RESUMO
On October 16, 2018, FDA expanded the adalimumab dosing regimen to adolescent hidradenitis suppurativa (HS) patients 12 years and older, weighing at least 30 kg without new clinical data. This approval was mainly supported by the model-informed drug development approach. Population pharmacokinetic simulations suggest body weight-tiered dosing regimens in adolescent patients will achieve similar exposure to adult patients across all weight range. Adalimumab has a well-established, 16-year long-term safety profile in various diseases in adult and pediatric populations. Current data of adalimumab in the pediatric population demonstrate no exposure-response relationship for adverse events. The effectiveness in adolescent patients was extrapolated from two adequate and well-controlled phase 3 studies in adult patients, assuming similar positive exposure-efficacy relationships in adults and adolescents. This article provides the insight of the application of MIDD on the adalimumab approval in adolescent HS patients and its implication on drug development and regulatory decision especially for pediatrics or rare diseases.
Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Hidradenite Supurativa/tratamento farmacológico , Modelos Biológicos , Adalimumab/efeitos adversos , Adalimumab/farmacologia , Adolescente , Fatores Etários , Anti-Inflamatórios/efeitos adversos , Criança , Relação Dose-Resposta a Droga , Aprovação de Drogas , Desenvolvimento de Medicamentos/métodos , Hidradenite Supurativa/fisiopatologia , Humanos , Resultado do TratamentoAssuntos
Anticorpos Monoclonais Humanizados/farmacocinética , Anticorpos Monoclonais Humanizados/uso terapêutico , Peso Corporal , Fármacos Dermatológicos/farmacocinética , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Fatores Etários , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Relação Dose-Resposta a Droga , Humanos , Modelos Logísticos , Taxa de Depuração Metabólica , Medição de Risco , Fatores SexuaisRESUMO
A pediatric kidney transplant recipient receiving tacrolimus for immunosuppression experienced symptoms consistent with idiopathic intracranial hypertension. The diagnosis of idiopathic intracranial hypertension and possible secondary causes of intracranial hypertension are reviewed in association with the patient's clinical course. Treatment options for the reversal of intracranial hypertension are summarized. Because of the complexity of associated conditions in kidney transplant recipients, symptoms of persistent headaches, visual changes and nausea and vomiting should be promptly investigated by fundoscopic examination in the setting of immunosuppression therapy to prevent vision loss.