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2. Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

Author

Chisari, Clara Grazia, primary, Solaro, Claudio, additional, Annunziata, Pasquale, additional, Bergamaschi, Roberto, additional, Bianco, Assunta, additional, Bonavita, Simona, additional, Brescia Morra, Vincenzo, additional, Bruno Bossio, Roberto, additional, Capello, Elisabetta, additional, Castelli, Letizia, additional, Cavalla, Paola, additional, Costantino, Gianfranco, additional, Centonze, Diego, additional, Cottone, Salvatore, additional, Danni, Maura Chiara, additional, Esposito, Federica, additional, Gajofatto, Alberto, additional, Gasperini, Claudio, additional, Guareschi, Angelica, additional, Lanzillo, Roberta, additional, Lus, Giacomo, additional, Maniscalco, Giorgia Teresa, additional, Matta, Manuela, additional, Paolicelli, Damiano, additional, Petrucci, Loredana, additional, Pontecorvo, Simona, additional, Righini, Isabella, additional, Rovaris, Marco, additional, Sessa, Edoardo, additional, Spinicci, Gabriella, additional, Spitaleri, Daniele, additional, Valentino, Paola, additional, Zaffaroni, Mauro, additional, Zappia, Mario, additional, and Patti, Francesco, additional

Published
2020
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3. 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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4. Long-term Effectiveness of 9-δ-tetrahydrocannabinol:Cannabidiol Oromucosal Spray in Clinical Practice: results from a 18-months Multicenter Italian Study (P5.2-085)

Author

Patti, Francesco, primary, Chisari, Clara, additional, D’Amico, Emanuele, additional, Solaro, Claudio, additional, Arena, Sebastiano, additional, Annunziata, Pasquale, additional, Benedetti, Maria Donata, additional, Berra, Eliana, additional, Bianco, Assunta, additional, Bossio, Roberto Bruno, additional, Buttari, Fabio, additional, Castelli, Letizia, additional, Cavalla, Paola, additional, Cerqua, Raffaella, additional, Costantino, Gianfranco, additional, Esposito, Federica, additional, Gasperini, Claudio, additional, Guareschi, Angelica, additional, Inglese, Matilde, additional, Ippolito, Domenico, additional, Lanzillo, Roberta, additional, Maniscalco, Giorgia Teresa, additional, Matta, Manuela, additional, Paolicelli, Damiano, additional, Petrucci, Loredana, additional, Pontecorvo, Simona, additional, Righini, Isabella, additional, Sessa, Edoardo, additional, Saccà, Francesco, additional, Salamone, Giovanna, additional, Signoriello, Elisabetta, additional, Spinicci, Gabriella, additional, Spitaleri, Daniele Litterio A., additional, Tavazzi, Eleonora, additional, Trotta, Maria, additional, Zaffaroni, Mauro, additional, and Zappia, Mario, additional

Published
2019
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5. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study.

Author

Patti, Francesco, Chisari, Clara Grazia, Solaro, Claudio, Benedetti, Maria Donata, Berra, Eliana, Bianco, Assunta, Bruno Bossio, Roberto, Buttari, Fabio, Castelli, Letizia, Cavalla, Paola, Cerqua, Raffaella, Costantino, Gianfranco, Gasperini, Claudio, Guareschi, Angelica, Ippolito, Domenico, Lanzillo, Roberta, Maniscalco, Giorgia Teresa, Matta, Manuela, Paolicelli, Damiano, and Petrucci, Loredana

Subjects
SPASTICITY, CANNABIDIOL, SYMPTOMS, MULTIPLE sclerosis, MEDICATION therapy management, SPRAYING, RESEARCH, COMBINATION drug therapy, RESEARCH methodology, RETROSPECTIVE studies, MEDICAL cooperation, EVALUATION research, HYDROCARBONS, COMPARATIVE studies, PLANT extracts, DISEASE complications
Abstract

Introduction: The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice.Materials and Methods: MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms.Results: Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group.Conclusion: Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients. [ABSTRACT FROM AUTHOR]

