Contributions
Abstract: P939
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Background: Natalizumab (NTZ) is an effective treatment for remitting-relapsing multiple sclerosis (RRMS) when used in the standard dose (SD) of 300 mg / 4 weeks. With this regime almost complete saturation (> 80%) of alpha4 integrin (CD49d) receptor in the CD4+ T lymphocytes is obtained, but it could be a risk factor for developing Progressive Multifocal Leukoencephalopathy.
Objectives: To evaluate the effectiveness of NTZ and NADIR saturation of CD49d in peripheral blood lymphocytes in patients receiving extended interval dose (EID) of 300mg/6 weeks.
Methods: A descriptive and prospective study of patients who after at least 13 administrations of NTZ in SD moved to EID/ 6 weeks. Clinical and radiological parameters: annual rate of relapse (ARR), Disability Scale (EDSS), and gadolinium enhancing T1Gd (+) lesions and new T2 lesions in brain MRI. The NADIR saturation of CD49d was measured by multiparametric quantitative flow cytometry in peripheral blood lymphocytes. The protocol was approved by the pharmaco-therapeutic Committee of the Hospital. All patients signed the informed consent.
Results: 21 patients; 61.9% women; mean age 43.48 ± 9.92 years; duration of MS 14.67 ± 8.5 years. Under treatment with NTZ_DS: EDSS 4.15 ± 1.39; ARR previous year 1.76 ± 0.83; brain MRI T1Gd (+) (47.6%) and > 9 T2 lesions (90.5%). Duration of NTZ_SD 41.33 ± 29.05. Duration of NTZ_ EID 34.24 ± 20.33 months, during the treatment periods NTZ_SD and NTZ_ EID and respectively, 20/21(95%) of the patients remained free of relapse (p = 0.82); ARR 0.0095 ± 0,044 and 0,024 ± 0.11 (p = 0.65); EDSS 3.45 ± 1.72 and 3.57 ± 1.84 (p = 0.95); 95% and 100% of the patients did not have T1Gd (+) or new T2 lesions. Saturation of CD49d in CD4+ T lymphocytes during EID period and at NADIR was 62.03 ± 11.44% in the 14 patients analyzed.
Conclusions: NTZ in EID every 6 weeks maintains the effectiveness of the SD. A lower level of saturation of the CD49d does not compromise the effectiveness of NTZ.
Disclosure: The authors declare that there are no conflicts of interest to this study
Abstract: P939
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Background: Natalizumab (NTZ) is an effective treatment for remitting-relapsing multiple sclerosis (RRMS) when used in the standard dose (SD) of 300 mg / 4 weeks. With this regime almost complete saturation (> 80%) of alpha4 integrin (CD49d) receptor in the CD4+ T lymphocytes is obtained, but it could be a risk factor for developing Progressive Multifocal Leukoencephalopathy.
Objectives: To evaluate the effectiveness of NTZ and NADIR saturation of CD49d in peripheral blood lymphocytes in patients receiving extended interval dose (EID) of 300mg/6 weeks.
Methods: A descriptive and prospective study of patients who after at least 13 administrations of NTZ in SD moved to EID/ 6 weeks. Clinical and radiological parameters: annual rate of relapse (ARR), Disability Scale (EDSS), and gadolinium enhancing T1Gd (+) lesions and new T2 lesions in brain MRI. The NADIR saturation of CD49d was measured by multiparametric quantitative flow cytometry in peripheral blood lymphocytes. The protocol was approved by the pharmaco-therapeutic Committee of the Hospital. All patients signed the informed consent.
Results: 21 patients; 61.9% women; mean age 43.48 ± 9.92 years; duration of MS 14.67 ± 8.5 years. Under treatment with NTZ_DS: EDSS 4.15 ± 1.39; ARR previous year 1.76 ± 0.83; brain MRI T1Gd (+) (47.6%) and > 9 T2 lesions (90.5%). Duration of NTZ_SD 41.33 ± 29.05. Duration of NTZ_ EID 34.24 ± 20.33 months, during the treatment periods NTZ_SD and NTZ_ EID and respectively, 20/21(95%) of the patients remained free of relapse (p = 0.82); ARR 0.0095 ± 0,044 and 0,024 ± 0.11 (p = 0.65); EDSS 3.45 ± 1.72 and 3.57 ± 1.84 (p = 0.95); 95% and 100% of the patients did not have T1Gd (+) or new T2 lesions. Saturation of CD49d in CD4+ T lymphocytes during EID period and at NADIR was 62.03 ± 11.44% in the 14 patients analyzed.
Conclusions: NTZ in EID every 6 weeks maintains the effectiveness of the SD. A lower level of saturation of the CD49d does not compromise the effectiveness of NTZ.
Disclosure: The authors declare that there are no conflicts of interest to this study