Burden of allergic rhinitis and impact of MP-AzeFlu from the patient perspective : pan European patient survey

Funding for this research was provided by Mylan Inc. Acknowledgements We thank Dr Ruth B Murray (Medscript NZ Ltd) for assistance in drafting and editing this manuscript.Peer reviewedPublisher PD

Burden of allergic rhinitis and impact of MP-AzeFlu from the patient perspective: pan European patient survey

ObjectiveThe aims of this survey were to (1) assess the burden of allergic rhinitis (AR) from the patient perspective, (2) investigate MP-AzeFlu use in real life and its impact on patients' lives and (3) explore factors associated with treatment satisfaction.MethodsA cross-sectional, quantitative, online, questionnaire-based survey was conducted in seven European countries (March-June 2019). Questions explored AR burden and treatment satisfaction. Satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication 9-item (TSQM-9; max score = 100). Participants (aged >= 18 years) had a doctor/healthcare provider confirmed AR diagnosis and used MP-AzeFlu within the last year.ResultsPre-MP-AzeFlu treatment, participants (n = 1004) reported an average of 3.3 (SD:3.5) doctor visits/year, 8.1 (SD:11.0) days/year absenteeism and 15.8 (SD:18.9) days/year presenteeism due to AR. Only 48% of participants used MP-AzeFlu twice/day as recommended. Post-MP-AzeFlu 57% of participants reported better QoL, 47% reported fewer doctor visits and 52% discontinued polypharmacy. Absenteeism and presenteeism were reduced by 2.5 (SD 10.0) and 7.3 (SD:16.0) days/year, respectively. 70% of participants were more/much more satisfied with MP-AzeFlu versus previous AR treatment(s), and >= 70% were satisfied/extremely satisfied with its ability to prevent/treat AR, relieve symptoms and with its onset of action. Mean global, effectiveness and convenience TSQM-9 scores were 70.0 (SD:19.8), 68.3 (SD:21.6) and 72.7 (SD:20.4), respectively. Treatment satisfaction and effectiveness were significantly improved when MP-AzeFlu was taken as recommended.ConclusionsThe impact of AR on patients' lives remains high. Real-life use of MP-AzeFlu reduces that impact and is associated with a high level of effectiveness, convenience and global satisfaction.</p

A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu

Background Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu (Dymista ® ) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. Methods This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ~14 days. On day 3, the patients assessed their level of disease control as well controlled, partly controlled, or uncontrolled. The proportion of Norwegian patients who achieved defined VAS score cutoffs for “well-controlled” and “partly controlled” AR were also calculated. Results MP-AzeFlu reduced the mean ± standard deviation VAS score from 68.1 ± 16.4 mm at baseline to 37.4 ± 25.9 mm on the last day, a reduction of 30.8 ± 27.2 mm. The results were consistent, irrespective of disease severity, phenotype (i.e., seasonal AR [SAR], perennial AR [PAR], SAR plus PAR, unknown) or age (i.e., 12–17, 18–65, and >65 years). Of the patients (with recorded data), 88.1% considered their symptoms to be partly or well controlled at day 3; and 19.5, 32.0, 50.0, and 61.0% of the patients achieved a ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7, and the last day, respectively. Conclusions MP-AzeFlu provided rapid sustained symptom control in a routine clinical practice in Norway, which provided support for its effectiveness for the treatment of AR in real life

MP-AzeFlu provides rapid and effective allergic rhinitis control in real life : a pan-European study

Background: The European Union has prioritized allergic rhinitis (AR) control. Contre les Maladies Chronique pour un Vieillissement Actif Allergic Rhinitis and its Impact on Asthma has endorsed the visual analog scale (VAS) as the AR control language and incorporated it into a new AR treatment algorithm. Concurrently, the Respiratory Effectiveness Group and the European Academy of Allergy and Clinical Immunology are striving to improve the quality of published real-life AR research. Our aim was to assess the effectiveness of MP-AzeFlu by using a VAS in a well-designed, real-life, pan-European study. Methods: A total of 2988 patients (aged >= 12 years) with Allergic Rhinitis and its Impact on Asthma defined moderate-to-severe AR from Germany, Sweden, Romania, United Kingdom, Denmark, and Norway were included. Patients (except from the United Kingdom) assessed symptom severity by using a VAS from 0 mm (not at all bothersome) to 100 mm (very bothersome) on days 0, 1, 3, 7, and the last visit (similar to day 14) in the morning before MP-AzeFlu use. Patients' perceived level of disease control was assessed on day 3. A VAS score cutoff on day 3 for "well controlled" was determined, and the proportion of patients who achieved this response was calculated. Results: MP-AzeFlu was associated with a mean VAS score reduction from 73.7 mm at baseline to 23.4 mm by the last visit. This reduction was significant (p < 0.001) compared with baseline from day 1 and sustained until the last day of the study. By day 3, 50.3% of patients considered their symptoms well controlled; 18.2, 40.0, 66.6, and 75.9% of the patients achieved the <= 38 mm well-controlled VAS score cutoff on days 1, 3, 7 and the last day, respectively. The results were consistent across countries, age, phenotype, and severity. Conclusion: MP-AzeFlu provided effective and rapid symptom control in a real-life pan-European setting and aligned with the European Union, Contre les Maladies Chronique pour un Vieillissement Actif Allergic Rhinitis and its Impact on Asthma, the Respiratory Effectiveness Group, and the European Academy of Allergy and Clinical Immunology objectives, supporting MP-AzeFlu as the drug of choice for the treatment of moderate-to-severe AR

Intralymphatic Immunotherapy: Update and Unmet Needs

Allergen-specific immunotherapy (AIT) is the only allergy treatment that confers long-term symptom amelioration for patients suffering from allergy. The most frequently used allergen application route is subcutaneous injection (SCIT), commonly taken as the gold standard, followed by sublingual (SLIT) or oral (OIT) application of allergen preparations. This is an up-to-date review of the clinical evidence for a novel route of allergen application, i.e., directly into lymph nodes – intralymphatic immunotherapy (ILIT). The major advantages of ILIT over the current AIT approaches are its short duration and the low allergen doses administered. The whole treatment consists of merely 3 ultrasound-guided injections into inguinal lymph nodes 1 month apart. While the number of patients included in randomised controlled trials is still limited, the clinical results for ILIT are encouraging, but more clinical trials are needed, as well as more preclinical work for optimising formulations