Liu Mark C, Bagnasco Diego, Matucci Andrea, Pilette Charles, Price Robert G, Maxwell Aoife C, Alfonso-Cristancho Rafael, Jakes Rupert W, Lee Jason K, Howarth Peter
Divisions of Allergy and Clinical Immunology, Pulmonary and Critical Care Medicine, Johns Hopkins Asthma and Allergy Center, Baltimore, Md.
Allergy and Respiratory Diseases, DIMI Department of Internal Medicine, University of Genoa, Ospedale Policlinico San Martino, Genoa, Italy.
J Allergy Clin Immunol Pract. 2023 Dec;11(12):3650-3661.e3. doi: 10.1016/j.jaip.2023.07.024. Epub 2023 Jul 26.
Severe asthma is complex; comorbidities may influence disease outcomes.
To assess mepolizumab effectiveness in patients with severe asthma and comorbidities.
REALITI-A was a 2-year international, prospective study enrolling adults with asthma newly prescribed mepolizumab (100 mg subcutaneously) at physician's discretion. This post hoc analysis assessed 1-year outcomes stratified by comorbidities at enrollment: chronic rhinosinusitis with nasal polyps (CRSwNP), gastroesophageal reflux disease (GERD), depression/anxiety, and chronic obstructive pulmonary disease (COPD). Outcomes included the rate of clinically significant asthma exacerbations (CSEs; requiring systemic corticosteroids and/or hospital/emergency room admission) between the 12 months pre- and post-mepolizumab treatment and changes from baseline in daily maintenance oral corticosteroid dose (mo 12), Asthma Control Questionnaire-5 score (mo 12) and forced expiratory volume in 1 second (FEV; mo 9-12).
At enrollment (n = 822), 321 of 822 (39%), 309 of 801 (39%), 203 of 785 (26%), and 81 of 808 (10%) patients had comorbid CRSwNP, GERD, depression/anxiety, and COPD, respectively. Post- versus pre-treatment across all comorbidity subgroups: the rate of CSEs decreased by 63% or more; among 298 (39%) patients on maintenance oral corticosteroids at baseline, median dose decreased by 50% or more; Asthma Control Questionnaire-5 score decreased by 0.63 or more points; FEV increased by 74 mL or more. Patients with versus without CRSwNP had the greatest improvements (eg, rate of CSEs decreased by 75%). Patients without GERD, depression/anxiety, or COPD had greater improvements than those with the respective comorbidities, except for FEV in patients with COPD.
Mepolizumab improved disease outcomes in patients with severe asthma irrespective of comorbidities, with additional benefit for patients with CRSwNP.
重度哮喘情况复杂;合并症可能影响疾病转归。
评估美泊利珠单抗对重度哮喘合并症患者的疗效。
REALITI-A是一项为期2年的国际前瞻性研究,纳入了由医生酌情新处方美泊利珠单抗(100mg皮下注射)的成年哮喘患者。这项事后分析评估了入组时按合并症分层的1年转归:伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)、胃食管反流病(GERD)、抑郁/焦虑和慢性阻塞性肺疾病(COPD)。转归包括美泊利珠单抗治疗前12个月和治疗后12个月期间具有临床意义的哮喘急性加重(CSE;需要全身使用糖皮质激素和/或住院/急诊)发生率,以及每日维持口服糖皮质激素剂量(第12个月)、哮喘控制问卷-5评分(第12个月)和第1秒用力呼气容积(FEV;第9 - 12个月)相对于基线的变化。
入组时(n = 822),822例患者中有321例(39%)、801例患者中有309例(39%)、785例患者中有203例(26%)以及808例患者中有81例(10%)分别患有合并症CRSwNP、GERD、抑郁/焦虑和COPD。在所有合并症亚组中,治疗后与治疗前相比:CSE发生率降低了63%或更多;在基线时接受维持口服糖皮质激素治疗的298例(39%)患者中,中位剂量降低了50%或更多;哮喘控制问卷-5评分降低了0.63分或更多;FEV增加了74mL或更多。伴有CRSwNP的患者与不伴有CRSwNP的患者相比改善最为显著(例如,CSE发生率降低了75%)。不伴有GERD、抑郁/焦虑或COPD的患者比伴有相应合并症的患者改善更大,但COPD患者的FEV情况除外。
无论是否存在合并症,美泊利珠单抗均改善了重度哮喘患者的疾病转归,对伴有CRSwNP的患者有额外益处。