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2. Impact of treatment on cellular immunophenotype in MS

Author

Cellerino, Maria, Ivaldi, Federico, Pardini, Matteo, Rotta, Gianluca, Vila, Gemma, Bäcker-Koduah, Priscilla, Berge, Tone, Laroni, Alice, Lapucci, Caterina, Novi, Giovanni, Boffa, Giacomo, Sbragia, Elvira, Palmeri, Serena, Asseyer, Susanna, Høgestøl, Einar, Campi, Cristina, Piana, Michele, Inglese, Matilde, Paul, Friedemann, Harbo, Hanne F., Villoslada, Pablo, Kerlero de Rosbo, Nicole, and Uccelli, Antonio

Subjects
Adult, Male, Fingolimod Hydrochloride, Norway, Middle Aged, Multiple Sclerosis, Chronic Progressive, Flow Cytometry, Article, Immunophenotyping, Young Adult, Cross-Sectional Studies, Multiple Sclerosis, Relapsing-Remitting, Italy, Spain, Germany, Disease Progression, Humans, Immunologic Factors, Female, Immunotherapy, Aged
Abstract

Objective To establish cytometry profiles associated with disease stages and immunotherapy in MS. Methods Demographic/clinical data and peripheral blood samples were collected from 227 patients with MS and 82 sex- and age-matched healthy controls (HCs) enrolled in a cross-sectional study at 4 European MS centers (Spain, Italy, Germany, and Norway). Flow cytometry of isolated peripheral blood mononuclear cells was performed in each center using specifically prepared antibody-cocktail Lyotubes; data analysis was centralized at the Genoa center. Differences in immune cell subsets were assessed between groups of untreated patients with relapsing-remitting or progressive MS (RRMS or PMS) and HCs and between groups of patients with RRMS taking 6 commonly used disease-modifying drugs. Results In untreated patients with MS, significantly higher frequencies of Th17 cells in the RRMS population compared with HC and lower frequencies of B-memory/B-regulatory cells as well as higher percentages of B-mature cells in patients with PMS compared with HCs emerged. Overall, the greatest deviation in immunophenotype in MS was observed by treatment rather than disease course, with the strongest impact found in fingolimod-treated patients. Fingolimod induced a decrease in total CD4+ T cells and in B-mature and B-memory cells and increases in CD4+ and CD8+ T-regulatory and B-regulatory cells. Conclusions Our highly standardized, multisite cytomics data provide further understanding of treatment impact on MS immunophenotype and could pave the way toward monitoring immune cells to help clinical management of MS individuals.

Published
2020

3. MSJ872889_supplemental_table – Supplemental material for Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience

Author

Zecca, Chiara, Bovis, Francesca, Novi, Giovanni, Capobianco, Marco, Lanzillo, Roberta, Frau, Jessica, Repice, Anna Maria, Hakiki, Bahia, Realmuto, Sabrina, Bonavita, Simona, Curti, Erica, Brambilla, Laura, Mataluni, Giorgia, Cavalla, Paola, Sapio, Alessia Di, Signoriello, Elisabetta, Barone, Stefania, Maniscalco, Giorgia T, Maietta, Ilaria, Maraffi, Isabella, Boffa, Giacomo, Malucchi, Simona, Nozzolillo, Agostino, Coghe, Giancarlo, Mechi, Claudia, Salemi, Giuseppe, Gallo, Antonio, Sacco, Rosaria, Cellerino, Maria, Malentacchi, Maria, Angelis, Marcello De, Lorefice, Lorena, Magnani, Eliana, Prestipino, Elio, Sperli, Francesca, Morra, Vincenzo Brescia, Fenu, Giuseppe, Barilaro, Alessandro, Abbadessa, Gianmarco, Signori, Alessio, Granella, Franco, Amato, Maria Pia, Uccelli, Antonio, Gobbi, Claudio, and Sormani, Maria Pia

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, MSJ872889_supplemental_table for Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience by Chiara Zecca, Francesca Bovis, Giovanni Novi, Marco Capobianco, Roberta Lanzillo, Jessica Frau, Anna Maria Repice, Bahia Hakiki, Sabrina Realmuto, Simona Bonavita, Erica Curti, Laura Brambilla, Giorgia Mataluni, Paola Cavalla, Alessia Di Sapio, Elisabetta Signoriello, Stefania Barone, Giorgia T Maniscalco, Ilaria Maietta, Isabella Maraffi, Giacomo Boffa, Simona Malucchi, Agostino Nozzolillo, Giancarlo Coghe, Claudia Mechi, Giuseppe Salemi, Antonio Gallo, Rosaria Sacco, Maria Cellerino, Maria Malentacchi, Marcello De Angelis, Lorena Lorefice, Eliana Magnani, Elio Prestipino, Francesca Sperli, Vincenzo Brescia Morra, Giuseppe Fenu, Alessandro Barilaro, Gianmarco Abbadessa, Alessio Signori, Franco Granella, Maria Pia Amato, Antonio Uccelli, Claudio Gobbi and Maria Pia Sormani in Multiple Sclerosis Journal