Published
2020
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6. Long-term follow-up of pediatric MS patients starting treatment with injectable first-line agents: A multicentre, Italian, retrospective, observational study

Author

Baroncini, Damiano, primary, Zaffaroni, Mauro, additional, Moiola, Lucia, additional, Lorefice, Lorena, additional, Fenu, Giuseppe, additional, Iaffaldano, Pietro, additional, Simone, Marta, additional, Fanelli, Fulvia, additional, Patti, Francesco, additional, D’Amico, Emanuele, additional, Capobianco, Marco, additional, Bertolotto, Antonio, additional, Gallo, Paolo, additional, Margoni, Monica, additional, Miante, Silvia, additional, Milani, Nicoletta, additional, Amato, Maria Pia, additional, Righini, Isabella, additional, Bellantonio, Paolo, additional, Scandellari, Cinzia, additional, Costantino, Gianfranco, additional, Scarpini, Elio, additional, Bergamaschi, Roberto, additional, Mallucci, Giulia, additional, Comi, Giancarlo, additional, and Ghezzi, Angelo, additional

Published
2018
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7. Prognostic indicators in pediatric clinically isolated syndrome.

Author

UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, 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, Van Pesch, Vincent, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, 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, and Van Pesch, Vincent

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.

Published
2017

8. Efficacy of Natalizumab and Fingolimod in Relapsing Remitting Multiple Sclerosis in Real World Clinical Setting: a 2-year follow-up (P6.377)

Author

Totaro, Rocco, primary, Costantino, Gianfranco, additional, Danni, Maura, additional, Bellantonio, Paolo, additional, Di Carmine, Caterina, additional, Fantozzi, Roberta, additional, Cerqua, Raffaella, additional, Fuiani, Aurora, additional, Mundi, Ciro, additional, Marini, Carmine, additional, Centonze, Diego, additional, Provinciali, Leandro, additional, and Carolei, Antonio, additional

Published
2017
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10. Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study).

Author

Messina, Silvia, Solaro, Claudio, Righini, Isabella, Bergamaschi, Roberto, Bonavita, Simona, Bossio, Roberto Bruno, Brescia Morra, Vincenzo, Costantino, Gianfranco, Cavalla, Paola, Centonze, Diego, Comi, Giancarlo, Cottone, Salvatore, Danni, Maura Chiara, Francia, Ada, Gajofatto, Alberto, Gasperini, Claudio, Zaffaroni, Mauro, Petrucci, Loredana, Signoriello, Elisabetta, and Maniscalco, Giorgia Teresa

Subjects
MULTIPLE sclerosis treatment, MEDICAL care cost control, MEDICARE reimbursement, MEDICAL sciences, CLINICAL medicine
Abstract

Background: The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients. Methods: We collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis. Results: During the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher NRS score at T1 (adjHR 2.23, 95% 2.07–2.41, p<0.001) and a lower baseline NRS score (adjHR 0.51 95% CI 0.46–0.56, p<0.001) were predictive of treatment discontinuation. Conclusion: These data show that the first 6 weeks are useful in identifying those patients in which Sativex could be effective, thus avoiding the cost of longer term evaluation. [ABSTRACT FROM AUTHOR]

Published
2017
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14. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

