Change of T2-markers in patients with severe uncontrolled asthma treated by monoclonal antibodies: 1 yr follow up

Abstract

The aim of this study was to assess the change of T2-biomarkers in patients with severe asthma during 1 yr treatment by monoclonal antibodies in a real clinical practice.

Methods: We examined 36 outpatients (33% male, aged 18-72 yr, mean age 54 yrs) with uncontrolled (ACQ5 score 2.58) severe asthma (ERS/ATS, 2014) treated with anti-IL-5/IL5R (mepolizumab, benralizumab, n=21, including 6 subjects with steroid-dependent asthma, mean daily dose 12.5 mg prednisolone) and anti-IL-4/13 antibodies (dupilumab, n=15, 6 steroid-dependent subjects, dose 15.0 mg) during 1 year. Blood eosinophils (Eos) count was measured by automatic haemoanalyser. FeNO was assessed by a chemiluminescence analyzer (LR4000; UK). Need for regular oral steroid use, Eos≥150 cell/μl and FeNO≥20 ppb were considered as markers of T2-inflammation.

Results: In patients treated by anti-IL-5/IL5R baseline Eos count and FeNO were 376 cell/μl and 31ppb, after 3 months: 136 cell/μl (p<0.001) and 21ppb (p<0.05), after 1 year: 129 cell/μl (p<0.001) and 18ppb (p<0.05 vs baseline). In asthmatics treated by anti-IL-4/13 baseline Eos count and FeNO were 488 cell/μl and 44ppb, after 3 months - 354 cell/μl (p>0.05, in 4 patients increased up to 1500 cell/μl) and 20ppb (p<0.05), after 1 year - 225 cell/μl (p<0.05) and 22ppb (p<0.05 vs baseline). Asthma control was improved in 3 and 12 months and daily prednisolone dose reduced in 12 months in both groups of patients.

Conclusion: In majority of patients with severe asthma treated by anti-IL-5/IL5R and anti-IL-4/13 clinical improvement was associated with the decrease of markers of T2-inflammation. Blood eosinophil count reduced faster during the treatment with anti-IL5/IL5R.