RESUMO
Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.
Assuntos
Imunodeficiência de Variável Comum/tratamento farmacológico , Fatores Imunológicos/administração & dosagem , Adolescente , Adulto , Agamaglobulinemia/sangue , Agamaglobulinemia/tratamento farmacológico , Agamaglobulinemia/imunologia , Agamaglobulinemia/fisiopatologia , Idoso , Infecções Bacterianas/prevenção & controle , Criança , Imunodeficiência de Variável Comum/sangue , Imunodeficiência de Variável Comum/imunologia , Imunodeficiência de Variável Comum/fisiopatologia , Feminino , Doenças Genéticas Ligadas ao Cromossomo X/sangue , Doenças Genéticas Ligadas ao Cromossomo X/tratamento farmacológico , Doenças Genéticas Ligadas ao Cromossomo X/imunologia , Doenças Genéticas Ligadas ao Cromossomo X/fisiopatologia , Humanos , Imunoglobulina G/sangue , Imunoglobulinas Intravenosas/uso terapêutico , Fatores Imunológicos/efeitos adversos , Fatores Imunológicos/uso terapêutico , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estabilidade ProteicaRESUMO
The antiplatelet agent clopidogrel has become a mainstay of treatment of patients with acute coronary syndromes and strokes, and to reduce ischemic complications after percutaneous coronary and peripheral interventions. As the use of this agent has become more widespread, hypersensitivity reactions to clopidogrel have been increasingly recognized. This problem can be difficult to manage, especially in patients who are in need of or have recently undergone intracoronary stenting, as therapeutic alternatives are limited. Our previously published experience shows that desensitization can allow clopidogrel to be used safely in these patients. The protocol is simple, rapid, and can be conducted by a team of cardiology and allergy-immunology specialists. This article outlines the procedural details of the protocol.