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Quality Assessment in Multiple Sclerosis Therapy (QUASIMS)

A comparison of interferon beta therapies for relapsing-remitting multiple sclerosis

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Abstract

Interferon beta (IFNβ) preparations are the most frequently prescribed therapies for patients with relapsing multiple sclerosis (MS). Several open-label observational studies report similar efficacy among IFNβ preparations. The Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study is a large, open-label observational study designed to compare the effectiveness and tolerability of available IFNβ preparations as disease-modifying therapies for relapsing MS across a wide range of clinical practice settings. This retrospective, controlled cohort study was conducted by chart review at 510 sites in Germany, Austria, and Switzerland. Enrolled patients had received one of the four available IFNβ preparations/dosing regimens (intramuscular IFNβ-1a 30 µg 1×/week [Avonex®], subcutaneous (SC) IFNβ-1a 22 or 44 µg 3×/week [Rebif®], or SC IFNβ-1b 250 µg 3.5×/week [Betaferon/Betaseron®]) for ≥ 2 years. Preplanned outcomes at 1 and 2 years included change from baseline Expanded Disability Status Scale (EDSS) score, percentage of progression-free patients (< 1.0 EDSS point), annualised relapse rate (RR), percentage of relapse-free patients, and reasons for therapy change. Of 4754 evaluable patients, 3991 (84%) received IFNβ as initial therapy. There were no significant differences among IFNβs when used as initial or follow-up therapy on almost all outcome variables. Relapse rate was consistently higher and percentage of relapse-free patients consistently lower for all products used as follow-up versus initial therapy. Results of QUASIMS showed similar effectiveness among IFNβ products. Benefits were consistently superior when IFNβ was used as initial rather than follow-up therapy. Our results suggest that patients do not benefit in terms of disease outcome from switching between IFNβ preparations/dosing regimens.

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Acknowledgments

This study is supported by Biogen Idec GmbH, Ismaning, Germany. Study design was done by Volker Limmroth; data collection was done by the study sponsor; data analysis was done by an independent CRO; interpretation of the data was done by all authors and the CRO statistician; the report was written by the CRO; the manuscript was written by all authors; and the decision to submit the paper for publication was that of the authors, which was supported by the study sponsor.

We are indebted to Anke Richter, Biogen Idec GmbH, Germany, for her logistic support, Petra Schicklmaier, PhD, Biogen Idec GmbH, Germany, for reviewing the manuscript, Reto Kessler, Biogen Dompé, Switzerland, and Dr. Robert Bezar, Biogen Idec GmbH, Austria, for their support.

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Authors and Affiliations

  1. Dept. of Neurology, Cologne City Hospitals, University of Colognen, Ostmerheimerstr. 200, 51109, Cologne, Germany

    Volker Limmroth MD, PhD

  2. Sophien und Hufeland-Klinikum, Weimar, Germany

    Rolf Malessa MD, PhD

  3. Dept. of Neurology, University Hospital Rostock, Rostock, Germany

    Uwe Klaus Zettl MD, PhD

  4. Dept. of Neurology, University Hospital Mainz, Mainz, Germany

    Jürgen Koehler MD, PhD

  5. Neurology Clinic, Königstein-Falkenstein, Germany

    Gudrun Japp MD

  6. Neurology Clinic, Osnabrück, Germany

    Peter Haller MD, PhD

  7. Neurological Practice, Hamburg, Germany

    Wolfgang Elias MD

  8. Rehabilitation Clinic, Waldbronn, Germany

    Winfried Obhof MD

  9. Dept. of Neurology, University of Heidelberg, Heidelberg, Germany

    Andrea Viehöver MD

  10. Rehabilitation Centre, Grevenbroich, Germany

    Uwe Meier MD & Arne Brosig MD

  11. Dept. of Medical Informatics and Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany

    Joerg Hasford MD, PhD

  12. Dept. of Neurology, University Hospital Essen, Essen, Germany

    Norman Putzki MD

  13. Biogen Idec GmbH, Ismaning, Germany

    Gabriele Kalski PhD & Colin Wernsdörfer MD

Authors
  1. Volker Limmroth MD, PhD
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  2. Rolf Malessa MD, PhD
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  3. Uwe Klaus Zettl MD, PhD
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  4. Jürgen Koehler MD, PhD
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  5. Gudrun Japp MD
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  6. Peter Haller MD, PhD
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  7. Wolfgang Elias MD
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  8. Winfried Obhof MD
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  9. Andrea Viehöver MD
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  10. Uwe Meier MD
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  11. Arne Brosig MD
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  12. Joerg Hasford MD, PhD
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  13. Norman Putzki MD
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  14. Gabriele Kalski PhD
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  15. Colin Wernsdörfer MD
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for the QUASIMS Study Group

Corresponding author

Correspondence to Volker Limmroth MD, PhD.

Additional information

Received in revised form: 7 April 2006

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Limmroth, V., Malessa, R., Zettl, U.K. et al. Quality Assessment in Multiple Sclerosis Therapy (QUASIMS). J Neurol 254, 67–77 (2007). https://doi.org/10.1007/s00415-006-0281-1

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  • DOI: https://doi.org/10.1007/s00415-006-0281-1

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