Author

Domenico Ippolito, Giorgia Teresa Maniscalco, Damiano Paolicelli, Daniele Spitaleri, Francesco Patti, Gianfranco Costantino, Margherita Russo, Clara Grazia Chisari, Letizia Castelli, Giovanna Salamone, Roberto Bruno Bossio, Maria Trotta, Claudio Solaro, Eliana Berra, Roberta Lanzillo, Elisabetta Signoriello, Raffaella Cerqua, Isabella Righini, Fabio Buttari, Gabriella Spinicci, Loredana Petrucci, Angelica Guareschi, Manuela Matta, Mario Zappia, Simona Pontecorvo, Maria Donata Benedetti, Paola Cavalla, Assunta Bianco, Claudio Gasperini, Eleonora Tavazzi, Francesco Saccà, Mauro Zaffaroni, Patti, F., Chisari, C. G., Solaro, C., Benedetti, M. D., Berra, E., Bianco, A., Bruno Bossio, R., Buttari, F., Castelli, L., Cavalla, P., Cerqua, R., Costantino, G., Gasperini, C., Guareschi, A., Ippolito, D., Lanzillo, R., Maniscalco, G. T., Matta, M., Paolicelli, D., Petrucci, L., Pontecorvo, S., Righini, I., Russo, M., Saccà, Francesco, Salamone, G., Signoriello, E., Spinicci, G., Spitaleri, D., Tavazzi, E., Trotta, M., Zaffaroni, M., Zappia, M., Patti, Francesco, Grazia Chisari, Clara, Solaro, Claudio, Donata Benedetti, Maria, Berra, Eliana, Bianco, Assunta, Bruno Bossio, Roberto, Buttari, Fabio, Castelli, Letizia, Cavalla, Paola, Cerqua, Raffaella, Costantino, Gianfranco, Gasperini, Claudio, Guareschi, Angelica, Ippolito, Domenico, Lanzillo, Roberta, Teresa Maniscalco, Giorgia, Matta, Manuela, Paolicelli, Damiano, Petrucci, Loredana, Pontecorvo, Simona, Righini, Isabella, Russo, Margherita, Salamone, Giovanna, Signoriello, Elisabetta, Spinicci, Gabriella, Spitaleri, Daniele, Tavazzi, Eleonora, Trotta, Maria, Zaffaroni, Mauro, and Zappia, Mario

Subjects
medicine.medical_specialty, Multiple Sclerosis, THC, Neurology, Dermatology, Clinical practice, Spasticity-related symptom, CBD, Multiple sclerosis, Spasticity-related symptoms, 03 medical and health sciences, 0302 clinical medicine, Rating scale, Internal medicine, medicine, Cannabidiol, Humans, Multiple sclerosi, Dronabinol, 030212 general & internal medicine, Spasticity, Oromucosal spray, Retrospective Studies, Plant Extracts, business.industry, General Medicine, medicine.disease, nervous system diseases, Clinical Practice, Drug Combinations, Psychiatry and Mental health, Italy, Muscle Spasticity, Neurology (clinical), Neurosurgery, medicine.symptom, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Introduction: The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice. Materials and methods: MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms. Results: Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group. Conclusion: Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients. © 2020, Fondazione Società Italiana di Neurologia.

Published
2020
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15. Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study

Author

Damiano Paolicelli, Assunta Bianco, Simona Pontecorvo, Paola Valentino, Elisabetta Capello, Roberta Lanzillo, M. Danni, Alberto Gajofatto, Gianfranco Costantino, Claudio Solaro, Roberto Bruno Bossio, Daniele Spitaleri, Giacomo Lus, Simona Bonavita, Mauro Zaffaroni, Pasquale Annunziata, Edoardo Sessa, Roberto Bergamaschi, Claudio Gasperini, Letizia Castelli, Diego Centonze, Salvatore Cottone, Loredana Petrucci, Vincenzo Brescia Morra, Marco Rovaris, Mario Zappia, Paola Cavalla, Angelica Guareschi, Gabriella Spinicci, Isabella Righini, Francesco Patti, Giorgia Teresa Maniscalco, Manuela Matta, Federica Esposito, Clara Grazia Chisari, Chisari, Clara Grazia, Solaro, Claudio, Annunziata, Pasquale, Bergamaschi, Roberto, Bianco, Assunta, Bonavita, Simona, Brescia Morra, Vincenzo, Bruno Bossio, Roberto, Capello, Elisabetta, Castelli, Letizia, Cavalla, Paola, Costantino, Gianfranco, Centonze, Diego, Cottone, Salvatore, Danni, Maura Chiara, Esposito, Federica, Gajofatto, Alberto, Gasperini, Claudio, Guareschi, Angelica, Lanzillo, Roberta, Lus, Giacomo, Maniscalco, Giorgia Teresa, Matta, Manuela, Paolicelli, Damiano, Petrucci, Loredana, Pontecorvo, Simona, Righini, Isabella, Rovaris, Marco, Sessa, Edoardo, Spinicci, Gabriella, Spitaleri, Daniele, Valentino, Paola, Zaffaroni, Mauro, Zappia, Mario, and Patti, Francesco

