Contributions
Abstract: P558
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Multiple sclerosis (MS) is a chronic, progressive neurologic disease that impairs daily activities and ability to work. Although previous research has shown that natalizumab (NTZ) treatment may improve work ability (WA), further data are needed to fully characterize this impact.
Objectives: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed the association of NTZ with WA improvement and evaluated its effects on disease activity, quality of life, and cognitive function.
Methods: WANT was a 1-year, prospective, multicentre observational study conducted in Italy. Inclusion criteria included relapsing-remitting MS, NTZ treatment, full-time worker status, and loss of working hours due to MS as measured by the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS). The primary endpoint was change in WPAI:MS domain scores (absenteeism, presenteeism, work productivity loss, and activity impairment) after 1 year on NTZ. Secondary endpoints included change in annualised relapse rate (ARR), MRI lesion load, and Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), and Symbol Digit Modalities Test (SDMT) scores.
Results: At baseline, the 91 patients enrolled had a mean age of 38.3 (standard deviation [SD], 9.0) years, mean ARR of 1.5 (SD, 0.8), and mean EDSS score of 2.8 (SD, 1.5). After 1 year, improvements in all domains of WPAI:MS were observed, though only reductions in absenteeism and work productivity loss domains reached significance (−4.2 [SD, 26.0] and −7.2 [SD, 28.6], respectively; P< 0.05). These changes were accompanied by reduction in disease activity: ARR decreased by 1.3 (SD, 0.8; P< 0.0001) and 87.9% of patients were relapse free; mean EDSS score decreased by 0.2 (SD, 0.6; P=0.0068); and the gadolinium-enhanced lesion count decreased by 0.7 (SD, 2.0; P=0.0078). Significant improvement was also observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6] and 6.3 [SD, 15.6], respectively; P< 0.05) and the SDMT (increase of 2.4 [SD, 7.9]; P=0.0006). Finally, an association between decrease in absenteeism and improvement in EDSS and ARR after 1 year was observed (P< 0.05).
Conclusions: NTZ was associated with significant reductions in absenteeism and work productivity loss, as well as improved physical and psychological functioning. The results extend our understanding of the effects of NTZ on important patient-centric and health economics outcomes.
Disclosure: Supported by Biogen.
RC: has received lecture fees and/or travel grants from Biogen, Celgene, Genzyme, Novartis, TEVA and Sanofi-Aventis.
NDR: has received speaker honoraria from Biogen Idec, Genzyme, Novartis, Sanofi-Aventis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for travel to scientific meetings from Almirall, Biogen Idec, Novartis, Sanofi-Genzyme, Teva, and Roche
SM, VZ: employees of and may hold stock and/or stock options in Biogen
VBM: has received funding for travel, speaker honoraria, and research support from Sanofi-Genzyme, Bayer Schering Pharma, Merck Serono, and Biogen.
MM: has received honoraria for lectures, consulting, and advisory boards from Almirall, Biogen, Bayer Schering, Merck, Novartis, Teva, and Ultragenix, and Pharmaceuticals; has received financial support for research activities from Merck, Almirall, Teva and Novartis Pharmaceuticals.
FP: has received honoraria for advisory boards from Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi-Genzyme and TEVA; has received research grants from Reload Onlus, FISM, ISS and MIUR
Abstract: P558
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Multiple sclerosis (MS) is a chronic, progressive neurologic disease that impairs daily activities and ability to work. Although previous research has shown that natalizumab (NTZ) treatment may improve work ability (WA), further data are needed to fully characterize this impact.
Objectives: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed the association of NTZ with WA improvement and evaluated its effects on disease activity, quality of life, and cognitive function.
Methods: WANT was a 1-year, prospective, multicentre observational study conducted in Italy. Inclusion criteria included relapsing-remitting MS, NTZ treatment, full-time worker status, and loss of working hours due to MS as measured by the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS). The primary endpoint was change in WPAI:MS domain scores (absenteeism, presenteeism, work productivity loss, and activity impairment) after 1 year on NTZ. Secondary endpoints included change in annualised relapse rate (ARR), MRI lesion load, and Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), and Symbol Digit Modalities Test (SDMT) scores.
Results: At baseline, the 91 patients enrolled had a mean age of 38.3 (standard deviation [SD], 9.0) years, mean ARR of 1.5 (SD, 0.8), and mean EDSS score of 2.8 (SD, 1.5). After 1 year, improvements in all domains of WPAI:MS were observed, though only reductions in absenteeism and work productivity loss domains reached significance (−4.2 [SD, 26.0] and −7.2 [SD, 28.6], respectively; P< 0.05). These changes were accompanied by reduction in disease activity: ARR decreased by 1.3 (SD, 0.8; P< 0.0001) and 87.9% of patients were relapse free; mean EDSS score decreased by 0.2 (SD, 0.6; P=0.0068); and the gadolinium-enhanced lesion count decreased by 0.7 (SD, 2.0; P=0.0078). Significant improvement was also observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6] and 6.3 [SD, 15.6], respectively; P< 0.05) and the SDMT (increase of 2.4 [SD, 7.9]; P=0.0006). Finally, an association between decrease in absenteeism and improvement in EDSS and ARR after 1 year was observed (P< 0.05).
Conclusions: NTZ was associated with significant reductions in absenteeism and work productivity loss, as well as improved physical and psychological functioning. The results extend our understanding of the effects of NTZ on important patient-centric and health economics outcomes.
Disclosure: Supported by Biogen.
RC: has received lecture fees and/or travel grants from Biogen, Celgene, Genzyme, Novartis, TEVA and Sanofi-Aventis.
NDR: has received speaker honoraria from Biogen Idec, Genzyme, Novartis, Sanofi-Aventis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for travel to scientific meetings from Almirall, Biogen Idec, Novartis, Sanofi-Genzyme, Teva, and Roche
SM, VZ: employees of and may hold stock and/or stock options in Biogen
VBM: has received funding for travel, speaker honoraria, and research support from Sanofi-Genzyme, Bayer Schering Pharma, Merck Serono, and Biogen.
MM: has received honoraria for lectures, consulting, and advisory boards from Almirall, Biogen, Bayer Schering, Merck, Novartis, Teva, and Ultragenix, and Pharmaceuticals; has received financial support for research activities from Merck, Almirall, Teva and Novartis Pharmaceuticals.
FP: has received honoraria for advisory boards from Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi-Genzyme and TEVA; has received research grants from Reload Onlus, FISM, ISS and MIUR