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