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2. Comparative effectiveness of autologous hematopoietic stem cell transplant vs Fingolimod, Natalizumab, and Ocrelizumab in highly active relapsing-remitting multiple sclerosis

Author

Kalincik, Tomas, Sharmin, Sifat, Roos, Izanne, Freedman, Mark S., Atkins, Harold, Burman, Joachim, Massey, Jennifer, Sutton, Ian, Withers, Barbara, Macdonell, Richard, Grigg, Andrew, Torkildsen, Øivind, Bo, Lars, Lehmann, Anne Kristine, Havrdova, Eva Kubala, Krasulova, Eva, Trněný, Marek, Kozak, Tomas, van der Walt, Anneke, Butzkueven, Helmut, McCombe, Pamela, Skibina, Olga, Lechner-Scott, Jeannette, Willekens, Barbara, Cartechini, Elisabetta, Ozakbas, Serkan, Alroughani, Raed, Kuhle, Jens, Patti, Francesco, Duquette, Pierre, Lugaresi, Alessandra, Khoury, Samia J., Slee, Mark, Turkoglu, Recai, Hodgkinson, Suzanne, John, Nevin, Maimone, Davide, Sa, Maria Jose, van Pesch, Vincent, Gerlach, Oliver, Laureys, Guy, Van Hijfte, Liesbeth, Karabudak, Rana, Spitaleri, Daniele, Csepany, Tunde, Gouider, Riadh, Castillo-Triviño, Tamara, Taylor, Bruce, Sharrack, Basil, Snowden, John A., Horakova, Dana, Buzzard, Katherine, Terzi, Murat, Prat, Alexandre, Girard, Marc, Grammond, Pierre, Barnett, Michael, Stewart, Grace, Onofrj, Marco, Izquierdo, Guillermo, Eichau, Sara, Grand'Maison, Francois, Prevost, Julie, Van Wijmeersch, Bart, Amato, Maria Pia, Shaygannejad, Vahid, Boz, Cavit, Bolaños, Ricardo Fernandez, Soysal, Aysun, Ramo-Tello, Cristina, Solaro, Claudio, Gobbi, Claudio, Cabrera-Gomez, Jose Antonio, Roullet, Etienne, Zwanikken, Cees, Den braber-Moerland, Leontien, Deri, Norma, Saladino, Maria Laura, Cristiano, Edgardo, Rojas, Juan Ignacio, Vrech, Carlos, Shaw, Cameron, Shuey, Neil, Boggild, Mike, Tan, Ik Lin, Hardy, Todd, Decoo, Danny, Moore, Fraser, Oh, Jiwon, Lalive, Patrice, Ampapa, Radek, Petersen, Thor, Oreja-Guevara, Celia, Perez Sempere, Angel, Dominguez, Jose Andres, Besora, Sarah, Hughes, Stella, Gray, Orla, Grigoriadis, Nikolaos, Piroska, Imre, Rozsa, Csilla, Kasa, Krisztian, Simo, Magdolna, Kovacs, Krisztina, Sas, Attila, Dobos, Eniko, Rajda, Cecilia, McGuigan, Chris, Mason, Deborah, Schepel, Jan, Alkhaboori, Jabir, Rio, Maria Edite, Mihaela, Simu, Al-Harbi, Talal, Altintas, Ayse, Kister, Ilya, Marriott, Mark, Kilpatrick, Trevor, King, John, Nguyen, Ai-Lan, Dwyer, Chris, Monif, Mastura, Taylor, Lisa, Diamanti, Matteo, Chisari, Clara, Toscano, Simona, Salvatore, Lo Fermo, Larochelle, Catherine, De Luca, Giovanna, Di Tommaso, Valeria, Travaglini, Daniela, Pietrolongo, Erika, di Ioia, Maria, Farina, Deborah, Mancinelli, Luca, Hupperts, Raymond, Olascoaga, Javier, Saiz, Albert, Zivadinov, Robert, Benedict, Ralph, Verheul, Freek, Fabis-Pedrini, Marzena, Mrabet, Saloua, Garber, Justin, Sanchez-Menoyo, Jose Luis, Aguera-Morales, Eduardo, Blanco, Yolanda, Al-Asmi, Abdullah, Weinstock-Guttman, Bianca, Fragoso, Yara, de Gans, Koen, and Kermode, Allan

