Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations
ABSTRACT Background Efficacy of allergen immunotherapy is dose‐dependent; however, high doses of allergen may imply a greater risk of adverse reactions. Objective To assess the safety and tolerability of subcutaneous immunotherapy (SCIT) with mixtures of mite allergen extracts, Dermatophagoides pter...
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| Format: | Article |
| Language: | English |
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Wiley
2024-12-01
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| Series: | Immunity, Inflammation and Disease |
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| Online Access: | https://doi.org/10.1002/iid3.70090 |
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| author | Carmen Vidal Laura Romero Sara Lopez‐Freire Francisco Carballada‐Gonzalez José Carlos Garcia‐Robaina Teresa Gonzalez‐Fernandez Paula Mendez‐Brea Eva Nieto Mónica Ruiz‐Garcia |
| author_facet | Carmen Vidal Laura Romero Sara Lopez‐Freire Francisco Carballada‐Gonzalez José Carlos Garcia‐Robaina Teresa Gonzalez‐Fernandez Paula Mendez‐Brea Eva Nieto Mónica Ruiz‐Garcia |
| author_sort | Carmen Vidal |
| collection | DOAJ |
| description | ABSTRACT Background Efficacy of allergen immunotherapy is dose‐dependent; however, high doses of allergen may imply a greater risk of adverse reactions. Objective To assess the safety and tolerability of subcutaneous immunotherapy (SCIT) with mixtures of mite allergen extracts, Dermatophagoides pteronyssinus/Blomia tropicalis (Dpt/Bt) and Dermatophagoides pteronyssinus/Lepidoglyphus destructor (Dpt/Ld) at maximum concentrations, in adult patients with allergic rhinitis or rhinoconjunctivitis, and controlled allergic asthma due to a clinically relevant sensitisation to these mites. Methods An open‐label, noncontrolled, nonrandomised, phase IIb clinical trial was carried out in three hospitals in Spain between September 2014 and May 2018. Patients received SCIT of either Dpt/Bt (100/1000 DPP/mL) or Dpt/Ld (100/100 DPP/mL) in two phases: a rush build‐up phase on the first day (0.2 mL and 0.3 mL with a 30‐min interval) and a monthly maintenance phase administration (0.5 mL) up to 48 months. Results Forty patients were recruited for the study, seven allocated to the Dpt/Bt group and 33 to the Dpt/Ld. None experienced immediate or delayed systemic Grade ≥ 2 reactions (EAACI classification) (systemic reactions were mostly Grade 1) nor died during the study. Local reactions were mostly mild (0‒10 cm). Thirty‐nine patients (97.5%) experienced at least one adverse event (AE). Of the 283 reported AEs, eight (2.8%) were systemic reactions experienced by six (15%) subjects and 14 (4.9%) were local reactions sustained by ten (25%) subjects. Conclusions SCIT treatment of patients with allergic rhinitis or rhinoconjunctivitis and controlled asthma with mixtures of Dpt/Bt and Dpt/Ld allergen extracts at maximum concentrations showed a favourable safety profile. |
| format | Article |
| id | doaj-art-ee46a8564c534b26906b35f4c0a14d13 |
| institution | Kabale University |
| issn | 2050-4527 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Immunity, Inflammation and Disease |
| spelling | doaj-art-ee46a8564c534b26906b35f4c0a14d132024-12-26T14:35:28ZengWileyImmunity, Inflammation and Disease2050-45272024-12-011212n/an/a10.1002/iid3.70090Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum ConcentrationsCarmen Vidal0Laura Romero1Sara Lopez‐Freire2Francisco Carballada‐Gonzalez3José Carlos Garcia‐Robaina4Teresa Gonzalez‐Fernandez5Paula Mendez‐Brea6Eva Nieto7Mónica Ruiz‐Garcia8Complejo Hospitalario de Santiago Santiago de Compostela SpainComplejo Hospitalario de Santiago Santiago de Compostela SpainComplejo Hospitalario de Santiago Santiago de Compostela SpainHospital Lucus Augusti Lugo SpainHospital Universitario de La Candelaria Santa Cruz de Tenerife SpainHospital Lucus Augusti Lugo SpainComplejo Hospitalario de Santiago Santiago de Compostela SpainMedical Affairs and Clinical Department LETI Pharma S.L.U. Madrid SpainMedical Affairs and Clinical Department LETI Pharma S.L.U. Madrid SpainABSTRACT Background Efficacy of allergen immunotherapy is dose‐dependent; however, high doses of allergen may imply a greater risk of adverse reactions. Objective To assess the safety and tolerability of subcutaneous immunotherapy (SCIT) with mixtures of mite allergen extracts, Dermatophagoides pteronyssinus/Blomia tropicalis (Dpt/Bt) and Dermatophagoides pteronyssinus/Lepidoglyphus destructor (Dpt/Ld) at maximum concentrations, in adult patients with allergic rhinitis or rhinoconjunctivitis, and controlled allergic asthma due to a clinically relevant sensitisation to these mites. Methods An open‐label, noncontrolled, nonrandomised, phase IIb clinical trial was carried out in three hospitals in Spain between September 2014 and May 2018. Patients received SCIT of either Dpt/Bt (100/1000 DPP/mL) or Dpt/Ld (100/100 DPP/mL) in two phases: a rush build‐up phase on the first day (0.2 mL and 0.3 mL with a 30‐min interval) and a monthly maintenance phase administration (0.5 mL) up to 48 months. Results Forty patients were recruited for the study, seven allocated to the Dpt/Bt group and 33 to the Dpt/Ld. None experienced immediate or delayed systemic Grade ≥ 2 reactions (EAACI classification) (systemic reactions were mostly Grade 1) nor died during the study. Local reactions were mostly mild (0‒10 cm). Thirty‐nine patients (97.5%) experienced at least one adverse event (AE). Of the 283 reported AEs, eight (2.8%) were systemic reactions experienced by six (15%) subjects and 14 (4.9%) were local reactions sustained by ten (25%) subjects. Conclusions SCIT treatment of patients with allergic rhinitis or rhinoconjunctivitis and controlled asthma with mixtures of Dpt/Bt and Dpt/Ld allergen extracts at maximum concentrations showed a favourable safety profile.https://doi.org/10.1002/iid3.70090allergic asthmaallergic rhinitisblomia tropicalisdermatophagoides pteronyssinushouse dust miteslepidoglyphus destructor |
| spellingShingle | Carmen Vidal Laura Romero Sara Lopez‐Freire Francisco Carballada‐Gonzalez José Carlos Garcia‐Robaina Teresa Gonzalez‐Fernandez Paula Mendez‐Brea Eva Nieto Mónica Ruiz‐Garcia Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations Immunity, Inflammation and Disease allergic asthma allergic rhinitis blomia tropicalis dermatophagoides pteronyssinus house dust mites lepidoglyphus destructor |
| title | Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations |
| title_full | Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations |
| title_fullStr | Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations |
| title_full_unstemmed | Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations |
| title_short | Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations |
| title_sort | clinical trial with a depigmented polymerized mite mixture extract at maximum concentrations |
| topic | allergic asthma allergic rhinitis blomia tropicalis dermatophagoides pteronyssinus house dust mites lepidoglyphus destructor |
| url | https://doi.org/10.1002/iid3.70090 |
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