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1. Cladribine vs other drugs in MS: Merging randomized trial with real-life data

Author

Signori, Alessio, Saccà, Francesco, Lanzillo, Roberta, Maniscalco, Giorgia Teresa, Signoriello, Elisabetta, Repice, Anna Maria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Perini, Paola, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Pareja-Gutierrez, Lorena, La Gioia, Sara, Frigeni, Barbara, Barcella, Valeria, Frau, Jessica, Cocco, Eleonora, Fenu, Giuseppe, Clerici, Valentina Torri, Sartori, Arianna, Rasia, Sarah, Cordioli, Cinzia, Stromillo, Maria Laura, Di Sapio, Alessia, Pontecorvo, Simona, Grasso, Roberta, Barone, Stefania, Barrilà, Caterina, Russo, Cinzia Valeria, Esposito, Sabrina, Ippolito, Domenico, Landi, Doriana, Visconti, Andrea, and Sormani, Maria Pia

Published
2020
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2. Assessing association of comorbidities with treatment choice and persistence in MS: A real-life multicenter study

Author

Laroni, Alice, Signori, Alessio, Maniscalco, Giorgia T., Lanzillo, Roberta, Russo, Cinzia Valeria, Binello, Eleonora, Lo Fermo, Salvatore, Repice, Annamaria, Annovazzi, Pietro, Bonavita, Simona, Clerico, Marinella, Baroncini, Damiano, Prosperini, Luca, La Gioia, Sara, Rossi, Silvia, Cocco, Eleonora, Frau, Jessica, Torri Clerici, Valentina, Signoriello, Elisabetta, Sartori, Arianna, Zarbo, Ignazio Roberto, Rasia, Sarah, Cordioli, Cinzia, Cerqua, Raffaella, Di Sapio, Alessia, Lavorgna, Luigi, Pontecorvo, Simona, Barrilà, Caterina, Saccà, Francesco, Frigeni, Barbara, Esposito, Sabrina, Ippolito, Domenico, Gallo, Fabio, and Sormani, Maria Pia

Published
2017
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3. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study

Author

Maniscalco, Giorgia T., primary, Saccà, Francesco, additional, Lanzillo, Roberta, additional, Annovazzi, Pietro, additional, Baroncini, Damiano, additional, Binello, Eleonora, additional, Repice, Annamaria, additional, Perini, Paola, additional, Clerico, Marinella, additional, Mataluni, Giorgia, additional, Bonavita, Simona, additional, La Gioia, Sara, additional, Gutierrez, Lorena Pareja, additional, Laroni, Alice, additional, Frau, Jessica, additional, Cocco, Eleonora, additional, Torri Clerici, Valentina, additional, Zarbo, Ignazio Roberto, additional, Sartori, Arianna, additional, Signoriello, Elisabetta, additional, Rasia, Sarah, additional, Cordioli, Cinzia, additional, Stromillo, Maria Laura, additional, Cerqua, Raffaella, additional, Pontecorvo, Simona, additional, Di Sapio, Alessia, additional, Grasso, Roberta, additional, Barone, Stefania, additional, Lavorgna, Luigi, additional, Barrilà, Caterina, additional, Landi, Doriana, additional, Russo, Cinzia Valeria, additional, Frigeni, Barbara, additional, Ippolito, Domenico, additional, Turano, Gabriella, additional, Carmisciano, Luca, additional, Sormani, Maria Pia, additional, and Signori, Alessio, additional

Published
2020
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5. MSJ790390_supplementary_material – Supplemental material for Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study

Author

Saccà, Francesco, Lanzillo, Roberta, Signori, Alessio, Maniscalco, Giorgia T, Signoriello, Elisabetta, Fermo, Salvatore Lo, Repice, Annamaria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Rossi, Silvia, Gutierrez, Lorena Pareja, Gioia, Sara La, Frigeni, Barbara, Barcella, Valeria, Frau, Jessica, Cocco, Eleonora, Fenu, Giuseppe, Clerici, Valentina Torri, Sartori, Arianna, Rasia, Sarah, Cordioli, Cinzia, Sapio, Alessia Di, Pontecorvo, Simona, Grasso, Roberta, Barrilà, Caterina, Russo, Cinzia Valeria, Esposito, Sabrina, Ippolito, Domenico, Bovis, Francesca, Gallo, Fabio, and Sormani, Maria Pia