Subjects
Human medicine
Abstract

you are agreeing to our Cookie Policy | Continue JAMA Network HomeJAMA Neurology This Issue Views 2,357 Citations 0 60 Full Text Share Comment Original Investigation May 15, 2023 Comparative Effectiveness of Autologous Hematopoietic Stem Cell Transplant vs Fingolimod, Natalizumab, and Ocrelizumab in Highly Active Relapsing-Remitting Multiple Sclerosis Tomas Kalincik, MD, PhD1,2; Sifat Sharmin, PhD1,2; Izanne Roos, MBChB, PhD1,2; Mark S. Freedman, MD3; Harold Atkins, MD4; Joachim Burman, MD, PhD5; Jennifer Massey, MBBS, PhD6,7; Ian Sutton, MBBS, PhD6,8; Barbara Withers, MD, PhD7,9; Richard Macdonell, MD, PhD10,11; Andrew Grigg, MD, PhD11,12; Øivind Torkildsen, MD, PhD13; Lars Bo, MD, PhD13; Anne Kristine Lehmann, MD, PhD14; Eva Kubala Havrdova, MD, PhD15; Eva Krasulova, MD, PhD15; Marek Trněný, MD, PhD16; Tomas Kozak, MD, PhD17; Anneke van der Walt, MBBS, PhD18,19; Helmut Butzkueven, MBBS, PhD18,19; Pamela McCombe, MBBS20,21; Olga Skibina, MBBS18,22,23; Jeannette Lechner-Scott, MD, PhD24,25; Barbara Willekens, MD, PhD26,27; Elisabetta Cartechini, MD28; Serkan Ozakbas, MD29; Raed Alroughani, MD30; Jens Kuhle, MD, PhD31; Francesco Patti, MD32,33; Pierre Duquette, MD34; Alessandra Lugaresi, MD, PhD35,36; Samia J. Khoury, MD, PhD37; Mark Slee, MD, PhD38; Recai Turkoglu, MD39; Suzanne Hodgkinson, MD40; Nevin John, MD, PhD41,42; Davide Maimone, MD43; Maria Jose Sa, MD44; Vincent van Pesch, MD, PhD45,46; Oliver Gerlach, MD, PhD47,48; Guy Laureys, MD49; Liesbeth Van Hijfte, MD49; Rana Karabudak, MD50; Daniele Spitaleri, MD51; Tunde Csepany, MD, PhD52; Riadh Gouider, MD53,54; Tamara Castillo-Triviño, MD55; Bruce Taylor, MD, PhD56,57; Basil Sharrack, MD, PhD58; John A. Snowden, MD, PhD59; and the MSBase Study Group Collaborators; and the MSBase Study Group Authors Author Affiliations JAMA Neurol. 2023;80(7):702-713. doi:10.1001/jamaneurol.2023.1184 editorial comment iconEditorial Comment Key Points Question What is the comparative effectiveness of autologous hematopoietic stem cell transplant (AHSCT) vs individual most potent disease-modifying therapies for relapsing-remitting multiple sclerosis (MS), such as natalizumab or ocrelizumab? Findings In this observational comparative effectiveness study of 4915 individuals using a composite cohort from specialized MS centers and the MSBase international registry, the effectiveness of AHSCT was compared with 1 medium-efficacy and 2 high-efficacy disease-modifying therapies (fingolimod, natalizumab, and ocrelizumab) in patients with relapsing-remitting MS, high frequency of relapses, and moderate disability. Over 5 years, AHSCT was associated with substantially lower relapse rate than fingolimod and marginally lower relapse rate than natalizumab and was also associated with a higher rate of recovery from disability compared with fingolimod and natalizumab, but no evidence of difference in clinical outcomes between AHSCT and ocrelizumab was found at 3-year follow-up. Meaning The results indicate that in relapsing-remitting MS, the clinical effectiveness of AHSCT is considerably superior to fingolimod and marginally superior to natalizumab. Abstract Importance Autologous hematopoietic stem cell transplant (AHSCT) is available for treatment of highly active multiple sclerosis (MS). Objective To compare the effectiveness of AHSCT vs fingolimod, natalizumab, and ocrelizumab in relapsing-remitting MS by emulating pairwise trials. Design, Setting, and Participants This comparative treatment effectiveness study included 6 specialist MS centers with AHSCT programs and international MSBase registry between 2006 and 2021. The study included patients with relapsing-remitting MS treated with AHSCT, fingolimod, natalizumab, or ocrelizumab with 2 or more years study follow-up including 2 or more disability assessments. Patients were matched on a propensity score derived from clinical and demographic characteristics. Exposure AHSCT vs fingolimod, natalizumab, or ocrelizumab. Main outcomes Pairwise-censored groups were compared on annualized relapse rates (ARR) and freedom from relapses and 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening and improvement. Results Of 4915 individuals, 167 were treated with AHSCT; 2558, fingolimod; 1490, natalizumab; and 700, ocrelizumab. The prematch AHSCT cohort was younger and with greater disability than the fingolimod, natalizumab, and ocrelizumab cohorts; the matched groups were closely aligned. The proportion of women ranged from 65% to 70%, and the mean (SD) age ranged from 35.3 (9.4) to 37.1 (10.6) years. The mean (SD) disease duration ranged from 7.9 (5.6) to 8.7 (5.4) years, EDSS score ranged from 3.5 (1.6) to 3.9 (1.9), and frequency of relapses ranged from 0.77 (0.94) to 0.86 (0.89) in the preceding year. Compared with the fingolimod group (769 [30.0%]), AHSCT (144 [86.2%]) was associated with fewer relapses (ARR: mean [SD], 0.09 [0.30] vs 0.20 [0.44]), similar risk of disability worsening (hazard ratio [HR], 1.70; 95% CI, 0.91-3.17), and higher chance of disability improvement (HR, 2.70; 95% CI, 1.71-4.26) over 5 years. Compared with natalizumab (730 [49.0%]), AHSCT (146 [87.4%]) was associated with marginally lower ARR (mean [SD], 0.08 [0.31] vs 0.10 [0.34]), similar risk of disability worsening (HR, 1.06; 95% CI, 0.54-2.09), and higher chance of disability improvement (HR, 2.68; 95% CI, 1.72-4.18) over 5 years. AHSCT (110 [65.9%]) and ocrelizumab (343 [49.0%]) were associated with similar ARR (mean [SD], 0.09 [0.34] vs 0.06 [0.32]), disability worsening (HR, 1.77; 95% CI, 0.61-5.08), and disability improvement (HR, 1.37; 95% CI, 0.66-2.82) over 3 years. AHSCT-related mortality occurred in 1 of 159 patients (0.6%). Conclusion In this study, the association of AHSCT with preventing relapses and facilitating recovery from disability was considerably superior to fingolimod and marginally superior to natalizumab. This study did not find evidence for difference in the effectiveness of AHSCT and ocrelizumab over a shorter available follow-up time.

Published
2023

3. Pregnancy in multiple sclerosis women with relapses in the year before conception increases the risk of long-term disability worsening

Author

Portaccio, Emilio, primary, Tudisco, Laura, additional, Pastò, Luisa, additional, Razzolini, Lorenzo, additional, Fonderico, Mattia, additional, Bellinvia, Angelo, additional, Ghezzi, Angelo, additional, Annovazzi, Pietro, additional, Zaffaroni, Mauro, additional, Moiola, Lucia, additional, Martinelli, Vittorio, additional, Chisari, Clara Grazia, additional, Patti, Francesco, additional, Mancardi, Gianluigi, additional, Pozzilli, Carlo, additional, De Giglio, Laura, additional, Totaro, Rocco, additional, Lugaresi, Alessandra, additional, Di Tommaso, Valeria, additional, Paolicelli, Damiano, additional, Cocco, Eleonora, additional, Marrosu, Maria Giovanna, additional, Comi, Giancarlo, additional, Filippi, Massimo, additional, Trojano, Maria, additional, Amato, Maria Pia, additional, Guaschino, Clara, additional, Protti, Alessandra, additional, Spreafico, Chiara, additional, Marazzi, Raffaella, additional, Cavalla, Paola, additional, Bergamaschi, Roberto, additional, Solaro, Claudio, additional, Caniatti, Luisa Maria, additional, Tola, Maria Rosaria, additional, Granella, Franco, additional, Immovilli, Paolo, additional, Annunziata, Pasquale, additional, Plewnia, Katrin, additional, Bartolozzi, Maria Letizia, additional, Guidi, Leonello, additional, Mazzoni, Monica, additional, De Luca, Giovanna, additional, Musu, Luigina, additional, and Fermo, Salvatore Lo, additional

Published
2021
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5. Pregnancy in multiple sclerosis women with relapses in the year before conception increases the risk of long-term disability worsening.

Author

Portaccio, Emilio, Tudisco, Laura, Pastò, Luisa, Razzolini, Lorenzo, Fonderico, Mattia, Bellinvia, Angelo, Ghezzi, Angelo, Annovazzi, Pietro, Zaffaroni, Mauro, Moiola, Lucia, Martinelli, Vittorio, Chisari, Clara Grazia, Patti, Francesco, Mancardi, Gianluigi, Pozzilli, Carlo, De Giglio, Laura, Totaro, Rocco, Lugaresi, Alessandra, Di Tommaso, Valeria, and Paolicelli, Damiano

Subjects
MULTIPLE sclerosis, DISABILITIES, PEOPLE with disabilities, YOUNG women, CONFIDENCE intervals, REGRESSION analysis, PREGNANCY
Abstract

