Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Neurology
Published in: BMC Neurology 1/2014

Open Access 01-12-2014 | Research article

Treatment satisfaction, adherence and behavioral assessment in patients de – escalating from natalizumab to interferon beta

Authors: Chiara Zecca, Gianna C Riccitelli, Pasquale Calabrese, Emanuele Pravatà, Ursula Candrian, Charles RG Guttmann, Claudio Gobbi

Published in: BMC Neurology | Issue 1/2014

Login to get access

Abstract

Background

De-escalating natalizumab (NTZ) to interferon beta 1b (IFN B 1B) is a possible treatment option in multiple sclerosis (MS) patients interrupting NTZ because of increased risk of progressive multifocal leukoencephalopathy (PML). The aim of this study was to evaluate satisfaction and adherence to treatment, behavioral and fatigue changes in patients switched to IFN B 1B compared to continued NTZ treatment.

Methods

A 1 year, prospective, randomized, rater-blinded, parallel-group study. Nineteen relapsing remitting (RR) MS patients, randomly assigned to undergo either NTZ (n = 10) or IFN B 1B (n = 9) treatment, who had previously received NTZ for at least 12 months with disease stability and fearing or at risk for PML were included. Patients underwent behavioral and treatment assessments at baseline, after 24-week and 1 year follow-up. Behavioral assessment included measures of cognition, fatigue and quality of life. Treatment assessment included measures of satisfaction, persistence and adherence to treatment. Clinical-radiological disease activity and safety were also assessed.

Results

Baseline characteristics of patients were similar between groups except for Euro Quality Visual Analogue Scale, being higher in the NTZ group (p = 0.04). Within-group comparisons at the three time points, as well as interaction analysis of treatment effect over time did not show any statistically significant differences in behavioral or treatment assessments, but a coherent trend favoring NTZ over IFN B 1B.

