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Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis.

MedStar author(s):

Citation: Annals of Allergy, Asthma, & Immunology. 123(1):70-80, 2019 Jul.PMID: 31009701Institution: Medstar Franklin Square Medical CenterDepartment: Allergy & ImmunologyForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Conjunctivitis, Allergic/dt [Drug Therapy] | *Conjunctivitis, Allergic/im [Immunology] | *Poaceae/im [Immunology] | *Pollen/ae [Adverse Effects] | *Pollen/im [Immunology] | *Tablets/ae [Adverse Effects] | *Tablets/tu [Therapeutic Use] | Administration, Sublingual | Allergens/im [Immunology] | Asthma/im [Immunology] | Child | Child, Preschool | Desensitization, Immunologic/mt [Methods] | Female | Humans | Male | Rhinitis, Allergic, Seasonal/im [Immunology] | Sublingual Immunotherapy/ae [Adverse Effects] | Sublingual Immunotherapy/mt [Methods]Year: 2019 Local holdings: Available online through MWHC library: 1996-2009, Available in print through MWHC library: 1999 - 2008ISSN:

1081-1206

Name of journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & ImmunologyAbstract: BACKGROUND: Although 5-grass pollen sublingual immunotherapy has a good safety profile in controlled clinical trials, additional safety information among pediatric patients in a real-world setting would be useful.CONCLUSION: The safety profile of 5-grass tablet in pediatric ARC patients aged 5 to 9 years was consistent with safety findings in older patients, most ADRs being at the application site and mild to moderate. ClinicalTrials.gov identifier: NCT02295969; EUPAS registration number: 8104.Copyright (c) 2019. Published by Elsevier Inc.METHODS: This multicenter, observational study included allergy immunotherapy-naive 5- to 9-year-old children with grass pollen-induced ARC prescribed with 5-grass tablet daily (3-day dose escalation to 300 index of reactivity [IR]). Patients were followed up daily for safety and tolerability over the first 30 treatment days. Adverse events (AEs) and adverse drug reactions (ADRs) were analyzed descriptively.OBJECTIVE: To further document the safety of 5-grass tablet among children aged 5 to 9 years with allergic rhinoconjunctivitis (ARC).RESULTS: Three hundred seven children (mean age, 7.1 years) were enrolled. Fifty-eight percent were confirmed as polysensitized, and 36% had mild-to-moderate asthma. Of 307 patients, 233 (76%) reported AEs, and 173/307 (56%) reported ADRs, most frequently mild application-site reactions (throat irritation, oral pruritus, oral paresthesia). Sixteen of 307 (5.2%) patients withdrew because of ADRs. In 143 of 173 (83%) patients, ADRs first occurred within 1 week of starting treatment. More than half of the ADRs lasted less than 2 days, and ADRs resolved spontaneously in 161 of 173 (93%) patients. Recurrences of ADRs were reported in 45 of 173 (26%) patients and were also mainly application-site reactions. No notable differences were found in ADRs related to whether patients had asthma at inclusion. Neither epinephrine use nor admission to intensive care unit was reported.All authors: de Blic J, Geng B, Gerstlauer M, Golden D, Szepfalusi ZFiscal year: FY2020Digital Object Identifier:

https://dx.doi.org/10.1016/j.anai.2019.04.011

Date added to catalog: 2019-07-24

Holdings ( 1 )
Title notes ( 8 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	31009701	Available		31009701

Available online through MWHC library: 1996-2009, Available in print through MWHC library: 1999 - 2008

BACKGROUND: Although 5-grass pollen sublingual immunotherapy has a good safety profile in controlled clinical trials, additional safety information among pediatric patients in a real-world setting would be useful.

CONCLUSION: The safety profile of 5-grass tablet in pediatric ARC patients aged 5 to 9 years was consistent with safety findings in older patients, most ADRs being at the application site and mild to moderate. ClinicalTrials.gov identifier: NCT02295969; EUPAS registration number: 8104.

METHODS: This multicenter, observational study included allergy immunotherapy-naive 5- to 9-year-old children with grass pollen-induced ARC prescribed with 5-grass tablet daily (3-day dose escalation to 300 index of reactivity [IR]). Patients were followed up daily for safety and tolerability over the first 30 treatment days. Adverse events (AEs) and adverse drug reactions (ADRs) were analyzed descriptively.

OBJECTIVE: To further document the safety of 5-grass tablet among children aged 5 to 9 years with allergic rhinoconjunctivitis (ARC).

RESULTS: Three hundred seven children (mean age, 7.1 years) were enrolled. Fifty-eight percent were confirmed as polysensitized, and 36% had mild-to-moderate asthma. Of 307 patients, 233 (76%) reported AEs, and 173/307 (56%) reported ADRs, most frequently mild application-site reactions (throat irritation, oral pruritus, oral paresthesia). Sixteen of 307 (5.2%) patients withdrew because of ADRs. In 143 of 173 (83%) patients, ADRs first occurred within 1 week of starting treatment. More than half of the ADRs lasted less than 2 days, and ADRs resolved spontaneously in 161 of 173 (93%) patients. Recurrences of ADRs were reported in 45 of 173 (26%) patients and were also mainly application-site reactions. No notable differences were found in ADRs related to whether patients had asthma at inclusion. Neither epinephrine use nor admission to intensive care unit was reported.

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