Post-Authorisation Safety Study of the SQ Tree Sublingual Immunotherapy Tablet in Real-Life Practice Across Europe

Speaker(s)

Borchert K1, Himmelhaus H1, Wolf H2, Pfaar O3, Reiber R4, Knulst A5, Sidenius K6, Mäkelä MJ7, Steinsvåg S8, Janson C9, van der Zwan L10, Uss E10, Arvidsson P11, Wüstenberg E2
1Xcenda GmbH, part of Cencora Inc., Hannover, Lower Saxony, Germany, 2ALK-Abelló Arzneimittel GmbH, Hamburg, Hamburg, Germany, 3Universitätsklinikum Gießen und Marburg GmbH, Marburg, Hesse, Germany, 4Praxisgemeinschaft Reiber und Partner, Schorndorf, Baden-Wuerttemberg, Germany, 5Utrecht University, Utrecht, Utrecht, Netherlands, 6Aleris Hospitaler København, København, Hovedstaden, Denmark, 7HUS lho-ja allergisairaala, Helsinki, Uusimaa, Finland, 8Sørlandet Sykehus, Kristiansand, Agder, Norway, 9Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Uppsala län, Sweden, 10ALK-Abelló Benelux, Almere, Flevoland, Netherlands, 11ALK Nordic A/S, Kungsbacka, Hallands län, Sweden

Presentation Documents

OBJECTIVES: The SQ tree sublingual immunotherapy (SLIT)-tablet is authorized for treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis (ARC) induced by tree pollen of the birch homologous group in adults. Study aim was to investigate real-world safety and tolerability of the SQ tree SLIT-tablet during the first 4-6 months of routine care treatment.

METHODS: A prospective, non-interventional, multicenter, open-label, multinational post-authorization safety study (NIS PASS, EUPAS31470) was conducted in outpatient centers across 6 European countries between March 2020 and June 2022. Data were collected for eligible patients aged ≥18 years with birch-pollen induced ARC at treatment initiation and during follow-up visits on medical history, allergy symptoms, concomitant medication, and adverse events (AEs)/adverse drug reactions (ADRs) categorized by seriousness, severity, and causality. Patients were stratified by clinical manifestations: ARC, ARC and allergic asthma (AA), ARC and pollen food syndrome (PFS), ARC+AA+PFS, ARC and atopic dermatitis (AD, ±AA±PFS). Frequencies of ADRs were compared with those listed in the Summary of Product Characteristics (SmPC).

RESULTS: Data from 1,069 patients from 112 sites were analyzed: mean age 37.5 (range 18-65) years, 53.7% female. Mean treatment duration was 5.2 months. Most patients were affected by ARC only (31.1%), followed by ARC+PFS (23.3%), ARC+AA+PFS (18.7%), ARC+AD(±AA±PFS) (14.3%), and ARC+AA (12.6%). AEs were reported in 61.7% of patients (ADRs: 57.7%) during the entire course of treatment, and in 46.7% (45.9%) at first administration; 53.5% of all AEs were mild, 23.9% moderate, 6.6% severe, and 1.9% serious. Tolerability was rated as ‘very good’ or ‘good’ by the physicians in 85.6% of patients.

CONCLUSIONS: The large sample size of >1,000 patients in this NIS PASS provide a representative picture of the safety and tolerability during initiation and early treatment with the SQ tree SLIT-tablet. The SQ tree SLIT-tablet was found to be safe and well tolerated in real-life with no new safety risks identified.

Code

SA38

Topic

Study Approaches

Topic Subcategory

Prospective Observational Studies

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)