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

Supplemental material, MSJ790390_supplementary_material for Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study by Francesco Saccà, Roberta Lanzillo, Alessio Signori, Giorgia T Maniscalco, Elisabetta Signoriello, Salvatore Lo Fermo, Annamaria Repice, Pietro Annovazzi, Damiano Baroncini, Marinella Clerico, Eleonora Binello, Raffaella Cerqua, Giorgia Mataluni, Simona Bonavita, Luigi Lavorgna, Ignazio Roberto Zarbo, Alice Laroni, Silvia Rossi, Lorena Pareja Gutierrez, Sara La Gioia, Barbara Frigeni, Valeria Barcella, Jessica Frau, Eleonora Cocco, Giuseppe Fenu, Valentina Torri Clerici, Arianna Sartori, Sarah Rasia, Cinzia Cordioli, Alessia Di Sapio, Simona Pontecorvo, Roberta Grasso, Caterina Barrilà, Cinzia Valeria Russo, Sabrina Esposito, Domenico Ippolito, Francesca Bovis, Fabio Gallo and Maria Pia Sormani in Multiple Sclerosis Journal

Published
2018
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6. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study

Author

Saccà, Francesco, primary, Lanzillo, Roberta, additional, Signori, Alessio, additional, Maniscalco, Giorgia T, additional, Signoriello, Elisabetta, additional, Lo Fermo, Salvatore, additional, Repice, Annamaria, additional, Annovazzi, Pietro, additional, Baroncini, Damiano, additional, Clerico, Marinella, additional, Binello, Eleonora, additional, Cerqua, Raffaella, additional, Mataluni, Giorgia, additional, Bonavita, Simona, additional, Lavorgna, Luigi, additional, Zarbo, Ignazio Roberto, additional, Laroni, Alice, additional, Rossi, Silvia, additional, Pareja Gutierrez, Lorena, additional, La Gioia, Sara, additional, Frigeni, Barbara, additional, Barcella, Valeria, additional, Frau, Jessica, additional, Cocco, Eleonora, additional, Fenu, Giuseppe, additional, Torri Clerici, Valentina, additional, Sartori, Arianna, additional, Rasia, Sarah, additional, Cordioli, Cinzia, additional, Di Sapio, Alessia, additional, Pontecorvo, Simona, additional, Grasso, Roberta, additional, Barrilà, Caterina, additional, Russo, Cinzia Valeria, additional, Esposito, Sabrina, additional, Ippolito, Domenico, additional, Bovis, Francesca, additional, Gallo, Fabio, additional, and Sormani, Maria Pia, additional

Published
2018
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7. Comorbidities affect treatment choice and persistence in RRMS: a real-life multicenter study

Author

Laroni, A., Signori, A., Maniscalco, G., Lanzillo, Raffaella, Sacca', Filippo, Clerico, Marinella, Lo Fermo, S., Annovazzi, P., Bonavita, S., Baroncini, D., Rasia, S., Cordioli, C., Prosperni, L., Cocco, Eleonora, Torri Clerici, V., Sartori, A., Signoriello, E., Repice, A., Zarbo, I., Cerqua, R., Pontecorvo, S., Di Sapio, A., Lavorgna, L., Barillà, C., La Gioia, S., Frigeni, B., Iaffaldano, P., Binello, Eleonora, Russo, Valentina, Esposito, S., Frau, J., Gallo, F., and Sorman, M.

Published
2016

8. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study.

Author

Saccà, Francesco, Lanzillo, Roberta, Signori, Alessio, Maniscalco, Giorgia T, Signoriello, Elisabetta, Lo Fermo, Salvatore, Repice, Annamaria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Rossi, Silvia, Pareja Gutierrez, Lorena, and La Gioia, Sara

Subjects
MULTIPLE sclerosis, MULTIPLE sclerosis treatment, DECISION making
Abstract