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Time Factors, Nabiximols, Delta-δ-tetrahydrocannabinol, cannabidiol: oromucosal spray, therapy continuation, therapy abandon, long-term clinical outcome, Settore MED/26, digestive system, 030226 pharmacology & pharmacy, Efficacy, 03 medical and health sciences, Drug withdrawal, 0302 clinical medicine, Internal medicine, mental disorders, Cannabidiol, Humans, Medicine, Dronabinol, Prospective Studies, Adverse effect, Prospective cohort study, business.industry, organic chemicals, Middle Aged, medicine.disease, digestive system diseases, Discontinuation, Clinical trial, Drug Combinations, Psychiatry and Mental health, Treatment Outcome, surgical procedures, operative, Withholding Treatment, Patient Compliance, Female, Surgery, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

IntroductionDelta-δ-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation.Materials and methodsThis prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12±3 weeks (T2), 24±3 weeks (T3), 48±3 weeks (T4) and 72±3 weeks (T5) from baseline.ResultsA total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of ≥20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, pDiscussionTHC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.

Published
2020

16. Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)

Author

Silvia Messina, Claudio Solaro, Isabella Righini, Roberto Bergamaschi, Simona Bonavita, Roberto Bruno Bossio, Vincenzo Brescia Morra, Gianfranco Costantino, Paola Cavalla, Diego Centonze, Giancarlo Comi, Salvatore Cottone, Maura Chiara Danni, Ada Francia, Alberto Gajofatto, Claudio Gasperini, Mauro Zaffaroni, Loredana Petrucci, Elisabetta Signoriello, Giorgia Teresa Maniscalco, Gabriella Spinicci, Manuela Matta, Massimiliano Mirabella, Graziella Pedà, Letizia Castelli, Marco Rovaris, Edoardo Sessa, Daniele Spitaleri, Damiano Paolicelli, Alfredo Granata, Mario Zappia, Francesco Patti, SA.FE. study group, Messina, S, Solaro, C, Righini, I, Bergamaschi, R, Bonavita, S, Bossio, Rb, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, Mc, Francia, A, Gajofatto, A, Gasperini, C, Zaffaroni, M, Petrucci, L, Signoriello, E, Maniscalco, Gt, Spinicci, G, Matta, M, Mirabella, M, Pedà, G, Castelli, L, Rovaris, M, Sessa, E, Spitaleri, D, Paolicelli, D, Granata, A, Zappia, M, Patti, F., Messina, Silvia, Solaro, Claudio, Righini, Isabella, Bergamaschi, Roberto, Bonavita, Simona, Bossio, Roberto Bruno, Brescia Morra, Vincenzo, Costantino, Gianfranco, Cavalla, Paola, Centonze, Diego, Comi, Giancarlo, Cottone, Salvatore, Danni, Maura Chiara, Francia, Ada, Gajofatto, Alberto, Gasperini, Claudio, Zaffaroni, Mauro, Petrucci, Loredana, Signoriello, Elisabetta, Maniscalco, Giorgia Teresa, Spinicci, Gabriella, Matta, Manuela, Mirabella, Massimiliano, Pedà, Graziella, Castelli, Letizia, Rovaris, Marco, Sessa, Edoardo, Spitaleri, Daniele, Paolicelli, Damiano, Granata, Alfredo, Zappia, Mario, Patti, Francesco, Morra, Vincenzo Brescia, and Pedã , Graziella

