Antonio Gallo (Italy)
University of Campania "Luigi Vanvitelli" Department of Advanced Medical and Surgical SciencesAuthor Of 2 Presentations
EXIT-STRATEGIES IN NATALIZUMAB RESPONDERS RRMS PATIENTS: AN ITALIAN COMPARISON AMONG OCRELIZUMAB, RETUXIMAB AND CLADRIBINE
- Emanuele D'Amico (Italy)
Abstract
Background and Aims:
The main aim of the study is to evaluate the efficacy and safety profile of Ocrelizumab (OCR), Rituximab (RTX), and Cladribine (CLA), employed as Natalizumab (NTZ) exit-strategies in Relapsing-Remitting Multiple Sclerosis (RRMS) patients at high-risk for progressive multifocal leukoencephalopathy (PML).
Methods:
This is a multicentre, retrospective, real-world study on consecutive RRMS patients from eleven tertiary Italian MS centres, who switched from NTZ to OCR, RTX and CLA from January 1st, 2019 to December 31st, 2019. The primary study outcomes were the annualized relapse rate (ARR) and Magnetic Resonance Imaging (MRI) outcome. Treatment effects were estimated by the inverse probability treatment weighting (IPTW), based on propensity score (PS) approach. Additional endpoint included confirmed disability progression (CDP) as measured by Expanded Disability Status Scale and adverse events (AEs).
Results:
Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX and 20 to CLA. Patients from the three groups did not shown differences for baseline characteristics, also after post-hoc analysis. The IPTW PS-adjusted models revealed that patients on OCR had a lower risk for ARR than patients on CLA (ExpB OCR 0.485, CI 95% 0.264-0.893, p=.020). This result was confirmed also for 12-months MRI activity (ExpB OCR 0.248 CI 95% 0.065-0.948, p=.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the three groups.
Conclusions:
Anti-CD20 drugs revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile
PRELIMINARY EVIDENCE OF BLUNTED HUMORAL RESPONSE TO SARS-COV-2 (MRNA) VACCINE IN MULTIPLE SCLEROSIS PATIENTS TREATED WITH OCRELIZUMAB.
- Antonio Gallo (Italy)
Abstract
Background and Aims:
Since the worldwide launch of the SARS-CoV-2 vaccine campaign, several concerns apply on the response to vaccines in people with multiple sclerosis (pwMS) particularly those on high efficacy disease modifying therapies (DMTs).
We report preliminary data on humoral response to Covid-19 vaccine assessed on four pwMS treated with ocrelizumab (OCR) and compared to that measured in a sample of healthy subjects (HS) enrolled in a surveillance programme at our Clinic.
Methods:
We collected serum samples -at 0,14,21 days after the first dose and 7 days after the second dose of NT162b2-mRNA-Covid-19 vaccine of: i) 55 health-care workers, and ii) four relapsing MS patients on OCR, that were vaccinated with the same Covid-19 vaccine. All subjects did not have a history of Covid-19 infection. Sera were tested using the LIAISON®SARS-CoV-2 TrimericS-IgG assay (DiaSorin-S.p.A.), for the detection of IgG antibodies to SARS-CoV-2 spike protein. The IgG-titers were expressed in Binding Antibody Units (BAU).
Results:
Seven days after the second dose of NT162b2-mRNA-Covid-19 vaccine, all HS mounted a significant humoral response (geometric mean 2010.4 BAU/mL C.I.95%1512.7-2672), while all the four pwMS showed a very low response (range 4,9-175 BAU/mL).
Conclusions:
As expected and in agreement with previous data, we found a blunted humoral response to NT162b2-mRNA-vaccine in pwMS treated with OCR. Further data are urgently needed in order to confirm and expand these preliminary, yet significant results and to inform if there is any strategy to optimize the response to vaccines such as the count of circulating CD20 cells, time-elapsed since the last anti-CD20 drug administration.
Presenter of 1 Presentation
PRELIMINARY EVIDENCE OF BLUNTED HUMORAL RESPONSE TO SARS-COV-2 (MRNA) VACCINE IN MULTIPLE SCLEROSIS PATIENTS TREATED WITH OCRELIZUMAB.
- Antonio Gallo (Italy)
Abstract
Background and Aims:
Since the worldwide launch of the SARS-CoV-2 vaccine campaign, several concerns apply on the response to vaccines in people with multiple sclerosis (pwMS) particularly those on high efficacy disease modifying therapies (DMTs).
We report preliminary data on humoral response to Covid-19 vaccine assessed on four pwMS treated with ocrelizumab (OCR) and compared to that measured in a sample of healthy subjects (HS) enrolled in a surveillance programme at our Clinic.
Methods:
We collected serum samples -at 0,14,21 days after the first dose and 7 days after the second dose of NT162b2-mRNA-Covid-19 vaccine of: i) 55 health-care workers, and ii) four relapsing MS patients on OCR, that were vaccinated with the same Covid-19 vaccine. All subjects did not have a history of Covid-19 infection. Sera were tested using the LIAISON®SARS-CoV-2 TrimericS-IgG assay (DiaSorin-S.p.A.), for the detection of IgG antibodies to SARS-CoV-2 spike protein. The IgG-titers were expressed in Binding Antibody Units (BAU).
Results:
Seven days after the second dose of NT162b2-mRNA-Covid-19 vaccine, all HS mounted a significant humoral response (geometric mean 2010.4 BAU/mL C.I.95%1512.7-2672), while all the four pwMS showed a very low response (range 4,9-175 BAU/mL).
Conclusions:
As expected and in agreement with previous data, we found a blunted humoral response to NT162b2-mRNA-vaccine in pwMS treated with OCR. Further data are urgently needed in order to confirm and expand these preliminary, yet significant results and to inform if there is any strategy to optimize the response to vaccines such as the count of circulating CD20 cells, time-elapsed since the last anti-CD20 drug administration.