Background: With many options now available, first therapy choice is challenging in multiple sclerosis (MS) and depends mainly on neurologist and patient preferences. Objectives: To identify prognostic factors for early switch after first therapy choice. Methods: Newly diagnosed relapsing–remitting MS patients from 24 Italian centers were included. We evaluated the association of baseline demographics, clinical, and magnetic resonance imaging (MRI) data to the switch probability for lack of efficacy or intolerance/safety with a multivariate Cox analysis and estimated switch rates by competing risks models. Results: We enrolled 3025 patients. The overall switch frequency was 48% after 3 years. Switch risk for lack of efficacy was lower with fingolimod (hazard ratio (HR) = 0.50; p = 0.009), natalizumab (HR = 0.13; p < 0.001), dimethyl-fumarate (HR = 0.60; p = 0.037), teriflunomide (HR = 0.21; p = 0.031) as compared to interferons. Younger age (HR = 0.96; p < 0.001), diagnosis delay (HR = 1.23; p = 0.021), higher baseline Expanded Disability Status Scale (HR = 1.17; p = 0.001), and spinal cord lesions (HR = 1.46; p = 0.001) were independently associated with higher inefficacy switch rates. We found lower switch for intolerance/safety with glatiramer acetate (HR = 0.61; p = 0.001), fingolimod (HR = 0.35; p = 0.002), and dimethyl-fumarate (HR = 0.57; p = 0.022) as compared to interferons, while it increased with natalizumab (HR = 1.43; p = 0.022). Comorbidities were associated with intolerance switch (HR = 1.28; p = 0.047). Conclusion: Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice. [ABSTRACT FROM AUTHOR]

Published
2019
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10. Progranulin genetic polymorphisms influence progression of disability and relapse recovery in multiple sclerosis.

Author

Vercellino, Marco, Fenoglio, Chiara, Galimberti, Daniela, Mattioda, Alessandra, Chiavazza, Carlotta, Binello, Eleonora, Pinessi, Lorenzo, Giobbe, Dario, Scarpini, Elio, and Cavalla, Paola

Subjects
PROGRANULIN, GENETIC polymorphisms, MULTIPLE sclerosis, MYELIN sheath diseases, VIRUS diseases
Abstract

Background: Progranulin (GRN) is a multifunctional protein involved in inflammation and repair, and also a neurotrophic factor critical for neuronal survival. Progranulin is strongly expressed in multiple sclerosis (MS) brains by macrophages and microglia. Methods: In this study we evaluated GRN genetic variability in 400 MS patients, in correlation with clinical variables such as disease severity and relapse recovery. We also evaluated serum progranulin levels in the different groups of GRN variants carriers. Results: We found that incomplete recovery after a relapse is correlated with an increased frequency of the rs9897526 A allele (odds ratio (OR) 4.367, p = 0.005). A more severe disease course (Multiple Sclerosis Severity Score > 5) is correlated with an increased frequency of the rs9897526 A allele (OR 1.886, p = 0.002) and of the rs5848 T allele (OR 1.580, p = 0.019). Carriers of the variants associated with a more severe disease course (rs9897526 A, rs5848 T) have significantly lower levels of circulating progranulin (80.5 ± 9.1 ng/mL vs. 165.7 ng/mL, p = 0.01). Conclusion: GRN genetic polymorphisms likely influence disease course and relapse recovery in MS. [ABSTRACT FROM AUTHOR]

Published
2016
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12. Cladribine vs other drugs in MS: Merging randomized trial with real-life data

Author

Domenico Ippolito, Sara La Gioia, Sabrina Esposito, Valentina Torri Clerici, Giorgia Teresa Maniscalco, Cinzia Cordioli, Lorena Pareja-Gutierrez, Elisabetta Signoriello, Cinzia Valeria Russo, Roberta Grasso, Doriana Landi, B. Frigeni, Andrea Visconti, Caterina Barrilà, Valeria Barcella, Raffaella Cerqua, Alice Laroni, Simona Bonavita, Stefania Barone, P. Perini, Sarah Rasia, Arianna Sartori, Maria Laura Stromillo, Roberta Lanzillo, Damiano Baroncini, Jessica Frau, Francesco Saccà, Luigi Lavorgna, Alessio Signori, Ignazio Roberto Zarbo, Giorgia Mataluni, Eleonora Cocco, Maria Pia Sormani, E Binello, Pietro Annovazzi, M Clerico, Simona Pontecorvo, Giuseppe Fenu, Alessia Di Sapio, Anna Maria Repice, Signori, A., Sacca, F., Lanzillo, R., Maniscalco, G. T., Signoriello, E., Repice, A. M., Annovazzi, P., Baroncini, D., Clerico, M., Binello, E., Cerqua, R., Mataluni, G., Perini, P., Bonavita, S., Lavorgna, L., Zarbo, I. R., Laroni, A., Pareja-Gutierrez, L., La Gioia, S., Frigeni, B., Barcella, V., Frau, J., Cocco, E., Fenu, G., Clerici, V. T., Sartori, A., Rasia, S., Cordioli, C., Stromillo, M. L., Di Sapio, A., Pontecorvo, S., Grasso, R., Barone, S., Barrila, C., Russo, C. V., Esposito, S., Ippolito, D., Landi, D., Visconti, A., Sormani, M. P., Signori, Alessio, Saccà, Francesco, Lanzillo, Roberta, Maniscalco, Giorgia Teresa, Signoriello, Elisabetta, Repice, Anna Maria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Perini, Paola, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Pareja-Gutierrez, Lorena, La Gioia, Sara, Frigeni, Barbara, Barcella, Valeria, Frau, Jessica, Cocco, Eleonora, Fenu, Giuseppe, Clerici, Valentina Torri, Sartori, Arianna, Rasia, Sarah, Cordioli, Cinzia, Stromillo, Maria Laura, Di Sapio, Alessia, Pontecorvo, Simona, Grasso, Roberta, Barone, Stefania, Barrilà, Caterina, Russo, Cinzia Valeria, Esposito, Sabrina, Ippolito, Domenico, Landi, Doriana, Visconti, Andrea, and Sormani, Maria Pia

