RESUMO
OBJECTIVE: To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. METHODS: Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). RESULTS: Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 µg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. CONCLUSION: Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.
Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Amplitude de Movimento Articular/efeitos dos fármacos , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Humanos , Injeções Intravenosas , Injeções Subcutâneas , Japão , Masculino , Pessoa de Meia-Idade , Medição da Dor , Satisfação do Paciente/estatística & dados numéricos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Two patients were admitted to Mie Prefectural General Medical Center and diagnosed as chronic hepatitis C complicated with monoclonal gammopathy of undetermined significance (MGUS). METHODS: The MGUS class were immunoglobulin (Ig)G. The hepatitis C virus (HCV) RNA genotype was Ib. Based on these findings, they were diagnosed as chronic hepatitis C complicated with MGUS. RESULTS: Histological studies showed chronic hepatitis in the liver and a mild rise in plasma cells without dysplasia and abnormalities in the bone marrow. Serum examination for cryoglobulin was negative. CONCLUSION: Chronic HCV infection might play a pathogenic role in the multistage process leading to lymphoproliferative disorders.