Contributions
Abstract: EP1758
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Natalizumab (NTZ) is notoriously associated with progressive multifocal leukoencephalopathy (PML) with a global incidence of 4.20 per 1000 treated patients. After 24 courses, patients and physicians decide whether to continue NTZ or not: a previous study (TY-STOP) showed a stopping rate of about 65%.
Goals: To describe study design, methods, state of enrollment, and preliminary results of the TY-STOP2 study, aimed to compare the efficacy and safety continuing versus not continuing NTZ.
Methods: An Italian, multicenter (8 centres), prospective, observational study, enrolling patients after at least 24 NTZ administrations. Patients underwent clinical evaluation, magnetic resonance imaging (MRI) and John Cunningham virus (JCV) antibodies testing every three months.
Results: Recruitment is still ongoing. Up to now 138 patients have been enrolled: mean age at baseline 37.3 years (SD: 10.7); median expanded disability status scale (EDSS) 2.0 (range: 0-6.5); mean disease duration 8.9 years; ARR pre-NTZ: 0.94. 125 patients (90.6%) continued NTZ after 24 courses; 8/13 that discontinued were JCV-positive (on total of positive of 59/138). During the follow-up, 3 patients stopped NTZ after 6 months, 4 after 9 and 2 after 12. A total of 6 patients out of 126 (4.8%) had a clinical relapse in the first year after 24 courses. Of these, only 1 had stopped NTZ. 8/87(9.2%) patients with available data had an EDSS increase >= 1 point in the first 12 months (delta EDSS: median 0 (range: -2.5 - 2)) and 1 of these have discontinued NTZ. 5/103 patients (4.9%) showed at least an active MRI during the first 12 months of follow-up and 1/9 of these with available information had stopped NTZ. 11/74 (14.9%) had an adverse event in the first 12 months (1 serious).
Conclusion: This descriptive analysis shows a NTZ stopping rate lower (10%) than in TY-STOP (65%), this is probably due to a better known PML management. However, PML is still a serious NTZ adverse event and more alternative drugs are and will become available. This will probably lead to a higher number of switching patients in our, still ongoing, recruitment. Our study will try to identify a possible therapeutic strategy preserving disease stability and preventing the occurrence of PML.
Disclosure: Dr Clerico received personal compensation by Merck and Biogen for participating to advisory boards, by Merck for editorial collaborations, and had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Signori received teaching honoraria from Novartis.
Dr. De Mercanti had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Artusi had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Maniscalco received personal compensation for public speaking or consultancies from Biogen, Novartis, Merck, Genzyme and Teva.
Dr. Carotenuto has nothing to disclose.
Dr. Lanzillo received personal compensation for public speaking or consultancies from Biogen, Novartis, Merck, Genzyme, Teva and Almirall.
Dr. Esposito has nothing to disclose.
Dr. Capuano has nothing to disclose.
Dr. Bonavita received speaking honoraria from Biogen, Merck, Novartis, Genzyme and Teva.
Dr. Lorefice received speaker fee from Teva and serves on scientific advisory boards for Biogen.
Dr. Cocco reports personal fees and non-financial support from Bayer, Biogen, Novartis, Genzyme, Merck Serono, Roche, and Teva.
Dr. Annovazzi received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck Serono, Biogen, Teva, Sanofi-Aventis, Almirall, Roche and Novartis.
Dr. Baroncini received honoraria for for lecturing and participation in advisory boards, for editorial projects and/or travel expenses for attending congresses and meetings from Almirall, Sanofi-Genzyme, Merck, Novartis and Teva.
Dr. Zaffaroni in the last 2 years received financial support for travel expenses or editorial projects and participation to conferences or advisory boards from Almirall, Biogen, Merck, Novartis, Sanofi-Genzyme, Roche, Teva.
Dr. Trebini has nothing to disclose.
Dr. Vercellino received consulting honoraria and/or speaker fees from Biogen, Genzyme and Merck.
Dr Cavalla has received Honoraria for consultancy or speaking from Almirall, Biogen, Sanofi,Genzyme, Merck,Teva, Novartis.
Dr. Torri Clerici has nothing to disclose.
Dr. Bardina has nothing to disclose.
Dr. Rolla has nothing to disclose.
Dr Durelli received personal compensation by Sanofi-Genzyme for participating to advisory boards, by Merck for editorial collaborations, and had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr.Sormani received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis, GeNeuro and Medday.
