Contributions
Abstract: EP1841
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Introduction: Data are limited on the quality of life (QoL) of patients with relapsing remitting multiple sclerosis (RRMS) treated with fingolimod, a disease modifying therapy (DMT), in the UK.
Methods: Prospective observational study of 144 consenting patients with RRMS in 14 secondary care NHS centres. Eligibility: aged 18-55 years at first initiation of fingolimod ('baseline') and treated within the European product licence. Baseline data collected from medical records: demographics, disease characteristics and DMT history; baseline, 3, 6 and 12 month (M) patient-reported data collected included the EQ-5D-5L, the Multiple Sclerosis Impact Scale (MSIS-29) and adverse events (AEs). Percentages have been rounded so may not total 100%; 95% confidence intervals [CI] presented where available.
Results: The results of an interim analysis of n=110/144 patients (76%) who had ≥1 post-baseline assessment of MSIS-29 are presented. Mean (standard deviation [SD]) patient age at baseline: 40 (8) years; n=87 (79%) female; n=5/110 patients (5%) had received no previous MS DMT, 65 (59%) had received 1, 30 (27%) had received 2, and 10 (9%) had received >2. Baseline mean (SD) MSIS-29 physical domain score: 34.7 (23.3); at 3M: 31.4 (22.2); mean change: -3.3 [CI:-5.7,-0.9]. Baseline mean (SD) MSIS-29 psychological domain score: 39.5 (23.8); at 3M: 35.4 (22.7); mean change: -4.2 [CI:-7.8,-0.5]. Baseline mean (SD) EQ-5D utility index score: 0.73 (0.21); at 3M: 0.74 (0.23); mean change: 0.01 [CI:-0.02,0.04]. Baseline mean (SD) EQ-5D visual analogue scale score: 67.9 (18.4); at 3M: 69.0 (17.3); mean change: 1.0 [CI:-2.2,4.3]. The largest increases in patients reporting no problems were in the EQ-5D usual activities subscale: n=38/110 (35%) at 3M, compared to n=27/110 (25%) at baseline, and in the self-care subscale: n=74/110 (67%) at 3M, compared to n=67/110 (61%) at baseline. AEs reported by n=38/110 patients (35%) at 3M; most frequently reported AE: headache (n=7/110, [6%]).
Conclusions: Patients reported improved scores in both the physical and psychological domains of the disease-specific MSIS-29 at 3M, indicating an improvement in MS-related QoL following initiation of fingolimod. Overall utility did not change significantly when measured by the EQ-5D, suggesting this generic tool may not be sensitive enough to capture disease-specific factors impacting on QoL. Forthcoming study assessments at 6 and 12 months will support understanding of longer term QoL in this patient group.
Disclosure:
Nick Adlard was an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study, at the time of the study.
Fiona Brisbane is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Jane Watson is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Michel Kroes is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Catherine Bottomley is an employee of pH Associates, the company contracted by Novartis Pharmaceuticals Ltd to provide scientific interpretation of the PROFILE study results and medical writing support.
Abstract: EP1841
Type: ePoster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Introduction: Data are limited on the quality of life (QoL) of patients with relapsing remitting multiple sclerosis (RRMS) treated with fingolimod, a disease modifying therapy (DMT), in the UK.
Methods: Prospective observational study of 144 consenting patients with RRMS in 14 secondary care NHS centres. Eligibility: aged 18-55 years at first initiation of fingolimod ('baseline') and treated within the European product licence. Baseline data collected from medical records: demographics, disease characteristics and DMT history; baseline, 3, 6 and 12 month (M) patient-reported data collected included the EQ-5D-5L, the Multiple Sclerosis Impact Scale (MSIS-29) and adverse events (AEs). Percentages have been rounded so may not total 100%; 95% confidence intervals [CI] presented where available.
Results: The results of an interim analysis of n=110/144 patients (76%) who had ≥1 post-baseline assessment of MSIS-29 are presented. Mean (standard deviation [SD]) patient age at baseline: 40 (8) years; n=87 (79%) female; n=5/110 patients (5%) had received no previous MS DMT, 65 (59%) had received 1, 30 (27%) had received 2, and 10 (9%) had received >2. Baseline mean (SD) MSIS-29 physical domain score: 34.7 (23.3); at 3M: 31.4 (22.2); mean change: -3.3 [CI:-5.7,-0.9]. Baseline mean (SD) MSIS-29 psychological domain score: 39.5 (23.8); at 3M: 35.4 (22.7); mean change: -4.2 [CI:-7.8,-0.5]. Baseline mean (SD) EQ-5D utility index score: 0.73 (0.21); at 3M: 0.74 (0.23); mean change: 0.01 [CI:-0.02,0.04]. Baseline mean (SD) EQ-5D visual analogue scale score: 67.9 (18.4); at 3M: 69.0 (17.3); mean change: 1.0 [CI:-2.2,4.3]. The largest increases in patients reporting no problems were in the EQ-5D usual activities subscale: n=38/110 (35%) at 3M, compared to n=27/110 (25%) at baseline, and in the self-care subscale: n=74/110 (67%) at 3M, compared to n=67/110 (61%) at baseline. AEs reported by n=38/110 patients (35%) at 3M; most frequently reported AE: headache (n=7/110, [6%]).
Conclusions: Patients reported improved scores in both the physical and psychological domains of the disease-specific MSIS-29 at 3M, indicating an improvement in MS-related QoL following initiation of fingolimod. Overall utility did not change significantly when measured by the EQ-5D, suggesting this generic tool may not be sensitive enough to capture disease-specific factors impacting on QoL. Forthcoming study assessments at 6 and 12 months will support understanding of longer term QoL in this patient group.
Disclosure:
Nick Adlard was an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study, at the time of the study.
Fiona Brisbane is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Jane Watson is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Michel Kroes is an employee of Novartis Pharmaceuticals Ltd, the sponsor of the PROFILE study.
Catherine Bottomley is an employee of pH Associates, the company contracted by Novartis Pharmaceuticals Ltd to provide scientific interpretation of the PROFILE study results and medical writing support.