Background: The influence of pregnancy on long-term disability in multiple sclerosis (MS) is still controversial. Objective: To assess the risk of long-term disability worsening after pregnancy in MS women as compared with a propensity-score (PS) matched group of MS women without pregnancy. Methods: In the setting of the Italian Pregnancy Dataset, MS patients with (pregnancy group (PG)) and without pregnancy (control group (CG)) were recruited. Time to disability worsening on the Expanded Disability Status Scale (EDSS) was assessed through a multivariable Cox regression model. Results: The PS-matching retained 230 PG and 102 CG patients. After a follow-up of 6.5 +/- 3.1 years, disability worsening occurred in 87 (26.2%) women. In the multivariable analysis, disability worsening was associated with pregnancy in women with relapses in the year before conception (adjusted hazard ratio (aHR) = 1.74; 95% confidence interval (CI) 1.06–2.84; p = 0.027), higher EDSS (aHR = 1.39; 95% CI 1.12–1.74; p = 0.003), younger age (aHR = 0.95; 95% CI 0.91–0.99; p = 0.022) and shorter DMD exposure over the follow-up (p < 0.008). Conclusion: Pregnancy in MS women with relapses in the year before conception increases the risk of long-term disability worsening. Our findings underscore the importance of counselling in MS women facing a pregnancy that should be planned after a period of clinical stability, favouring treatment optimization in patients with recent disease activity. [ABSTRACT FROM AUTHOR]

Published
2022
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6. Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis

Author

Wilkins, Alastair, Slee, Mark, TERZİ, MURAT, Grand'Maison, Francois, Ferraro, Diana, Sola, Patrizia, Van Pesch, Vincent, McCombe, Pamela, Hupperts, Raymond, Alroughani, Raed, Grammond, Pierre, Bergamaschi, Roberto, Lugaresi, Alessandra, Shaygannejad, Vahid, Pucci, Eugenio, Granella, Franco, Jokubaitis, Vilija, Pearson, Owen R., Ziemssen, Tjalf, Hutchinson, Michael, McGuigan, Christopher, Butzkueven, Helmut, Kalincik, Tomas, Onofrj, Marco, Trojano, Maria, Duquette, Pierre, Girard, Marc, Prat, Alexandre, Izquierdo, Guillermo, Havrdova, Eva, Horakova, Dana, Zwanikken, Cees, Soysal, Aysun, Yamout, Bassem, Piroska, Imre, McDonnell, Gavin, Moore, Fraser, Butler, Ernest, De Luca, Giovanna, Di Tommaso, Valeria, Travaglini, Daniela, Pietrolongo, Erika, di Ioia, Maria, Farina, Deborah, Mancinelli, Luca, Hodgkinson, Suzanne, Oreja-Guevara, Celia, BOZ, CAVİT, Prevost, Julie, Olascoaga, Javier, Van Wijmeersch, Bart, Barnett, Michael, Verheul, Freek, Rojas, Juan Ingacio, Spitaleri, Daniele, Rio, Maria Edite, Taylor, Bruce, Luis Sanchez-Menoyo, Jose, Ramo-Tello, Cristina, Solaro, Claudio, Csepany, Tunde, Iuliano, Gerardo, Skibina, Olga, Petersen, Thor, Bolanos, Ricardo Fernandez, Sidhom, Youssef, Riadh, Riadh, Vucic, Steve, Macdonell, Richard, Sempere, Angel Perez, Simo, Magdolna, Kister, Ilya, Shuey, Neil, Radek, Radek, Dominguez, Jose Andres, Pia Amato, Maria, Saladino, Maria Laura, Kermode, Allan, Brown, J. William L., Coles, Alasdair, Lechner-Scott, Jeannette, Willis, Mark, Rice, Claire, Scolding, Neil, Flechter, Schlomo, Harding, Katharine, Jones, Joanne, Robertson, Neil, Hughes, Stella, ÖZAKBAŞ, SERKAN, Brown, J William L, Coles, Alasdair, Horakova, Dana, Havrdova, Eva, Izquierdo, Guillermo, Prat, Alexandre, Girard, Marc, Duquette, Pierre, Trojano, Maria, Lugaresi, Alessandra, Bergamaschi, Roberto, Grammond, Pierre, Alroughani, Raed, Hupperts, Raymond, McCombe, Pamela, Van Pesch, Vincent, Sola, Patrizia, Ferraro, Diana, Grand'Maison, Francoi, Terzi, Murat, Lechner-Scott, Jeannette, Flechter, Schlomo, Slee, Mark, Shaygannejad, Vahid, Pucci, Eugenio, Granella, Franco, Jokubaitis, Vilija, Willis, Mark, Rice, Claire, Scolding, Neil, Wilkins, Alastair, Pearson, Owen R, Ziemssen, Tjalf, Hutchinson, Michael, Harding, Katharine, Jones, Joanne, McGuigan, Christopher, Butzkueven, Helmut, Kalincik, Toma, Robertson, Neil, Brown, Will [0000-0002-7737-5834], Coles, Alasdair [0000-0003-4738-0760], Jones, Joanna [0000-0003-4974-1371], Apollo - University of Cambridge Repository, DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE, UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, and OMÜ

Subjects
Male, INTERFERON-BETA, MULTICENTER, Interferon-beta/therapeutic use, multiple sclerosis, 01 natural sciences, Cohort Studies, 0302 clinical medicine, Natalizumab, 030212 general & internal medicine, Alemtuzumab, Original Investigation, GLATIRAMER ACETATE, NATALIZUMAB, Natalizumab/therapeutic use, OUTCOMES, treatment, ALEMTUZUMAB, Absolute risk reduction, General Medicine, Immunologic Factors/therapeutic use, Fingolimod, TIME, Disease Progression, Female, Immunosuppressive Agents, medicine.drug, Cohort study, Adult, medicine.medical_specialty, Alemtuzumab/therapeutic use, Lower risk, Time-to-Treatment, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Immunologic Factors, 0101 mathematics, Glatiramer acetate, Fingolimod Hydrochloride/therapeutic use, business.industry, Fingolimod Hydrochloride, Multiple sclerosis, DISABILITY, 010102 general mathematics, Glatiramer Acetate, Interferon-beta, Multiple Sclerosis, Relapsing-Remitting/drug therapy, medicine.disease, FINGOLIMOD, Immunosuppressive Agents/therapeutic use, multiple sclerosis, progression, treatment, progression, business, Glatiramer Acetate/therapeutic use
Abstract

none 40 si his study was financially supported by National Health and Medical Research Council of Australia (fellowships 1140766 and 1080518, project grants 1129189 and 1083539), the University of Melbourne (Faculty of Medicine, Dentistry and Health Sciences research fellowship), a Next Generation Fellowship funded by the Grand Charity of the Freemason’s (recipient JWLB), and the MSBase 2017 Fellowship (recipient JWLB). Alemtuzumab studies done in Cambridge were supported by the NIHR Cambridge Biomedical Research Centre and the MS Society UK. The MSBase Foundation is a not-for-profit organization that receives support from Roche, Merck, Biogen, Novartis, Bayer Schering, Sanofi Genzyme, and Teva. IMPORTANCE: Within 2 decades of onset, 80% of untreated patients with relapsing-remitting multiple sclerosis (MS) convert to a phase of irreversible disability accrual termed secondary progressive MS. The association between disease-modifying treatments (DMTs), and this conversion has rarely been studied and never using a validated definition. OBJECTIVE: To determine the association between the use, the type of, and the timing of DMTs with the risk of conversion to secondary progressive MS diagnosed with a validated definition. DESIGN, SETTING, AND PARTICIPANTS: Cohort study with prospective data from 68 neurology centers in 21 countries examining patients with relapsing-remitting MS commencing DMTs (or clinical monitoring) between 1988-2012 with minimum 4 years' follow-up. EXPOSURES: The use, type, and timing of the following DMTs: interferon beta, glatiramer acetate, fingolimod, natalizumab, or alemtuzumab. After propensity-score matching, 1555 patients were included (last follow-up, February 14, 2017). MAIN OUTCOME AND MEASURE: Conversion to objectively defined secondary progressive MS. RESULTS: Of the 1555 patients, 1123 were female (mean baseline age, 35 years [SD, 10]). Patients initially treated with glatiramer acetate or interferon beta had a lower hazard of conversion to secondary progressive MS than matched untreated patients (HR, 0.71; 95% CI, 0.61-0.81; P

