Contributions
Abstract: P823
Type: Poster
Abstract Category: Clinical aspects of MS - Paediatric MS
Background: Several observational studies have provided data on safety and efficacy of Interferon-beta (IFNB) and glatiramer acetate (GA) in the pediatric multiple sclerosis (ped-MS) population. Data are not available after a long-term follow-up.Objectives: in 2009 we published the results of an Italian cohort of ped-MS patients treated with IFNB and GA and followed for a mean of 4-6 years. Now we provide data updated to 2016.
Methods: we retrospectively reviewed clinical records of ped-MSs included in our previous study (Ghezzi et al. Neurol Sci 2009), followed in many Italian MS centers. Demographic, clinical and treatments data were collected. All patients initiating GA or IFNB in pediatric age and regularly followed were included in the study.
Results: of the 130 ped-MS patients of previous cohort data were obtained of 97 of them (67 females, age of onset: 12.3±2.5 years, monofocal onset in 69). All patients started first-line drugs (IFNB: 88, GA: 9;) at a mean age of 13.9±2.1 years. At that time EDSS was 0-1.5 in 67 patients, 2-3.5 in 29 and 4.5 in one. Patients were followed for 12.5±3.3 years (72 patients for >10 years). Forty-two patients (43%) remained on first-line agents (GA, IFNs, Dimethyl fumarate, Teriflunomide), the remaining (57%) received other treatments (1 or more): second-line drugs (Fingolimod, Natalizumab, Alemtuzumab) in 47, immunosuppressants (Mitoxantrone, Azatioprine, Cyclophosphamide) in 13, intravenous immunoglobulin in 2, and steam cell transplantation in 2. Fifteen patients did not change the treatment, the others switched to a median of 3 therapies (range 2-7); 23 patients received no treatment for more than 6 months. At the last follow-up (age: 26.5±3.9 years) EDSS was 0-1.5 in 57 patients, 2-3.5 in 31 and 4-6 in 8; one patient died because of MS. Annualized relapse rate was 3.2±2.7 before the treatment, 0.7±1.5 during the first treatment and 0.5±0.3 during the whole follow-up period.
Conclusions: over 12 years of follow-up 43% of ped-MS patients remained on first-line therapies, while 57% patients switched to second-line/other treatments. The large majority of patients had an EDSS ≤ 3.5, about 8% had EDSS >4 at last observation, and one patient (≈1%) died because of MS. Relapse rate remained lower than that of the pre-treatment period in patients who continued the first line treatment and also in those who switched to second-line/other treatments.
Disclosure: Angelo Ghezzi received fees for consultant or speaking activity from Merck Serono, Novartis, Genzyme, Biogen Idec, Teva, Almirall.
Damiano Baroncini received a grant from Almirall
Maria Pia Amato received personal compensation for activities with Merck Serono, Biogen Dompe, Sanofi-Aventis Pharmaceuticals, and Bayer Schering; received research support from Merck Serono, Sanofi-Aventis Pharmaceuticals, Biogen Dompe, and Bayer Schering.
Paolo Bellantonio no conflict of interest
Roberto Bergamaschi served on scientific advisory boards for Biogen Idec and Almirall, received honoraria for speaking from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; has received funding for congress and travel/accommodation expenses for scientific meetings from Sanofi-Aventis, Genzyme, Biogen Idec, Bayer Schering, Teva, Merck Serono, Almirall, and Novartis;received research grants from Merck Serono, Biogen Idec, Teva, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme
Marco Capobianco received consultant fees/speaking honoraria from Biogen, Merck-Serono, Novartis, Teva, Genzyme, Almirall
Gianfranco Costantino no conflict of interest
Paolo Gallo received support to participate in National and International Congresses from Biogen Idec, Bayer Schering Pharma, Merck Serono, and Sanofi-Aventis.
Maria Giovanna Marrosu serves on scientific board for Almirall, Biogen, Merck-Serono, Novartis, Teva and received honoraria Almirall, Biogen, Merck-Serono, Novartis, Teva
Nicoletta Milani no conflict of interest
Moiola has received support to participate in National and International Congresses from Biogen Idec, Bayer Schering Pharma, Merck Serono, and Sanofi-Aventis.
Francesco Patti received personal compensation for activities with Merck-Serono, Bayer Schering, and Dompe Biotec.
Carlo Pozzilli serves on advisory boards for and received speaker honoraria from Sanofi Aventis, Biogen, Bayer Schering Pharma, Novartis, Teva, Merck Serono and research grants from Merck Serono, Sanofi Aventis, Novartis and Biogen.
Elio Scarpini no conflict of interest
Maria Trojano received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec and Sanofi-Aventis Pharmaceuticals, Inc. as a consultant and/or speaker; received research support from Merck & Co., Inc.
Prof. Comi serves on scientific advisory boards for Bayer Schering Pharma, Merck Serono, Teva Pharmaceutical Industries Ltd, Sanofi Aventis, Novartis and Biogen-Idec; has received speaker honoraria from Teva Pharmaceutical Industries Ltd, Sanofi Aventis, Serono Sumposia International Foundation, Biogen-Idec, Merck Serono, Novartis, Bayer Schering and Sanofi Aventis.
