Abstract
Objectives: BT is a one-time treatment recommended as a GINA Step 5 add-on treatment for severe uncontrolled asthma as an alternative to monthly injected biologic OM. No clinical trials have directly compared BT and OM. An indirect treatment comparison (ITC) is presented using optimized asthma therapy (OAT) as a common control. ITCs are often utilised in health technology assessment to establish comparative effectiveness in the absence of direct trial evidence.
Methods: The ITC comprises a sham-controlled trial of BT (AIR2) and two placebo-controlled trials of OM (INNOVATE; EXTRA), identified in a systematic literature review, and uses Bucher's method.
Results: Comparing the post-treatment period with BT to ongoing treatment with OM, there were no significant differences in the rate ratios (RRs) for severe exacerbations (RR of BT versus OM via OAT 0.92, p=0.67) or hospitalisations (RR 0.68; p=0.63). The rate of emergency department (ED) visits was reduced by 75% with BT versus OM and was statistically significant (RR 0.25, p=0.01). Improvements in patients' quality of life (response on asthma quality of life questionnaire - AQLQ) were comparable (RR 1.06; p=0.59).
Conclusion: BT compares favourably to potentially more-costly pharmaceutical therapies for asthma. We observe a significant decrease in Post-treatment ED visits; clinicians evaluating these two add-on treatments should consider the totality of evidence as well as patient preferences to make an informed decision. Due to potential differences of the trial populations and the indirect comparison, the analyses should be interpreted with some caution.
- Copyright ©ERS 2015
