SESSION TITLE: Allergy and Airway Poster Discussions
SESSION TYPE: Original Investigation Poster Discussion
PRESENTED ON: Wednesday, October 28, 2015 at 08:45 AM - 10:00 AM
PURPOSE: To evaluate clinical characteristics, comorbidity and health-related quality of life (QoL) in patients with persistent asthma receiving medium- to high-dose inhaled corticosteroids (ICS) plus a long-acting beta-agonist (LABA).
METHODS: Baseline clinical and patient-reported parameters in a phase 2 dupilumab clinical trial (NCT01854047) were analyzed and included: FEV1, exacerbation history, Asthma Control Questionnaire 5-item version (ACQ-5), Asthma Quality of Life Questionnaire (AQLQ), Sino-Nasal Outcomes Test (SNOT-22), Hospital Anxiety and Depression Scale (HADS), EuroQol 5-dimensions (EQ-5D).
RESULTS: 63% of patients were female and 78% Caucasian; mean age was 49±13.0 years. Patients (N=776) had asthma for 22±15.4 years. FEV1 was 1.8±0.5 L, FEV1%predicted 61±10.7, median ICS dose 1000/640/800mcg for fluticasone+salmeterol/budesonide+formoterol/mometasone+formoterol. Patients had 2.2±2.14 asthma-related exacerbations in the past year; 25% of patients had ≥3 exacerbations. 74% of patients had concomitant atopic conditions. Mean ACQ-5 was 2.74±0.81; over 50% of patients reported ‘moderate’ to ‘maximum’ impairment on 4 out of 5 ACQ-5 items. 63% of patients reported at least ‘moderate’ symptoms upon waking, 70% reported at least ‘moderate’ shortness of breath, and 61% experienced wheezing at least a ‘moderate amount of the time’. 53% of patients reported ‘moderate’ to ‘total’ activity limitation due to asthma on the ACQ-5; likewise, 39% and 43% of patients reported they had ‘moderate problems/unable’ to walk or do usual activities, respectively, on the EQ-5D. Overall AQLQ score was 4.0±1.1, indicating a moderate impact of asthma on QoL. Patients with sino-nasal conditions also reported a moderate effect of these conditions on QoL (SNOT-22: 37.4±18.8). One quarter (25%) of patients scored ≥11 on the HADS, the cutoff for anxiety/depression; over one third (35%) scored ≥8, indicating possible anxiety/depression. Similarly, 31% of patients reported ‘moderate to extreme’ anxiety/depression on the EQ-5D.
CONCLUSIONS: Despite receiving ICS+LABA, patients entering the study had recurrent exacerbations, as well as moderate to severe asthma-related symptoms and daily activity limitations. Concomitant atopic diseases were common and about one third of patients had symptoms of anxiety/depression.
CLINICAL IMPLICATIONS: New treatment options may be warranted for some patients with persistent asthma despite ICS+LABA therapy. Patients may also present with comorbidities requiring medical attention.
DISCLOSURE: Jonathan Corren: Other: Received funding from Sanofi for dupilumab clinical trial Mario Castro: Other: Washington University received funding from Sanofi for participation in dupilumab clinical trial Vijay Joish: Employee: Regeneron Pharmaceuticals, Inc. ‐ employee and shareholder Vera Mastey: Employee: Regeneron Pharmaceuticals, Inc. ‐ employee and shareholder Caroline Amand: Employee: Sanofi employee, may hold stock and/or stock options in the company Christine Taniou: Employee: Sanofi employee, may hold stock and/or stock options in the company Robert Evans: Employee: Regeneron Pharmaceuticals, Inc. ‐ employee and shareholder Mariana Louis Tisserand: Employee: Sanofi employee, may hold stock and/or stock options in the company Ariel Teper: Employee: Sanofi employee, may hold stock and/or stock options in the company Laurent Eckert: Employee: Sanofi employee, may hold stock and/or stock options in the company
Dupilumab is in clinical development and has no marketing authorization yet.