Natalizumab is associated with early improvement of working ability in relapsing-remitting multiple sclerosis patients: WANT observational study results

被引:15
作者
Capra, Ruggero [1 ]
Morra, Vincenzo Brescia [2 ]
Mirabella, Massimiliano [3 ]
Gasperini, Claudio [4 ]
Scandellari, Cinzia [5 ]
Totaro, Rocco [6 ]
De Rossi, Nicola [1 ]
Masera, Silvia [7 ]
Zipoli, Valentina [7 ]
Patti, Francesco [8 ]
机构
[1] Spedali Civili Brescia, Multiple Sclerosis Ctr, Brescia, Italy
[2] Univ Studi Napoli Federico II, Dipartimento Neurosci Sci Riprodutt & Odontostoma, Naples, Italy
[3] Univ Cattolica Sacro Cuore, Fdn Policlin Univ A Gemelli IRCCS, Multiple Sclerosis Ctr, Rome, Italy
[4] San Camillo Forlanini Hosp, Dept Neurosci, Rome, Italy
[5] Osped Bellaria, UOsI Riabilitaz Sclerosi Multipla, IRCCS Ist Sci Neurol Bologna, Bologna, Italy
[6] San Salvatore Hosp, Multiple Sclerosis Ctr, Laquila, Italy
[7] Biogen, Cambridge, MA USA
[8] Univ Catania, Multiple Sclerosis Ctr, DANA Dept GF Ingrassia Med & Surg Sci Adv Technol, Catania, Italy
关键词
Multiple sclerosis; Quality of life; Work productivity; Cognitive function; Clinical outcomes; QUALITY-OF-LIFE; PRODUCTIVITY; VALIDITY; MS; DISABILITY; IMPACT; TRIAL; SCALE; TESTS;
D O I
10.1007/s10072-020-04838-z
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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收藏
页码:2837 / 2845
页数:9
相关论文
共 31 条
[1]   Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS [J].
Balcer, Laura J. ;
Galetta, Steven L. ;
Polman, Chris H. ;
Eggenberger, Eric ;
Calabresi, Peter A. ;
Zhang, Annie ;
Scanlon, James V. ;
Hyde, Robert .
JOURNAL OF THE NEUROLOGICAL SCIENCES, 2012, 318 (1-2) :119-124
[2]  
Butzkueven H, 2014, J NEUROL NEUROSUR PS, V85, P1190, DOI 10.1136/jnnp-2013-306936
[3]   Effects of multiple sclerosis disease-modifying therapies on employment measures using patient-reported data [J].
Chen, Jing ;
Taylor, Bruce V. ;
Blizzard, Leigh ;
Simpson, Steve, Jr. ;
Palmer, Andrew J. ;
van der Mei, Ingrid A. F. .
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 2018, 89 (11) :1200-1207
[4]   Caregiver burden, quality of life and walking ability in different disability levels of multiple sclerosis [J].
Ertekin, Ozge ;
Ozakbas, Serkan ;
Idiman, Egemen .
NEUROREHABILITATION, 2014, 34 (02) :313-321
[5]  
European Medicines Agency, 2020, TYSABRI NATALIZUMAB
[6]   Construct Validity of the Work Productivity and Activity Impairment Questionnaire across Informal Caregivers of Chronically Ill Older Patients [J].
Giovannetti, Erin R. ;
Wolff, Jennifer L. ;
Frick, Kevin D. ;
Boult, Chad .
VALUE IN HEALTH, 2009, 12 (06) :1011-1017
[7]   Clinically meaningful performance benchmarks in MS Timed 25-Foot Walk and the real world [J].
Goldman, Myla D. ;
Motl, Robert W. ;
Scagnelli, John ;
Pula, John H. ;
Sosnoff, Jacob J. ;
Cadavid, Diego .
NEUROLOGY, 2013, 81 (21) :1856-1863
[8]   Alemtuzumab CARE-MS I 5-year follow-up Durable efficacy in the absence of continuous MS therapy [J].
Havrdova, Eva ;
Arnold, Douglas L. ;
Cohen, Jeffrey A. ;
Hartung, Hans-Peter ;
Fox, Edward J. ;
Giovannoni, Gavin ;
Schippling, Sven ;
Selmaj, Krzysztof W. ;
Traboulsee, Anthony ;
Compston, D. Alastair S. ;
Margolin, David H. ;
Thangavelu, Karthinathan ;
Rodriguez, Claudio E. ;
Jody, Darlene ;
Hogan, Richard J. ;
Xenopoulos, Panos ;
Panzara, Michael A. ;
Coles, Alasdair J. .
NEUROLOGY, 2017, 89 (11) :1107-1116
[9]   The Multiple Sclerosis Impact Scale (MSIS-29) - A new patient-based outcome measure [J].
Hobart, J ;
Lamping, D ;
Fitzpatrick, R ;
Riazi, A ;
Thompson, A .
BRAIN, 2001, 124 :962-973
[10]   The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL [J].
Hutchinson, Michael ;
Kappos, Ludwig ;
Calabresi, Peter A. ;
Confavreux, Christian ;
Giovannoni, Gavin ;
Galetta, Steven L. ;
Havrdova, Eva ;
Lublin, Fred D. ;
Miller, David H. ;
O'Connor, Paul W. ;
Phillips, J. Theodore ;
Polman, Chris H. ;
Radue, Ernst-Wilhelm ;
Rudick, Richard A. ;
Stuart, William H. ;
Wajgt, Andrzej ;
Weinstock-Guttman, Bianca ;
Wynn, Daniel R. ;
Lynn, Frances ;
Panzara, Michael A. .
JOURNAL OF NEUROLOGY, 2009, 256 (03) :405-415