Published
2019
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7. Epidural analgesia and cesarean delivery in multiple sclerosis post-partum relapses: the Italian cohort study

Author

Pastò Luisa, Portaccio Emilio, Ghezzi Angelo, Hakiki Bahia, Giannini Marta, Razzolini Lorenzo, Piscolla Elisa, De Giglio Laura, Pozzilli Carlo, Paolicelli Damiano, Trojano Maria, Marrosu Maria Giovanna, Patti Francesco, La Mantia Loredana, Mancardi Gian Luigi, Solaro Claudio, Totaro Rocco, Tola Maria Rosaria, Di Tommaso Valeria, Lugaresi Alessandra, Moiola Lucia, Martinelli Vittorio, Comi Giancarlo, and Amato Maria Pia

Subjects
Epidural analgesia, Caesarean delivery, Multiple sclerosis, Pregnancy, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Few studies have systematically addressed the role of epidural analgesia and caesarean delivery in predicting the post-partum disease activity in women with Multiple Sclerosis (MS). The objective of this study was to assess the impact of epidural analgesia (EA) and caesarean delivery (CD) on the risk of post-partum relapses and disability in women with MS. Methods In the context of an Italian prospective study on the safety of immunomodulators in pregnancy, we included pregnancies occurred between 2002 and 2008 in women with MS regularly followed-up in 21 Italian MS centers. Data were gathered through a standardized, semi-structured interview, dealing with pregnancy outcomes, breastfeeding, type of delivery (vaginal or caesarean) and EA. The risk of post-partum relapses and disability progression (1 point on the Expanded Disability Status Sclae, EDSS, point, confirmed after six months) was assessed through a logistic multivariate regression analysis. Results We collected data on 423 pregnancies in 415 women. Among these, 349 pregnancies resulted in full term deliveries, with a post-partum follow-up of at least one year (mean follow-up period 5.5±3.1 years). One hundred and fifty-five patients (44.4%) underwent CD and 65 (18.5%) EA. In the multivariate analysis neither CD, nor EA were associated with a higher risk of post-partum relapses. Post-partum relapses were related to a higher EDSS score at conception (OR=1.42; 95% CI 1.11-1.82; p=0.005), a higher number of relapses in the year before pregnancy (OR=1.62; 95% CI 1.15-2.29; p=0.006) and during pregnancy (OR=3.07; 95% CI 1.40-6.72; p=0.005). Likewise, CD and EA were not associated with disability progression on the EDSS after delivery. The only significant predictor of disability progression was the occurrence of relapses in the year after delivery (disability progression in the year after delivery: OR= 4.00; 95% CI 2.0-8.2; p Conclusions Our findings, show no correlation between EA, CD and postpartum relapses and disability. Therefore these procedures can safely be applied in MS patients. On the other hand, post-partum relapses are significantly associated with increased disability, which calls for the need of preventive therapies after delivery.

Published
2012
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8. Association of inflammation and disability accrual in patients with progressive-onset multiple sclerosis

Author

Hughes, Jordana, Jokubaitis, Vilija, Lugaresi, Alessandra, Hupperts, Raymond, Izquierdo, Guillermo, Prat, Alexandre, Girard, Marc, Duquette, Pierre, Grand'maison, Francois, Grammond, Pierre, Sola, Patrizia, Ferraro, Diana, Ramo-Tello, Cristina, Trojano, Maria, Slee, Mark, Shaygannejad, Vahid, Boz, Cavit, Lechner-Scott, Jeanette, Van Pesch, Vincent, Pucci, Eugenio, Solaro, Claudio, Verheul, Freek, Terzi, Murat, Granella, Franco, Spitaleri, Daniele, Alroughani, Raed, Jun, Jae-Kwan, Fambiatos, Adam, Van Der Walt, Anneke, Butzkueven, Helmut, Kalincik, Tomas, De Luca, Giovanna, Di Tommaso, Valeria, Travaglini, Daniela, Pietrolongo, Erika, Di Ioia, Maria, Farina, Deborah, Mancinelli, Luca, Vitetta, Francesca, Simone, Anna Maria, Haartsen, Jodi, Spelman, Tim, Marriott, Mark, Kilpatrick, Trevor, King, John, Buzzard, Katherine, Nguyen, Ai-Lan, Dwyer, Chris, Monif, Mastura, Brown, J William L, Kunchok, Amy, Diamanti, Matteo, Cartechini, Elisabetta, Curti, Erica, Tsantes, Elena, Zwanikken, Cees, Rio, Maria Edite, Hughes, Stella, Amato, Maria Pita, Van Wijmeersch, Bart, Sanchez-Menoyo, Jose Luis, Bolaños, Ricardo Fernandez, Sajedi, Seyed Aidin, Iuliano, Gerardo, Den Braber-Moerland, Leontien, Prevost, Julie, Sempere, Angel Perez, Sidhom, Youssef, Butler, Ernest, Vucic, Steve, Taylor, Bruce, Cabrera-Gomez, Jose Antonio, Oreja-Guevara, Celia, Bergamaschi, Roberto, Turkoglu, Recai, Olascoaga, Javier, Cristiano, Edgardo, Rojas, Juan Ingacio, Hodgkinson, Suzanne, Skibina, Olga, Al-Harbi, Talal, Altintas, Ayse, McCombe, Pamela, Sinnige, LGF, Ozakbas, Serken, Saladino, Maria Laura, Bacile, Elizabeth Alejandra, Vrech, Carlos, Shaw, Cameron, Hughes, Jordana, Jokubaitis, Vilija, Lugaresi, Alessandra, Hupperts, Raymond, Izquierdo, Guillermo, Prat, Alexandre, Girard, Marc, Duquette, Pierre, Grand'maison, Francois, Grammond, Pierre, Sola, Patrizia, Ferraro, Diana, Ramo-Tello, Cristina, Trojano, Maria, Slee, Mark, Shaygannejad, Vahid, Boz, Cavit, Lechner-Scott, Jeanette, Van Pesch, Vincent, Pucci, Eugenio, Solaro, Claudio, Verheul, Freek, Terzi, Murat, Granella, Franco, Spitaleri, Daniele, Alroughani, Raed, Jun, Jae-Kwan, Fambiatos, Adam, Van Der Walt, Anneke, Butzkueven, Helmut, Kalincik, Tomas, De Luca, Giovanna, Di Tommaso, Valeria, Travaglini, Daniela, Pietrolongo, Erika, Di Ioia, Maria, Farina, Deborah, Mancinelli, Luca, Vitetta, Francesca, Simone, Anna Maria, Haartsen, Jodi, Spelman, Tim, Marriott, Mark, Kilpatrick, Trevor, King, John, Buzzard, Katherine, Nguyen, Ai-Lan, Dwyer, Chris, Monif, Mastura, Brown, J William L, Kunchok, Amy, Diamanti, Matteo, Cartechini, Elisabetta, Curti, Erica, Tsantes, Elena, Zwanikken, Cees, Rio, Maria Edite, Hughes, Stella, Amato, Maria Pita, Van Wijmeersch, Bart, Sanchez-Menoyo, Jose Luis, Bolaños, Ricardo Fernandez, Sajedi, Seyed Aidin, Iuliano, Gerardo, Den Braber-Moerland, Leontien, Prevost, Julie, Sempere, Angel Perez, Sidhom, Youssef, Butler, Ernest, Vucic, Steve, Taylor, Bruce, Cabrera-Gomez, Jose Antonio, Oreja-Guevara, Celia, Bergamaschi, Roberto, Turkoglu, Recai, Olascoaga, Javier, Cristiano, Edgardo, Rojas, Juan Ingacio, Hodgkinson, Suzanne, Skibina, Olga, Al-Harbi, Talal, Altintas, Ayse, McCombe, Pamela, Sinnige, LGF, Ozakbas, Serken, Saladino, Maria Laura, Bacile, Elizabeth Alejandra, Vrech, Carlos, and Shaw, Cameron

