Department of Clinical Science and Education, Södersjukhuset and Karolinska Institutet, Stockholm, Sweden.
Sachś Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden.
Immun Inflamm Dis. 2018 Sep;6(3):382-391. doi: 10.1002/iid3.225. Epub 2018 May 7.
Omalizumab has been available for treatment of allergic asthma for more than a decade and thus, its efficacy in routine treatment was of interest to evaluate. Basophil allergen threshold sensitivity (CD-sens) has been shown to correlate with the bronchial allergen threshold sensitivity and can be used to objectively measure omalizumab treatment efficacy. We aimed to evaluate the effect of omalizumab treatment of allergic asthma by CD-sens, as an objective marker of the IgE-mediated inflammation, and related to SPT, spirometry, FeNO, Asthma Control Questionnaire (ACQ), and Global Evaluation of Treatment Effectiveness (GETE).
Thirty-two patients were treated with omalizumab for 16 weeks. CD-sens was used to define the response and related to clinical parameters. If CD-sens was negative (<0.1) (CD-sens low Group) the patient continued with the standard dose. If CD-sens was ≥0.1 (CD-sens high Group) a second 16 weeks period with 25-50% dosage increase was started and evaluated after a total of 32 weeks.
Nine of 32 patients became CD-sens negative after treatment (CD-sens start: 8.0; 16 weeks: <0.01) and regarded as successful. 15/23 were unsuccessful (CD-sens start: 13; 16 weeks: 1.65) and the omalizumab dose was increased. CD-sens decreased significantly (p < 0.05) and further 3/15 patients became CD-sens negative (CD-sens at 32 weeks: 0.5). There was a significantly smaller IgE-ab fraction (IgE-ab/IgE) in the CD-sens low versus the CD-sens high Group (p < 0.0001). A significant decrease in ACQ was seen in both groups after 16 weeks treatment (p = 0.05 and 0.01, respectively). No significant changes could be detected for the other clinical parameters.
By the use of the objective laboratory method CD-sens, which effectively measure the direct effect of omalizumab, that is, the IgE-mediated part of the allergic asthma, in combination with clinical parameters it might be possible to more effectively monitor and treat IgE-mediated allergic asthma.
奥马珠单抗已被用于治疗过敏性哮喘超过十年，因此，评估其在常规治疗中的疗效引起了关注。嗜碱性粒细胞过敏原阈值敏感性（CD-sens）已被证明与支气管过敏原阈值敏感性相关，可用于客观测量奥马珠单抗治疗的疗效。我们旨在通过 CD-sens 评估奥马珠单抗治疗过敏性哮喘的效果，CD-sens 是 IgE 介导炎症的客观标志物，与 SPT、肺功能、FeNO、哮喘控制问卷（ACQ）和治疗效果全球评估（GETE）相关。
32 例患者接受奥马珠单抗治疗 16 周。CD-sens 用于定义反应并与临床参数相关。如果 CD-sens 为阴性（<0.1）（CD-sens 低组），患者继续使用标准剂量。如果 CD-sens 为阳性（≥0.1）（CD-sens 高组），则开始第二个 16 周的 25-50%剂量增加期，并在总共 32 周后进行评估。
32 例患者中有 9 例治疗后 CD-sens 转为阴性（CD-sens 开始：8.0；16 周：<0.01），被认为是成功的。15/23 例治疗失败（CD-sens 开始：13；16 周：1.65），增加了奥马珠单抗剂量。CD-sens 显著降低（p<0.05），进一步有 3/15 例患者 CD-sens 转为阴性（CD-sens 第 32 周：0.5）。CD-sens 低组与 CD-sens 高组的 IgE-ab 分数（IgE-ab/IgE）显著降低（p<0.0001）。两组患者在治疗 16 周后 ACQ 均显著下降（p=0.05 和 0.01）。其他临床参数未检测到显著变化。
通过使用客观的实验室方法 CD-sens，可以有效地测量奥马珠单抗的直接作用，即过敏性哮喘的 IgE 介导部分，结合临床参数，可能可以更有效地监测和治疗 IgE 介导的过敏性哮喘。