Conclusions

De-escalating NTZ to IFN B 1B is feasible and associated with overall good patient related outcome and persistently stable behavioral measures.
Appendix
Available only for authorised users
Literature
1.
Bloomgren G, Richman S, Hotermans C, Subramanyam M, Goelz S, Natarajan A, Lee S, Plavina T, Scanlon JV, Sandrock A, Bozic C: Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012, 366: 1870-1880. 10.1056/NEJMoa1107829.CrossRefPubMed
2.
Clifford DB, De Luca A, Simpson DM, Arent G, Giovannoni G, Nath A: Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol. 2010, 9: 438-446. 10.1016/S1474-4422(10)70028-4.CrossRefPubMed
3.
Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M: Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010, 68: 295-303. 10.1002/ana.22128.CrossRefPubMed
4.
Hunt D, Giovannoni G: Natalizumab-associated progressive multifocal leucoencephalopathy: a practical approach to risk profiling and monitoring. Pract Neurol. 2012, 12: 25-35. 10.1136/practneurol-2011-000092.CrossRefPubMed
5.
Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW: A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006, 354: 899-910. 10.1056/NEJMoa044397.CrossRefPubMed
6.
Sørensen PS, Bertolotto A, Edan G, Giovannoni G, Gold R, Havrdova E, Kappos L, Kieseier BC, Montalban X, Olsson T: Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult Scler. 2012, 18: 143-152. 10.1177/1352458511435105.CrossRefPubMed
7.
Trampe AK, Hemmelmann C, Stroet A, Haghikia A, Hellwig K, Wiendl H, Goelz S, Ziegler A, Gold R, Chan A: Anti-JC virus antibodies in a large German natalizumab-treated multiple sclerosis cohort. Neurology. 2012, 78: 1736-1742. 10.1212/WNL.0b013e3182583022.CrossRefPubMed
8.
Yousry TA, Major EO, Ryschkewitsch C, Fahle G, Fischer S, Hou J, Curfman B, Miszkiel K, Mueller-Lenke N, Sanchez E, Barkhof F, Radue EW, Jäger HR, Clifford DB: Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med. 2006, 354: 924-933. 10.1056/NEJMoa054693.CrossRefPubMedPubMedCentral
9.
O’Connor PW, Goodman A, Kappos L, Lublin FD, Miller DH, Polman C, Rudick RA, Aschenbach W, Lucas N: Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis. Neurology. 2011, 76: 1858-1865. 10.1212/WNL.0b013e31821e7c8a.CrossRefPubMed
10.
Fox R, Kappos L, Cree B, Kaufman M, Jeffery D, Weinstock-Guttman B, Hartung HP, Gold R, Montalban X, De Seze J, Natarajan A, Morse R, Ticho B, Duda P: Effects of a 24-week natalizumab treatment interruption on clinical and radiologic parameters of multiple sclerosis disease activity: the RESTORE study. Mult Scler. 2011, 17 (S10): S509-S510.
11.
Rossi S, Motta C, Studer V, De Chiara V, Barbieri F, Monteleone F, Fornasiero A, Coarelli G, Bernardi G, Cutter G, Stüve O, Salvetti M, Centonze D: Effect of glatiramer acetate on disease reactivation in MS patients discontinuing natalizumab. Eur J Neurol. 2013, 20: 87-94. 10.1111/j.1468-1331.2012.03794.x.CrossRefPubMed
12.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CR, Zecca C: Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial. BioMed Cent Neurol. 2013, 13: 101-
13.
Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O’Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS: Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol. 2005, 58: 840-846. 10.1002/ana.20703.CrossRefPubMed
14.
Gronwall DM: Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977, 44: 367-373. 10.2466/pms.1977.44.2.367.CrossRefPubMed
15.
Rudick RA, Cutter G, Reingold S: The multiple sclerosis functional composite: a new clinical outcome measure for multiple sderosis trials. Mult Scler. 2002, 8: 359-365. 10.1191/1352458502ms845oa.CrossRefPubMed
16.
Penner IK, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P: The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Mult Scler. 2009, 15: 1509-1517. 10.1177/1352458509348519.CrossRefPubMed
17.
Cella DF, Dineen K, Arnason B, Reder A, Webster KA, Karabatsos G, Chang C, Lloyd S, Steward J, Stefoski D: Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996, 47: 129-139. 10.1212/WNL.47.1.129.CrossRefPubMed
18.
Fayers P, Machin D: Quality of Life: The Assessment, Analysis and Interpretation of Patient Reported Outcomes. 2007, Chichester: J. Wiley, 2CrossRef
19.
Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK: Medication compliance and persistence: terminology and definitions. Value Health. 2008, 11 (1): 44-47. 10.1111/j.1524-4733.2007.00213.x.CrossRefPubMed
20.
Menzin J, Caon C, Nichols C, Ann White L, Friedman M, Pill MW: Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis. J Manag Care Pharm. 2013, 19 (1SupplA): S24-S40.PubMed
21.
Kurtzke JF: Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983, 33: 1444-1452. 10.1212/WNL.33.11.1444.CrossRefPubMed
22.
Moraal B, van den Elskamp IJ, Knol DL, Uitdehaag BM, Geurts JJ, Vrenken H, Pouwels PJ, van Schijndel RA, Meier DS, Guttmann CR, Barkhof F: Long-interval T2-weighted subtraction magnetic resonance imaging: a powerful new outcome measure in multiple sclerosis trials. Ann Neurol. 2010, 67: 667-675.PubMed
23.
West TW, Cree BA: Natalizumab dosage suspension: are we helping or hurting?. Ann Neurol. 2010, 68: 395-399. 10.1002/ana.22163.CrossRefPubMed
24.
Fischer JS, Priore RL, Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Goodkin DE, Granger CV, Simon JH, Grafman JH, Lezak MD, O’Reilly Hovey KM, Perkins KK, Barilla-Clark D, Schacter M, Shucard DW, Davidson AL, Wende KE, Bourdette DN, Kooijmans-Coutinho MF, Multiple Sclerosis Collaborative Research Group: Neuropsychological effects of interferon beta-1a in relapsing multiple sclerosis. Ann Neurol. 2000, 48: 885-892. 10.1002/1531-8249(200012)48:6<885::AID-ANA9>3.0.CO;2-1.CrossRefPubMed
