Contributions
Abstract: P1240
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Natalizumab is highly effective in reducing multiple sclerosis disease activity, however it carries a risk of progressive multifocal leukoencephalopathy (PML), that represents the major reason of treatment discontinuation. No guidelines about patients´ management after natalizumab withdrawal exist. In a previous study we presented our experience about the use of rituximab after natalizumab discontinuation in 10 patients. Here we describe a larger population treated with rituximab after natalizumab.
Aim of the study: To evaluate rituximab efficacy in controlling disease activity after natalizumab discontinuation.
Patients and methods: 29 relapsing remitting multiple sclerosis patients (22 female and 7 male) have been treated with natalizumab for a median number of 51 infusions (range 12-100). 28 patients stopped natalizumab due to the high risk of PML and 1 patient stopped it for convenience. Although in Italy the use of rituximab in multiple sclerosis is "off label", these patients have been proposed to switch to rituximab after a wash out period of about two months because of the lack of valid therapeutic options.
Each patient underwent gadolinium-enhanced brain MRI scan after the last infusion of natalizumab and two months later, in order to exclude radiological signs suggestive for PML ; then brain MRI was performed every six months.
Median wash out period after natalizumab discontinuation was 3.3 months (1.4-7.9 months). At first Rituximab protocol was 375mg/mq once/week for 4 weeks (first cycle) and 1000mg at day 0 and day 15 in case of CD19 increase and/or clinical relapse or radiological reactivation (second cycle); subsequently the protocol has been changed in 1000mg at day 0 and day 15 every six months.
Results: During the wash out period disease stability was observed in all patients except the one with a wash out of 7.9months; radiological stability was observed at 6 months after rituximab administration in all the patients and at 12 months in 20 out of 29 patients with a follow up of one year. Exacerbation of sensitive symptoms without evidence of brain MRI activity was observed in two patients during the follow up.
Conclusions: rituximab represents a valid and effective treatment option after natalizumab discontinuation; rituximab therapy must be started after a short wash out period.
Disclosure:
Malucchi S received speaking honoraria from Biogen, Novartis, Teva.
di Sapio A received consultant fees from Biogen, Merck Serono
Malentacchi M received speaking honoraria from Biogen.
Matta M, received speaking honoraria from Biogen, Almirall
Sperli F received speaking honoraria from Biogen.
Oggero A, received speaking honoraria from Biogen
Marianna Lo Re, received travel expenses from Biogen, Novartis and Teva.
Marco Capobianco received speaking honoraria and/or consultant fees from Biogen, Merck-Serono, Novartis, Teva, Genzyme and Almirall.
Antonio Bertolotto received honoraria for serving in the scientific advisory boards of Almirall, Bayer, Biogen, Genzyme with approval by the Director of AOU San Luigi University Hospital and received speaker honoraria from Biogen, Genzyme, Novartis, TEVA; his institution has received grant support from Bayer, Biogen, Merck, Novartis, TEVA from the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS and San Luigi ONLUS.
Abstract: P1240
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Natalizumab is highly effective in reducing multiple sclerosis disease activity, however it carries a risk of progressive multifocal leukoencephalopathy (PML), that represents the major reason of treatment discontinuation. No guidelines about patients´ management after natalizumab withdrawal exist. In a previous study we presented our experience about the use of rituximab after natalizumab discontinuation in 10 patients. Here we describe a larger population treated with rituximab after natalizumab.
Aim of the study: To evaluate rituximab efficacy in controlling disease activity after natalizumab discontinuation.
Patients and methods: 29 relapsing remitting multiple sclerosis patients (22 female and 7 male) have been treated with natalizumab for a median number of 51 infusions (range 12-100). 28 patients stopped natalizumab due to the high risk of PML and 1 patient stopped it for convenience. Although in Italy the use of rituximab in multiple sclerosis is "off label", these patients have been proposed to switch to rituximab after a wash out period of about two months because of the lack of valid therapeutic options.
Each patient underwent gadolinium-enhanced brain MRI scan after the last infusion of natalizumab and two months later, in order to exclude radiological signs suggestive for PML ; then brain MRI was performed every six months.
Median wash out period after natalizumab discontinuation was 3.3 months (1.4-7.9 months). At first Rituximab protocol was 375mg/mq once/week for 4 weeks (first cycle) and 1000mg at day 0 and day 15 in case of CD19 increase and/or clinical relapse or radiological reactivation (second cycle); subsequently the protocol has been changed in 1000mg at day 0 and day 15 every six months.
Results: During the wash out period disease stability was observed in all patients except the one with a wash out of 7.9months; radiological stability was observed at 6 months after rituximab administration in all the patients and at 12 months in 20 out of 29 patients with a follow up of one year. Exacerbation of sensitive symptoms without evidence of brain MRI activity was observed in two patients during the follow up.
Conclusions: rituximab represents a valid and effective treatment option after natalizumab discontinuation; rituximab therapy must be started after a short wash out period.
Disclosure:
Malucchi S received speaking honoraria from Biogen, Novartis, Teva.
di Sapio A received consultant fees from Biogen, Merck Serono
Malentacchi M received speaking honoraria from Biogen.
Matta M, received speaking honoraria from Biogen, Almirall
Sperli F received speaking honoraria from Biogen.
Oggero A, received speaking honoraria from Biogen
Marianna Lo Re, received travel expenses from Biogen, Novartis and Teva.
Marco Capobianco received speaking honoraria and/or consultant fees from Biogen, Merck-Serono, Novartis, Teva, Genzyme and Almirall.
Antonio Bertolotto received honoraria for serving in the scientific advisory boards of Almirall, Bayer, Biogen, Genzyme with approval by the Director of AOU San Luigi University Hospital and received speaker honoraria from Biogen, Genzyme, Novartis, TEVA; his institution has received grant support from Bayer, Biogen, Merck, Novartis, TEVA from the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS and San Luigi ONLUS.