Published
2018

9. Prognostic indicators in pediatric clinically isolated syndrome

Author

Iaffaldano, Pietro, Simone, Marta, Lucisano, Giuseppe, Ghezzi, Angelo, Coniglio, Gabriella, Brescia Morra, Vincenzo, Salemi, Giuseppe, Patti, Francesco, Lugaresi, Alessandra, Izquierdo, Guillermo, Bergamaschi, Roberto, Cabrera-Gomez, Jose Antonio, Pozzilli, Carlo, Millefiorini, Enrico, Alroughani, Raed, Boz, Cavit, Pucci, Eugenio, Zimatore, Giovanni Bosco, Sola, Patrizia, Lus, Giacomo, Maimone, Davide, Avolio, Carlo, Cocco, Eleonora, Sajedi, Seyed Aidin, Costantino, Gianfranco, Duquette, Pierre, Shaygannejad, Vahid, Petersen, Thor, Fernández Bolaños, Ricardo, Paolicelli, Damiano, Tortorella, Carla, Spelman, Tim, Margari, Lucia, Amato, Maria Pia, Comi, Giancarlo, Butzkueven, Helmut, Trojano, Maria, Spitaleri, Daniele, Rottoli, Maria Rosa, Ardito, Bonaventura, Iuliano, Gerardo, Montanari, Enrico, Granieri, Enrico, Tedeschi, Gioacchino, Bertolotto, Antonio, Granella, Franco, Di Battista, Giancarlo, Gallo, Paolo, Cavalla, Paola, Bellantonio, Paolo, De Robertis, Francesca, Durelli, Luca, Scarpini, Elio, Rezzonico, Monica, Protti, Alessandra, Solaro, Claudio, Corea, Francesco, Bosco, Antonio, Vianello, Marika, Ferrò, Maria Teresa, Balgera, Roberto, Grasso, Roberta, De Luca, Giovanna, Farina, Deboah, Travaglini, Daniela, di Ioia, Maria, Di Tommaso, Valeria, Mancinelli, Luca, Pietrolongo, Erika, Hupperts, Raymond, Rio, Maria Edite, Terzi, Murat, Barnett, Michael, Slee, Mark, Van Pesch, Vincent, Savino, Aldo, Lechner-Scott, Jeannette, Grammond, Pierre, Singhal, Bhim, Zwanikken, Cees, Fiol, Marcela, Patrucco, Liliana, Paine, Mark, Mccombefrom, Pamela, Grand'Maison, Francois, Iaffaldano, Pietro, Simone, Marta, Lucisano, Giuseppe, Ghezzi, Angelo, Coniglio, Gabriella, Brescia Morra, Vincenzo, Salemi, Giuseppe, Patti, Francesco, Lugaresi, Alessandra, Izquierdo, Guillermo, Bergamaschi, Roberto, Cabrera-Gomez, Jose Antonio, Pozzilli, Carlo, Millefiorini, Enrico, Alroughani, Raed, Boz, Cavit, Pucci, Eugenio, Zimatore, Giovanni Bosco, Sola, Patrizia, Lus, Giacomo, Maimone, Davide, Avolio, Carlo, Cocco, Eleonora, Sajedi, Seyed Aidin, Costantino, Gianfranco, Duquette, Pierre, Shaygannejad, Vahid, Petersen, Thor, Fernández Bolaños, Ricardo, Paolicelli, Damiano, Tortorella, Carla, Spelman, Tim, Margari, Lucia, Amato, Maria Pia, Comi, Giancarlo, Butzkueven, Helmut, Trojano, Maria, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, Morra, Vincenzo Brescia, Cabrera Gomez, Jose Antonio, and Bolaños, Ricardo Fernández

Subjects
Registrie, Male, Multiple Sclerosis, Adolescent, Age of Onset, Child, Demyelinating Diseases, Female, Follow-Up Studies, Humans, Prognosis, Retrospective Studies, Risk Factors, Disease Progression, Registries, Neurology, Neurology (clinical), Prognosi, ONSET MULTIPLE-SCLEROSIS, CHILDHOOD, CHILDREN, PARACLINICAL FEATURES, DISABILITY PROGRESSION, NO, Follow-Up Studie, Retrospective Studie, prognostic indicators, Multiple Sclerosi, pediatric, multiple sclerosis, prognosis, indicators, OPTIC NEURITIS, Risk Factor, Demyelinating Disease, NATURAL-HISTORY, multiple sclerosis, clinically isolated syndrome, prognostic indicators, TRANSVERSE MYELITIS, clinically isolated syndrome, INTERFERON BETA-1B, Settore MED/26 - Neurologia, FOLLOW-UP, Human
Abstract

