A Retrospective Multicenter Cohort Study on the Effectiveness of Triple Inhaled Therapy in Severe Asthma.

Abstract

Background and objectives: Triple therapy (TT) is effective for asthma patients whose disease remains uncontrolled with dual therapy. However, relevant questions remain unanswered. Objectives: To evaluate the long-term effectiveness of TT in a real-world setting; to determine the extent to which it prevents escalation to oral corticosteroids (OCS), azithromycin, or biologics; and to identify factors related to failure.

Methods: Retrospective multicenter cohort study. Data were collected at baseline, 16-24 weeks, 52 weeks, and at the last visit. Follow-up extended to treatment escalation or the last visit. Effectiveness of TT was defined as no treatment escalation plus asthma control (Asthma Control Test [ACT] ≥20 and no severe exacerbations in the preceding 12 months).

Results: A total of 390 patients were analyzed (median follow-up 40.0 months). Of these, 83 (22.5%) escalated treatment; TT was effective in 54% at the last visit. Complete remission (control plus FEV1 ≥80%) was achieved in 20.6%. Severe exacerbations, OCS load, symptoms, and FEV1 improved significantly. The factors associated with failure of TT in the previous year were smoking history (HR 1.84), lack of asthma control at 16-24 weeks (HR 3.41), bronchiectasis (HR 1.91), baseline ACT ≤15 (HR 1.81), ≥2 severe exacerbations in the previous year (HR 2.01), and low eosinophil count (HR 2.58). FEV1 declined >30 mL/year in 25.3% of patients in whom TT was effective.

Conclusions: TT achieved sustained control in a significant proportion of patients whose disease was not controlled with dual therapy. Bronchiectasis, smoking history, greater clinical severity at initiation of TT, and lack of control at 16-24 weeks predicted poorer outcome.