A snapshot on patient-reported outcome measures of people with multiple sclerosis on first-line therapies in a real world setting.
Disease-modifying therapies
First-line therapies
Multiple sclerosis
Patient-reported outcomes
Journal
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
ISSN: 1590-3478
Titre abrégé: Neurol Sci
Pays: Italy
ID NLM: 100959175
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
28
12
2019
accepted:
20
03
2020
pubmed:
11
5
2020
medline:
15
5
2021
entrez:
11
5
2020
Statut:
ppublish
Résumé
Patient-reported outcomes (PROs) may help patients and clinicians in selecting disease-modifying therapies (DMTs) for multiple sclerosis (MS). To evaluate PRO differences among first-line DMTs for relapsing-remitting (RR) people with MS (pwMS). Multicenter study. RR pwMS on first-line DMTs completed Fatigue Severity Scale (FSS), PROs Indices for MS (PRIMUS), 36-item Short-Form Health Survey (SF-36), treatment satisfaction questionnaire for medication (TSQM), Beck Depression Inventory-II (BDI-II), and Symbol Digit Modalities Test (SDMT). Differences among PROs across DMTs were tested by ANOVA. Multivariable linear regressions were used to investigate associations between PROs and the treatment group. Two-hundred eighty pwMS were enrolled: 56% were on interferons (INF), 22% on dimethylfumarate (DMF), 13% on glatiramer acetate, and 9% on teriflunomide (Teri). Compared with INF, pwMS on Teri were the oldest, with higher disability, worst depression at BDI, worst cognitive performances at SDMT (p = 0.001), fatigue at FSS (p = 0.001), and activity limitation and quality of life respectively at PRIMUS (p = 0.005) and SF-36 Mental Composite Score (p < 0.001); pwMS on DMF reported highest side effects and, together with pwMS on Teri, better treatment satisfaction at TSQM. Compared with INF-treated patients, pwMS on DMF and Teri reported the best treatment satisfaction, although DMF-treated pwMS reported higher side effects and those on Teri the worst QoL and fatigue; however, the older age, higher disability and depression, and worse cognitive performance of pwMS on Teri suggest to be careful in evaluating these results.
Sections du résumé
BACKGROUND
BACKGROUND
Patient-reported outcomes (PROs) may help patients and clinicians in selecting disease-modifying therapies (DMTs) for multiple sclerosis (MS).
OBJECTIVE
OBJECTIVE
To evaluate PRO differences among first-line DMTs for relapsing-remitting (RR) people with MS (pwMS).
METHODS
METHODS
Multicenter study. RR pwMS on first-line DMTs completed Fatigue Severity Scale (FSS), PROs Indices for MS (PRIMUS), 36-item Short-Form Health Survey (SF-36), treatment satisfaction questionnaire for medication (TSQM), Beck Depression Inventory-II (BDI-II), and Symbol Digit Modalities Test (SDMT). Differences among PROs across DMTs were tested by ANOVA. Multivariable linear regressions were used to investigate associations between PROs and the treatment group.
RESULTS
RESULTS
Two-hundred eighty pwMS were enrolled: 56% were on interferons (INF), 22% on dimethylfumarate (DMF), 13% on glatiramer acetate, and 9% on teriflunomide (Teri). Compared with INF, pwMS on Teri were the oldest, with higher disability, worst depression at BDI, worst cognitive performances at SDMT (p = 0.001), fatigue at FSS (p = 0.001), and activity limitation and quality of life respectively at PRIMUS (p = 0.005) and SF-36 Mental Composite Score (p < 0.001); pwMS on DMF reported highest side effects and, together with pwMS on Teri, better treatment satisfaction at TSQM.
CONCLUSIONS
CONCLUSIONS
Compared with INF-treated patients, pwMS on DMF and Teri reported the best treatment satisfaction, although DMF-treated pwMS reported higher side effects and those on Teri the worst QoL and fatigue; however, the older age, higher disability and depression, and worse cognitive performance of pwMS on Teri suggest to be careful in evaluating these results.