To assess prognostic factors for a second clinical attack and a first disability worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of Multiple Sclerosis (MS) patients. Objective: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients. Methods: A cohort of 770 pCIS patients was followed up for at least 10 years. Cox proportional hazard models and Recursive Partitioning and Amalgamation (RECPAM) tree-regression were used to analyze data. Results: In pCIS, female sex and a multifocal onset were risk factors for a second clinical attack (hazard ratio [HR], 95% confidence interval [CI] = 1.28, 1.06–1.55; 1.42, 1.10–1.84, respectively), whereas disease-modifying drug (DMD) exposure reduced this risk (HR, 95% CI = 0.75, 0.60–0.95). After pediatric onset MS (POMS) diagnosis, age at onset younger than 15 years and DMD exposure decreased the risk of a first Expanded Disability Status Scale (EDSS)-worsening event (HR, 95% CI = 0.59, 0.42–0.83; 0.75, 0.71–0.80, respectively), whereas the occurrence of relapse increased this risk (HR, 95% CI = 5.08, 3.46–7.46). An exploratory RECPAM analysis highlighted a significantly higher incidence of a first EDSS-worsening event in patients with multifocal or isolated spinal cord or optic neuritis involvement at onset in comparison to those with an isolated supratentorial or brainstem syndrome. A Cox regression model including RECPAM classes confirmed DMD exposure as the most protective factor against EDSS-worsening events and relapses as the most important risk factor for attaining EDSS worsening. Interpretation: This work represents a step forward in identifying predictors of unfavorable course in pCIS and POMS and supports a protective effect of early DMD treatment in preventing MS development and disability accumulation in this population. Ann Neurol 2017;81:729–739.

Published
2017
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11. Pregnancy and Fetal Outcomes after In Utero Exposure to Natalizumab in Patients with Multiple Sclerosis: A Prospective, Nation-Wide, Controlled Study (S24.006)

Author

Giannini, Marta, primary, Portaccio, Emilio, additional, Hakiki, Bahia, additional, Luisa, Pasto', additional, Razzolini, Lorenzo, additional, Isabella, Righini, additional, Tortorella, Carla, additional, Trojano, Maria, additional, Cocco, Eleonora, additional, Melis, Maurizio, additional, Maria Giovanna, Marrosu, additional, Di Tommaso, Valeria, additional, Farina, Deborah, additional, Lugaresi, Alessandra, additional, Annovazzi, Pietro, additional, Ghezzi, Angelo, additional, Gasperini, Claudio, additional, Iudice, Alfonso, additional, Fantozzi, Roberta, additional, Bellantonio, Paolo, additional, Messina, Silvia, additional, Patti, Francesco, additional, Carlotta, Chiavazza, additional, Cavalla, Paola, additional, Protti, Alessandra, additional, Totaro, Rocco, additional, Pozzilli, Carlo, additional, De Giglio, Laura, additional, Uccelli, Antonio, additional, Sartori, Arianna, additional, Bosco, Antonio, additional, Lanzillo, Roberta, additional, Brescia Morra, Vincenzo, additional, and Amato, Maria Pia, additional

Published
2016
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12. Pregnancy does not prevent disease re-activation after natalizumab suspension in patients with multiple sclerosis (S20.003)

Author

Amato, Maria, primary, Hakiki, Bahia, additional, Pastò, Luisa, additional, Giannini, Marta, additional, Razzolini, Lorenzo, additional, Tortorella, Carla, additional, D'Onghia, Mariangela, additional, Trojano, Maria, additional, Cocco, Eleonora, additional, Melis, Marta, additional, Marrosu, Maria, additional, Di Tommaso, Valeria, additional, Farina, Deborah, additional, Lugaresi, Alessandra, additional, Annovazzi, Pietro, additional, Ghezzi, Angelo, additional, Gasperini, Claudio, additional, Iudice, Alfonso, additional, Fantozzi, Roberta, additional, Bellantonio, Paolo, additional, Messina, Silvia, additional, Patti, Francesco, additional, Masera, Silvia, additional, Cavalla, Paola, additional, Protti, Alessandra, additional, Rossi, Maria, additional, Totaro, Rocco, additional, De Giglio, Laura, additional, Pozzilli, Carlo, additional, and Portaccio, Emilio, additional

Published
2015
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14. Holmes-Like Tremor in Ataxia With Oculomotor Apraxia Type 2

Author

D'Amico, Maria Chiara, primary, Borrelli, Iole, additional, Zhuzhuni, Holta, additional, D'Amico, Aurelio, additional, Di Giacomo, Roberta, additional, Mancinelli, Luca, additional, di Tommaso, Valeria, additional, Di Muzio, Antonio, additional, and Onofrj, Marco, additional

Published
2014
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15. Epidural analgesia and cesarean delivery in multiple sclerosis post-partum relapses: the Italian cohort study.

Author

Past•, Luisa, Portaccio, Emilio, Ghezzi, Angelo, Hakiki, Bahia, Gianni, Marta, Razzolini, Loranzo, Piscolla, Elisa, De Giglio, Laura, Pozzili, Carlo, Paolicelli, Damiano, Trojano, Maria, Marrosu, Maria Giovanna, Patti, Francesco, La Mantia, Loredana, Mancardi, Gian Luigi, Solaro, Claudio, Totaro, Rocco, tola, Maria Rosaria, Di Tommaso, Valeria, and Lugaresi, Alessandro

Subjects
EPIDURAL analgesia, CESAREAN section, OBSTETRICS, MULTIPLE sclerosis, PREGNANCY
Abstract

Background: Few studies have systematically addressed the role of epidural analgesia and caesarean delivery in predicting the post-partum disease activity in women with Multiple Sclerosis (MS).The objective of this study was to assess the impact of epidural analgesia (EA) and caesarean delivery (CD) on the risk of post-partum relapses and disability in women with MS. Methods: In the context of an Italian prospective study on the safety of immune modulators in pregnancy, we included pregnancies occurred between 2002 and 2008 in women with MS regularly followed-up in 21 Italian MS centers. Data were gathered through a standardized, semi-structured interview, dealing with pregnancy outcomes, breast feeding, type of delivery (vaginal or caesarean) and EA. The risk of post-partum relapses and disability progression (1 point on the Expanded Disability Status Sclae, EDSS, point, confirmed after six months) was assessed through a logistic multivariate regression analysis. Results: We collected data on 423 pregnancies in 415 women. Among these, 349 pregnancies resulted in full term deliveries, with a post-partum follow-up of at least one year (mean follow-up period 5.5±3.1 years). One hundred and fifty-five patients (44.4%) underwent CD and 65 (18.5%) EA. In the multivariate analysis neither CD, nor EA were associated with a higher risk of post-partum relapses. Post-partum relapses were related to a higher EDSS score at conception (OR=1.42; 95% CI 1.11-1.82; p=0.005), a higher number of relapses in the year before pregnancy(OR=1.62; 95% CI 1.15-2.29; p=0.006) and during pregnancy (OR=3.07; 95% CI 1.40-6.72; p=0.005). Likewise, CD and EA were not associated with disability progression on the EDSS after delivery. The only significant predictor of disability progression was the occurrence of relapses in the year after delivery (disability progression in the year after delivery: OR= 4.00; 95% CI 2.0-8.2; p<0.001; disability progression over the whole follow-up period: OR= 2.0;95% CI 1.2-3.3; p=0.005).Conclusions: Our findings, show no correlation between EA, CD and postpartum relapses and disability. Therefore these procedures can safely be applied in MS patients. On the other hand, post-partum relapses are significantly associated with increased disability, which calls for the need of preventive therapies after delivery. [ABSTRACT FROM AUTHOR]

