Contributions
Abstract: EP1596
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Ocrelizumab, a humanized monoclonal antibody targeting CD20+ B cells, has recently been approved by EMA for a subset of primary progressive MS (PPMS) patients. According to regulators, patients should be treated if strict clinical and paraclinical criteria are met (i.e.: early PPMS in terms of disease duration, level of disability, and MRI activity). Although efficacy and safety has been well established in in early PPMS patients, most patients in clinical practice do not fulfill all of the above criteria. Additionally, safety and efficacy outcomes in longstanding, non-ambulating or older PPMS patients have yet to be studied and compared with those of PPMS patients fulfilling EMA criteria.
Aims: To evaluate, in a single center real life MS clinic, safety and efficacy of ocrelizumab treatment using clinical and paraclinical parameters.
Methods: PPMS patients were enrolled in the ocrelizumab compassionate use program before EMA pronouncement on prescription restrictions. Patients were infused with ocrelizumab and underwent MRI scan before ocrelizumab administration in order to detect radiological activity. All patients were followed, according to good clinical practice guidelines, with serial EDSS, BICAMS, patient reported outcomes (PRO), MRI, OCT, and laboratory assessment.
Results: 34 patients were included in the analysis (F/M ratio 22/12, mean age 52 (range 36-66) years). The median follow-up was 4.5 months (range 1.2-14). Mean and median disease duration at ocrelizumab initiation were 12.4 and 9.3 years, respectively. Median pre-treatment EDSS was 6.0 (range 2.0-7.5). 10 patients (29%) were treatment-naïve at ocrelizumab treatment onset. Infusion related AE were experienced by 4 patients and serious AE (SAE) by 1 patient. Radiological activity was found in 6 patients. Only 4 out of 34 patients (12%) fulfilled all EMA criteria for PPMS treatment with ocrelizumab but there was no significant difference in terms of AE and SAE between the two groups of patients (p=0.32 for AE).
Conclusions: Ocrelizumab induction regimen appears to be safe in our real-life cohort of patients with longstanding disease, greater age and disability than those enrolled in clinical trials and absence of radiological activity.
Disclosure: Giovanni Novi: nothing to disclose.
Maria Cellerino: nothing to disclose.
Lorenzo Nesi: nothing to disclose.
Elvira Sbragia: nothing to disclose.
Caterina Lapucci: nothing to disclose.
Alice Laroni: received personal compensation from Novartis, Genzyme, Biogen, Merck and Teva.
Luca Roccatagliata: nothing to disclose.
Maria Pia Sormani: received consulting fees from TEVA, Biogen, Merck Serono, Genzyme, Roche, GeNeuro, Novartis, Medday.
Matilde Inglese: received research grants from NIH, DOD, NMSS, FISM, and Teva Neuroscience.
Antonio Uccelli: received grants and contracts from FISM, Novartis, Fondazione Cariplo, Italian Ministry of Health; received honoraria or consultation fees from Biogen, Roche, Teva, Merck, Genzyme, Novartis.
Abstract: EP1596
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Ocrelizumab, a humanized monoclonal antibody targeting CD20+ B cells, has recently been approved by EMA for a subset of primary progressive MS (PPMS) patients. According to regulators, patients should be treated if strict clinical and paraclinical criteria are met (i.e.: early PPMS in terms of disease duration, level of disability, and MRI activity). Although efficacy and safety has been well established in in early PPMS patients, most patients in clinical practice do not fulfill all of the above criteria. Additionally, safety and efficacy outcomes in longstanding, non-ambulating or older PPMS patients have yet to be studied and compared with those of PPMS patients fulfilling EMA criteria.
Aims: To evaluate, in a single center real life MS clinic, safety and efficacy of ocrelizumab treatment using clinical and paraclinical parameters.
Methods: PPMS patients were enrolled in the ocrelizumab compassionate use program before EMA pronouncement on prescription restrictions. Patients were infused with ocrelizumab and underwent MRI scan before ocrelizumab administration in order to detect radiological activity. All patients were followed, according to good clinical practice guidelines, with serial EDSS, BICAMS, patient reported outcomes (PRO), MRI, OCT, and laboratory assessment.
Results: 34 patients were included in the analysis (F/M ratio 22/12, mean age 52 (range 36-66) years). The median follow-up was 4.5 months (range 1.2-14). Mean and median disease duration at ocrelizumab initiation were 12.4 and 9.3 years, respectively. Median pre-treatment EDSS was 6.0 (range 2.0-7.5). 10 patients (29%) were treatment-naïve at ocrelizumab treatment onset. Infusion related AE were experienced by 4 patients and serious AE (SAE) by 1 patient. Radiological activity was found in 6 patients. Only 4 out of 34 patients (12%) fulfilled all EMA criteria for PPMS treatment with ocrelizumab but there was no significant difference in terms of AE and SAE between the two groups of patients (p=0.32 for AE).
Conclusions: Ocrelizumab induction regimen appears to be safe in our real-life cohort of patients with longstanding disease, greater age and disability than those enrolled in clinical trials and absence of radiological activity.
Disclosure: Giovanni Novi: nothing to disclose.
Maria Cellerino: nothing to disclose.
Lorenzo Nesi: nothing to disclose.
Elvira Sbragia: nothing to disclose.
Caterina Lapucci: nothing to disclose.
Alice Laroni: received personal compensation from Novartis, Genzyme, Biogen, Merck and Teva.
Luca Roccatagliata: nothing to disclose.
Maria Pia Sormani: received consulting fees from TEVA, Biogen, Merck Serono, Genzyme, Roche, GeNeuro, Novartis, Medday.
Matilde Inglese: received research grants from NIH, DOD, NMSS, FISM, and Teva Neuroscience.
Antonio Uccelli: received grants and contracts from FISM, Novartis, Fondazione Cariplo, Italian Ministry of Health; received honoraria or consultation fees from Biogen, Roche, Teva, Merck, Genzyme, Novartis.