Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Sep 18;13(9):100462.
doi: 10.1016/j.waojou.2020.100462. eCollection 2020 Sep.

Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities

Claudia Crimi  1 , Raffaele Campisi  1 , Giulia Cacopardo  2 , Rossella Intravaia  2 , Santi Nolasco  2 , Morena Porto  2 , Corrado Pelaia  3 , Nunzio Crimi  2
Affiliations

Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities

Claudia Crimi et al. World Allergy Organ J. .

Abstract

Background: Data on mepolizumab in patients with severe eosinophilic asthma (EA) and comorbidities are needed to assess whether randomized controlled trial results are applicable in the real world.

Objective: To evaluate real-life effectiveness and the presence/absence of predictors of treatment response in patients with one or more comorbidities (nasal polyps, allergic rhinitis, gastro-esophageal reflux disease, nonallergic rhinitis with eosinophilia syndrome, obesity, bronchiectasis) who received mepolizumab (MEPO) for the treatment of severe EA.

Methods: We performed a single-center retrospective study in patients with severe asthma and presence of comorbidities treated with mepolizumab at the respiratory outpatient clinic, Policlinico-Vittorio Emanuele, Catania, Italy. Health records of 31 severe asthmatic patients were retrieved and analyzed. Asthma control test (ACT) score, blood eosinophil count, forced expiratory volume in 1 s (FEV1), FEV1% of predicted and FEV1/FVC (Forced Vital Capacity) ratio, oral corticosteroid (OCS) dosage, and exacerbations were recorded at baseline (T0), after 3 (T1), 6 (T3), 9 (T6), and 12 months (T12). Clinical response was defined when 3 of these 4 criteria were fulfilled: i) 30% exacerbation decrease; ii) 80% blood eosinophilia reduction; iii) 3 point ACT increase; iv) FEV1 increase ≥200 mL.

Results: 83.87% of patients were classified as responsive to MEPO treatment. Substantial depletion of the blood eosinophils (>80%) was found in 87.1% of patients, FEV1 > 200 mL was seen in 54.84% of patients, a 3-point ACT improvement from baseline was recorded in 80.65% 25 of patients and a 30% reduction of exacerbations rates was seen in 96.77% of patients. Moreover, the majority 38.71% of patients met 3/4 parameters after 12 months. Neither the comorbidities nor other characteristics (sex, BMI, age, smoking) influenced treatment response.

Conclusions: MEPO in patients with severe EA is effective regardless of the presence of comorbidities.

Keywords: ACT, Asthma Control Test; BMI, Body Mass Index; DREAM, Dose Ranging Efficacy And safety with Mepolizumab; EA, Eosinophilic Asthma; ECRS, Eosinophilic Chronic Rhinosinusitis; ERS/ATS, European Respiratory Society/American Thoracic Society; FEV1, Forced Expiratory Volume in 1 s; FEV1/FVC, Forced Expiratory Volume in 1 s/Forced Vital Capacity ratio; FVC, Forced Vital Capacity; GERD, Gastro-Esophageal Reflux Disease; GINA, Global INitiative for Asthma; IL-5, Interleukin-5; IQR, Interquartile Range; IgG, Immunoglobulin G; MEPO, Mepolizumab; Mepolizumab; Multiple comorbidities; NARES, Non Allergic Rhinitis with Eosinophilia Syndrome; OCS, Oral Corticosteroid; RCTs, Randomized Controlled Trials; RV, Residual Volume; SD, Standard Deviation; SEM, Standard Error Mean; Severe eosinophilic asthma; T0, baseline; T1, 3 months after baseline; T12, 12 months after baseline; T3, 6 months after baseline; T6, 9 months after baseline.

PubMed Disclaimer

Conflict of interest statement

All the authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Comparison of clinical parameters from baseline (T0) to 12 months (T12). (A) Median blood eosinophil count; (B) Mean of FEV1; (C) Mean of ACT score; (D) Median of OCS mg/30days. ∗indicates p < 0.05. EOS, Eosinophil count; FEV1, forced expiratory volume in 1 s; ACT, asthma control test; OCS, oral corticosteroids
Fig. 2
Fig. 2
Analysis of potential predictors of treatment outcome. EOS, eosinophil count; BMI, body mass index; GERD, Gastro-esophageal reflux disease; NARES, Nonallergic rhinitis with eosinophilia syndrome
See this image and copyright information in PMC

References

    1. Chung K.F., Wenzel S.E., Brozek J.L. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–373. - PubMed
    1. European Medicine Agency (Ema). https://www.ema.europa.eu/en/documents/overview/nucala-epar-medicine-ove... accessed 25 november 2019.
    1. Chupp G.L., Bradford E.S., Albers F.C. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390–400. - PubMed
    1. Pavord I.D., Korn S., Howarth P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651–659. - PubMed
    1. Ortega H.G., Liu M.C., Pavord I.D. MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198–1207. - PubMed