Published
2012
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16. Pregnancy and Fetal Outcomes after In Utero Exposure to Natalizumab in Patients with Multiple Sclerosis: A Prospective, Nation-Wide, Controlled Study

Author

Giannini, Marta, Portaccio, Emilio, Bahia Hakiki, Luisa, Panto, Razzolini, Lorenzo, Isabella, Righini, Tortorella, Carla, Trojano, Maria, Cocco, Eleonora, Melis, Maurizio, Giovanna, Marrosu Maria, Di Tommaso, Valeria, Farina, Deborah, Lugaresi, Alessandra, Annovazzi, Pietro, Ghezzi, Angelo, Gasperini, Claudio, Iudice, Alfonso, Fantozzli, Roberta, Bellantonio, Paolo, Messina, Silvia, Patti, Francesco, Carlotta, Chiavazza, Cavalla, Paola, Protti, Alessandra, Totaro, Rocco, Pozzilli, Carlo, Giglio, Laura, Uccelli, Antonio, Sartori, Arianna, Bosco, Antonio, Lanzillo, Roberta, Morrao, Vincenzo Brescia, and Amato, Maria Pia

17. Pregnancy in multiple sclerosis women with relapses in the year before conception increases the risk of long-term disability worsening

Author

Emilio Portaccio, Laura Tudisco, Luisa Pastò, Lorenzo Razzolini, Mattia Fonderico, Angelo Bellinvia, Angelo Ghezzi, Pietro Annovazzi, Mauro Zaffaroni, Lucia Moiola, Vittorio Martinelli, Clara Grazia Chisari, Francesco Patti, Gianluigi Mancardi, Carlo Pozzilli, Laura De Giglio, Rocco Totaro, Alessandra Lugaresi, Valeria Di Tommaso, Damiano Paolicelli, Eleonora Cocco, Maria Giovanna Marrosu, Giancarlo Comi, Massimo Filippi, Maria Trojano, Maria Pia Amato, Clara Guaschino, Alessandra Protti, Chiara Spreafico, Raffaella Marazzi, Paola Cavalla, Roberto Bergamaschi, Claudio Solaro, Luisa Maria Caniatti, Maria Rosaria Tola, Franco Granella, Paolo Immovilli, Pasquale Annunziata, Katrin Plewnia, Maria Letizia Bartolozzi, Leonello Guidi, Monica Mazzoni, Giovanna De Luca, Luigina Musu, Salvatore Lo Fermo, Portaccio, Emilio, Tudisco, Laura, Pastò, Luisa, Razzolini, Lorenzo, Fonderico, Mattia, Bellinvia, Angelo, Ghezzi, Angelo, Annovazzi, Pietro, Zaffaroni, Mauro, Moiola, Lucia, Martinelli, Vittorio, Chisari, Clara Grazia, Patti, Francesco, Mancardi, Gianluigi, Pozzilli, Carlo, De Giglio, Laura, Totaro, Rocco, Lugaresi, Alessandra, Di Tommaso, Valeria, Paolicelli, Damiano, Cocco, Eleonora, Marrosu, Maria Giovanna, Comi, Giancarlo, Filippi, Massimo, Trojano, Maria, Amato, Maria Pia, Guaschino, Clara, Protti, Alessandra, Spreafico, Chiara, Marazzi, Raffaella, Cavalla, Paola, Bergamaschi, Roberto, Solaro, Claudio, Caniatti, Luisa Maria, Tola, Maria Rosaria, Granella, Franco, Immovilli, Paolo, Annunziata, Pasquale, Plewnia, Katrin, Bartolozzi, Maria Letizia, Guidi, Leonello, Mazzoni, Monica, De Luca, Giovanna, Musu, Luigina, Fermo, Salvatore Lo, and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE

Subjects
2019-20 coronavirus outbreak, Pediatrics, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Multiple sclerosis, disability worsening, pregnancy, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Recurrence, medicine, Humans, Disabled Persons, 030212 general & internal medicine, Pregnancy, business.industry, Long term disability, medicine.disease, Neurology, Italy, Disease Progression, Female, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

none 26 no Background: The influence of pregnancy on long-term disability in multiple sclerosis (MS) is still controversial. Objective: To assess the risk of long-term disability worsening after pregnancy in MS women as compared with a propensity-score (PS) matched group of MS women without pregnancy. Methods: In the setting of the Italian Pregnancy Dataset, MS patients with (pregnancy group (PG)) and without pregnancy (control group (CG)) were recruited. Time to disability worsening on the Expanded Disability Status Scale (EDSS) was assessed through a multivariable Cox regression model. Results: The PS-matching retained 230 PG and 102 CG patients. After a follow-up of 6.5 +/- 3.1 years, disability worsening occurred in 87 (26.2%) women. In the multivariable analysis, disability worsening was associated with pregnancy in women with relapses in the year before conception (adjusted hazard ratio (aHR) = 1.74; 95% confidence interval (CI) 1.06-2.84; p = 0.027), higher EDSS (aHR = 1.39; 95% CI 1.12-1.74; p = 0.003), younger age (aHR = 0.95; 95% CI 0.91-0.99; p = 0.022) and shorter DMD exposure over the follow-up (p < 0.008). Conclusion: Pregnancy in MS women with relapses in the year before conception increases the risk of long-term disability worsening. Our findings underscore the importance of counselling in MS women facing a pregnancy that should be planned after a period of clinical stability, favouring treatment optimization in patients with recent disease activity. mixed Portaccio, Emilio; Tudisco, Laura; Pastò, Luisa; Razzolini, Lorenzo; Fonderico, Mattia; Bellinvia, Angelo; Ghezzi, Angelo; Annovazzi, Pietro; Zaffaroni, Mauro; Moiola, Lucia; Martinelli, Vittorio; Chisari, Clara Grazia; Patti, Francesco; Mancardi, Gianluigi; Pozzilli, Carlo; De Giglio, Laura; Totaro, Rocco; Lugaresi, Alessandra; Di Tommaso, Valeria; Paolicelli, Damiano; Cocco, Eleonora; Marrosu, Maria Giovanna; Comi, Giancarlo; Filippi, Massimo; Trojano, Maria; Amato, Maria Pia Portaccio, Emilio; Tudisco, Laura; Pastò, Luisa; Razzolini, Lorenzo; Fonderico, Mattia; Bellinvia, Angelo; Ghezzi, Angelo; Annovazzi, Pietro; Zaffaroni, Mauro; Moiola, Lucia; Martinelli, Vittorio; Chisari, Clara Grazia; Patti, Francesco; Mancardi, Gianluigi; Pozzilli, Carlo; De Giglio, Laura; Totaro, Rocco; Lugaresi, Alessandra; Di Tommaso, Valeria; Paolicelli, Damiano; Cocco, Eleonora; Marrosu, Maria Giovanna; Comi, Giancarlo; Filippi, Massimo; Trojano, Maria; Amato, Maria Pia

