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Table 2 Data on impact of some biologic therapies on HRQOL of severe asthma patients

From: Severe asthma and quality of life

Medication Publication Study design Population Results
Omalizumab Holgate et al., 2004 [47] RDBPC study Patients ≥12 years with severe allergic asthma (n = 246) Improved AQLQ scores through 32 weeks.
Humbert et al., 2005 [48] RDBPC study Patients ≥12 years with uncontrolled severe persistent allergic asthma (n = 419) Improved AQLQ scores after 28 weeks or discontinuation.
Hanania et al., 2011 [49] Prospective, MC, RDBPC, parallel-group, study Patients ≥12 years with uncontrolled severe allergic asthma (n = 850) Improved mean AQLQ scores (0.29 point [CI, 0.15 to 0.43]) after 48 weeks
Brodlie et al., 2012 [50] 16-week therapeutic study Children with severe asthma (median age 12 years; 15 children <12 years and 19 ≥ 12 years). Mini-AQLQ score increased from 3.5 to 5.9 (p < 0.0001).
Barnes et al., 2013 [51] MC retrospective observational study Patients aged ≥12 years with severe persistent allergic asthma (n = 136) Improved median AQLQ scores at 16 weeks and up to 12 months post-omalizumab initiation.
Braunstahl et al., 2013 [52] International, single-arm, open-label, observational registry Uncontrolled persistent allergic asthma (n = 943). Two patients aged <12; the rest ≥12 years. Clinically relevant (> 0.5 point) improvement from baseline in the AQLQ and mini-AQLQ scores in 67.2% of patients at month 12 and 60.7% at month 24.
Odajima et al., 2015 [53] multicenter, uncontrolled, open label study Children (6–15 years) with uncontrolled severe allergic asthma (n = 38) Improved scores of asthma-specific QOL questionnaire for pediatric patients after 24 weeks.
Li et al., 2016 [54] RDBPC, parallel-group, phase III study Patients ≥18 years with uncontrolled moderate-to-severe persistent allergic asthma (n = 616) Improved overall AQLQ scores and all individual domain scores after 24 weeks.
Alhossan et al., 2017 [55] Meta-analysis (24 observational studies across 32 countries) Adults with Severe Allergic Asthma (n = 9213) Improvements in quality of life at 4–6 months (Cohen’s d = 1.05; 1.29 AQLQ points) and at 12 months of therapy (Cohen’s d = 1.20; 1.51 AQLQ points).
Mepolizumab Haldar et al., 2009 [56] RDBPC, parallel group trial Adults with refractory eosinophilic asthma (n = 61) Improved AQLQ scores along one year (mean increase from baseline 0.55)
Ortega et al., 2014 [33] RDBPC, double dummy study Adults with severe eosinophilic asthma (n = 576) Improved SGRQ scores after 32 weeks
Bel et al., 2014 [35] RDBPC study Adults with severe eosinophilic asthma (n = 135) Improved SGRQ scores after 24 weeks
Magnan et al., 2016 [57] Post hoc analyses from two RDBPC, parallel group, studies Adults with severe eosinophilic asthma previously treated with omalizumab (n = 711) Improved SGRQ (after 24–32 weeks) vs placebo in both studies independent of prior omalizumab use.
Chupp et al., 2017 [58] RDBPC, MC, parallel-group, phase 3b study Patients ≥12 years with severe eosinophilic asthma (n = 551) A significant improvement in HRQOL from baseline (SGRQ total score at week 24) and a safety profile similar to that of placebo.
Lebrikizumab Hanania et al., 2015 [59] Pooled data from two MC, RDBPC studies Patients ≥18 years with uncontrolled moderate-severe asthma (n = 463) No placebo-corrected improvements in AQLQ scores at week 12 (wide confidence intervals) despite improvements in lung functions.
Tralokinumab Piper et al., 2013 [42] RDBPC, MC, parallel-group, phase 2a study Patients >18 years with uncontrolled moderate-severe asthma (n = 194) No differential effect was apparent in any of the patient reported outcomes at week 12 despite improved lung functions.
Brightling et al., 2015 [43] RDBPC, MC, parallel-group, phase 2b study Patients >18 years with uncontrolled severe asthma (n = 383) Improvement in AQLQ[S] (p = 0.019) in patients treated every 2 weeks (n = 33) compared with placebo (n = 48)
  1. AQLQ Asthma Quality of Life Questionnaire, HRQOL health related quality of life, MC multicentre, RDBPC randomized double-blind placebo-controlled, SGRQ St George’s Respiratory Questionnaire