ABSTRACT
BACKGROUND: Chronic rhinosinusitis with nasal polyposis (CRSwNP) negatively affects health-related quality of life (HRQoL). In a previously reported randomized clinical trial (NCT01920893), addition of dupilumab to mometasone furoate in patients with CRSwNP refractory to intranasal corticosteroids (INCS) significantly improved endoscopic, radiographic, and clinical endpoints and patient-reported outcomes. The objective of this analysis was to examine the impact of dupilumab treatment on HRQoL and productivity using secondary outcome data from this trial. METHODS: Following a 4-week mometasone furoate nasal spray run-in, patients were randomized to commence subcutaneous dupilumab (600 mg loading dose, then 300 mg once weekly for 15 weeks [n = 30], or matched placebo [n = 30]). Outcomes included scores on the CRS disease severity visual analog scale (VAS), 22-item Sino-Nasal Outcome Test (SNOT-22), 5-dimension EuroQoL (EQ-5D) general health status VAS, and 36-item Short-Form Health Survey (SF-36) for HRQoL and nasal polyp-related healthcare resource use questionnaires. RESULTS: Following 16 weeks of treatment, the proportion of patients with moderate-to-severe CRSwNP (VAS > 3-10) decreased from 86.2% to 21.4% with dupilumab and 88.0% to 84.2% with placebo. Dupilumab (vs placebo) resulted in significantly greater improvement in HRQoL, based on SNOT-22, SF-36, and EQ-5D VAS scores. The dupilumab group had a significantly lower adjusted annualized mean number of sick leave days (0.09, vs 4.18 with placebo, P = .015) and significantly greater improvement (vs placebo) in the SNOT-22 item "reduced productivity." CONCLUSIONS: In adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Nasal Polyps/drug therapy , Quality of Life , Rhinitis/drug therapy , Sinusitis/drug therapy , Adult , Chronic Disease , Double-Blind Method , Female , Humans , Male , Middle Aged , Mometasone Furoate/therapeutic use , Patient Reported Outcome Measures , Treatment OutcomeABSTRACT
BACKGROUND: In a pivotal, phase 2b study (NCT01854047) in patients with uncontrolled persistent asthma, despite using medium-to-high-dose inhaled corticosteroids plus long-acting ß2 agonists, dupilumab improved lung function, reduced severe exacerbations, and showed an acceptable safety profile. OBJECTIVE: To assess the impact of dupilumab on asthma control, symptoms, quality of life (QoL), and productivity. METHODS: Data are shown for the intention-to-treat population receiving dupilumab 200/300 mg every 2 weeks (doses being assessed in phase 3; NCT02414854), or placebo. Predefined analyses of total scores were conducted at week 24 for the 5-item Asthma Control Questionnaire (ACQ-5), patient-reported morning/evening (AM/PM) asthma symptoms, Asthma Quality of Life Questionnaire (AQLQ), and asthma-related productivity loss. Responder rate analyses for these measures, subgroup analyses by baseline characteristics, and asthma-related productivity loss analyses were conducted post hoc. RESULTS: Data from 465 patients were analyzed (158 placebo; 307 dupilumab). Both dupilumab doses significantly improved scores through week 24 (all outcomes, overall population). The proportion of patients meeting or exceeding the minimal clinically important difference for the overall population were significantly greater vs placebo (P < .05) for ACQ-5 (range, 72.6%-76.7% vs 61.4%), for AM/PM asthma symptoms score (48.7%-54.1% vs 34.2% and 52.7%-53.5% vs 34.2%, respectively) and for AQLQ (64.0%-65.0% vs 51.3%). The effect of dupilumab was consistent across most subgroups. Productivity loss was significantly higher in placebo- vs dupilumab-treated patients (P < .0001). CONCLUSION: Dupilumab produced significant, clinically meaningful improvements in asthma control, symptoms, QoL, and productivity. REGISTRATION: ClinicalTrials.gov Identifier: NCT01854047.
Subject(s)
Anti-Asthmatic Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Asthma/drug therapy , Quality of Life/psychology , Activities of Daily Living , Antibodies, Monoclonal, Humanized , Female , Humans , Interleukin-4 Receptor alpha Subunit/antagonists & inhibitors , Interleukin-4 Receptor alpha Subunit/immunology , Male , Middle Aged , Patient Reported Outcome Measures , Placebos/administration & dosage , Surveys and Questionnaires , Treatment OutcomeSubject(s)
Absenteeism , Antibodies, Monoclonal, Humanized/therapeutic use , Dermatitis, Atopic/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Clinical Trials, Phase III as Topic , Female , Humans , Male , Middle Aged , Randomized Controlled Trials as Topic , Severity of Illness Index , Young AdultABSTRACT
American and European society guidelines for atrial fibrillation management mostly agree on the utilization of rate and rhythm control strategies and the indications for oral anticoagulant (OAC) use. However, the level of adherence to guidelines in clinical practice may vary by region. In this study, data analysis from The Registry on Cardiac rhythm disorders assessing the control of Atrial Fibrillation (RECORD-AF) registry, an international registry in patients with newly diagnosed atrial fibrillation of <1 year, shows that differences in practice exist between 3 regions, namely Western Europe, Eastern Europe, and North America. Data analyzed included major cardiovascular outcomes at 12 months, choice of rhythm versus rate control strategy and the use of OAC according to CHADS2 score between regions, and the cost incurred according to management strategy. In conclusion, there is preference for rhythm control strategy in Europe compared to North America without a significant impact on major cardiovascular outcomes; there is significant discrepancy in the use of OAC in Eastern Europe compared to the 2 other regions; and rate control was found to be more costly in all regions.