Subjects
Adult, Male, medicine.medical_specialty, Databases, Factual, Datasets as Topic, Settore MED/26, Placebo, Severity of Illness Index, law.invention, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Randomized controlled trial, law, Internal medicine, Outcome Assessment, Health Care, Severity of illness, medicine, Humans, Immunologic Factors, Multicenter Studies as Topic, Glatiramer acetate, Cladribine, Randomized Controlled Trials as Topic, Retrospective Studies, business.industry, Middle Aged, Fingolimod, Observational Studies as Topic, Neurology, Propensity score matching, Disease Progression, Female, Neurology (clinical), business, medicine.drug
Abstract

ObjectiveCladribine tablets were tested against placebo in randomized controlled trials (RCTs). In this study, the effectiveness of cladribine vs other approved drugs in patients with relapsing-remitting MS (RRMS) was compared by matching RCT to observational data.MethodsData from the pivotal trial assessing cladribine tablets vs placebo (CLARITY) were propensity score matched to data from the Italian multicenter database i-MuST. This database included 3,150 patients diagnosed between 2010 and 2018 at 24 Italian MS centers who started a disease-modifying drug. The annualized relapse rate (ARR) over 2 years from treatment start and the 24-week confirmed disability progression were compared between patients treated with cladribine and other approved drugs (interferon, glatiramer acetate, fingolimod, natalizumab, and dimethyl fumarate), with comparisons with placebo as a reference. Treatment effects were estimated by the inverse probability weighting negative binomial regression model for ARR and Cox model for disability progression. The treatment effect has also been evaluated according to baseline disease activity.ResultsAll weighted baseline characteristics were well balanced between groups. All drugs tested had an effect vs placebo close to that detected in the RCT. Patients treated with cladribine had a significantly lower ARR compared with interferon (relapse ratio [RR] = 0.48; p < 0.001), glatiramer acetate (RR = 0.49; p < 0.001), and dimethyl fumarate (RR = 0.6; p = 0.001); a similar ARR to that with fingolimod (RR = 0.74; p = 0.24); and a significantly higher ARR than natalizumab (RR = 2.13; p = 0.014), confirming results obtained by indirect treatment comparisons from RCTs (network meta-analyses). The relative effect of cladribine tablets 10 mg (cumulative dose 3.5 mg/kg over 2 years) was higher in patients with high disease activity vs all treatments except fingolimod and natalizumab. Effects on disability progression were largely nonsignificant, probably due to lack of power for such analysis.ConclusionIn patients with RRMS, cladribine tablets showed lower ARR compared with matched patients who started interferon, glatiramer acetate, or dimethyl fumarate; was similar to fingolimod; and was higher than natalizumab. The beneficial effect of cladribine tablets was generally amplified in the subgroup of patients with high disease activity.Classification of evidenceThis study provides Class III evidence that for patients with RRMS, cladribine-treated patients had lower ARR compared with interferon, glatiramer acetate, or dimethyl fumarate; similar ARR compared with fingolimod; and higher ARR compared with natalizumab.

