Introduction: During the COVID-19 pandemic, ocrelizumab (OCR) infusions for MS patients were often re-scheduled because of MS center's disruption and concerns regarding immunosuppression. The aim of the present study was to assess changes in OCR schedule during the first wave of pandemic in Italy and to evaluate the effect of delayed infusion on clinical/radiological endpoints. Methods: Data were extracted from the Italian MS Register database. Standard interval dosing was defined as an infusion interval ≤ 30 weeks, while extended interval dosing was defined as an infusion interval > 30 weeks at the time of the observation period. Clinico-demographics variables were tested as potential predictors for treatment delay. Time to first relapse and time to first MRI event were evaluated. Cumulative hazard curves were reported along their 95% confidence intervals. A final sample of one-thousand two patients with MS from 65 centers was included in the analysis: 599 pwMS were selected to evaluate the modification of OCR infusion intervals, while 717 pwRMS were selected to analyze the effect of infusion delay on clinical/MRI activity. Results: Mean interval between two OCR infusions was 28.1 weeks before pandemic compared to 30.8 weeks during the observation period, with a mean delay of 2.74 weeks (p < 0.001). No clinico-demographic factors emerged as predictors of infusion postponement, except for location of MS centers in the North of Italy. Clinical relapses (4 in SID, 0 in EID) and 17 MRI activity reports (4 in SID, 13 in EID) were recorded during follow-up period. Discussion: Despite the significant extension of OCR infusion interval during the first wave of pandemic in Italy, a very small incidence of clinical/radiological events was observed, thus suggesting durable efficacy of OCR, as well as the absence of rebound after its short-term suspension.
COVID-19 outbreak in Italy: an opportunity to evaluate extended interval dosing of ocrelizumab in MS patients / Bisecco, Alvino; Matrone, Federica; Capobianco, Marco; De Luca, Giovanna; Filippi, Massimo; Granella, Franco; Lus, Giacomo; Marfia, Girolama Alessandra; Mirabella, Massimiliano; Patti, Francesco; Trojano, Maria; Mascolo, Agnese; Copetti, Massimiliano; Tedeschi, Gioacchino; Gallo, Antonio; Null, Null; Malucchi, Simona; Talentacci, Maria; Tomassini, Valentina; Farina, Deborah; Moiola, Lucia; Nozzolillo, Agostino; Franceschini, Alessandro; Minetti, Matteo; Signoriello, Elisabetta; Romano, Giuseppe; Risi, Mario; D'Ambrosio, Alessandro; Landi, Doriana; Nicoletti, Carolina Gabri; Bianco, Assunta; Lucchini, Matteo; Chisari, Clara; Toscano, Simona; Paolicelli, Damiano; Iaffaldano, Pietro; Inglese, Matilde; Cellerino, Maria; Bellantonio, Paolo; Fantozzi, Roberta; Salemi, Giuseppe; Ragonese, Paolo; Danni, Maura; Coniglio, Gabriella; Ferraro, Diana; Maniscalco, Giorgia Teresa; Conte, Antonella; Cavalla, Paola; Vianello, Marika; Cargnelutti, Daniela; Gatto, Maurizia; Buonaventura, Ardito; Lugaresi, Alessandra; Amato, Maria Pia; Gazzola, Paola; Iodice, Rosa; Pesci, Ilaria; Montepietra, Sara; Pozzilli, Carlo; Ferraro, Elisabetta; Zaffaroni, Mauro; Nasuelli, Davide. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 271:2(2024), pp. 699-710. [10.1007/s00415-023-12084-4]
COVID-19 outbreak in Italy: an opportunity to evaluate extended interval dosing of ocrelizumab in MS patients
Patti, Francesco;d'Ambrosio, Alessandro;Bianco, Assunta;Paolicelli, Damiano;Bellantonio, Paolo;Salemi, Giuseppe;Conte, Antonella;Pozzilli, Carlo;
2024
Abstract
Introduction: During the COVID-19 pandemic, ocrelizumab (OCR) infusions for MS patients were often re-scheduled because of MS center's disruption and concerns regarding immunosuppression. The aim of the present study was to assess changes in OCR schedule during the first wave of pandemic in Italy and to evaluate the effect of delayed infusion on clinical/radiological endpoints. Methods: Data were extracted from the Italian MS Register database. Standard interval dosing was defined as an infusion interval ≤ 30 weeks, while extended interval dosing was defined as an infusion interval > 30 weeks at the time of the observation period. Clinico-demographics variables were tested as potential predictors for treatment delay. Time to first relapse and time to first MRI event were evaluated. Cumulative hazard curves were reported along their 95% confidence intervals. A final sample of one-thousand two patients with MS from 65 centers was included in the analysis: 599 pwMS were selected to evaluate the modification of OCR infusion intervals, while 717 pwRMS were selected to analyze the effect of infusion delay on clinical/MRI activity. Results: Mean interval between two OCR infusions was 28.1 weeks before pandemic compared to 30.8 weeks during the observation period, with a mean delay of 2.74 weeks (p < 0.001). No clinico-demographic factors emerged as predictors of infusion postponement, except for location of MS centers in the North of Italy. Clinical relapses (4 in SID, 0 in EID) and 17 MRI activity reports (4 in SID, 13 in EID) were recorded during follow-up period. Discussion: Despite the significant extension of OCR infusion interval during the first wave of pandemic in Italy, a very small incidence of clinical/radiological events was observed, thus suggesting durable efficacy of OCR, as well as the absence of rebound after its short-term suspension.| File | Dimensione | Formato | |
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