Grazax (timothy grass pollen allergen extract tablet) / Abbott, ALK-Abello, Merck (MSD) - LARVOL DELTA

The PreS-Based Recombinant Vaccine VVX001 Induces Hepatitis B Virus Neutralizing Antibodies in a Low-Responder to HBsAg-Based HBV Vaccines. (PubMed, Vaccines (Basel)) - "BM32 is a recombinant grass pollen allergy vaccine containing the HBV-derived preS surface antigen as an immunological carrier protein. Maximal HBV neutralization (98.4%) in vitro was achieved 1 month after the last injection, which correlated with the maximal IgG reactivity to the N-terminal part of preS. Our data suggest that VVX001 may be used as a preventive vaccination against HBV even in non-responders to HBsAg-based HBV vaccines."

Journal • Allergy • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • CD4

Quantifying the benefits of early sublingual allergen immunotherapy tablet initiation in children. (PubMed, Allergy) - "Initiation of SLIT tablets in early childhood is associated with a clinically meaningful and permanent reduction in new cases of AA and lower healthcare costs among children with AR. This finding supports the clinical relevance of initiating SLIT tablets early for children with AR to obtain long-term clinical benefits."

Journal • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

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

Health Economic Evaluation of Early Initiation of Grass Sublingual Immunotherapy Tablets in Children (ISPOR 2023) - "Age-specific risk of developing asthma and treatment-specific transition matrices for movements between mild and moderate/severe AR were estimated and extrapolated for grass SLIT-tablet and symptom-relieving medication using the GRAZAX ® Asthma Prevention (GAP) placebo-controlled trial in children aged 5–12 years... Results suggest initiating 75,000 SQ-T grass SLIT-tablet at age five compared to initiation later in childhood is associated with a clinically meaningful reduction in new AA cases. Moreover, early initiation of 75,000 SQ-T grass SLIT-tablet is a dominant treatment (better efficacy and cost-saving) strategy compared to both later initiation and treatment with symptom-relieving medication alone."

Clinical • HEOR • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

"Odactra grastek ragwitek" (@what__the__hek)

Vestibular Versus Sublingual Route of AIT Tablets (clinicaltrials.gov) - P4 | N=200 | Active, not recruiting | Sponsor: Clinique Spécialisée en Allergies de la Capitale | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Jan 2022 ➔ Apr 2022

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Immunology

Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32. (PubMed, EBioMedicine) - "BM32 induces high levels of IgG and IgG antibodies against the receptor binding sites of all eight HBV genotypes and hence might be suitable for therapeutic HBV vaccination."

Clinical • Journal • Allergy • Hepatitis B • Hepatology • Immunology • Infectious Disease

Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics. (PubMed, Allergy) - "The most relevant systemic change detected after two years of SLIT was the desensitization of effector cells, which was only detected in Mono-sensitized patients. This change may be related to the clinical improvement, as previously reported, and, together with the other results, may explain why clinical effect is lost if SLIT is discontinued at this point."

Biomarker • IO Biomarker • Journal • Allergy • Immunology

Allergy immunotherapies for allergic rhinitis: systematic review and assessment of evolving quality. (PubMed, Eur Ann Allergy Clin Immunol) - "17 of 44 unique RCTs (38.6%) (sample size range: 18-1,501 subjects) were subcutaneous grass immunotherapy trials and 27 (61.4%) were sublingual grass immunotherapy trials (Allergovit, 5 trials; Alutard, 8; Grazax, 13; Oralair, 6; Staloral, 8; Pollinex, 2; Phostal and Purethal, 1 each). Conclusions. When as-sessing grass AIT, it is important to focus not only on endpoints but also on the quality of evidence."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Immunology • Respiratory Diseases

GRAZAX®: A Sublingual Immunotherapy Vaccine for Hay Fever Treatment: From Concept to Commercialization. (PubMed, Hum Vaccin Immunother) - "Here we provide a rationale description of GRAZAX®, providing a sequential description of its pharmaceutical and clinical development. With more than 25 clinical trial, involving more than 8000 patients, including as well three five years prospective clinical trials, GRAZAX® is a key product to understand the unique position of allergen specific immunotherapy as a disease modifying intervention."

