Odactra (house dust mite allergy vaccine tablet) / ALK-Abello - LARVOL DELTA

Potency of Dermatophagoides spp SLIT tablet compared to US standardized mite in ID testing (EAACI 2025) - "Lately, is was shown SLIT tablet (Acarizax(R)) dilutions can be used for such goal, and how tablets should be diluted was published: 0.8 SQ/ml being the best dilution for testing...As the monthly HDM SCIT dose is 500-2000AU, this confirms in this case that the daily SLIT dose is the monthly SCIT dose. For NAC 0.8 SQ/ml would be 48 AU/ml in this study."

Immunology

TEZEPAIT: Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab (clinicaltrials.gov) - P3 | N=38 | Not yet recruiting | Sponsor: University Hospital, Montpellier

New P3 trial • Allergy • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL5

ACARIZAX approved in Canada for treatment of young children (GlobeNewswire) - "ALK...today announced that Health Canada has approved ALK’s ACARIZAX tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. ACARIZAX is now indicated for treatment of moderate to severe HDM-induced allergic rhinitis, with or without conjunctivitis, in children, adolescents, and adults in Canada aged five to 65...The approval is based on the largest-ever paediatric AIT Phase 3 clinical trial, MT-12, involving 1,460 children aged five to 11 in North America and Europe...In parallel, separate regulatory reviews of ALK’s tree pollen allergy tablet ITULAZAX are ongoing in Europe and Canada, for use in young children and adolescents. These reviews are expected to complete in the middle of 2025..."

Canada approval • EMA approval • Allergic Rhinitis • Allergy • Immunology

FDA approves ODACTRA for the treatment of house dust mite allergy in young children (GlobeNewswire) - "ALK...announced that the US Food and Drug Administration (FDA) has approved ALK’s ODACTRA.tablet for use in young children with house dust mite (HDM) allergy....ODACTRA is an allergy immunotherapy (AIT) tablet which dissolves under the tongue and helps patients reduce their allergy symptoms and their reliance on symptomatic medication....The data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase 3 clinical trial, MT-12, which involved 1,460 children in North America and Europe."

FDA approval • Allergy

ALK’s house dust mite tablet (ACARIZAX) now recommended by NICE for use in the UK health system (GlobeNewswire) - "ALK...today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of ACARIZAX for the treatment of persistent, moderate to severe house dust mite allergic rhinitis in adults and adolescents. The recommendation paves the way for patients to gain access to ACARIZAX through the National Health Service (NHS) systems in England, Wales, and Northern Ireland, now making it eligible for general reimbursement....NICE is expected to publish a Final Guidance in March..."

NICE • Allergic Rhinitis

The impact of adverse reactions on adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy in Japan. (PubMed, Acta Otolaryngol) - "Severe reactions were more common in MITICURE® patients with seven or more positive antigen types. Severe adverse reactions reduced early adherence."

Adherence • Journal • Allergic Rhinitis • Allergy • Immunology • Inflammation

DuHDM: Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis (clinicaltrials.gov) - P=N/A | N=132 | Completed | Sponsor: Medical University of Silesia

New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

MATIC: House Dust Mite Allergy Trial In Children (clinicaltrials.gov) - P3 | N=1460 | Completed | Sponsor: ALK-Abelló A/S | Active, not recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Allergy • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Demystifying the fear of lack of adherence to sublingual immunotherapy (SLIT) (EAACI 2024) - "Background This study aims to assess adherence to sublingual immunotherapy (SLIT) using Acarizax® (Dermatophagoides pteronyssinus + Dermatophagoides farinae 12SQ-HDM oral lyophilisate) in patients treated at the Allergy Department of Araba University Hospital...However, initial oral antihistamine pretreatment significantly improved tolerability and reduced SLIT discontinuation rates. Additionally, telephone follow-ups after 3 weeks and 3 months were effective in reinforcing adherence."

Adherence • Allergy • Immunology • Inflammation

HDM-SLIT in general practices vs outpatient clinics (EAACI 2024) - "OC patients used more oral antihistamine and nasal corticosteroids than GP patients. This may have influenced their disease burden and AE severity."

Clinical • Allergic Rhinitis • Immunology • Inflammation

Utility of silver birch and house dust mite extracts derived from licensed sublingual tablets for nasal allergen challenge. (PubMed, Clin Transl Allergy) - "For both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate-severity response ("provoking dose 7/12") was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR."