Identifiants
pubmed: 32388646
doi: 10.1007/s10072-020-04367-9
pii: 10.1007/s10072-020-04367-9
doi:
Substances chimiques
Glatiramer Acetate
5M691HL4BO
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
3235-3241Références
Laroni A, Signori A, Maniscalco GT, Lanzillo R, Russo CV, Binello E, Lo Fermo S, Repice A, Annovazzi P, Bonavita S, Clerico M, Baroncini D, Prosperini L, la Gioia S, Rossi S, Cocco E, Frau J, Torri Clerici V, Signoriello E, Sartori A, Zarbo IR, Rasia S, Cordioli C, Cerqua R, di Sapio A, Lavorgna L, Pontecorvo S, Barrilà C, Saccà F, Frigeni B, Esposito S, Ippolito D, Gallo F, Sormani MP, iMUST group. (2017) Assessing association of comorbidities with treatment choice and persistence in MS: a real-life multicenter study. Neurology 89: 2222–2229
D’Amico E, Leone C, Caserta C et al (2015) Oral drugs in multiple sclerosis therapy: an overview and a critical appraisal. Expert Rev Neurother 15:803–824
doi: 10.1586/14737175.2015.1058162
Lanzillo R, Prosperini L, Gasperini C, Moccia M, Fantozzi R, Tortorella C, Nociti V, Annovazzi P, Cavalla P, Radaelli M, Malucchi S, Clerici VT, Boffa L, Buttari F, Ragonese P, Maniscalco GT, di Filippo M, Buscarinu MC, Pinardi F, Gallo A, Coghe G, Pesci I, Laroni A, Gajofatto A, Calabrese M, Tomassini V, Cocco E, Solaro C, R.I.Re.MS study group. (2018) R.I.Re.MS study group. A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study. J Neurol 265(5):1174–1183
Havrdova E, Galetta S, Stefoski D et al (2010) Freedom from disease activity in multiple sclerosis. Neurology 74(Suppl. 3):S3–S7
doi: 10.1212/WNL.0b013e3181dbb51c
US Department of Health and Human Services Food and Drug Administration, FDA (2009). Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims
Speight J, Barendse SM (2010) FDA guidance on patient reported outcomes. BMJ 340:c292
doi: 10.1136/bmj.c2921
Giovannoni G, Tomic D, Bright JR et al (2017) “No evident disease activity”: the use of combined assessments in the management of patients with multiple sclerosis. Mult Scler 23(9):1179–1187
doi: 10.1177/1352458517703193
Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483
doi: 10.1097/00005650-199206000-00002
Doward LC, McKenna SP, Meads DM, Twiss J, Eckert BJ (2009) The development of patient-reported outcome indices for multiple sclerosis (PRIMUS). Mult Scler 15(9):1092–1102
doi: 10.1177/1352458509106513
Atkinson MJ, Sinha A, Hass SL et al (2004) Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2:12
doi: 10.1186/1477-7525-2-12
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD (1989) The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 46:1121–1123
doi: 10.1001/archneur.1989.00520460115022
Beck AT, Steer RA, Brown GA (1996) Beck Depression Inventory-II (BDI-II) manual. Pearson, Oxford, England
Learmonth YC, Motl RW, Sandroff BM et al (2013) Validation of patient determined disease steps (PDDS) scale scores in persons with multiple sclerosis. BMC Neurol 13:37
doi: 10.1186/1471-2377-13-37
Lavorgna L, Sparaco M, Esposito S, Motl RW, Gallo A, Bisecco A, Tedeschi G, Bonavita S (2017) Validity and reproducibility of the Italian version of the patient determined disease steps scale in people with multiple sclerosis. Mult Scler Relat Disord 18:173–176
doi: 10.1016/j.msard.2017.09.027
Lavorgna L, Miele G, Petruzzo M, Lanzillo R, Bonavita S (2018) Online validation of the Italian version of the patient determined disease steps scale (PDDS) in people with multiple sclerosis. Mult Scler Relat Disord. 21:108–109
doi: 10.1016/j.msard.2018.02.014
Tur C, Moccia M, Barkhof F, Chataway J, Sastre-Garriga J, Thompson AJ, Ciccarelli O (2018) Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting. Nat Rev Neurol 14(2):75–93
doi: 10.1038/nrneurol.2017.171
Benedict, R.H., DeLuca, J., Phillips, G., LaRocca N., Hudson L.D., Rudick R., Multiple Sclerosis Outcome Assessments Consortium. (2017) Validity of the symbol digit modalities test as a cognition performance outcome measure for multiple sclerosis. Mult Scler 23(5): 721–733
Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L (2014) Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther 36(12):1958–1971
doi: 10.1016/j.clinthera.2014.08.013
Saccà F, Lanzillo R, Signori A, et al. (2018) On behalf of the iMUST group. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: a real-life study. Mult Scler 1352458518790390
Coyle PK, Khatri B, Edwards KR et al (2018) Teri-PRO trial group. Patient-reported outcomes in patients with relapsing forms of MS switching to teriflunomide from other disease-modifying therapies: results from the global phase 4 Teri-PRO study in routine clinical practice. Mult Scler Relat Disord. 26:211–218
doi: 10.1016/j.msard.2018.09.017
Apolone G, Mosconi P (1998) The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol 51(11):1025–1036
doi: 10.1016/S0895-4356(98)00094-8
Condé S, Moisset X, Pereira B, Zuel M, Colamarino R, Maillet-Vioud M, Lauxerois M, Taithe F, Clavelou P, Réseau NeuroSEP Auvergne. (2018) Dimethyl-fumarate and teriflunomide for multiple sclerosis in a real-life setting: a French retrospective cohort study. Eur J Neurol 26(3):460–467