Abstract: EP1758
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Natalizumab (NTZ) is notoriously associated with progressive multifocal leukoencephalopathy (PML) with a global incidence of 4.20 per 1000 treated patients. After 24 courses, patients and physicians decide whether to continue NTZ or not: a previous study (TY-STOP) showed a stopping rate of about 65%.
Goals: To describe study design, methods, state of enrollment, and preliminary results of the TY-STOP2 study, aimed to compare the efficacy and safety continuing versus not continuing NTZ.
Methods: An Italian, multicenter (8 centres), prospective, observational study, enrolling patients after at least 24 NTZ administrations. Patients underwent clinical evaluation, magnetic resonance imaging (MRI) and John Cunningham virus (JCV) antibodies testing every three months.
Results: Recruitment is still ongoing. Up to now 138 patients have been enrolled: mean age at baseline 37.3 years (SD: 10.7); median expanded disability status scale (EDSS) 2.0 (range: 0-6.5); mean disease duration 8.9 years; ARR pre-NTZ: 0.94. 125 patients (90.6%) continued NTZ after 24 courses; 8/13 that discontinued were JCV-positive (on total of positive of 59/138). During the follow-up, 3 patients stopped NTZ after 6 months, 4 after 9 and 2 after 12. A total of 6 patients out of 126 (4.8%) had a clinical relapse in the first year after 24 courses. Of these, only 1 had stopped NTZ. 8/87(9.2%) patients with available data had an EDSS increase >= 1 point in the first 12 months (delta EDSS: median 0 (range: -2.5 - 2)) and 1 of these have discontinued NTZ. 5/103 patients (4.9%) showed at least an active MRI during the first 12 months of follow-up and 1/9 of these with available information had stopped NTZ. 11/74 (14.9%) had an adverse event in the first 12 months (1 serious).
Conclusion: This descriptive analysis shows a NTZ stopping rate lower (10%) than in TY-STOP (65%), this is probably due to a better known PML management. However, PML is still a serious NTZ adverse event and more alternative drugs are and will become available. This will probably lead to a higher number of switching patients in our, still ongoing, recruitment. Our study will try to identify a possible therapeutic strategy preserving disease stability and preventing the occurrence of PML.
Disclosure: Dr Clerico received personal compensation by Merck and Biogen for participating to advisory boards, by Merck for editorial collaborations, and had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Signori received teaching honoraria from Novartis.
Dr. De Mercanti had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Artusi had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr. Maniscalco received personal compensation for public speaking or consultancies from Biogen, Novartis, Merck, Genzyme and Teva.
Dr. Carotenuto has nothing to disclose.
Dr. Lanzillo received personal compensation for public speaking or consultancies from Biogen, Novartis, Merck, Genzyme, Teva and Almirall.
Dr. Esposito has nothing to disclose.
Dr. Capuano has nothing to disclose.
Dr. Bonavita received speaking honoraria from Biogen, Merck, Novartis, Genzyme and Teva.
Dr. Lorefice received speaker fee from Teva and serves on scientific advisory boards for Biogen.
Dr. Cocco reports personal fees and non-financial support from Bayer, Biogen, Novartis, Genzyme, Merck Serono, Roche, and Teva.
Dr. Annovazzi received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck Serono, Biogen, Teva, Sanofi-Aventis, Almirall, Roche and Novartis.
Dr. Baroncini received honoraria for for lecturing and participation in advisory boards, for editorial projects and/or travel expenses for attending congresses and meetings from Almirall, Sanofi-Genzyme, Merck, Novartis and Teva.
Dr. Zaffaroni in the last 2 years received financial support for travel expenses or editorial projects and participation to conferences or advisory boards from Almirall, Biogen, Merck, Novartis, Sanofi-Genzyme, Roche, Teva.
Dr. Trebini has nothing to disclose.
Dr. Vercellino received consulting honoraria and/or speaker fees from Biogen, Genzyme and Merck.
Dr Cavalla has received Honoraria for consultancy or speaking from Almirall, Biogen, Sanofi,Genzyme, Merck,Teva, Novartis.
Dr. Torri Clerici has nothing to disclose.
Dr. Bardina has nothing to disclose.
Dr. Rolla has nothing to disclose.
Dr Durelli received personal compensation by Sanofi-Genzyme for participating to advisory boards, by Merck for editorial collaborations, and had travel expenses for congresses paid by Merck, Biogen, Novartis, and Sanofi-Genzyme.
Dr.Sormani received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis, GeNeuro and Medday.