Published
2019
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7. Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience

Author

Antonio Gallo, Gianmarco Abbadessa, Chiara Zecca, Giancarlo Coghe, Giuseppe Salemi, Antonio Uccelli, Marco Capobianco, Stefania Barone, Rosaria Sacco, Lorena Lorefice, Claudia Mechi, Giorgia Mataluni, Elio Prestipino, Jessica Frau, Claudio Gobbi, Alessandro Barilaro, Giorgia Teresa Maniscalco, Erica Curti, E. Magnani, Bahia Hakiki, Maria Malentacchi, Simona Bonavita, Alessia Di Sapio, Francesca Bovis, Maria Cellerino, Franco Granella, Roberta Lanzillo, Anna Maria Repice, Marcello De Angelis, Isabella Maraffi, Laura Brambilla, Giuseppe Fenu, Elisabetta Signoriello, Alessio Signori, Paola Cavalla, Maria Pia Sormani, Agostino Nozzolillo, Giacomo Boffa, Simona Malucchi, Maria Pia Amato, Giovanni Novi, Sabrina Realmuto, Francesca Sperli, Ilaria Maietta, Vincenzo Brescia Morra, Zecca, C., Bovis, F., Novi, G., Capobianco, M., Lanzillo, R., Frau, J., Repice, A. M., Hakiki, B., Realmuto, S., Bonavita, S., Curti, E., Brambilla, L., Mataluni, G., Cavalla, P., Di Sapio, A., Signoriello, E., Barone, S., Maniscalco, G. T., Maietta, I., Maraffi, I., Boffa, G., Malucchi, S., Nozzolillo, A., Coghe, G., Mechi, C., Salemi, G., Gallo, A., Sacco, R., Cellerino, M., Malentacchi, M., De Angelis, M., Lorefice, L., Magnani, E., Prestipino, E., Sperli, F., Brescia Morra, V., Fenu, G., Barilaro, A., Abbadessa, G., Signori, A., Granella, F., Amato, M. P., Uccelli, A., Gobbi, C., Sormani, M. P., Zecca, Chiara, Bovis, Francesca, Novi, Giovanni, Capobianco, Marco, Lanzillo, Roberta, Frau, Jessica, Repice, Anna Maria, Hakiki, Bahia, Realmuto, Sabrina, Bonavita, Simona, Curti, Erica, Brambilla, Laura, Mataluni, Giorgia, Cavalla, Paola, Di Sapio, Alessia, Signoriello, Elisabetta, Barone, Stefania, Maniscalco, Giorgia T, Maietta, Ilaria, Maraffi, Isabella, Boffa, Giacomo, Malucchi, Simona, Nozzolillo, Agostino, Coghe, Giancarlo, Mechi, Claudia, Salemi, Giuseppe, Gallo, Antonio, Sacco, Rosaria, Cellerino, Maria, Malentacchi, Maria, De Angelis, Marcello, Lorefice, Lorena, Magnani, Eliana, Prestipino, Elio, Sperli, Francesca, Brescia Morra, Vincenzo, Fenu, Giuseppe, Barilaro, Alessandro, Abbadessa, Gianmarco, Signori, Alessio, Granella, Franco, Amato, Maria Pia, Uccelli, Antonio, Gobbi, Claudio, and Sormani, Maria Pia

Subjects
Multiple Sclerosis, medicine.drug_class, Lymphocyte depletion, relapsing–remitting, Monoclonal antibody, Primary progressive, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, real life, medicine, Humans, Immunologic Factors, 030212 general & internal medicine, Secondary progressive, Retrospective Studies, primary progressive, business.industry, Multiple sclerosis, Rituximab, multiple sclerosis, secondary progressive, Treatment options, medicine.disease, Neurology, Relapsing remitting, Italy, multiple sclerosi, Immunology, Settore MED/26 - Neurologia, Neurology (clinical), business, 030217 neurology & neurosurgery, Switzerland, medicine.drug
Abstract

Background: Rituximab, an anti-CD20 monoclonal antibody leading to B lymphocyte depletion, is increasingly used as an off-label treatment option for multiple sclerosis (MS). Objective: To investigate the effectiveness and safety of rituximab in relapsing–remitting (RR) and progressive MS. Methods: This is a multicenter, retrospective study on consecutive MS patients treated off-label with rituximab in 22 Italian and 1 Swiss MS centers. Relapse rate, time to first relapse, Expanded Disability Status Scale (EDSS) progression, incidence of adverse events, and radiological outcomes from 2009 to 2019 were analyzed. Results: A total of 355/451 enrolled subjects had at least one follow-up visit and were included in the outcome analysis. Annualized relapse rate significantly decreases after rituximab initiation versus the pre-rituximab start year in RRMS (from 0.86 to 0.09, p Conclusion: Consistently with other observational studies, our data show effectiveness of rituximab in reducing disease activity in patients with MS.

