Ruggero Capra1, Vincenzo Brescia Morra2, Massimiliano Mirabella3, Claudio Gasperini4, Cinzia Scandellari5, Rocco Totaro6, Nicola De Rossi7, Silvia Masera8, Valentina Zipoli8, Francesco Patti9. 1. Multiple Sclerosis Center, Spedali Civili of Brescia, Montichiari, Brescia, Italy. ruggero.capra@gmail.com. 2. Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontostomatologiche, Universita degli Studi di Napoli Federico II, Naples, Italy. 3. Multiple Sclerosis Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Rome, Rome, Italy. 4. Department of Neurosciences, San Camillo Forlanini Hospital, Rome, Italy. 5. IRCCS Istituto delle Scienze Neurologiche di Bologna, UOsI Riabilitazione Sclerosi Multipla, Ospedale Bellaria, Bologna, Italy. 6. Multiple Sclerosis Center, San Salvatore Hospital, L'Aquila, Italy. 7. Multiple Sclerosis Center, Spedali Civili of Brescia, Montichiari, Brescia, Italy. 8. Biogen, Cambridge, MA, USA. 9. DANA Department, "GF Ingrassia", Medical and Surgical Sciences, Advanced Technologies, Multiple Sclerosis Center, University of Catania, Catania, Italy.
Abstract
BACKGROUND: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed work ability, quality of life, and cognitive processing speed during natalizumab treatment. METHODS: WANT was a 1-year, prospective, multicenter observational study conducted in Italy. Inclusion criteria included relapsing-remitting multiple sclerosis (MS), natalizumab 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 after 1 year on natalizumab. Secondary endpoints included change in annualized relapse rate (ARR), Multiple Sclerosis Impact Scale (MSIS-29) score, and Symbol Digit Modalities Test (SDMT) score. RESULTS: At enrollment, the 91 patients had a mean age of 38.3 (standard deviation [SD], 9.0) years and a mean ARR of 1.5 (SD, 0.8). After 1 year, improvements were observed in all WPAI:MS domains, with significant reductions in Absenteeism (-4.2 [SD, 26.0], p = 0.0190) and Work Productivity Loss (-7.2 [SD, 28.6]; p = 0.0456). These changes were accompanied by a low ARR (0.1), and 87.9% of patients were relapse free. Significant improvement was observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6; p = 0.0295] and 6.3 [SD, 15.6; p = 0.0007], respectively) and SDMT score (increase of 2.4 [SD, 7.9; p = 0.0006]). Adverse events were reported in 32 of 104 patients (30.8%). CONCLUSIONS: The reductions in Absenteeism and Work Productivity Loss and the improved physical and psychological functioning reported after 1 year of natalizumab treatment in real-world settings extend our understanding of natalizumab's effects on patient-centric and health economics outcomes.
BACKGROUND: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed work ability, quality of life, and cognitive processing speed during natalizumab treatment. METHODS: WANT was a 1-year, prospective, multicenter observational study conducted in Italy. Inclusion criteria included relapsing-remitting multiple sclerosis (MS), natalizumab 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 after 1 year on natalizumab. Secondary endpoints included change in annualized relapse rate (ARR), Multiple Sclerosis Impact Scale (MSIS-29) score, and Symbol Digit Modalities Test (SDMT) score. RESULTS: At enrollment, the 91 patients had a mean age of 38.3 (standard deviation [SD], 9.0) years and a mean ARR of 1.5 (SD, 0.8). After 1 year, improvements were observed in all WPAI:MS domains, with significant reductions in Absenteeism (-4.2 [SD, 26.0], p = 0.0190) and Work Productivity Loss (-7.2 [SD, 28.6]; p = 0.0456). These changes were accompanied by a low ARR (0.1), and 87.9% of patients were relapse free. Significant improvement was observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6; p = 0.0295] and 6.3 [SD, 15.6; p = 0.0007], respectively) and SDMT score (increase of 2.4 [SD, 7.9; p = 0.0006]). Adverse events were reported in 32 of 104 patients (30.8%). CONCLUSIONS: The reductions in Absenteeism and Work Productivity Loss and the improved physical and psychological functioning reported after 1 year of natalizumab treatment in real-world settings extend our understanding of natalizumab's effects on patient-centric and health economics outcomes.
Entities:
Keywords:
Clinical outcomes; Cognitive function; Multiple sclerosis; Quality of life; Work productivity
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