Journal • Allergic Rhinitis • Allergy • Immunology

Immunotherapy with the recombinant B cell epitope-based grass pollen allergy vaccine BM32 induces a biphasic allergen-specific IgG1 and IgG4 response (EAACI 2018) - "Treatment with BM32 induces a biphasic allergen-specific IgG response consisting of an early IgG1 and a sustained allergen-specific IgG4 response which may be responsible for early and sustained protection against allergic symptoms."

Immunology

[VIRTUAL] PreS-based grass pollen allergy vaccine BM32 may protect against hepatitis B (EAACI 2020) - P2 | "The anti-HBV antibody response elicited in BM32 treated patients is composed mostly of IgG1 and IgG4and is directed against the regions of PreS important for liver cell attachment and infection. These findings support the usefulness of BM32 as a potential HBV vaccine."

Late-breaking abstract • Allergy • Immunology

Two years of treatment with the recombinant grass pollen allergy vaccine BM32 induces a continuously increasing allergen-specific IgG response. (PubMed, EBioMedicine) - "AIT with BM32 is characterised by the induction of a non-inflammatory, continuously increasing allergen-specific IgG response (year 2 > year1) which may explain that clinical efficacy was higher in year 2 than in year 1. The good safety profile of BM32 may be explained by lack of IgE reactivity and low stimulation of allergen-specific T cell and cytokine responses."

Journal

Sublingual immunotherapy alters salivary IgA and systemic immune mediators in timothy allergic children. (PubMed, Pediatr Allergy Immunol) - "Phleum pratense sublingual immunotherapy in grass pollen allergic children modulates the immune response in the oral mucosa as well as systemically, by increasing Th1-responses, decreasing Th2-responses and inducing immunoregulatory responses - all signs of tolerance induction."

Clinical • Journal

Cost-effectiveness of grass pollen allergen immunotherapy in adults. (PubMed, Allergy) - "In daily practice AIT for grass pollens may be a cost-effective option only in patients with low discontinuation rates. SCIT, which is less affected by this limitation than SLIT, seems the most cost-effective AIT form."

Clinical • HEOR • Journal

Cost-Effectiveness Of The SQ Grass SLIT-Tablet In Children With Allergic Rhinitis: A German Payer Perspective. (PubMed, Clinicoecon Outcomes Res) - "The Grazax Asthma Prevention (GAP) trial has recently demonstrated significant reductions in the odds of asthma symptoms or medication use in patients treated with SQ grass SLIT-tablet relative to placebo, both in combination with allergy and asthma pharmacotherapy...The base case results were insensitive to changes in all individual model parameters. Improvements in quality of life with the SQ grass SLIT-tablet would be accompanied by only a modest increase in costs over a 10-year time horizon, with the SQ grass SLIT-tablet therefore representing excellent value for money from the German healthcare payer perspective."

Clinical • HEOR • Journal

"We already have Grazax and Acarizax, the -ax suffixe was essential ! 😁" (@SarahCo14)

"Hi Dave @AllergyKidsDoc , what is the evidence for use of sublingual Grazax in moderate to severe allergic rhino-conjunctivitis re grass pollen please?" (@pash22)

FLYING SOLO: IT WORKS! THE FIRST 18 MONTHS (ACAAI 2019) - "Fifteen of 17 SLIT patients were on ODACTRA and 2 were on GRASTEK...Similar to previous reports, SCIT and especially SLIT nonadherence continues to be an issue for private practice allergy. Therefore, mechanisms to improve adherence should be implemented to increase adherence."

Adherence and quality of life in adults and children during 3-years of SLIT treatment with Grazax-a real life study. (PubMed, NPJ Prim Care Respir Med) - "The study suggests a good adherence to treatment in a real life setting among the patients finalizing 3-years SLIT therapy. The treatment was effective both on symptoms and HRQL."

Clinical • HEOR • Journal

Safety and efficacy of immunotherapy with the recombinant B-cell epitope-based grass pollen vaccine BM32. (PubMed, J Allergy Clin Immunol) - "Injections of BM32 induced allergen-specific IgG, improved clinical symptoms of seasonal grass pollen allergy, and were well tolerated."

Clinical • Journal