Published
2022

18. Italian Alemtuzumab Study Group. No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study

Author

Luca Prosperini, Pietro Annovazzi, Laura Boffa, Maria Chiara Buscarinu, Antonio Gallo, Manuela Matta, Lucia Moiola, Luigina Musu, Paola Perini, Carlo Avolio, Valeria Barcella, Assunta Bianco, Deborah Farina, Elisabetta Ferraro, Simona Pontecorvo, Franco Granella, Luigi M E Grimaldi, Alice Laroni, Giacomo Lus, Francesco Patti, Eugenio Pucci, Matteo Pasca, Paola Sarchielli, Angelo Ghezzi, Mauro Zaffaroni, Damiano Baroncini, Fabio Buttari, Diego Centonze, Arianna Fornasiero, Marco Salvetti, Renato Docimo, Elisabetta Signoriello, Gioacchino Tedeschi, Antonio Bertolotto, Marco Capobianco, Giancarlo Comi, Eleonora Cocco, Paolo Gallo, Marco Puthenparampil, Roberta Grasso, Valeria Di Francescantonio, Maria Rosaria Rottoli, Massimiliano Mirabella, Alessandra Lugaresi, Giovanna De Luca, Maria Di Ioia, Valeria Di Tommaso, Luca Mancinelli, Giancarlo Di Battista, Ada Francia, Serena Ruggieri, Carlo Pozzilli, Erica Curti, Elena Tsantes, Barbara Palmeri, Caterina Lapicci, Giovanni Luigi Mancardi, Antonio Uccelli, Clara Chisari, Emanuele D'Amico, Elisabetta Cartechini, Anna Maria Repice, Eliana Magnani, Luca Massaccesi, Paolo Calabresi, Massimiliano Di Filippo, Maria Di Gregorio, Prosperini, Luca, Annovazzi, Pietro, Boffa, Laura, Chiara Buscarinu, Maria, Gallo, Antonio, Matta, Manuela, Moiola, Lucia, Musu, Luigina, Perini, Paola, Avolio, Carlo, Barcella, Valeria, Bianco, Assunta, Farina, Deborah, Ferraro, Elisabetta, Pontecorvo, Simona, Granella, Franco, E Grimaldi, Luigi M, Laroni, Alice, Lus, Giacomo, Patti, Francesco, Pucci, Eugenio, Pasca, Matteo, Sarchielli, Paola, Ghezzi, Angelo, Zaffaroni, Mauro, Baroncini, Damiano, Buttari, Fabio, Centonze, Diego, Fornasiero, Arianna, Salvetti, Marco, Docimo, Renato, Signoriello, Elisabetta, Tedeschi, Gioacchino, Bertolotto, Antonio, Capobianco, Marco, Comi, Giancarlo, Cocco, Eleonora, Gallo, Paolo, Puthenparampil, Marco, Grasso, Roberta, Di Francescantonio, Valeria, Rosaria Rottoli, Maria, Mirabella, Massimiliano, Lugaresi, Alessandra, De Luca, Giovanna, Di Ioia, Maria, Di Tommaso, Valeria, Mancinelli, Luca, Di Battista, Giancarlo, Francia, Ada, Ruggieri, Serena, Pozzilli, Carlo, Curti, Erica, Tsantes, Elena, Palmeri, Barbara, Lapicci, Caterina, Luigi Mancardi, Giovanni, Uccelli, Antonio, Chisari, Clara, D'Amico, Emanuele, Cartechini, Elisabetta, Maria Repice, Anna, Magnani, Eliana, Massaccesi, Luca, Calabresi, Paolo, Di Filippo, Massimiliano, and Di Gregorio, Maria

Published
2018

19. Pregnancy in multiple sclerosis women with relapses in the year before conception increases the risk of long-term disability worsening.

Author

Portaccio E, Tudisco L, Pastò L, Razzolini L, Fonderico M, Bellinvia A, Ghezzi A, Annovazzi P, Zaffaroni M, Moiola L, Martinelli V, Chisari CG, Patti F, Mancardi G, Pozzilli C, De Giglio L, Totaro R, Lugaresi A, Di Tommaso V, Paolicelli D, Cocco E, Marrosu MG, Comi G, Filippi M, Trojano M, and Amato MP

Subjects
Disability Evaluation, Disease Progression, Female, Humans, Italy epidemiology, Pregnancy, Recurrence, Disabled Persons, Multiple Sclerosis drug therapy, Multiple Sclerosis epidemiology, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis, Relapsing-Remitting epidemiology
Abstract

Background: The influence of pregnancy on long-term disability in multiple sclerosis (MS) is still controversial., Objective: To assess the risk of long-term disability worsening after pregnancy in MS women as compared with a propensity-score (PS) matched group of MS women without pregnancy., Methods: In the setting of the Italian Pregnancy Dataset, MS patients with (pregnancy group (PG)) and without pregnancy (control group (CG)) were recruited. Time to disability worsening on the Expanded Disability Status Scale (EDSS) was assessed through a multivariable Cox regression model., Results: The PS-matching retained 230 PG and 102 CG patients. After a follow-up of 6.5 +/- 3.1 years, disability worsening occurred in 87 (26.2%) women. In the multivariable analysis, disability worsening was associated with pregnancy in women with relapses in the year before conception (adjusted hazard ratio (aHR) = 1.74; 95% confidence interval (CI) 1.06-2.84; p = 0.027), higher EDSS (aHR = 1.39; 95% CI 1.12-1.74; p = 0.003), younger age (aHR = 0.95; 95% CI 0.91-0.99; p = 0.022) and shorter DMD exposure over the follow-up ( p < 0.008)., Conclusion: Pregnancy in MS women with relapses in the year before conception increases the risk of long-term disability worsening. Our findings underscore the importance of counselling in MS women facing a pregnancy that should be planned after a period of clinical stability, favouring treatment optimization in patients with recent disease activity.

Published
2022
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20. Simultaneous early-onset severe autoimmune hemolytic anemia and albuminuria during alemtuzumab treatment for multiple sclerosis.

Author

di Ioia M, Farina D, di Tommaso V, Travaglini D, Pietrolongo E, Onofrj M, and de Luca G

Subjects
Adult, Humans, Male, Albuminuria chemically induced, Alemtuzumab adverse effects, Anemia, Hemolytic, Autoimmune chemically induced, Immunologic Factors adverse effects, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background: Alemtuzumab, approved for multiple sclerosis (MS), can cause secondary autoimmune adverse events including thyroid disorders, immune thrombocytopenia (ITP), and glomerular nephropathies. Non-ITP autoimmune cytopenias are rarely reported., Objective: To report a case of autoimmune hemolytic anemia (AIHA) and nephropathy in a MS patient treated with alemtuzumab., Case Report: A 34-year-old man with MS developed albuminuria and AIHA after the first and only alemtuzumab treatment, with positive Coombs' direct and indirect tests and IgG autoantibodies. Both AIHA and nephropathy resolved 1 month after treatment with steroids and intravenous immunoglobulins., Conclusion: Our report adds to literature on AIHA and nephropathy after alemtuzumab treatment and suggests to add Coombs' tests to the screening panel required for alemtuzumab treatment.

Published
2018
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