Contributions
Abstract: P825
Type: Poster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Background: Fingolimod is the first approved,oral disease-modifying therapy for patients with relapsing multiple sclerosis (MS). Real-world evidence on long-term treatment satisfaction (TS) and impact of fingolimod on the patients' quality of life (QoL) remains limited.
Methods: This non-interventional 24-month study evaluated TS and QoL in 498 fingolimod-treated MS patients, using the Greek version of the validated TS questionnaire for medication (TSQM) v.1.4 and the EuroQol 5-dimension 3-level (EQ-5D-3L) instrument, which were completed at enrolment and at 6, 12, 18 and 24 months post-enrolment.
Results: At enrolment, 6, 12, 18 and 24 months post-enrolment, the median EQ-VAS score was 65.0, 70.0, 71.0, 70.0 and 74.5, and the EQ-5D index score 0.78, 0.80, 0.80, 0.79, and 0.80, respectively. Pairwise comparisons revealed significant increases from enrolment at 6, 12, 18 and 24 months for the EQ-VAS (p< 0.001 for all) and at 6, 12 and 18 months for the EQ-5D index score (p< 0.05 for all).
At enrolment, 6, 12 and 24 months the percentage of patients that reported 'problems'in EQ-5D-3L dimensions were: 74.2, 66.9, 64.0, and 64.0% for 'anxiety/depression'; 65.7, 62.0, 62.2 and 61.3% for 'mobility'; 56.6, 49.2, 50.3, and 50.0% for 'usual activities', 45.0, 40.1, 37.8, 38.2% for 'pain/discomfort'; and 30.2, 29.2, 29.9 and 30.2% for 'self-care'. According to 12- and 24-month paired assessments, the percentage of patients who switched from 'problems' at enrolment to 'no problems' was significantly higher than those who switched from 'no problems' to 'problems' for 'anxiety/depression' at 12 and 24 months, and for 'mobility' at 24 months (p< 0.05 for all); no other significant differences were noted. Regarding treatment satisfaction, at 6, 12 and 24 months the median TSQM domain scores were: 100.0 for 'side effects' and 66.7 for 'effectiveness' at all timepoints, 88.9, 94.4 and 94.4 for 'convenience', and 64.3, 64.3 and 71.4 for 'global satisfaction'. Pairwise comparisons between 6-month and 12- and 24-month domain scores revealed significant increases in 'effectiveness' at 12 and 24 months, and in 'global satisfaction' at 24 months (p< 0.001 for all); no significant decreases were noted.
Conclusions: Fingolimod improved QoL of MS patients treated in routine care settings. Through the 2-year observation period, treatment satisfaction in terms of side effects and convenience remained high, while patient-rated effectiveness and global satisfaction increased.
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
A. Kyritsis has nothing to disclose
N.Vlaikidis has received honoraria for consultancy, speaking and research support for investigator initiated studies from Pfizer, UCB, Lilly, Schering, Serono, Biogen Idec, Roche, Merck, Novartis, Bayer, Genzyme, TEVA and Astellas.
G.Nasios has nothing to disclose
T. Ntoskas has received honoraria from Sanofi, Genesis, Teva, Merck, Novartis
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: P825
Type: Poster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Background: Fingolimod is the first approved,oral disease-modifying therapy for patients with relapsing multiple sclerosis (MS). Real-world evidence on long-term treatment satisfaction (TS) and impact of fingolimod on the patients' quality of life (QoL) remains limited.
Methods: This non-interventional 24-month study evaluated TS and QoL in 498 fingolimod-treated MS patients, using the Greek version of the validated TS questionnaire for medication (TSQM) v.1.4 and the EuroQol 5-dimension 3-level (EQ-5D-3L) instrument, which were completed at enrolment and at 6, 12, 18 and 24 months post-enrolment.
Results: At enrolment, 6, 12, 18 and 24 months post-enrolment, the median EQ-VAS score was 65.0, 70.0, 71.0, 70.0 and 74.5, and the EQ-5D index score 0.78, 0.80, 0.80, 0.79, and 0.80, respectively. Pairwise comparisons revealed significant increases from enrolment at 6, 12, 18 and 24 months for the EQ-VAS (p< 0.001 for all) and at 6, 12 and 18 months for the EQ-5D index score (p< 0.05 for all).
At enrolment, 6, 12 and 24 months the percentage of patients that reported 'problems'in EQ-5D-3L dimensions were: 74.2, 66.9, 64.0, and 64.0% for 'anxiety/depression'; 65.7, 62.0, 62.2 and 61.3% for 'mobility'; 56.6, 49.2, 50.3, and 50.0% for 'usual activities', 45.0, 40.1, 37.8, 38.2% for 'pain/discomfort'; and 30.2, 29.2, 29.9 and 30.2% for 'self-care'. According to 12- and 24-month paired assessments, the percentage of patients who switched from 'problems' at enrolment to 'no problems' was significantly higher than those who switched from 'no problems' to 'problems' for 'anxiety/depression' at 12 and 24 months, and for 'mobility' at 24 months (p< 0.05 for all); no other significant differences were noted. Regarding treatment satisfaction, at 6, 12 and 24 months the median TSQM domain scores were: 100.0 for 'side effects' and 66.7 for 'effectiveness' at all timepoints, 88.9, 94.4 and 94.4 for 'convenience', and 64.3, 64.3 and 71.4 for 'global satisfaction'. Pairwise comparisons between 6-month and 12- and 24-month domain scores revealed significant increases in 'effectiveness' at 12 and 24 months, and in 'global satisfaction' at 24 months (p< 0.001 for all); no significant decreases were noted.
Conclusions: Fingolimod improved QoL of MS patients treated in routine care settings. Through the 2-year observation period, treatment satisfaction in terms of side effects and convenience remained high, while patient-rated effectiveness and global satisfaction increased.
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
A. Kyritsis has nothing to disclose
N.Vlaikidis has received honoraria for consultancy, speaking and research support for investigator initiated studies from Pfizer, UCB, Lilly, Schering, Serono, Biogen Idec, Roche, Merck, Novartis, Bayer, Genzyme, TEVA and Astellas.
G.Nasios has nothing to disclose
T. Ntoskas has received honoraria from Sanofi, Genesis, Teva, Merck, Novartis
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