Contributions
Abstract: P1194
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Objective: To assess evidence about efficacy and safety switching from natalizumab [NTZ] to alemtuzumab [ATZ] in stable MS patients due to risk of progressive multifocal leukoencephalopathy [PML] in a German MS center.
Background: For the treatment of RRMS patients who discontinue NTZ being positive for John Cunningham virus [JCV] it is important to evaluate data on the efficacy and safety outcomes. Data in real world clinical practice are still limited.
Design and methods: 20 patients discontinued NTZ treatment (19 due to risk of progressive multifocal leukoencephalopathy [PML]; 1 due to the experience of a massive rebound after NTZ cessation during a prior pregnancy); after a median of 55,1 months (range 7-102). No patients experienced clinical or radiologic disease activity in the 12 months prior to discontinuation. To rule out an asymptomatic PML, 19 patients received a recent contrast-enhanced brain MRI with DWI (median 15,5 days; range 2-65) and CSF-examination for JCV-PCR (median 14,6 days; range 7-27) prior to initiation of ATZ. Median washout period was 11,8 weeks (range 7-20) before receiving ATZ 12 mg/day (Course 1 [C1]: 5 days; Course 2 [C2, 12 months later]: 3 days). At least one brain MRI and Expanded Disability Status Scale [EDSS] was performed 12 months after ATZ initiation.
Results: All 20 patients have follow-up data for 12 months after ATZ-C1. All patients received C2. None of the patients experienced a relapse or progression of disability. EDSS was unchanged in all patients. Only 1 patient had active or new brain MRI lesions (2 gadolinium-enhancing lesions at 7 months [after C1] and 1 lesion 12 months [just before C2]), without clinical signs of MS activity. Only 1 patient had active or new brain MRI lesions (5 gadolinium-enhancing lesions) 2 days before C1 (washout 20 weeks). 4 patients had prolonged respiratory tract infections with high fever, thyroid AEs occurred in 2 patients (1 M. Basedow; 1 hypothyreosis); herpes zoster in 2 patients. No PML was diagnosed.
Conclusions: In this single center cohort of patients who discontinued natalizumab, alemtuzumab effectively maintained clinical stability over 12 months with no unexpected safety findings. Main AEs where respiratory tract infections with high fever within the first month. No carry over-PML occurred. The median washout for these patients was approximately 2,5 months.
Disclosure: S. Richter received travel support from Bayer, Biogen, Celgene, Merck, Novartis, Sanofi Genzyme and Teva. B. Wagner received travel support from Bayer, Biogen, Novartis and Sanofi Genzyme.
Abstract: P1194
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Objective: To assess evidence about efficacy and safety switching from natalizumab [NTZ] to alemtuzumab [ATZ] in stable MS patients due to risk of progressive multifocal leukoencephalopathy [PML] in a German MS center.
Background: For the treatment of RRMS patients who discontinue NTZ being positive for John Cunningham virus [JCV] it is important to evaluate data on the efficacy and safety outcomes. Data in real world clinical practice are still limited.
Design and methods: 20 patients discontinued NTZ treatment (19 due to risk of progressive multifocal leukoencephalopathy [PML]; 1 due to the experience of a massive rebound after NTZ cessation during a prior pregnancy); after a median of 55,1 months (range 7-102). No patients experienced clinical or radiologic disease activity in the 12 months prior to discontinuation. To rule out an asymptomatic PML, 19 patients received a recent contrast-enhanced brain MRI with DWI (median 15,5 days; range 2-65) and CSF-examination for JCV-PCR (median 14,6 days; range 7-27) prior to initiation of ATZ. Median washout period was 11,8 weeks (range 7-20) before receiving ATZ 12 mg/day (Course 1 [C1]: 5 days; Course 2 [C2, 12 months later]: 3 days). At least one brain MRI and Expanded Disability Status Scale [EDSS] was performed 12 months after ATZ initiation.
Results: All 20 patients have follow-up data for 12 months after ATZ-C1. All patients received C2. None of the patients experienced a relapse or progression of disability. EDSS was unchanged in all patients. Only 1 patient had active or new brain MRI lesions (2 gadolinium-enhancing lesions at 7 months [after C1] and 1 lesion 12 months [just before C2]), without clinical signs of MS activity. Only 1 patient had active or new brain MRI lesions (5 gadolinium-enhancing lesions) 2 days before C1 (washout 20 weeks). 4 patients had prolonged respiratory tract infections with high fever, thyroid AEs occurred in 2 patients (1 M. Basedow; 1 hypothyreosis); herpes zoster in 2 patients. No PML was diagnosed.
Conclusions: In this single center cohort of patients who discontinued natalizumab, alemtuzumab effectively maintained clinical stability over 12 months with no unexpected safety findings. Main AEs where respiratory tract infections with high fever within the first month. No carry over-PML occurred. The median washout for these patients was approximately 2,5 months.
Disclosure: S. Richter received travel support from Bayer, Biogen, Celgene, Merck, Novartis, Sanofi Genzyme and Teva. B. Wagner received travel support from Bayer, Biogen, Novartis and Sanofi Genzyme.