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

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)