Published
2020

13. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study

Author

Caterina Barrilà, Alice Laroni, Raffaella Cerqua, Giorgia Teresa Maniscalco, Alessia Di Sapio, Jessica Frau, Alessio Signori, A. Repice, Domenico Ippolito, Sara La Gioia, Giuseppe Fenu, Ignazio Roberto Zarbo, Francesco Saccà, Giorgia Mataluni, Sabrina Esposito, Elisabetta Signoriello, Arianna Sartori, Simona Bonavita, Eleonora Cocco, Roberta Lanzillo, Salvatore Lo Fermo, B. Frigeni, Valeria Barcella, Maria Pia Sormani, Simona Pontecorvo, E Binello, Pietro Annovazzi, Sarah Rasia, Cinzia Cordioli, Roberta Grasso, Valentina Torri Clerici, Damiano Baroncini, Lorena Pareja Gutierrez, Luigi Lavorgna, Marinella Clerico, Cinzia Valeria Russo, Fabio Gallo, Francesca Bovis, Silvia Rossi, Saccà, Francesco, Lanzillo, Roberta, Signori, Alessio, Maniscalco, Giorgia T, Signoriello, Elisabetta, Lo Fermo, Salvatore, Repice, Annamaria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Rossi, Silvia, Pareja Gutierrez, Lorena, La Gioia, Sara, Frigeni, Barbara, Barcella, Valeria, Frau, Jessica, Cocco, Eleonora, Fenu, Giuseppe, Torri Clerici, Valentina, Sartori, Arianna, Rasia, Sarah, Cordioli, Cinzia, Di Sapio, Alessia, Pontecorvo, Simona, Grasso, Roberta, Barrilà, Caterina, Russo, Cinzia Valeria, Esposito, Sabrina, Ippolito, Domenico, Bovis, Francesca, Gallo, Fabio, and Sormani, Maria Pia

Subjects
Persistence (psychology), Adult, Male, medicine.medical_specialty, Pediatrics, Neurology, Adolescent, naïve, relapsing–remitting, Therapy naive, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, disease modifying therapies, Medicine, Humans, Immunologic Factors, 030212 general & internal medicine, real-life, Aged, Retrospective Studies, business.industry, Drug Substitution, Multiple sclerosis, Switch, persistence, Middle Aged, medicine.disease, Relapsing remitting, Italy, disease modifying therapies, naïve, persistence, real-life, relapsing–remitting, Switch, Neurology, Neurology (clinical), disease modifying therapie, Female, Neurology (clinical), business, Life study, 030217 neurology & neurosurgery
Abstract

Background: With many options now available, first therapy choice is challenging in multiple sclerosis (MS) and depends mainly on neurologist and patient preferences. Objectives: To identify prognostic factors for early switch after first therapy choice. Methods: Newly diagnosed relapsing–remitting MS patients from 24 Italian centers were included. We evaluated the association of baseline demographics, clinical, and magnetic resonance imaging (MRI) data to the switch probability for lack of efficacy or intolerance/safety with a multivariate Cox analysis and estimated switch rates by competing risks models. Results: We enrolled 3025 patients. The overall switch frequency was 48% after 3 years. Switch risk for lack of efficacy was lower with fingolimod (hazard ratio (HR) = 0.50; p = 0.009), natalizumab (HR = 0.13; p Conclusion: Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice.