Abstract: P823
Type: Poster
Abstract Category: Clinical aspects of MS - Paediatric MS
Background: Several observational studies have provided data on safety and efficacy of Interferon-beta (IFNB) and glatiramer acetate (GA) in the pediatric multiple sclerosis (ped-MS) population. Data are not available after a long-term follow-up.Objectives: in 2009 we published the results of an Italian cohort of ped-MS patients treated with IFNB and GA and followed for a mean of 4-6 years. Now we provide data updated to 2016.
Methods: we retrospectively reviewed clinical records of ped-MSs included in our previous study (Ghezzi et al. Neurol Sci 2009), followed in many Italian MS centers. Demographic, clinical and treatments data were collected. All patients initiating GA or IFNB in pediatric age and regularly followed were included in the study.
Results: of the 130 ped-MS patients of previous cohort data were obtained of 97 of them (67 females, age of onset: 12.3±2.5 years, monofocal onset in 69). All patients started first-line drugs (IFNB: 88, GA: 9;) at a mean age of 13.9±2.1 years. At that time EDSS was 0-1.5 in 67 patients, 2-3.5 in 29 and 4.5 in one. Patients were followed for 12.5±3.3 years (72 patients for >10 years). Forty-two patients (43%) remained on first-line agents (GA, IFNs, Dimethyl fumarate, Teriflunomide), the remaining (57%) received other treatments (1 or more): second-line drugs (Fingolimod, Natalizumab, Alemtuzumab) in 47, immunosuppressants (Mitoxantrone, Azatioprine, Cyclophosphamide) in 13, intravenous immunoglobulin in 2, and steam cell transplantation in 2. Fifteen patients did not change the treatment, the others switched to a median of 3 therapies (range 2-7); 23 patients received no treatment for more than 6 months. At the last follow-up (age: 26.5±3.9 years) EDSS was 0-1.5 in 57 patients, 2-3.5 in 31 and 4-6 in 8; one patient died because of MS. Annualized relapse rate was 3.2±2.7 before the treatment, 0.7±1.5 during the first treatment and 0.5±0.3 during the whole follow-up period.
Conclusions: over 12 years of follow-up 43% of ped-MS patients remained on first-line therapies, while 57% patients switched to second-line/other treatments. The large majority of patients had an EDSS ≤ 3.5, about 8% had EDSS >4 at last observation, and one patient (≈1%) died because of MS. Relapse rate remained lower than that of the pre-treatment period in patients who continued the first line treatment and also in those who switched to second-line/other treatments.
Disclosure: Angelo Ghezzi received fees for consultant or speaking activity from Merck Serono, Novartis, Genzyme, Biogen Idec, Teva, Almirall.
Damiano Baroncini received a grant from Almirall
Maria Pia Amato received personal compensation for activities with Merck Serono, Biogen Dompe, Sanofi-Aventis Pharmaceuticals, and Bayer Schering; received research support from Merck Serono, Sanofi-Aventis Pharmaceuticals, Biogen Dompe, and Bayer Schering.
Paolo Bellantonio no conflict of interest
Roberto Bergamaschi served on scientific advisory boards for Biogen Idec and Almirall, received honoraria for speaking from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; has received funding for congress and travel/accommodation expenses for scientific meetings from Sanofi-Aventis, Genzyme, Biogen Idec, Bayer Schering, Teva, Merck Serono, Almirall, and Novartis;received research grants from Merck Serono, Biogen Idec, Teva, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme
Marco Capobianco received consultant fees/speaking honoraria from Biogen, Merck-Serono, Novartis, Teva, Genzyme, Almirall
Gianfranco Costantino no conflict of interest
Paolo Gallo received support to participate in National and International Congresses from Biogen Idec, Bayer Schering Pharma, Merck Serono, and Sanofi-Aventis.
Maria Giovanna Marrosu serves on scientific board for Almirall, Biogen, Merck-Serono, Novartis, Teva and received honoraria Almirall, Biogen, Merck-Serono, Novartis, Teva
Nicoletta Milani no conflict of interest
Moiola has received support to participate in National and International Congresses from Biogen Idec, Bayer Schering Pharma, Merck Serono, and Sanofi-Aventis.
Francesco Patti received personal compensation for activities with Merck-Serono, Bayer Schering, and Dompe Biotec.
Carlo Pozzilli serves on advisory boards for and received speaker honoraria from Sanofi Aventis, Biogen, Bayer Schering Pharma, Novartis, Teva, Merck Serono and research grants from Merck Serono, Sanofi Aventis, Novartis and Biogen.
Elio Scarpini no conflict of interest
Maria Trojano received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec and Sanofi-Aventis Pharmaceuticals, Inc. as a consultant and/or speaker; received research support from Merck & Co., Inc.
Prof. Comi serves on scientific advisory boards for Bayer Schering Pharma, Merck Serono, Teva Pharmaceutical Industries Ltd, Sanofi Aventis, Novartis and Biogen-Idec; has received speaker honoraria from Teva Pharmaceutical Industries Ltd, Sanofi Aventis, Serono Sumposia International Foundation, Biogen-Idec, Merck Serono, Novartis, Bayer Schering and Sanofi Aventis.