Contributions
Abstract: EP1713
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: MS disease progression negatively affects employment, leading to high economic costs. Hence, therapeutic strategies to reduce disease activity are recommended. In CARE-MS II (NCT00548405), alemtuzumab significantly improved clinical and MRI outcomes vs SC IFNB-1a over 2 years in patients with active RRMS and inadequate response to prior therapy.
Goal: To explore potential impact of alemtuzumab on work capacity in CARE-MS II alemtuzumab-treated patients, measured by the Health Resource Utilization questionnaire (HRUQ).
Methods: HRUQ evaluates patients' use of healthcare resources, non-medical resources, informal care, and work capacity, and was completed at baseline and every 3 months during the 2-year study by 426 alemtuzumab- and 202 SC IFNB-1a-treated CARE-MS II patients. Questions related to work capacity assessed sick leave due to MS during the past 3 months. Primary analysis excluded sick leave at Months 3 and 15, as it included alemtuzumab treatment at baseline (5 days) and 12 months later (3 days). Statistical analyses to compare alemtuzumab and SC IFNB-1a groups included descriptive analysis, chi-square test on cumulative percentages over each visit, and generalised linear mixed-effect model for repeated measurements.
Results: At baseline, 53.3% and 55.5% of patients randomised to alemtuzumab or SC IFNB-1a, respectively, reported being employed or self-employed. Six SC IFNB-1a and no alemtuzumab patients discontinued study due to lack of efficacy (LOE). During CARE-MS II, the cumulative percentage of alemtuzumab-treated patients taking sick leave due to MS was significantly lower vs SC IFNB-1a-treated patients at Months 6 (11.5% vs 18.8%, P=0.018), 9 (15.3% vs 25.9%, P=0.002), 18 (24.6% vs 33.5%, P=0.023), 21 (26.1% vs 35.1%, P=0.022), and 24 (27.7% vs 36.0%, P=0.035) and was numerically lower at Month 12 (21.6% vs 27.7%, P=0.1). In a longitudinal model over 2 years, alemtuzumab-treated patients took significantly less sick leave due to MS vs the SC IFNB-1a group (P=0.04); this finding was confirmed by sensitivity analysis including Months 3 and 15.
Conclusion: These exploratory analyses showed that alemtuzumab-treated patients took significantly reduced sick leave due to MS vs SC IFNB-1a over 2 years, a difference that may have been greater if no SC IFNB-1a patients had discontinued due to LOE. These findings suggest that alemtuzumab may offer a unique treatment approach for patients with active RRMS, potentially improving work capacity.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).
HW, WZ, KT, MM and JDG: Employees of Sanofi.
Abstract: EP1713
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: MS disease progression negatively affects employment, leading to high economic costs. Hence, therapeutic strategies to reduce disease activity are recommended. In CARE-MS II (NCT00548405), alemtuzumab significantly improved clinical and MRI outcomes vs SC IFNB-1a over 2 years in patients with active RRMS and inadequate response to prior therapy.
Goal: To explore potential impact of alemtuzumab on work capacity in CARE-MS II alemtuzumab-treated patients, measured by the Health Resource Utilization questionnaire (HRUQ).
Methods: HRUQ evaluates patients' use of healthcare resources, non-medical resources, informal care, and work capacity, and was completed at baseline and every 3 months during the 2-year study by 426 alemtuzumab- and 202 SC IFNB-1a-treated CARE-MS II patients. Questions related to work capacity assessed sick leave due to MS during the past 3 months. Primary analysis excluded sick leave at Months 3 and 15, as it included alemtuzumab treatment at baseline (5 days) and 12 months later (3 days). Statistical analyses to compare alemtuzumab and SC IFNB-1a groups included descriptive analysis, chi-square test on cumulative percentages over each visit, and generalised linear mixed-effect model for repeated measurements.
Results: At baseline, 53.3% and 55.5% of patients randomised to alemtuzumab or SC IFNB-1a, respectively, reported being employed or self-employed. Six SC IFNB-1a and no alemtuzumab patients discontinued study due to lack of efficacy (LOE). During CARE-MS II, the cumulative percentage of alemtuzumab-treated patients taking sick leave due to MS was significantly lower vs SC IFNB-1a-treated patients at Months 6 (11.5% vs 18.8%, P=0.018), 9 (15.3% vs 25.9%, P=0.002), 18 (24.6% vs 33.5%, P=0.023), 21 (26.1% vs 35.1%, P=0.022), and 24 (27.7% vs 36.0%, P=0.035) and was numerically lower at Month 12 (21.6% vs 27.7%, P=0.1). In a longitudinal model over 2 years, alemtuzumab-treated patients took significantly less sick leave due to MS vs the SC IFNB-1a group (P=0.04); this finding was confirmed by sensitivity analysis including Months 3 and 15.
Conclusion: These exploratory analyses showed that alemtuzumab-treated patients took significantly reduced sick leave due to MS vs SC IFNB-1a over 2 years, a difference that may have been greater if no SC IFNB-1a patients had discontinued due to LOE. These findings suggest that alemtuzumab may offer a unique treatment approach for patients with active RRMS, potentially improving work capacity.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).
HW, WZ, KT, MM and JDG: Employees of Sanofi.