Published
2019

14. Assessing association of comorbidities with treatment choice and persistence in MS: A real-life multicenter study

Author

Alice, Laroni, Alessio, Signori, Giorgia T, Maniscalco, Roberta, Lanzillo, Cinzia Valeria, Russo, Eleonora, Binello, Salvatore, Lo Fermo, Annamaria, Repice, Pietro, Annovazzi, Simona, Bonavita, Marinella, Clerico, Damiano, Baroncini, Luca, Prosperini, Sara, La Gioia, Silvia, Rossi, Eleonora, Cocco, Jessica, Frau, Valentina, Torri Clerici, Elisabetta, Signoriello, Arianna, Sartori, Ignazio Roberto, Zarbo, Sarah, Rasia, Cinzia, Cordioli, Raffaella, Cerqua, Alessia, Di Sapio, Luigi, Lavorgna, Simona, Pontecorvo, Caterina, Barrilà, Francesco, Saccà, Barbara, Frigeni, Sabrina, Esposito, Domenico, Ippolito, Fabio, Gallo, Maria Pia, Sormani, Laroni, Alice, Signori, Alessio, Maniscalco, Giorgia T., Lanzillo, Roberta, Russo, Cinzia Valeria, Binello, Eleonora, Lo Fermo, Salvatore, Repice, Annamaria, Annovazzi, Pietro, Bonavita, Simona, Clerico, Marinella, Baroncini, Damiano, Prosperini, Luca, La Gioia, Sara, Rossi, Silvia, Cocco, Eleonora, Frau, Jessica, Torri Clerici, Valentina, Signoriello, Elisabetta, Sartori, Arianna, Zarbo, Ignazio Roberto, Rasia, Sarah, Cordioli, Cinzia, Cerqua, Raffaella, Di Sapio, Alessia, Lavorgna, Luigi, Pontecorvo, Simona, Barrilà, Caterina, Saccà, Francesco, Frigeni, Barbara, Esposito, Sabrina, Ippolito, Domenico, Gallo, Fabio, Sormani, Maria Pia, Laroni, A, Signori, A, Maniscalco, Gt, Lanzillo, R, Russo, Cv, Binello, E, Lo Fermo, S, Repice, A, Annovazzi, P, Bonavita, S, Clerico, M, Baroncini, D, Prosperini, L, La Gioia, S, Rossi, S, Cocco, E, Frau, J, Torri Clerici, V, Signoriello, E, Sartori, A, Zarbo, Ir, Rasia, S, Cordioli, C, Cerqua, R, Di Sapio, A, Lavorgna, L, Pontecorvo, S, Barrilà, C, Saccà, F, Frigeni, B, Esposito, S, Ippolito, D, Gallo, F, and Sormani, Mp

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Cardiovascular Abnormalities, Cohort Studies, Comorbidity, Disability Evaluation, Female, Humans, Immunosuppressive Agents, Italy, Mental Disorders, Metabolic Diseases, Middle Aged, Nervous System Diseases, Severity of Illness Index, Drug Substitution, Neurology (clinical), Immunosuppressive Agent, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Internal medicine, Multiple Sclerosi, Severity of illness, medicine, Cardiovascular Abnormalitie, Glatiramer acetate, Nervous System Disease, business.industry, Odds ratio, medicine.disease, Fingolimod, Metabolic Disease, 030104 developmental biology, Cohort, Mental Disorder, Cohort Studie, business, 030217 neurology & neurosurgery, Human, Cohort study, medicine.drug
Abstract

Objective:To assess whether the presence of concomitant diseases at multiple sclerosis (MS) diagnosis is associated with the choice and the treatment persistence in an Italian MS cohort.Methods:We included newly diagnosed patients (2010–2016) followed in 20 MS centers and collected demographic and clinical data. We evaluated baseline factors related to the presence of comorbidities and the association between comorbidities and the clinical course of MS and the time to the first treatment switch.Results:The study cohort included 2,076 patients. Data on comorbidities were available for 1,877/2,076 patients (90.4%). A total of 449/1,877 (23.9%) patients had at least 1 comorbidity at MS diagnosis. Age at diagnosis (odds ratio 1.05, 95% confidence interval [CI] 1.04–1.06; p < 0.001) was the only baseline factor independently related to the presence of comorbidities. Comorbidities were not significantly associated with the choice of the first disease-modifying treatment, but were significantly associated with higher risk to switch from the first treatment due to intolerance (hazard ratio 1.42, CI 1.07–1.87; p = 0.014). Association of comorbidities with risk of switching for intolerance was significantly heterogeneous among treatments (interferon β, glatiramer acetate, natalizumab, or fingolimod; interaction test, p = 0.04).Conclusions:Comorbidities at diagnosis should be taken into account at the first treatment choice because they are associated with lower persistence on treatment.

Published
2017

15. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study.

