Catalytic Health

4 Special Supplement, May 2023 • Canadian Allergy & Immunology Today second-generation antihistamines such as bilastine, cetirizine, desloratadine, fexofenadine, loratadine, and rupatadine are recommended over first-generation antihistamines (i.e., diphenhydramine, hydroxyzine, chlorpheniramine). 8-10 Rupatadine is the only antihistamine that also has potent anti-PAF effects. 5 Despite the many available treatments for AR, clinical studies show that patients are often dissatisfied with their AR treatment, and their symptoms may remain uncontrolled. 1,3 Measurement-based care is a relatively new trend in healthcare that involves the systematic use of standardized measurements during office visits, the results of which are used to inform treatment decisions. The quantitative measures typically are in the form of short, validated, patient- and/or clinician-reported rating scales. 11,12 Measurement-based care has been studied primarily for behavioural and mental health issues, where its success has been documented. 12-14 The use of measurement-based care has yet to be studied for the treatment of AR, and its use in this context may be helpful in a real-world setting where symptom assessment is often subjective. The Improving symptom Control of Allergic Rhinitis (ICAR) study was conducted to determine if improving the assessment and management of AR through measurement-based care can lead to improved patient outcomes. M E T H O D S Study design ICAR was a real-world, open-label, prospective, multicenter study conducted in 60 sites across Canada between September 2021 and December 2021. The study was reviewed and approved by the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Verbal informed consent to participate in the study was obtained from each patient. At the baseline visit, information was collected from patients on demographics, comorbidities, disease characteristics, and AR treatment history. Current AR treatment satisfaction was assessed by the question "If you took medication in the past month for your allergies, were your allergy symptoms relieved to your satisfaction?" and by the question "How satisfied are you with your current treatment?" The impact of AR symptoms on health-related quality of life (QOL) was assessed by the Rhinitis Control Assessment Test (RCAT), and an overall AR assessment was determined by both the patient and the clinician on a visual analog scale (VAS). Patients were then provided four weeks of treatment of 10 mg daily oral rupatadine. Use of all other antihistamines was discontinued; however, patients could continue nasal corticosteroid treatment. At a follow-up visit conducted four weeks later, the RCAT and patient and clinician symptom VAS were repeated. Patient selection criteria Patients age 18 years or over with mild, moderate or severe AR were prospectively enrolled in the study. Each patient's AR was categorized as uncontrolled, partially controlled or controlled by physician assessment at baseline. Patients were further categorized as treatment- naïve, uncontrolled despite OTC or prescription AR treatment, or requiring a switch in treatment due to adverse effects. Patient eligibility included both seasonal and perennial AR. Measurements The primary study objective was to determine if improving assessment and management of AR through measurement-based care leads to better patient outcomes. The secondary objectives included monitoring the difference between controlled, partially controlled and uncontrolled patients; monitoring previously-treated versus treatment-naïve patients; monitoring the impact of rupatadine on nasal symptoms; and monitoring the physician's symptom assessment vs the patient's symptom assessment. The frequency of AR symptoms and the impact of symptoms on patients' health-related QOL at baseline and follow-up were assessed by the RCAT. The RCAT is a validated six-item questionnaire that evaluates the frequency of nasal congestion, sneeze, and watery eyes (not related to a cold or the flu) during the previous week. 15 The RCAT also determines how often activities were avoided in the last week because of AR symptoms and how well AR symptoms were controlled in the previous week. RCAT scores range from 6 to 30, with a score of ≤21 indicating patients are experiencing problems with AR symptom control. 15 An improvement in RCAT score of 2.4 points on a population level and 3 points on an individual level is considered clinically meaningful. 16 The patient's overall AR assessment was determined by the response to the questions "How are you feeling today? Think about how troublesome your symptoms have been for the last 24 hours." These were rated on a VAS of 0-10, with 0 being "not troublesome at all" and 10 being "very troublesome." The clinician's overall AR assessment was determined by the response to "classification of allergic rhinitis control" rated on a VAS of 0-10, with 0 being "not troublesome at all" and 10 being "very troublesome." VAS scores of <2 indicated controlled, 2 to 5 indicated partially controlled, and ≥5 indicated uncontrolled. Data analysis Results were analyzed primarily by descriptive statistics alone. Data were analyzed by AR patient category (treatment-naïve, uncontrolled despite treatment or switch patients) and by comorbidities. T-tests were conducted to determine statistical differences between baseline and follow-up for each item of the RCAT.

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