25.
Portaccio E, Stromillo ML, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP: Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study. Eur J Neurol. 2013, 20: 986-990. 10.1111/j.1468-1331.2012.03882.x.CrossRefPubMed
26.
Hadjimichael O, Vollmer T, Oleen-Burkey M: Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey. Health Qual Life Outcomes. 2008, 6: 100-10.1186/1477-7525-6-100.CrossRefPubMedPubMedCentral
27.
Metz LM, Patten SB, Archibald CJ, Bakker JI, Harris CJ, Patry DG, Bell RB, Yeung M, Murphy WF, Stoian CA, Billesberger K, Tillotson L, Peters S, McGowan D: The effect of immunomodulatory treatment on multiple sclerosis fatigue. J Neurol Neurosurg Psychiatry. 2004, 75: 1045-1047. 10.1136/jnnp.2002.007724.CrossRefPubMedPubMedCentral
28.
Patti F, Amato MP, Trojano M, Bastianello S, Tola MR, Picconi O, Cilia S, Cottone S, Centonze D, Gasperini C, COGIMUS Study Group: Quality of life, depression and fatigue in mildly disabled patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: 3-year results from the COGIMUS (COGnitive Impairment in MUltiple Sclerosis) study. Mult Scler. 2011, 17: 991-1001. 10.1177/1352458511401943.CrossRefPubMed
29.
Putzki N, Katsarava Z, Vago S, Diener HC, Limmroth V: Prevalence and severity of multiple-sclerosis-associated fatigue in treated and untreated patients. Eur Neurol. 2008, 59: 136-142. 10.1159/000111876.CrossRefPubMed
30.
Putzki N, Yaldizli O, Tettenborn B, Diener HC: Multiple sclerosis associated fatigue during natalizumab treatment. J Neurol Sci. 2009, 285: 109-113. 10.1016/j.jns.2009.06.004.CrossRefPubMed
31.
Svenningsson A, Falk E, Celius EG, Fuchs S, Schreiber K, Berkö S, Sun J, Penner IK: Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting. PLoS One. 2013, 8: e58643-10.1371/journal.pone.0058643.CrossRefPubMedPubMedCentral
32.
Van Rossum JA, Vennegoor A, Uitdehaag BM BL, Polman CH, Killestein J: Safety, anxiety and natalizumab continuation in JC virus-seropositive MS patients. Mult Scler. 2014, 20 (1): 108-111. 10.1177/1352458513495582.CrossRefPubMed
33.
Fernandez O, Aguera E, Izquierdo G, Millán-Pascual J, Ramió I, Torrentà L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farrés J: Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012, 7: e35600-10.1371/journal.pone.0035600.CrossRefPubMedPubMedCentral
34.
Lugaresi A, Florio C, Brescia-Morra V, Cottone S, Bellantonio P, Clerico M, Centonze D, Uccelli A, di Ioia M, De Luca G, Marcellusi A, Paolillo A: Patient adherence to and tolerability of self-administered interferon beta-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study. BioMed Cent Neurol. 2012, 12: 7-
35.
Steinberg SC, Faris RJ, Chang CF, Chan A, Tankersley MA: Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig. 2010, 30: 89-100. 10.2165/11533330-000000000-00000.CrossRefPubMed
36.
Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L: Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010, 362: 402-415. 10.1056/NEJMoa0907839.CrossRefPubMed
37.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O’Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE study group: Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial. Neurology. 2002, 59: 1496-1506. 10.1212/01.WNL.0000034080.43681.DA.CrossRefPubMed
38.
Tan H, Cai Q, Agarwal S, Stephenson JJ, Kamat S: Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther. 2011, 28: 51-61. 10.1007/s12325-010-0093-7.CrossRefPubMed
39.
Havrdova E, Galetta S, Hutchinson M, Stefoski D, Bates D, Polman CH, O’Connor PW, Giovannoni G, Phillips JT, Lublin FD, Pace A, Kim R, Hyde R: Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. Lancet Neurol. 2009, 8: 254-260. 10.1016/S1474-4422(09)70021-3.CrossRefPubMed
40.
Hutchinson M, Kappos L, Calabresi PA, Confavreux C, Giovannoni G, Galetta SL, Havrdova E, Lublin FD, Miller DH, O’Connor PW, Phillips JT, Polman CH, Radue EW, Rudick RA, Stuart WH, Wajgt A, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA: The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. J Neurol. 2009, 256: 405-415. 10.1007/s00415-009-0093-1.CrossRefPubMed
Metadata
Title
Treatment satisfaction, adherence and behavioral assessment in patients de – escalating from natalizumab to interferon beta
Authors
Chiara Zecca
Gianna C Riccitelli
Pasquale Calabrese
Emanuele Pravatà
Ursula Candrian
Charles RG Guttmann
Claudio Gobbi
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2014
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/1471-2377-14-38

Other articles of this Issue 1/2014

BMC Neurology 1/2014 Go to the issue

Study protocol

Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial

Research article

Anti-leucine rich glioma inactivated 1 protein and anti-N-methyl-D-aspartate receptor encephalitis show distinct patterns of brain glucose metabolism in 18F-fluoro-2-deoxy-d-glucose positron emission tomography

Research article

Leukocyte count and incidence of subarachnoid haemorrhage: a prospective cohort study

Research article

Donepezil and life expectancy in Alzheimer’s disease: A retrospective analysis in the Tajiri Project

Research article

Post-stroke memory impairment among patients with vascular mild cognitive impairment

Research article

An open-label pilot trial of minocycline in children as a treatment for Angelman syndrome