Decisions with patients, not for patients: Shared decision-making in allergy and immunology.

Shared Decision-Making (SDM) is an increasingly implemented patient-centred approach to navigating patient preferences regarding diagnostic and treatment options and supported decision-making. This therapeutic approach prioritizes the patient's perspectives, considering current medical evidence to provide a balanced approach to clinical scenarios. In light of numerous recent guideline recommendations that are conditional in nature, and are clinical scenarios defined by preference-sensitive care options, there is a tremendous opportunity for SDM and validated decision aids. Despite the expansion of the literature on SDM, formal acceptance among clinicians remains inconsistent. Surprisingly, a significant disparity exists between clinicians' self-reported adherence to SDM principles and patients' perceptions of its implementation during clinical encounters. This discrepancy underscores a fundamental issue in the delivery of healthcare, where clinicians may overestimate their integration of SDM, while patients' experiences suggest otherwise. This review critically examines the factors contributing to this inconsistency, including barriers within the healthcare system, clinician attitudes and behaviours, and patient expectations and preferences. By elucidating these factors in the fields of food allergy, asthma, eosinophilic esophagitis, and other allergic diseases, this review aims to provide insights into bridging the gap between clinician perception and patient experience in SDM. Addressing this discordance is crucial for advancing patient-centred care and ensuring that SDM is not merely a theoretical concept but a tangible reality in the practice of Allergy and Immunology.

Real-world users of triple therapy for asthma in the US.

OBJECTIVES: For patients with asthma who remain symptomatic on a medium-dose inhaled corticosteroid/long-acting ß2 agonist, addition of a long-acting muscarinic antagonist as a supplementary controller is a recommended option. However, real-world data on the characteristics and treatment patterns of these patients are limited. This study described the demographics and clinical characteristics of new users of single- or multiple-inhaler triple therapy and treatment patterns preceding triple-therapy initiation. STUDY DESIGN: This retrospective cohort study used medical and pharmacy claims data from the IQVIA PharMetrics Plus database. METHODS: The study population comprised adults with asthma with or without chronic obstructive pulmonary disease (COPD) initiating triple therapy with single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; 100/62.5/25 µg) or multiple-inhaler triple therapy (MITT) between September 18, 2017, and September 30, 2019. Demographics, clinical characteristics, and treatment patterns in the 12 months preceding triple-therapy initiation were described (baseline period). RESULTS: A total of 12,395 patients were included. Among FF/UMEC/VI initiators with asthma (n = 1301), the mean age was 49.0 years and 59.3% were women. During the baseline period, 81.5% of patients used controller therapy, 94.7% used rescue medications, and 42.0% reported at least 1 asthma-related exacerbation; the annual mean exacerbation rate was 0.96. Similar trends were observed among patients with asthma initiating MITT and patients with comorbid asthma-COPD initiating FF/UMEC/VI or MITT. CONCLUSION: In real-world practice, triple therapy is often utilized following other asthma controller medication use. High disease burden, as evidenced by substantial use of rescue medications and continued asthma-related exacerbations, suggests that patients may not have achieved adequate asthma control prior to triple-therapy initiation.

Adding tiotropium or long-acting ß2-agonists to inhaled corticosteroids: Asthma-related exacerbation risk and healthcare resource utilization.

Background: Based on current clinical guidelines, long-acting ß2-agonists (LABA) are frequently prescribed before long-acting muscarinic antagonists (LAMA) as an add-on to inhaled corticosteroids (ICS) in uncontrolled asthma. However, there is insufficient real-world evidence that supports this therapeutic approach. Objective: The objective was to compare asthma exacerbations and healthcare resource utilization in patients with asthma using the LAMA tiotropium bromide (Tio) or a LABA as an add-on to ICS (ICS + Tio or ICS/LABA) in a real-world setting. Methods: This retrospective, observational study included patients aged ≥12 years with asthma diagnoses identified in a U.S. longitudinal claims database (October 2015 to August 2020). The ICS + Tio and ICS/LABA cohorts were 1:2 propensity score matched for baseline variables. Outcomes were compared in the postmatched cohorts, and the risk of exacerbation was evaluated by using Kaplan-Meier curves. Results: After propensity score matching, there were 633 and 1266 patients in the ICS + Tio and ICS/LABA cohorts, respectively. The proportion of patients who experienced a severe or a moderate-or-severe exacerbation during follow-up was similar between the ICS + Tio versus ICS/LABA cohorts (4% versus 3%, p = 0.472, and 50% versus 45%, p = 0.050, respectively). The mean time to first severe (ICS + Tio 43.8 days versus ICS/LABA 49.4 days, p = 0.758) and moderate-or-severe exacerbation (ICS + Tio 65.8 days versus ICS/LABA 58.9 days, p = 0.474) was not statistically different between cohorts. The treatments had no effect on the risk of severe exacerbation, although it was 36% lower in ICS + Tio users than in ICS/LABA users (hazard ratio 0.64 [95% confidence interval, 0.22-1.84]). All-cause and asthma-related average monthly healthcare resource utilization were comparable between the treatments for hospitalizations and emergency department visits but were significantly greater in the ICS + Tio cohort than in the ICS/LABA cohort for asthma-related outpatient visits (p < 0.0001). Conclusion: This study provides real-world evidence that ICS + Tio may be a valid alternative when ICS/LABA cannot be used as first-line treatment for asthma maintenance therapy.

