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Published in: Neurological Sciences 11/2020

01-11-2020 | Multiple Sclerosis | Original Article

A snapshot on patient-reported outcome measures of people with multiple sclerosis on first-line therapies in a real world setting

Authors: R. Lanzillo, M. Sparaco, L. Lavorgna, L. Carmisciano, E. Signoriello, A. Signori, T. Costabile, G. T. Maniscalco, F. Saccà, S. Cepparulo, C. V. Russo, A. Bisecco, N. Frattaruolo, A. Strianese, G. Lus, V. Brescia Morra, S. Bonavita

Published in: Neurological Sciences | Issue 11/2020

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Abstract

Background

Patient-reported outcomes (PROs) may help patients and clinicians in selecting disease-modifying therapies (DMTs) for multiple sclerosis (MS).

Objective

To evaluate PRO differences among first-line DMTs for relapsing-remitting (RR) people with MS (pwMS).

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

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

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.
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Literature
1.
go back to reference 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 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
2.
go back to reference 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 15:803–824CrossRef 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 15:803–824CrossRef
3.
go back to reference 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 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
4.
go back to reference Havrdova E, Galetta S, Stefoski D et al (2010) Freedom from disease activity in multiple sclerosis. Neurology 74(Suppl. 3):S3–S7CrossRef Havrdova E, Galetta S, Stefoski D et al (2010) Freedom from disease activity in multiple sclerosis. Neurology 74(Suppl. 3):S3–S7CrossRef
5.
go back to reference 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 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
6.
go back to reference Speight J, Barendse SM (2010) FDA guidance on patient reported outcomes. BMJ 340:c292CrossRef Speight J, Barendse SM (2010) FDA guidance on patient reported outcomes. BMJ 340:c292CrossRef
7.
go back to reference 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):1179–1187CrossRef 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):1179–1187CrossRef
8.
go back to reference Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483CrossRef Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483CrossRef
9.
go back to reference 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):1092–1102CrossRef 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):1092–1102CrossRef
10.
go back to reference 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 2:12CrossRef 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 2:12CrossRef
11.
go back to reference 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 46:1121–1123CrossRef 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 46:1121–1123CrossRef
12.
go back to reference Beck AT, Steer RA, Brown GA (1996) Beck Depression Inventory-II (BDI-II) manual. Pearson, Oxford, England Beck AT, Steer RA, Brown GA (1996) Beck Depression Inventory-II (BDI-II) manual. Pearson, Oxford, England
13.
go back to reference 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 13:37CrossRef 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 13:37CrossRef
14.
go back to reference 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 18:173–176CrossRef 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 18:173–176CrossRef
15.
go back to reference 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. 21:108–109CrossRef 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. 21:108–109CrossRef
16.
go back to reference 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):75–93CrossRef 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):75–93CrossRef
17.
go back to reference 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 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
18.
go back to reference 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):1958–1971CrossRef 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):1958–1971CrossRef
19.
go back to reference 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 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
20.
go back to reference 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. 26:211–218CrossRef 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. 26:211–218CrossRef
21.
go back to reference Apolone G, Mosconi P (1998) The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol 51(11):1025–1036CrossRef Apolone G, Mosconi P (1998) The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol 51(11):1025–1036CrossRef
22.
go back to reference 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 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
Metadata
Title
A snapshot on patient-reported outcome measures of people with multiple sclerosis on first-line therapies in a real world setting
Authors
R. Lanzillo
M. Sparaco
L. Lavorgna
L. Carmisciano
E. Signoriello
A. Signori
T. Costabile
G. T. Maniscalco
F. Saccà
S. Cepparulo
C. V. Russo
A. Bisecco
N. Frattaruolo
A. Strianese
G. Lus
V. Brescia Morra
S. Bonavita
Publication date
01-11-2020
Publisher
Springer International Publishing
Published in
Neurological Sciences / Issue 11/2020
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-020-04367-9

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