Subjects
Registrie, Genetics and Molecular Biology (all), Male, Economics, Social Sciences, Drug research and development, Biochemistry, Severity of Illness Index, 0302 clinical medicine, Multiple Sclerosi, 80 and over, Ethnicities, Medicine, Dronabinol, lcsh:Science, Drug Approval, Aged, 80 and over, evaluation, Sativex, multiple sclerosis spasticity, discontinuation, effectiveness, Drug Combinations, Neurology, Italy, Regression Analysis, Human, medicine.medical_specialty, Multiple Sclerosis, Drug Industry, Immunology, Plant Extract, 03 medical and health sciences, Health Economics, Pharmacotherapy, Drug Therapy, Severity of illness, Humans, Spasticity, Adult, Aged, Cannabidiol, Cost Sharing, Drug Costs, Female, Kaplan-Meier Estimate, Middle Aged, Multivariate Analysis, Muscle Spasticity, Parasympatholytics, Plant Extracts, Proportional Hazards Models, Registries, Young Adult, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Adverse effect, Demography, Pharmacology, Proportional hazards model, Parasympatholytic, lcsh:R, Biology and Life Sciences, Management of multiple sclerosis, medicine.disease, Discontinuation, Health Care, Proportional Hazards Model, Population Groupings, lcsh:Q, Clinical Medicine, 030217 neurology & neurosurgery, Multivariate analysis, lcsh:Medicine, Medicine (all), Geographical Locations, Clinical trials, Drug Combination, Medicine and Health Sciences, 030212 general & internal medicine, Multivariate Analysi, Drug Cost, Multidisciplinary, Pharmaceutics, Neurodegenerative Diseases, Italian People, Phase III clinical investigation, Europe, Settore MED/26 - NEUROLOGIA, Research Design, medicine.symptom, Research Article, Clinical Research Design, Research and Analysis Methods, Settore MED/26, Regression Analysi, Autoimmune Diseases, Internal medicine, business.industry, Demyelinating Disorders, People and Places, Physical therapy, Clinical Immunology, Adverse Events, business
Abstract

Background The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients. Methods We collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis. Results During the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher NRS score at T1 (adjHR 2.23, 95% 2.07–2.41, p

Published
2017

17. Long-term follow-up of pediatric MS patients starting treatment with injectable first-line agents: A multicentre, Italian, retrospective, observational study.

Author

Baroncini D, Zaffaroni M, Moiola L, Lorefice L, Fenu G, Iaffaldano P, Simone M, Fanelli F, Patti F, D'Amico E, Capobianco M, Bertolotto A, Gallo P, Margoni M, Miante S, Milani N, Amato MP, Righini I, Bellantonio P, Scandellari C, Costantino G, Scarpini E, Bergamaschi R, Mallucci G, Comi G, and Ghezzi A

Subjects
Adolescent, Adult, Age Factors, Child, Female, Follow-Up Studies, Glatiramer Acetate pharmacology, Humans, Immunologic Factors administration & dosage, Injections, Interferon-beta pharmacology, Italy, Male, Retrospective Studies, Severity of Illness Index, Young Adult, Disease Progression, Immunologic Factors pharmacology, Multiple Sclerosis drug therapy, Outcome Assessment, Health Care
Abstract

Background: Few data are available on very long-term follow-up of pediatric multiple sclerosis (MS) patients treated with disease modifying treatments (DMTs)., Objectives: To present a long-term follow-up of a cohort of Pediatric-MS patients starting injectable first-line agents., Methods: Data regarding treatments, annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, and serious adverse event were collected. Baseline characteristics were tested in multivariate analysis to identify predictors of disease evolution., Results: In total, 97 patients were followed for 12.5 ± 3.3 years. They started therapy at 13.9 ± 2.1 years, 88 with interferons and 9 with copaxone. During the whole follow-up, 82 patients changed therapy, switching to immunosuppressors/second-line treatment in 58% of cases. Compared to pre-treatment phase, the ARR was significantly reduced during the first treatment (from 3.2 ± 2.6 to 0.7 ± 1.5, p < 0.001), and it remained low during the whole follow-up (0.3 ± 0.2, p < 0.001). At last observation, 40% had disability worsening, but EDSS score remained <4 in 89%. One patient died at age of 23 years due to MS. One case of natalizumab-related progressive multifocal encephalopathy (PML) was recorded. Starting therapy before 12 years of age resulted in a better course of disease in multivariate analysis., Conclusion: Pediatric-MS patients benefited from interferons/copaxone, but the majority had to switch to more powerful drugs. Starting therapy before 12 years of age could lead to a more favorable outcome.

Published
2019
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