Journal • Allergic Rhinitis • Immunology • Inflammation

TWO CASES OF LARYNGEAL EDEMA CAUSED BY SUBLINGUAL ALLERGEN IMMUNOTHERAPY (PubMed, Arerugi) - "He started treatment with Miticure® and developed laryngeal edema 30 minutes after taking the 10000JAU dose on the 10th day...Sublingual immunotherapy is a safe treatment, but sudden adverse reactions may occur. Laryngeal symptoms may be treated by changing to the sublingual spitting method, but laryngeal findings should be examined, and the dosage should be carefully increased."

Journal

Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: ALK-Abelló A/S | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Genetic and T2 biomarkers linked to the efficacy of HDM sublingual immunotherapy in asthma. (PubMed, Thorax) - P3 | "HDM SLIT-tablet AIT is efficacious in HDM-sensitised asthma subjects with a genetic asthma predisposition and/or an underlying T2 endotype."

Biomarker • IO biomarker • Journal • Allergy • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: ALK-Abelló A/S

New trial • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Safety of Sublingual Immunotherapy: A Secondary Analysis of Post-marketing Adverse Events Reports Using a Japanese Public Database. (PubMed, Cureus) - "Methods We conducted a secondary analysis of adverse events reported in the Pharmaceutical Adverse Events Information Database for three SLIT drugs (Actair®, Cedarcure®, and Miticure®) approved in Japan. Conclusions Our research illuminated the safety of SLIT drugs in Japan, revealing a favorable profile. It underscores the need for vigilance, particularly among younger patients and during initial doses, emphasizing the importance of proper patient selection and further research to enhance the treatment's efficacy."

Adverse events • Journal • P4 data • Allergic Rhinitis • Immunology • Inflammation • Pediatrics

Non- interventional studies with the SQ grass, tree, ragweed, and house dust mite SLIT- tablets – a systematic literature review (EAACI 2023) - "Method PubMed, ClinicalTrials.gov, and EU Clinical Trials Register were screened for NISs with SQ grass, tree, ragweed, and HDM SLIT-tablets in June 2022 using the string (Product Surveillance, Postmarketing[MH] OR post-marketing OR post-authorization OR cohort or case-control OR observational OR non-interventional OR prospective OR real-world OR retrospective OR drug utilization OR longitudinal) AND (grazax OR itulazax OR ragwizax OR acarizax OR grastek OR itulatek OR ragwitek OR miticure OR odactra OR ALK[AD] OR ALK-abello[AD]) AND (2006/01/01 [PDAT] : 2022/06/15[PDAT]). Conclusion The totality of real-world clinical evidence from NISs with the SQ grass, ragweed, and HDM SLIT-tablets is substantial and further complements the efficacy and safety profile established in RCTs. NISs studying clinical efficacy and safety of the SQ tree SLIT-tablet is warranted."

Review • Allergic Rhinitis • Allergy • Immunology • Inflammation

CLINICAL EFFICASY OF HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY WITH MITICURE TABLETS IN 115 PAITENTS FOR 3 YEARS (PubMed, Arerugi) - "The efficacy of house dust mite sublingual immunotherapy from 1 to 3 years was demonstrated."

Journal • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

MAPIT: Mite Asthma Pediatric Immunotherapy Trial (clinicaltrials.gov) - P3 | N=533 | Completed | Sponsor: ALK-Abelló A/S | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ May 2022

Trial completion • Trial completion date • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases

A Case of Successful Introduction of Miticure under Inpatient Management (JSPACI 2022) - No abstract available

Clinical

QUEST: A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber (clinicaltrials.gov) - P3 | N=80 | Terminated | Sponsor: ALK-Abelló A/S | N=202 ➔ 80 | Trial completion date: Jul 2022 ➔ Jan 2022 | Recruiting ➔ Terminated; COVID-19

Enrollment change • Trial completion date • Trial termination • Allergic Rhinitis • Allergy • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Vestibular Versus Sublingual Route of AIT Tablets (clinicaltrials.gov) - P4 | N=172 | Completed | Sponsor: Clinique Spécialisée en Allergies de la Capitale | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Apr 2022

Trial completion • Trial completion date • Allergy • Immunology

MATIC: Mite Allergy Trial In Children (clinicaltrials.gov) - P3 | N=1459 | Active, not recruiting | Sponsor: ALK-Abelló A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergic Rhinitis • Allergy • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

VITAL: The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma (clinicaltrials.gov) - P4 | N=39 | Completed | Sponsor: Bispebjerg Hospital | Active, not recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Feb 2022

IO biomarker • Trial completion • Trial completion date • Asthma • Immune Modulation • Immunology • Pulmonary Disease • Respiratory Diseases • CD8 • IFNG • IL12A • IL13 • IL33 • IL4 • IL5 • SOCS1 • TLR3 • TSLP

"Odactra grastek ragwitek" (@what__the__hek)