Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis
Golden, David
text
xx
2019
monographic
en
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.
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English
*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]
Medstar Franklin Square Medical Center
Allergy & Immunology
1081-1206
https://dx.doi.org/10.1016/j.anai.2019.04.011
https://dx.doi.org/10.1016/j.anai.2019.04.011
Ovid MEDLINE(R)
190724