Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study
Pivotal trials showed the effectiveness of the monoclonal antibody ocrelizumab in relapsing and progressive multiple sclerosis (MS). However, data on everyday practice in MS patients and markers of treatment effectiveness are scarce. We aimed to collect real-world data from ocrelizumab-treated MS pa...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-04-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/8/2081 |
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| author | Roberta Lanzillo Antonio Carotenuto Elisabetta Signoriello Rosa Iodice Giuseppina Miele Alvino Bisecco Giorgia Teresa Maniscalco Leonardo Sinisi Felice Romano Maria Di Gregorio Luigi Lavorgna Francesca Trojsi Marcello Moccia Mario Fratta Nicola Capasso Raffaele Dubbioso Maria Petracca Antonio Luca Spiezia Antonio Gallo Martina Petruzzo Marcello De Angelis Simona Bonavita Giacomo Lus Gioacchino Tedeschi Vincenzo Brescia Morra |
| author_facet | Roberta Lanzillo Antonio Carotenuto Elisabetta Signoriello Rosa Iodice Giuseppina Miele Alvino Bisecco Giorgia Teresa Maniscalco Leonardo Sinisi Felice Romano Maria Di Gregorio Luigi Lavorgna Francesca Trojsi Marcello Moccia Mario Fratta Nicola Capasso Raffaele Dubbioso Maria Petracca Antonio Luca Spiezia Antonio Gallo Martina Petruzzo Marcello De Angelis Simona Bonavita Giacomo Lus Gioacchino Tedeschi Vincenzo Brescia Morra |
| author_sort | Roberta Lanzillo |
| collection | DOAJ |
| description | Pivotal trials showed the effectiveness of the monoclonal antibody ocrelizumab in relapsing and progressive multiple sclerosis (MS). However, data on everyday practice in MS patients and markers of treatment effectiveness are scarce. We aimed to collect real-world data from ocrelizumab-treated MS patients, relapsing-remitting (RR) and progressive MS patients (PMS), including active secondary progressive MS (aSPMS) and primary progressive MS (PPMS) patients, and to explore potential prognostic factors of clinical outcome. Patients were enrolled at MS centres in the Campania region, Italy. We collected clinic-demographic features retrospectively one year before ocrelizumab start (T<sub>−1</sub>), at ocrelizumab start (T<sub>0</sub>), and after one year from ocrelizumab start (T<sub>1</sub>). We explored possible clinical markers of treatment effectiveness in those patients receiving ocrelizumab treatment for at least one year using multilevel-mixed models. We included a total of 383 MS patients (89 RRMS and 294 PMS; 205 females, mean age: 45.8 ± 11.2, disease duration: 12.7 ± 11.6 years). Patients had a mean follow-up of 12.4 ± 8.2 months, and 217 patients completed one-year ocrelizumab treatment. Overall, EDSS increased from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.30, 95% coefficient interval [CI] = 0.19–0.41, <i>p</i> < 0.001) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.61). RRMS patients did not show an EDSS change between T<sub>−1</sub> and T<sub>0</sub> nor between T<sub>0</sub> and T<sub>1</sub>. Conversely, PMS patients showed EDSS increase from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.34, 95% CI = 0.22–0.45, <i>p</i> < 0.001) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.21). PMS patients with a time from conversion shorter than 2 years showed increased EDSS from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.63, 95% CI = 0.18–1.08, <i>p</i> = 0.006) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.94), whereas PMS patients with a time from conversion longer than 2 years showed increased EDSS from T<sub>0</sub> to T<sub>1</sub> (coeff. = 0.30, 95% CI = 0.11–0.49, <i>p</i> = 0.002). Naïve patients showed an EDSS decrease between T<sub>0</sub> and T<sub>1</sub> (coeff. = −0.30, 95% CI = −0.50–−0.09, <i>p</i> = 0.004). In conclusion, our study highlighted that early ocrelizumab treatment is effective in modifying the disability accrual in MS patients. |
| first_indexed | 2024-03-09T10:32:57Z |
| format | Article |
| id | doaj.art-532a518c591c4051997476a6856d25f0 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T10:32:57Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-532a518c591c4051997476a6856d25f02023-12-01T21:06:24ZengMDPI AGJournal of Clinical Medicine2077-03832022-04-01118208110.3390/jcm11082081Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter StudyRoberta Lanzillo0Antonio Carotenuto1Elisabetta Signoriello2Rosa Iodice3Giuseppina Miele4Alvino Bisecco5Giorgia Teresa Maniscalco6Leonardo Sinisi7Felice Romano8Maria Di Gregorio9Luigi Lavorgna10Francesca Trojsi11Marcello Moccia12Mario Fratta13Nicola Capasso14Raffaele Dubbioso15Maria Petracca16Antonio Luca Spiezia17Antonio Gallo18Martina Petruzzo19Marcello De Angelis20Simona Bonavita21Giacomo Lus22Gioacchino Tedeschi23Vincenzo Brescia Morra24Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania Luigi Vanvitelli, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania Luigi Vanvitelli, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, ItalyMultiple Sclerosis Center, Antonio Cardarelli Hospital, 80131 Naples, ItalyNeurological Unit, San Paolo Hospital, ASL Napoli 1 Centro, 80125 Naples, ItalyNeurological and Stroke Unit, CTO Hospital, AORN Ospedali dei Colli, 80131 Naples, ItalyMedical Sciences Department, Azienda Ospedaliero-Universitaria San Giovanni di Dio e Ruggi d’Aragona, 84125 Salerno, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania Luigi Vanvitelli, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania Luigi Vanvitelli, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, II Clinic of Neurology, University of Campania Luigi Vanvitelli, 80131 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, ItalyDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University, 80131 Naples, ItalyPivotal trials showed the effectiveness of the monoclonal antibody ocrelizumab in relapsing and progressive multiple sclerosis (MS). However, data on everyday practice in MS patients and markers of treatment effectiveness are scarce. We aimed to collect real-world data from ocrelizumab-treated MS patients, relapsing-remitting (RR) and progressive MS patients (PMS), including active secondary progressive MS (aSPMS) and primary progressive MS (PPMS) patients, and to explore potential prognostic factors of clinical outcome. Patients were enrolled at MS centres in the Campania region, Italy. We collected clinic-demographic features retrospectively one year before ocrelizumab start (T<sub>−1</sub>), at ocrelizumab start (T<sub>0</sub>), and after one year from ocrelizumab start (T<sub>1</sub>). We explored possible clinical markers of treatment effectiveness in those patients receiving ocrelizumab treatment for at least one year using multilevel-mixed models. We included a total of 383 MS patients (89 RRMS and 294 PMS; 205 females, mean age: 45.8 ± 11.2, disease duration: 12.7 ± 11.6 years). Patients had a mean follow-up of 12.4 ± 8.2 months, and 217 patients completed one-year ocrelizumab treatment. Overall, EDSS increased from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.30, 95% coefficient interval [CI] = 0.19–0.41, <i>p</i> < 0.001) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.61). RRMS patients did not show an EDSS change between T<sub>−1</sub> and T<sub>0</sub> nor between T<sub>0</sub> and T<sub>1</sub>. Conversely, PMS patients showed EDSS increase from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.34, 95% CI = 0.22–0.45, <i>p</i> < 0.001) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.21). PMS patients with a time from conversion shorter than 2 years showed increased EDSS from T<sub>−1</sub> to T<sub>0</sub> (coeff. = 0.63, 95% CI = 0.18–1.08, <i>p</i> = 0.006) without a further change between T<sub>0</sub> and T<sub>1</sub> (<i>p</i> = 0.94), whereas PMS patients with a time from conversion longer than 2 years showed increased EDSS from T<sub>0</sub> to T<sub>1</sub> (coeff. = 0.30, 95% CI = 0.11–0.49, <i>p</i> = 0.002). Naïve patients showed an EDSS decrease between T<sub>0</sub> and T<sub>1</sub> (coeff. = −0.30, 95% CI = −0.50–−0.09, <i>p</i> = 0.004). In conclusion, our study highlighted that early ocrelizumab treatment is effective in modifying the disability accrual in MS patients.https://www.mdpi.com/2077-0383/11/8/2081progressionmultiple sclerosisocrelizumabdisease-modifying treatmentreal-world |
| spellingShingle | Roberta Lanzillo Antonio Carotenuto Elisabetta Signoriello Rosa Iodice Giuseppina Miele Alvino Bisecco Giorgia Teresa Maniscalco Leonardo Sinisi Felice Romano Maria Di Gregorio Luigi Lavorgna Francesca Trojsi Marcello Moccia Mario Fratta Nicola Capasso Raffaele Dubbioso Maria Petracca Antonio Luca Spiezia Antonio Gallo Martina Petruzzo Marcello De Angelis Simona Bonavita Giacomo Lus Gioacchino Tedeschi Vincenzo Brescia Morra Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study Journal of Clinical Medicine progression multiple sclerosis ocrelizumab disease-modifying treatment real-world |
| title | Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study |
| title_full | Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study |
| title_fullStr | Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study |
| title_full_unstemmed | Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study |
| title_short | Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study |
| title_sort | prognostic markers of ocrelizumab effectiveness in multiple sclerosis a real world observational multicenter study |
| topic | progression multiple sclerosis ocrelizumab disease-modifying treatment real-world |
| url | https://www.mdpi.com/2077-0383/11/8/2081 |
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