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QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients

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Abstract

Treatment of symptoms and signs beyond the expanded disability status scale remains a major target in multiple sclerosis. QualiCOP was an observational, non-interventional, open-label study conducted at 170 sites in Germany. Of the 754 enrolled patients, 96 % had relapsing-remitting multiple sclerosis (MS) and were either disease-modifying therapy naïve (de novo, n = 481) or previously treated (n = 237) with once-daily, subcutaneous 20-mg/mL glatiramer acetate (GA). Assessments of relapse rate, disease progression, overall functioning, quality of life (QoL), cognition, fatigue, and depression were performed over 24 months. GA treatment over 24 months was associated with reduced annual relapse rate for previously treated (from 0.98 to 0.54 relapses) and de novo (from 0.81 to 0.48 relapses) patients. Multiple Sclerosis Functional Composite scores showed slight improvement in both cohorts (all p < 0.01). Paced Auditory Serial Addition Test and Multiple Sclerosis Inventory Cognition scale scores showed robust improvement in cognition among previously treated and de novo cohorts (all p < 0.001). General Depression Scale scores showed significantly reduced depressive symptoms (p < 0.001). Disease severity, fatigue, and QoL were stable over the observational period. These real-world findings suggest that patients with MS show benefit from GA treatment in important QoL parameters beyond standard measures of relapse and disease severity.

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References

  1. Johnson KP (2010) Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis. Ther Clin Risk Manag 6:153–172

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Zwibel H, Smrtka J (2011) Improving quality of life in multiple sclerosis: an unmet need. Am J Manag Care 17:S139–S145

    PubMed  Google Scholar 

  3. Krause I, Kern S, Horntrich A, Ziemssen T (2013) Employment status in multiple. Mult Scler 19(13):1792–1799

    Article  PubMed  Google Scholar 

  4. Ziemssen T (2009) Multiple sclerosis beyond EDSS: depression and fatigue. J Neurol Sci 227(suppl 1):S37–S41

    Article  Google Scholar 

  5. Freal JE, Kraft GH, Coryell JK (1984) Symptomatic fatigue in multiple sclerosis. Arch Phys Med Rehabil 65(3):135–138

    CAS  PubMed  Google Scholar 

  6. Williams AE, Vietri JT, Isherwood G, Flor A (2014) Symptoms and association with health outcomes in relapsing-remitting multiple sclerosis: results of a US patient survey. Mult Scler Int 2014:203183

    PubMed  PubMed Central  Google Scholar 

  7. Feinstein A (2002) An examination of suicidal intent in patients with multiple sclerosis. Neurology 59(5):674–678

    Article  PubMed  Google Scholar 

  8. Mohr DC, Goodkin DE, Likosky W et al (1996) Therapeutic expectations of patients with multiple sclerosis upon initiating interferon beta-1b: relationship to adherence to treatment. Mult Scler 2(5):222–226

    CAS  PubMed  Google Scholar 

  9. Syed M, Rog D, Parkes L, Shepherd GL (2014) Patient expectations and experiences of multiple sclerosis interferon β-1a treatment: a longitudinal, observational study in routine UK clinical practice. Patient Prefer Adherence 8:247–255

    Article  PubMed  PubMed Central  Google Scholar 

  10. Kern S, Reichmann H, Ziemssen T (2008) Adherence to neurologic treatment. Lessons from multiple sclerosis. Nervenarzt 79(8):877–890

    Article  CAS  PubMed  Google Scholar 

  11. Tan H, Cai Q, Agarwal S et al (2011) Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther 28(1):51–61

    Article  PubMed  Google Scholar 

  12. Johnson KP, Brooks BR, Cohen JA et al (1995) Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 45(7):1268–1276

    Article  CAS  PubMed  Google Scholar 

  13. Ziemssen T, Neuhaus O, Hohlfeld R (2011) Risk-benefit assessment of glatiramer acetate in multiple sclerosis. Drug Saf 24(13):979–990

    Article  Google Scholar 

  14. Ford C, Ladkani D (2013) Twenty years of continuous treatment of multiple sclerosis with glatiramer acetate 20 mg daily: long-term clinical results of the US open-label extension study. Presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). October 3, 2013; Copenhagen, Denmark

