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.
引用
收藏
页码:2837 / 2845
页数:9
相关论文
共 31 条
[21]   Diagnostic Criteria for Multiple Sclerosis: 2010 Revisions to the McDonald Criteria [J].
Polman, Chris H. ;
Reingold, Stephen C. ;
Banwell, Brenda ;
Clanet, Michel ;
Cohen, Jeffrey A. ;
Filippi, Massimo ;
Fujihara, Kazuo ;
Havrdova, Eva ;
Hutchinson, Michael ;
Kappos, Ludwig ;
Lublin, Fred D. ;
Montalban, Xavier ;
O'Connor, Paul ;
Sandberg-Wollheim, Magnhild ;
Thompson, Alan J. ;
Waubant, Emmanuelle ;
Weinshenker, Brian ;
Wolinsky, Jerry S. .
ANNALS OF NEUROLOGY, 2011, 69 (02) :292-302
[22]   THE VALIDITY AND REPRODUCIBILITY OF A WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT INSTRUMENT [J].
REILLY, MC ;
ZBROZEK, AS ;
DUKES, EM .
PHARMACOECONOMICS, 1993, 4 (05) :353-365
[23]   Switching therapy from natalizumab to fingolimod in relapsing-remitting multiple sclerosis: clinical and magnetic resonance imaging findings [J].
Rinaldi, F. ;
Seppi, D. ;
Calabrese, M. ;
Perini, P. ;
Gallo, P. .
MULTIPLE SCLEROSIS JOURNAL, 2012, 18 (11) :1640-1643
[24]   Quantitative functional measures in MS: What is a reliable change? [J].
Schwid, SR ;
Goodman, AD ;
McDermott, MP ;
Bever, CF ;
Cook, SD .
NEUROLOGY, 2002, 58 (08) :1294-1296
[25]   Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study [J].
Stephenson, Judith J. ;
Kern, David M. ;
Agarwal, Sonalee S. ;
Zeidman, Ruth ;
Rajagopalan, Krithika ;
Kamat, Siddhesh A. ;
Foley, John .
HEALTH AND QUALITY OF LIFE OUTCOMES, 2012, 10
[26]   Cognition in multiple sclerosis: State of the field and priorities for the future [J].
Sumowski, James F. ;
Benedict, Ralph ;
Enzinger, Christian ;
Filippi, Massimo ;
Geurts, Jeroen J. ;
Hamalainen, Paivi ;
Hulst, Hanneke ;
Inglese, Matilde ;
Leavitt, Victoria M. ;
Rocca, Maria A. ;
Rosti-Otajarvi, Eija M. ;
Rao, Stephen .
NEUROLOGY, 2018, 90 (06) :278-288
[27]   Natalizumab Treatment Reduces Fatigue in Multiple Sclerosis. Results from the TYNERGY Trial; A Study in the Real Life Setting [J].
Svenningsson, Anders ;
Falk, Eva ;
Celius, Elisabeth G. ;
Fuchs, Siegrid ;
Schreiber, Karen ;
Berko, Sara ;
Sun, Jennifer ;
Penner, Iris-Katharina .
PLOS ONE, 2013, 8 (03)
[28]   The MS@Work study: a 3-year prospective observational study on factors involved with work participation in patients with relapsing-remitting Multiple Sclerosis [J].
van der Hiele, Karin ;
van Gorp, Dennis A. M. ;
Heerings, Marco A. P. ;
van Lieshout, Irma ;
Jongen, Peter J. ;
Reneman, Michiel F. ;
van der Klink, Jac J. L. ;
Vosman, Frans ;
Middelkoop, Huub A. M. ;
Visser, Leo H. .
BMC NEUROLOGY, 2015, 15
[29]   A 12-item short-form health survey - Construction of scales and preliminary tests of reliability and validity [J].
Ware, JE ;
Kosinski, M ;
Keller, SD .
MEDICAL CARE, 1996, 34 (03) :220-233
[30]   Beyond cognitive dysfunction: Relevance of ecological validity of neuropsychological tests in multiple sclerosis [J].
Weber, Erica ;
Goverover, Yael ;
DeLuca, John .
MULTIPLE SCLEROSIS JOURNAL, 2019, 25 (10) :1412-1419