Contributions
Abstract: EP1709
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: This non-interventional, prospective observational study aimed to provide real-world data to complement pre-authorization evidence on fingolimod's effectiveness in relapse rate, disability progression and MRI measures in multiple sclerosis (MS) patients.
Methods: 498 adult MS patients, who had recent (up to 15 days) treatment initiation with, or had been prescribed fingolimod,according to the approved label prior to enrolment, comprised the eligible study population. Data were collected over a median follow-up of 23.6 months, during 7 visits occurring at enrolment and at approximately 1, 3, 6, 12, 18 and 24 months post-enrolment. 25.3% of the patients prematurely discontinued study participation at a median of 12.8 months, mainly due to loss of follow-up (9.0%), adverse events (6.8%), and patient decision/non-compliance/consent withdrawal (4.6%).
Results: Eligible patients (age: 41.2±9.8 years; 63.7% females) had been diagnosed with MS a median of 7.5 years prior to fingolimod onset. All patients had experienced at least one relapse over 12 months prior to treatment onset [total 803 (mean: 1.6±0.8); 675 treated with corticosteroids]. 95.8% of patients had received prior MS-related treatment; 73.8% of these patients had discontinued their most recent prior medication within the 6-month period prior to fingolimod treatment onset treatment. The median baseline EDSS score of 3.2±1.9 significantly decreased to 3.1±1.9 (p< 0.001), 3.0±1.9 (p=0.003), 3.1±1.9 (p=0.020) and 3.0±1.9 (p=0.010) point at 6,12,18 and 24 months post-treatment, respectively .Brain MRI among patients with available data demonstrated significant decreases from baseline in gadolinium-enhancing lesion count at 6, 12, 18 and 24 months (p< 0.001 for all) and in T1 lesion count at 12 (p=0.006) and 24 months (p=0.046), while the T2 lesion counts remained unchanged. The 12- and 24-month annualised relapse rates were 1.81 and 1.85 per patient-year, respectively, prior to fingolimod onset, and 0.10, and 0.09, respectively, post-treatment onset. Median decreases of 1 and 3 relapses were noted from the 12- and 24-month periods prior to fingolimod onset to the respective periods post-treatment onset (p< 0.001 for both).
Conclusions: Fingolimod displays beneficial effects on disability progression, relapse rate and brain MRI outcomes of MS patients in routine clinical practice in Greece. Also, this study supports data of relevant international literature and phase III studies.
Disclosure: Novartis Hellas S.A.C.I is the sponsor of the study
D.D. Mitsikostas has received grants and honoraria from: Allergan, Amgen, Biogen, Genesis Pharma, Electocore, Eli Lilly, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, Teva
E. Zafeiropoulou is currently a Novartis (Hellas) S.A.C.I employee
I. Iliopoulos received personal compensation from Genesis, Merck Serono, Novartis and Sanofi as member of scientific advisory boards, steering committees or independent data monitoring boards in clinical trials, or as speaker at meetings
N. Fakas has received honoraria from Novartis as a member of scientific advisory boards or, as a speaker in congresses
T. Thomaides and M. Maltezou have nothing to disclose
N. Grigoriadis received honoraria, travel support, consultancy and lecture fees from Biogen Idec, Novartis, TEVA, Bayer, Merck Serono, Genesis Pharma, Sanofi - Aventis and Research grants from Biogen Idec, Novartis, TEVA, Merck Serono, Genesis Pharma
All authors, except of E.Z are Principal Investigators of the study.
Abstract: EP1709
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: This non-interventional, prospective observational study aimed to provide real-world data to complement pre-authorization evidence on fingolimod's effectiveness in relapse rate, disability progression and MRI measures in multiple sclerosis (MS) patients.
Methods: 498 adult MS patients, who had recent (up to 15 days) treatment initiation with, or had been prescribed fingolimod,according to the approved label prior to enrolment, comprised the eligible study population. Data were collected over a median follow-up of 23.6 months, during 7 visits occurring at enrolment and at approximately 1, 3, 6, 12, 18 and 24 months post-enrolment. 25.3% of the patients prematurely discontinued study participation at a median of 12.8 months, mainly due to loss of follow-up (9.0%), adverse events (6.8%), and patient decision/non-compliance/consent withdrawal (4.6%).
Results: Eligible patients (age: 41.2±9.8 years; 63.7% females) had been diagnosed with MS a median of 7.5 years prior to fingolimod onset. All patients had experienced at least one relapse over 12 months prior to treatment onset [total 803 (mean: 1.6±0.8); 675 treated with corticosteroids]. 95.8% of patients had received prior MS-related treatment; 73.8% of these patients had discontinued their most recent prior medication within the 6-month period prior to fingolimod treatment onset treatment. The median baseline EDSS score of 3.2±1.9 significantly decreased to 3.1±1.9 (p< 0.001), 3.0±1.9 (p=0.003), 3.1±1.9 (p=0.020) and 3.0±1.9 (p=0.010) point at 6,12,18 and 24 months post-treatment, respectively .Brain MRI among patients with available data demonstrated significant decreases from baseline in gadolinium-enhancing lesion count at 6, 12, 18 and 24 months (p< 0.001 for all) and in T1 lesion count at 12 (p=0.006) and 24 months (p=0.046), while the T2 lesion counts remained unchanged. The 12- and 24-month annualised relapse rates were 1.81 and 1.85 per patient-year, respectively, prior to fingolimod onset, and 0.10, and 0.09, respectively, post-treatment onset. Median decreases of 1 and 3 relapses were noted from the 12- and 24-month periods prior to fingolimod onset to the respective periods post-treatment onset (p< 0.001 for both).
Conclusions: Fingolimod displays beneficial effects on disability progression, relapse rate and brain MRI outcomes of MS patients in routine clinical practice in Greece. Also, this study supports data of relevant international literature and phase III studies.
Disclosure: Novartis Hellas S.A.C.I is the sponsor of the study
D.D. Mitsikostas has received grants and honoraria from: Allergan, Amgen, Biogen, Genesis Pharma, Electocore, Eli Lilly, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, Teva
E. Zafeiropoulou is currently a Novartis (Hellas) S.A.C.I employee
I. Iliopoulos received personal compensation from Genesis, Merck Serono, Novartis and Sanofi as member of scientific advisory boards, steering committees or independent data monitoring boards in clinical trials, or as speaker at meetings
N. Fakas has received honoraria from Novartis as a member of scientific advisory boards or, as a speaker in congresses
T. Thomaides and M. Maltezou have nothing to disclose
N. Grigoriadis received honoraria, travel support, consultancy and lecture fees from Biogen Idec, Novartis, TEVA, Bayer, Merck Serono, Genesis Pharma, Sanofi - Aventis and Research grants from Biogen Idec, Novartis, TEVA, Merck Serono, Genesis Pharma
All authors, except of E.Z are Principal Investigators of the study.