Author

Saccà F, Lanzillo R, Signori A, Maniscalco GT, Signoriello E, Lo Fermo S, Repice A, Annovazzi P, Baroncini D, Clerico M, Binello E, Cerqua R, Mataluni G, Bonavita S, Lavorgna L, Zarbo IR, Laroni A, Rossi S, Pareja Gutierrez L, La Gioia S, Frigeni B, Barcella V, Frau J, Cocco E, Fenu G, Torri Clerici V, Sartori A, Rasia S, Cordioli C, Di Sapio A, Pontecorvo S, Grasso R, Barrilà C, Russo CV, Esposito S, Ippolito D, Bovis F, Gallo F, and Sormani MP

Subjects
Adolescent, Adult, Aged, Drug Substitution, Female, Humans, Italy, Male, Middle Aged, Retrospective Studies, Young Adult, Immunologic Factors adverse effects, Immunologic Factors therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background: With many options now available, first therapy choice is challenging in multiple sclerosis (MS) and depends mainly on neurologist and patient preferences., Objectives: To identify prognostic factors for early switch after first therapy choice., Methods: Newly diagnosed relapsing-remitting MS patients from 24 Italian centers were included. We evaluated the association of baseline demographics, clinical, and magnetic resonance imaging (MRI) data to the switch probability for lack of efficacy or intolerance/safety with a multivariate Cox analysis and estimated switch rates by competing risks models., Results: We enrolled 3025 patients. The overall switch frequency was 48% after 3 years. Switch risk for lack of efficacy was lower with fingolimod (hazard ratio (HR) = 0.50; p  = 0.009), natalizumab (HR = 0.13; p  < 0.001), dimethyl-fumarate (HR = 0.60; p  = 0.037), teriflunomide (HR = 0.21; p  = 0.031) as compared to interferons. Younger age (HR = 0.96; p  < 0.001), diagnosis delay (HR = 1.23; p  = 0.021), higher baseline Expanded Disability Status Scale (HR = 1.17; p  = 0.001), and spinal cord lesions (HR = 1.46; p  = 0.001) were independently associated with higher inefficacy switch rates. We found lower switch for intolerance/safety with glatiramer acetate (HR = 0.61; p  = 0.001), fingolimod (HR = 0.35; p  = 0.002), and dimethyl-fumarate (HR = 0.57; p  = 0.022) as compared to interferons, while it increased with natalizumab (HR = 1.43; p  = 0.022). Comorbidities were associated with intolerance switch (HR = 1.28; p  = 0.047)., Conclusion: Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice.

Published
2019
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16. Progranulin genetic polymorphisms influence progression of disability and relapse recovery in multiple sclerosis.

Author

Vercellino M, Fenoglio C, Galimberti D, Mattioda A, Chiavazza C, Binello E, Pinessi L, Giobbe D, Scarpini E, and Cavalla P

Subjects
Adult, Disease Progression, Female, Gene Frequency, Genetic Association Studies, Genetic Predisposition to Disease, Humans, Intercellular Signaling Peptides and Proteins blood, Italy, Logistic Models, Male, Middle Aged, Multiple Sclerosis, Chronic Progressive blood, Multiple Sclerosis, Chronic Progressive diagnosis, Multiple Sclerosis, Relapsing-Remitting blood, Multiple Sclerosis, Relapsing-Remitting diagnosis, Multivariate Analysis, Odds Ratio, Phenotype, Predictive Value of Tests, Progranulins, Recovery of Function, Recurrence, Risk Factors, Disability Evaluation, Intercellular Signaling Peptides and Proteins genetics, Multiple Sclerosis, Chronic Progressive genetics, Multiple Sclerosis, Relapsing-Remitting genetics, Polymorphism, Single Nucleotide
Abstract

Background: Progranulin (GRN) is a multifunctional protein involved in inflammation and repair, and also a neurotrophic factor critical for neuronal survival. Progranulin is strongly expressed in multiple sclerosis (MS) brains by macrophages and microglia., Methods: In this study we evaluated GRN genetic variability in 400 MS patients, in correlation with clinical variables such as disease severity and relapse recovery. We also evaluated serum progranulin levels in the different groups of GRN variants carriers., Results: We found that incomplete recovery after a relapse is correlated with an increased frequency of the rs9897526 A allele (odds ratio (OR) 4.367, p = 0.005). A more severe disease course (Multiple Sclerosis Severity Score > 5) is correlated with an increased frequency of the rs9897526 A allele (OR 1.886, p = 0.002) and of the rs5848 T allele (OR 1.580, p = 0.019). Carriers of the variants associated with a more severe disease course (rs9897526 A, rs5848 T) have significantly lower levels of circulating progranulin (80.5 ± 9.1 ng/mL vs. 165.7 ng/mL, p = 0.01)., Conclusion: GRN genetic polymorphisms likely influence disease course and relapse recovery in MS., (© The Author(s), 2015.)

Published
2016
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