (hayfever). A five-grass pollen extract sublingual immunotherapy (5GPE-SLIT) has been developed for the treatment of allergic rhinitis to grass pollen. The objective of this study was to describe real-world treatment patterns with 5GPE-SLIT in France with respect to the prescribing information.
This prospective cohort study was conducted by 90 community and hospital allergists. Adults and children (> 5 years old) starting a first treatment with 5GPE-SLIT prior to the 2015 pollen season were eligible. Data was collected at the inclusion visit and at the end of the pollen season. The primary outcome variable was compatibility of 5GPE-SLIT prescription with the prescribing information. This was determined with respect to four variables: (1) interval between 5GPE-SLIT initiation and onset of the pollen season ≥ 3 months, (2) age of patient ≥ 5 years, (3) intermittent symptoms or mild symptom severity (4) confirmatory diagnostic test. At study end, symptoms reported during the pollen season and any modifications to treatment or adverse events were documented.
280 adults and 203 children were enrolled. The prescribing information was respected for 82.5% of adults and 86.7% of children. A skin test was performed for all patients. 5GPE-SLIT was started 3-5 months before the pollen season for 85.3%. Treatment was discontinued before the start of the pollen season in 11.0% of patients overall, generally because of an adverse event (78.8% of discontinuations). The mean duration of treatment was 5.2 months in adults and 5.6 months in children. At the end of follow-up, symptoms during the pollen season were intermittent for 75.0% of adults and 85.7% of children, and severity was mild for 61.8 and 66.0% respectively. During 5GPE-SLIT, the following symptoms reported during the previous year were not reported again in > 50% of patients: nasal congestion, rhinorrhoea, repeated sneezing, conjunctivitis and nasal pruritus.
5GPE-SLIT use was generally consistent with prescribing recommendations and was associated with an improvement of AR severity, with resolution of the principal AR symptoms in around half the patients treated. EUPAS9358. Registered 13 May 2015. Not prospectively registered. http://www.encepp.eu/encepp/viewResource.htm?id=16229.
变应性鼻炎影响约四分之一的西欧人口。预防性变应原免疫疗法可能有助于降低急性症状发作（花粉症）的风险。一种五草花粉提取物舌下免疫疗法（5GPE-SLIT）已被开发用于治疗对草花粉的变应性鼻炎。本研究的目的是描述法国5GPE-SLIT在实际应用中的治疗模式，并与处方信息进行对比。
这项前瞻性队列研究由90名社区和医院的过敏症专科医生进行。在2015年花粉季节之前开始首次使用5GPE-SLIT治疗的成人和儿童（>5岁）符合入选标准。在入选时和花粉季节结束时收集数据。主要结局变量是5GPE-SLIT处方与处方信息的兼容性。这是根据四个变量确定的：（1）5GPE-SLIT开始与花粉季节开始之间的间隔≥3个月；（2）患者年龄≥5岁；（3）间歇性症状或症状严重程度较轻；（4）确诊诊断试验。在研究结束时，记录花粉季节期间报告的症状以及治疗的任何改变或不良事件。
共纳入280名成人和203名儿童。82.5%的成人和86.7%的儿童的处方信息符合要求。所有患者均进行了皮肤试验。85.3%的患者在花粉季节前3-5个月开始使用5GPE-SLIT。总体而言，11.0%的患者在花粉季节开始前停止治疗，通常是因为不良事件（78.8%的停药原因）。成人的平均治疗持续时间为5.2个月，儿童为5.6个月。随访结束时，75.0%的成人和85.7%的儿童在花粉季节的症状为间歇性，症状严重程度较轻的分别为61.8%和66.0%。在5GPE-SLIT治疗期间，超过50%的患者未再次报告上一年出现的以下症状：鼻塞、流涕、反复打喷嚏、结膜炎和鼻痒。
5GPE-SLIT的使用总体上与处方建议一致，并与变应性鼻炎严重程度的改善相关，约一半接受治疗的患者主要变应性鼻炎症状得到缓解。EUPAS9358。于2015年5月13日注册。未进行前瞻性注册。http://www.encepp.eu/encepp/viewResource.htm?id=16229。