Dupilumab provides early and durable improvement of symptoms in patients with chronic rhinosinusitis with nasal polyps.

Objectives: To evaluate within-patient symptom improvement in the dupilumab SINUS-24/-52 studies in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) (NCT02912468/NCT02898454). Methods: Patients received dupilumab 300 mg or placebo every 2 weeks for 24 (SINUS-24) or 52 weeks (SINUS-52) on background intranasal corticosteroids. Patients daily reported symptoms of nasal congestion (NC), loss of smell (LoS) and rhinorrhoea on a scale of 0-3 (0 - no symptoms, 1 - mild, 2 - moderate, 3 - severe symptoms). The proportions of patients with moderate-to-severe symptoms (score ≥ 2) at baseline who improved to no-to-mild symptoms (score ≤ 1) were determined at Weeks 2, 24 (pooled studies) and 52 (SINUS-52). Subgroups with prior sinonasal surgery and coexisting asthma were analysed. Results: At baseline in the pooled intention-to-treat population (n = 724), the proportions of patients with scores ≥ 2 for NC, LoS and rhinorrhoea were 87, 94 and 64%, respectively. Significantly, more patients achieved scores ≤ 1 (no/mild symptoms) with dupilumab vs placebo for each symptom at each time point {Week 2 NC 12% vs 2% [odds ratio 8.9 (95% CI 3.0-26.3)], LoS 5% vs 1% [4.6 (1.3-16.8)], rhinorrhoea 9% vs 2% [4.8 (1.5-15.4)], all P < 0.05; Week 24 NC 54% vs 14% [8.7 (5.6-13.5)], LoS 43% vs 6% [14.4 (7.9-26.0)], rhinorrhoea 53% vs 16% [6.6 (4.1-10.9)], all P < 0.0001}. Results were similar in subgroups with prior surgery and coexisting asthma. Conclusion: Significantly, more patients achieved improvement from moderate-to-severe symptoms to no-to-mild symptoms with dupilumab than placebo, regardless of prior surgery or coexisting asthma. Improvement was observed as early as Week 2 and continued through to Week 52.

Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry.

BACKGROUND: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation. In clinical studies, dupilumab reduced the risk of severe asthma exacerbations, and improved forced expiratory volume in 1 s and quality of life in patients with uncontrolled moderate-to-severe asthma. OBJECTIVES: The objectives of RAPID (NCT04287621) are to characterize patients with asthma initiating dupilumab in routine clinical practice and to collect information on long-term effectiveness and safety in these patients. METHODS: RAPID is a global, prospective, observational registry that will enroll approximately 1000 patients (aged ≥ 12 years) with asthma from 150 sites globally. Dupilumab treatment will be initiated in routine clinical practice according to country-specific prescribing information, per physician discretion as part of routine care. Patients will be followed prospectively for up to 3 years, with postbaseline assessments at months 1 and 3, and every 3 months thereafter. PLANNED OUTCOMES: Baseline data collected will include patient demographics, disease characteristics, and medication history. Patient adherence and persistence will be recorded alongside health-care resource utilization, and effectiveness of dupilumab will be assessed (clinician assessment) as per standard of care. Quality of life, asthma control, type 2 inflammatory comorbidities, work productivity, and physical activity limitation will be assessed. Incidence and severity of adverse events will be recorded. CONCLUSION: RAPID is the first global registry to characterize patients beginning dupilumab treatment for asthma in clinical practice and will expand on prior clinical studies by providing real-world data. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04287621.

Allergen immunotherapy and shared decision-making.

Clinical decision-making in allergic rhinoconjunctivitis management involves a significant degree of complexity given the number of pharmaceutical agents; the option for allergen immunotherapy (AIT); and the risk for disease advancement, including the development of asthma as well as new environmental allergic sensitivities. Given the complex array of treatment options that are currently available, there is an opportunity to use a shared decision-making (SDM) approach with associated aids and tools that facilitate the interactive participation of practitioners and patients in the SDM process. This article reviews the general constructs of SDM, the unmet need for SDM aids, the collection of patient preference data for allergic rhinoconjunctivitis, the utility of SDM aids which have been specifically created for AIT, and outlines actionable steps to implement AIT SDM in clinical practice.