OBJECTIVE: To assess the long-term benefit-risk profile of repeated courses of rituximab in Caucasian patients affected by neuromyelitis optica (NMO) and related disorders, in everyday clinical practice. METHODS: This is a prospective observational study performed at San Raffaele Hospital, Milan, Italy. From February 2006, we recruited 21 patients affected by NMO and NMO spectrum of disorders (NMOSD) whom underwent at least one cycle of intravenous (i.v.) rituximab and then were followed for at least 2 years. RESULTS: At a mean follow-up time of 48 months, we observed a significant reduction of the annualized relapse rate (ARR), from 2.0 to 0.16 (p < 0.01); and of the median Expanded Disability Status Scale (EDSS), from 5.5 to 4.0 (p < 0.013). There were 12 patients (57%) who remained disease free during the follow-up period. Five patients (24%) reported mild hematological adverse events. Serious infectious adverse events were reported by another four patients: These were all wheelchair bound at the beginning of their rituximab treatment. CONCLUSIONS: A fixed treatment scheme of rituximab, with re-treatment every 6 months, was efficacious for NMO and NMOSD, with a good safety profile; however, to obtain an even better benefit-risk ratio, close monitoring of CD19(+) B cells should be performed before the re-treatment of patients with high-level disability, concomitant leukopenia and hypogammaglobulinemia.
OBJECTIVE: To assess the long-term benefit-risk profile of repeated courses of rituximab in Caucasian patients affected by neuromyelitis optica (NMO) and related disorders, in everyday clinical practice. METHODS: This is a prospective observational study performed at San Raffaele Hospital, Milan, Italy. From February 2006, we recruited 21 patients affected by NMO and NMO spectrum of disorders (NMOSD) whom underwent at least one cycle of intravenous (i.v.) rituximab and then were followed for at least 2 years. RESULTS: At a mean follow-up time of 48 months, we observed a significant reduction of the annualized relapse rate (ARR), from 2.0 to 0.16 (p < 0.01); and of the median Expanded Disability Status Scale (EDSS), from 5.5 to 4.0 (p < 0.013). There were 12 patients (57%) who remained disease free during the follow-up period. Five patients (24%) reported mild hematological adverse events. Serious infectious adverse events were reported by another four patients: These were all wheelchair bound at the beginning of their rituximab treatment. CONCLUSIONS: A fixed treatment scheme of rituximab, with re-treatment every 6 months, was efficacious for NMO and NMOSD, with a good safety profile; however, to obtain an even better benefit-risk ratio, close monitoring of CD19(+) B cells should be performed before the re-treatment of patients with high-level disability, concomitant leukopenia and hypogammaglobulinemia.
Authors: Pietro Annovazzi; M Capobianco; L Moiola; F Patti; J Frau; A Uccelli; D Centonze; P Perini; C Tortorella; L Prosperini; G Lus; A Fuiani; M Falcini; V Martinelli; G Comi; A Ghezzi Journal: J Neurol Date: 2016-06-10 Impact factor: 4.849
Authors: Daniel H Whittam; Alvaro Cobo-Calvo; A Sebastian Lopez-Chiriboga; Santiago Pardo; Matthew Gornall; Silvia Cicconi; Alexander Brandt; Klaus Berek; Thomas Berger; Ilijas Jelcic; Grace Gombolay; Luana Micheli Oliveira; Dagoberto Callegaro; Kimihiko Kaneko; Tatsuro Misu; Marco Capobianco; Emily Gibbons; Venkatraman Karthikeayan; Bruno Brochet; Bertrand Audoin; Guillaume Mathey; David Laplaud; Eric Thouvenot; Mikaël Cohen; Ayman Tourbah; Elisabeth Maillart; Jonathan Ciron; Romain Deschamps; Damien Biotti; Kevin Rostasy; Rinze Neuteboom; Cheryl Hemingway; Rob Forsyth; Marcelo Matiello; Stewart Webb; David Hunt; Katy Murray; Yael Hacohen; Ming Lim; M Isabel Leite; Jacqueline Palace; Tom Solomon; Andreas Lutterotti; Kazuo Fujihara; Ichiro Nakashima; Jeffrey L Bennett; Lekha Pandit; Tanuja Chitnis; Brian G Weinshenker; Brigitte Wildemann; Douglas Kazutoshi Sato; Su-Hyun Kim; Saif Huda; Ho Jin Kim; Markus Reindl; Michael Levy; Sven Jarius; Silvia Tenembaum; Friedemann Paul; Sean Pittock; Romain Marignier; Anu Jacob Journal: Mult Scler Relat Disord Date: 2020-06-02 Impact factor: 4.339