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Rituximab vs placebo induction prior to glatiramer acetate monotherapy in multiple sclerosis.
Honce, Justin M; Nair, Kavita V; Sillau, Stefan; Valdez, Brooke; Miravalle, Augusto; Alvarez, Enrique; Schreiner, Teri; Corboy, John R; Vollmer, Timothy L.
Afiliação
  • Honce JM; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Nair KV; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Sillau S; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Valdez B; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Miravalle A; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Alvarez E; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Schreiner T; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Corboy JR; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
  • Vollmer TL; From the Departments of Radiology (J.M.H.) and Clinical Pharmacy (K.V.N.), University of Colorado Hospital, Aurora; Department of Neurology (K.V.N., S.S., B.V., E.A., T.S., J.R.C., T.L.V.), University of Colorado, and Rocky Mountain Multiple Sclerosis Center at the University of Colorado, Aurora; an
Neurology ; 92(7): e723-e732, 2019 02 12.
Article em En | MEDLINE | ID: mdl-30635477
ABSTRACT

OBJECTIVE:

To examine whether rituximab induction followed by glatiramer acetate (GA) monotherapy is more effective than GA alone for the treatment of relapsing multiple sclerosis with active disease.

METHODS:

This was a single-center, double-blind, placebo-controlled study. Fifty-five participants were randomly assigned (11 ratio) to either rituximab (R-GA) or placebo (P-GA) induction, followed by GA therapy initiated in all participants. Participants were followed up to 3 years. The primary endpoint was the number of participants with no evidence of disease activity (NEDA) those without relapse, new MRI lesions, and sustained change in disability.

RESULTS:

Twenty-eight and 27 participants received rituximab and placebo induction, respectively, with one participant in each arm withdrawing before 6-month MRI. There were no significant differences in baseline characteristics. At end of study, 44.44% of R-GA participants demonstrated NEDA vs 19.23% of P-GA participants (p = 0.049). Treatment failed for a smaller proportion of R-GA participants (37.04% R-GA vs 69.23% P-GA, p = 0.019), and time to treatment failure was longer (23.32 months R-GA vs 11.29 months P-GA, p = 0.027). Fewer participants in the R-GA arm had new lesions (25.93% R-GA vs 61.54% P-GA, p = 0.009), and there were fewer new T2 lesions (0.48 R-GA vs 1.96 P-GA, p = 0.027). Probability of demonstrating NEDA in the R-GA arm returned to baseline within the study period. There were no differences in adverse events.

CONCLUSIONS:

Induction therapy with rituximab followed by GA may provide superior efficacy in the short term than GA alone in relapsing multiple sclerosis, but this benefit appears to wane within the study period. Larger studies are needed to assess sustainability of results. CLINICALTRIALSGOV IDENTIFIER NCT01569451.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Recidivante-Remitente / Acetato de Glatiramer / Rituximab / Fatores Imunológicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Neurology Ano de publicação: 2019 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Recidivante-Remitente / Acetato de Glatiramer / Rituximab / Fatores Imunológicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Neurology Ano de publicação: 2019 Tipo de documento: Article