Cockle Sarah M, Stynes Gillian, Gunsoy Necdet B, Parks Daniel, Alfonso-Cristancho Rafael, Wex Jaro, Bradford Eric S, Albers Frank C, Willson Jenny
Value Evidence and Outcomes, GSK, GSK House, Brentford, Middlesex, UK.
Clinical Statistics, GSK, Stockley Park, Uxbridge, UK.
Respir Med. 2017 Feb;123:140-148. doi: 10.1016/j.rmed.2016.12.009. Epub 2016 Dec 21.
Severe asthma is a heterogeneous disease. Patients with both eosinophilic and allergic asthma phenotypes may be eligible for treatment with mepolizumab and omalizumab. Evidence on the relative effectiveness of these treatments in this 'overlap' population would be informative for clinical and payer decision making.
A systematic literature review and indirect treatment comparison (Bayesian framework) were performed to assess the comparative effectiveness and tolerability of mepolizumab and omalizumab, as add-ons to standard of care. Studies included in the primary analysis were double-blind, randomized controlled trials, ≥12 weeks' duration enrolling patients with severe asthma with a documented exacerbation history and receiving high-dose inhaled corticosteroids plus ≥1 additional controller. Two populations were examined: patients potentially eligible for 1) both treatments (Overlap population) and 2) either treatment (Trial population).
In the Overlap population, no differences between treatments in clinically significant exacerbations and exacerbations requiring hospitalization were found, although trends favored mepolizumab (rate ratio [RR]:0.66 [95% credible intervals (Crl):0.37,1.19]; 0.19[0.02,2.32], respectively). In the Trial population, mepolizumab treatment produced greater reductions in clinically significant exacerbations (RR:0.63 [95% CrI:0.45,0.89]) but not exacerbations requiring hospitalization compared with omalizumab (RR:0.58 [95% Crl: 0.16,2.13]), although the trend favored mepolizumab. Both treatments had broadly comparable effects on lung function, and similar tolerability profiles.
Whilst this analysis has limitations due to a restricted evidence base and residual heterogeneity, it showed that in patients with severe asthma, mepolizumab seems to be at least as effective as omalizumab and that the tolerability profiles of the two treatments did not meaningfully differentiate.
重度哮喘是一种异质性疾病。嗜酸性粒细胞性和过敏性哮喘表型的患者可能适合使用美泊利珠单抗和奥马珠单抗进行治疗。这些治疗方法在这一“重叠”人群中的相对有效性证据，将为临床和支付方的决策提供参考。
进行了一项系统的文献综述和间接治疗比较（贝叶斯框架），以评估美泊利珠单抗和奥马珠单抗作为标准治疗补充剂的比较有效性和耐受性。纳入初步分析的研究为双盲、随机对照试验，持续时间≥12周，纳入有明确加重病史且接受高剂量吸入性糖皮质激素加≥1种其他控制药物的重度哮喘患者。研究了两个人群：1）可能适合两种治疗的患者（重叠人群）和2）适合任意一种治疗的患者（试验人群）。
在重叠人群中，未发现两种治疗在具有临床意义的加重和需要住院治疗的加重方面存在差异，尽管趋势上美泊利珠单抗更具优势（率比[RR]：0.66[95%可信区间（Crl）：0.37，1.19]；分别为0.19[0.02，2.32]）。在试验人群中，与奥马珠单抗相比，美泊利珠单抗治疗在具有临床意义的加重方面有更大程度的降低（RR：0.63[95%CrI：0.45，0.89]），但在需要住院治疗的加重方面没有差异（RR：0.58[95%Crl：0.16，2.13]），尽管趋势上美泊利珠单抗更具优势。两种治疗对肺功能的影响大致相当，耐受性也相似。
尽管由于证据基础有限和残留异质性，本分析存在局限性，但结果表明，在重度哮喘患者中，美泊利珠单抗似乎至少与奥马珠单抗一样有效，且两种治疗的耐受性没有显著差异。
