Contributions
Abstract: EP1706
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Introduction: Natalizumab (NTZ) is used in patients with high active disease or a severe and rapid onset. The efficacy of NTZ has originated the concept of NEDA. The concept of NEDA-3, 'no evidence of disease activity' is based on the absence of relapses, progression of disability and activity on MRI. The major limitation for the use of NTZ is the development of progressive multifocal leukoencephalopathy (PML).
Objectives: Our objective is to analyze the percentage and the duration over time patients meet NEDA-3 criteria in real world clinical practice in multiple sclerosis (MS) under treatment with NTZ.
Methods: We retrospectively reviewed the clinical records of 97 MS patients who have received NTZ therapy for at least one year at the Neurology Service of Hospital Universitario Central de Asturias (Oviedo, Spain) since year 2008 to present.
Results: We analyzed 97 patients, 75.3% women, 93.8% with relapsing-remitting MS. The median age of the patients at the beginning of treatment was 41,1 years old. The baseline EDSS was 3.3. The time from diagnosis to the onset of NTZ was 5.84 years. The annualized relapse rate (ARR) in the year prior to treatment was 1,91. The reason for initiating NTZ was the lack of efficacy of prior treatment in 83.5% and 8.24% for an aggressive onset of the disease. The mean treatment time was 4.24 years. At the beginning of treatment 60% of the patients had anti-JCV positive antibodies. 25% of patients with negative anti-JCV antibodies become positive in the course of treatment. In 74.4% the reason for withdrawal of NTZ was the risk of PML.
In the case of NEDA-3 after one year of treatment, 66.7% of the patients fulfilled the criteria, after two years 54.7%, after three 50.7%, after four 44.4%, after five 40.5%, after six 34, 4%, after seven 39.1%, after eight 53.8% and after nine 60%. The ARR reduction was 87.44% that was maintained over the years.
Conclusion: NTZ is used in patients with high clinical and MRI activity. In our series, a high percentage of patients treated with NTZ met NEDA-3 criteria and maintained over the years. One of the major limitations of treatment is the risk of PML, which is the most frequent reason for withdrawal.
Disclosure:
Suárez-Santos, P. Nothing to disclose.
García-Rua, A. Nothing to disclose.
Oliva Nacarino, P. Has recibed grants as a speaker's from Biogen, TEVA, Genzyme and Novartis.
Ameijide-Sanluis, E. Nothing to disclose.
Castañón-Apilánez, M. Nothing to disclose.
Villafani, J. Has recibed grants as a speaker's from Biogen, TEVA, Genzyme and Novartis
Abstract: EP1706
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Introduction: Natalizumab (NTZ) is used in patients with high active disease or a severe and rapid onset. The efficacy of NTZ has originated the concept of NEDA. The concept of NEDA-3, 'no evidence of disease activity' is based on the absence of relapses, progression of disability and activity on MRI. The major limitation for the use of NTZ is the development of progressive multifocal leukoencephalopathy (PML).
Objectives: Our objective is to analyze the percentage and the duration over time patients meet NEDA-3 criteria in real world clinical practice in multiple sclerosis (MS) under treatment with NTZ.
Methods: We retrospectively reviewed the clinical records of 97 MS patients who have received NTZ therapy for at least one year at the Neurology Service of Hospital Universitario Central de Asturias (Oviedo, Spain) since year 2008 to present.
Results: We analyzed 97 patients, 75.3% women, 93.8% with relapsing-remitting MS. The median age of the patients at the beginning of treatment was 41,1 years old. The baseline EDSS was 3.3. The time from diagnosis to the onset of NTZ was 5.84 years. The annualized relapse rate (ARR) in the year prior to treatment was 1,91. The reason for initiating NTZ was the lack of efficacy of prior treatment in 83.5% and 8.24% for an aggressive onset of the disease. The mean treatment time was 4.24 years. At the beginning of treatment 60% of the patients had anti-JCV positive antibodies. 25% of patients with negative anti-JCV antibodies become positive in the course of treatment. In 74.4% the reason for withdrawal of NTZ was the risk of PML.
In the case of NEDA-3 after one year of treatment, 66.7% of the patients fulfilled the criteria, after two years 54.7%, after three 50.7%, after four 44.4%, after five 40.5%, after six 34, 4%, after seven 39.1%, after eight 53.8% and after nine 60%. The ARR reduction was 87.44% that was maintained over the years.
Conclusion: NTZ is used in patients with high clinical and MRI activity. In our series, a high percentage of patients treated with NTZ met NEDA-3 criteria and maintained over the years. One of the major limitations of treatment is the risk of PML, which is the most frequent reason for withdrawal.
Disclosure:
Suárez-Santos, P. Nothing to disclose.
García-Rua, A. Nothing to disclose.
Oliva Nacarino, P. Has recibed grants as a speaker's from Biogen, TEVA, Genzyme and Novartis.
Ameijide-Sanluis, E. Nothing to disclose.
Castañón-Apilánez, M. Nothing to disclose.
Villafani, J. Has recibed grants as a speaker's from Biogen, TEVA, Genzyme and Novartis