Published
2020

8. Efficacy of different rituximab therapeutic strategies in patients with neuromyelitis optica spectrum disorders

Author

Ilaria Maietta, Antonio Uccelli, Erica Curti, Francesca Bovis, Marco Capobianco, Giorgia Mataluni, Giovanni Novi, Maria Pia Sormani, Pietro Annovazzi, Sabrina Realmuto, Sabrina Esposito, Roberta Lanzillo, Paola Cavalla, Luigi Zuliani, Fabio Buttari, Simona Malucchi, Maria Malentacchi, Simona Bonavita, Doriana Landi, Alessio Signori, Anna Maria Repice, Francesco Sica, Chiara Bosa, Jessica Frau, Franco Granella, Giuseppe Fenu, Laura Brambilla, Luana Benedetti, Novi, Giovanni, Bovis, Francesca, Capobianco, Marco, Frau, Jessica, Mataluni, Giorgia, Curti, Erica, Zuliani, Luigi, Cavalla, Paola, Brambilla, Laura, Annovazzi, Pietro, Repice, Anna Maria, Lanzillo, Roberta, Esposito, Sabrina, Benedetti, Luana, Maietta, Ilaria, Sica, Francesco, Buttari, Fabio, Malucchi, Simona, Fenu, Giuseppe, Landi, Doriana, Bosa, Chiara, Realmuto, Sabrina, Malentacchi, Maria, Granella, Franco, Signori, Alessio, Bonavita, Simona, Uccelli, Antonio, Sormani, Maria Pia, Novi, G., Bovis, F., Capobianco, M., Frau, J., Mataluni, G., Curti, E., Zuliani, L., Cavalla, P., Brambilla, L., Annovazzi, P., Repice, A. M., Lanzillo, R., Esposito, S., Benedetti, L., Maietta, I., Sica, F., Buttari, F., Malucchi, S., Fenu, G., Landi, D., Bosa, C., Realmuto, S., Malentacchi, M., Granella, F., Signori, A., Bonavita, S., Uccelli, A., and Sormani, M. P.

Subjects
Adult, Male, medicine.medical_specialty, Multivariate analysis, Efficacy, Outcome and Process Assessment, Settore MED/26, 03 medical and health sciences, 0302 clinical medicine, Maintenance therapy, Internal medicine, medicine, Humans, Immunologic Factors, In patient, 030212 general & internal medicine, Adverse effect, Aged, Retrospective Studies, Neuromyelitis optica, business.industry, Multiple sclerosis, General Medicine, Middle Aged, medicine.disease, Health Care, Regimen, Outcome and Process Assessment, Health Care, Neurology, Efficacy, Neuromyelitis optica, Rituximab, Rituximab, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug, Follow-Up Studies
Abstract

Objective To evaluate disease activity according to rituximab (RTX) induction and maintenance regimens in a multicenter real-life dataset of NMOSD patients. Methods This is an observational-retrospective multicentre study including patients with NMOSD treated with RTX in 21 Italian and 1 Swiss centers. Demographics, relapse rate and adverse events over the follow-up were summarized taking into account induction strategy (two-1 g infusions at a 15-day interval (IND-A) vs. 375 mg/m2/week infusions for one month (IND-B)) and maintenance therapy (regimen A (M-A) with fixed time-points infusions vs. regimen B (M-B) based on cytofluorimetric driven reinfusion regimens, the least further subdivided according to CD19+ B cells (M-B1) or CD27+ memory B cells (M-B2) monitoring). Results 131 subjects were enrolled, 127 patients completed the induction regimen and 119 patients had at least one follow-up visit and were included in the outcome analysis. Median follow-up was 1.7 years (range 0.1–11.6). Annualized relapse rate (ARR) was 1.7 in the year before RTX start and decreased to 0.19 during the follow-up. Both ARR and Time to first relapse (TTFR) analysis showed a trend toward an increased disease activity for IND-B and M-A. No patients with MT-B2 experienced relapses during the follow-up. Number of relapses in the year before RTX initiation and having received a previous treatment were significantly associated with higher ARR and reduced TTFR in the multivariate analysis. Interpretation We confirm RTX efficacy in NMOSD patients. Use of specific induction and maintenance protocols is warranted in order to foster RTX efficacy and to reduce costs and side effects.

Published
2019

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