PMID- 38487467 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240316 IS - 2673-6101 (Electronic) IS - 2673-6101 (Print) IS - 2673-6101 (Linking) VI - 5 DP - 2024 TI - House dust mite sublingual allergen immunotherapy tablet is safe and well-tolerated in Dutch clinical practice. PG - 1355324 LID - 10.3389/falgy.2024.1355324 [doi] LID - 1355324 AB - BACKGROUND: Half (49%) of clinically diagnosed allergic rhinitis (AR) patients are sensitized to house dust mite (HDM). If allergen avoidance and symptomatic medication fail, allergen immunotherapy may be indicated. OBJECTIVE: We investigated safety and tolerability of HDM-sublingual immunotherapy by HDM-SLIT tablets in Dutch daily clinical practice. METHODS: Daily intake of 12 SQ-HDM SLIT-tablet was investigated in a prospective, multicenter, observational study (EUPAS43753). It comprised 4 consultations in 1 year. Data on safety, tolerability, treatment satisfaction, symptomatic medication, compliance, and clinical effectiveness (Control of Allergic Rhinitis and Asthma Test; CARAT) were collected. Descriptive and longitudinal regression data analysis were performed. RESULTS: Adult patients (n = 415), mean (SD) age 36.6 (12.2) years, 61.4% female and 36% asthmatic were included. The preponderance (65.1%) experienced adverse events (AEs). These, mostly mild (67%), AEs comprised: oral allergic reactions (58.6%), respiratory (12.4%) and gastrointestinal symptoms (9.4%). Sixty (14.5%) patients stopped due to AEs and 76 (18.3%) for non-AE reasons. CARAT scores improved clinically significant by 6 points and symptomatic medication use decreased from 96.1% to 77.4%. Most patients (74.5%) tolerated the treatment and were compliant (>86.5%). The majority of patients (62.4%) and investigators (69.4%) were satisfied with treatment. CONCLUSIONS: HDM SLIT-tablet is a safe and well-tolerated AR treatment. AEs occur often but are mostly mild and decreasing during the first year. CARAT scores improved and symptomatic medication use decreased suggesting better control of AR with treatment. Compliance, tolerability, and treatment satisfaction are good. However, patient follow-up and compliance remain important points of attention when initiating treatment. CI - (c) 2024 Tempels-Pavlica, Aarts, Welsing, van der Meer, van der Zwan, Uss and Knulst. FAU - Tempels-Pavlica, Zana AU - Tempels-Pavlica Z AD - Department of Allergology, Diakonessenhuis, Utrecht, Netherlands. FAU - Aarts, Mark C J AU - Aarts MCJ AD - Department of Otorhinolaryngology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. FAU - Welsing, Paco M J AU - Welsing PMJ AD - Department of Rheumatology & Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands. FAU - van der Meer, Akke-Nynke AU - van der Meer AN AD - Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, Netherlands. FAU - van der Zwan, Leonard P AU - van der Zwan LP AD - Medical Department, ALK-Abello BV, Almere, Netherlands. FAU - Uss, Elena AU - Uss E AD - Medical Department, ALK-Abello BV, Almere, Netherlands. FAU - Knulst, Andre C AU - Knulst AC AD - Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands. LA - eng PT - Journal Article DEP - 20240229 PL - Switzerland TA - Front Allergy JT - Frontiers in allergy JID - 9918227355906676 PMC - PMC10937523 OTO - NOTNLM OT - Control of Allergic Rhinitis and Asthma Test (CARAT) OT - allergic rhinitis OT - general medicine OT - house dust mite (HDM) OT - non-interventional study OT - outpatient clinic OT - safety OT - sublingual immunotherapy tablet COIS- Author (all authors) and research fees are paid by ALK-Abello BV. Two authors (5 and 6) work for ALK-Abello BV. The study was funded by ALK-Abello BV. The funder had the following involvement in the study: study sponsor. EDAT- 2024/03/15 06:44 MHDA- 2024/03/15 06:45 PMCR- 2024/02/29 CRDT- 2024/03/15 04:09 PHST- 2023/12/13 00:00 [received] PHST- 2024/02/16 00:00 [accepted] PHST- 2024/03/15 06:45 [medline] PHST- 2024/03/15 06:44 [pubmed] PHST- 2024/03/15 04:09 [entrez] PHST- 2024/02/29 00:00 [pmc-release] AID - 10.3389/falgy.2024.1355324 [doi] PST - epublish SO - Front Allergy. 2024 Feb 29;5:1355324. doi: 10.3389/falgy.2024.1355324. eCollection 2024.