  15. Penner IK, Raselli C, Stöcklin M et al (2009) The Fatigue Scale for motor and cognitive functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Mult Scler 15(12):1509–1517

    Article  CAS  PubMed  Google Scholar 

  16. Calabrese P, Kessler J, Kalbe E (2004) Das Multiple Sklerose Inventar Cognition (MUSIC). Psychoneuro 30(7):384–388

    Article  Google Scholar 

  17. Kurtzke JF (1983) Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33(11):1444–1452

    Article  CAS  PubMed  Google Scholar 

  18. Ziemssen T, Calabrese P, Penne IK, Apfel R; QualiCOP Study Group (2014) QualiCOP: an open-label, prospective, observational study of glatiramer acetate in patients with relapsing-remitting multiple sclerosis. Presented at the Joint Congress of European Neurology, May 31–June 3, 2014; Istanbul, Turkey

  19. Hautzinger M, Bailer M (1993) Allgemeine Depressions Skala. Manual. Beltz Test GmbH, Göttingen

    Google Scholar 

  20. Polman CH, Reingold SC, Edan G et al (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 58(6):840–846

    Article  PubMed  Google Scholar 

  21. Ziemssen T, Hoffman J, Apfel R, Kern s (2008) Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis. Health Qual Life Outcomes 6:67

    Article  PubMed  PubMed Central  Google Scholar 

  22. Ziemssen T, Bajenaru O, Carrá A et al (2014) A 2-year observational study of patients with relapsing-remitting multiple sclerosis switching to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial. J Neurol 261(11):2101–2111

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Río J, Porcel J, Téllez N et al (2005) Factors related with treatment adherence to interferon beta and glatiramer acetate therapy in multiple sclerosis. Mult Scler 11(3):306–309

    Article  PubMed  Google Scholar 

  24. Jongen PJ, Lehnick D, Sanders E et al (2010) Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study. FOCUS Study Group. Health Qual Life Outcomes 8:133

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgments

Editorial and writing assistance was provided by Patricia C. Walter, Marie Bialek, and Nicholas C. Stilwell of Connexion Healthcare (Newtown, PA), with financial support from Teva Pharmaceutical Industries (Frazer, PA).

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Authors and Affiliations

  1. Center of Clinical Neuroscience, University Clinic Carl Gustav Carus, University of Technology Dresden, Fetscherstrasse 74, 01307, Dresden, Germany

    Tjalf Ziemssen

  2. Division of Molecular and Cognitive Neuroscience, University of Basel, Basel, Switzerland

    Pasquale Calabrese

  3. Department of Cognitive Psychology and Methodology, University of Basel, Basel, Switzerland

    Iris-Katharina Penner

  4. Teva Deutschland, Berlin, Germany

    Rainer Apfel

Authors
  1. Tjalf Ziemssen
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  2. Pasquale Calabrese
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  3. Iris-Katharina Penner
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  4. Rainer Apfel
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Corresponding author

Correspondence to Tjalf Ziemssen.

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Conflicts of interest

Tjalf Ziemssen has served on scientific advisory boards and has received scientific grants speaker honoraria from Bayer, Biogen Idec, Genzyme, Teva, Merck Serono, and Novartis. Pasquale Calabrese and Iris-Katharina Penner have no disclosures. Rainer Apfel was an employee of Teva Pharmaceutical Industries at the time of this study.

Ethical standards

This study was conducted in accordance with the 18th World Medical Assembly (Helsinki) recommendations and amendments, as well as guidelines for Good Epidemiology Practice. The study protocol was approved by the institutional review boards and independent ethics committees at all participating study locations; each site ensured all necessary regulatory submissions in accordance with local regulations including local data protection regulations. All patients provided informed, written consent according to local independent review board ruling.

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On behalf of the QualiCOP Study Group.

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Ziemssen, T., Calabrese, P., Penner, IK. et al. QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients. J Neurol 263, 784–791 (2016). https://doi.org/10.1007/s00415-016-8058-7

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  • DOI: https://doi.org/10.1007/s00415-016-8058-7

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