Abstract: Resource Use, Employment Status, and Escalation to Second Line Therapy in Patients from the Benefit Study 11 Years after Onset of MS Symptoms (2015 CMSC Annual Meeting)

DX22
Resource Use, Employment Status, and Escalation to Second Line Therapy in Patients from the Benefit Study 11 Years after Onset of MS Symptoms

Friday, May 29, 2015

Griffin Hall

Edward J. Fox, MD, PhD , Central Texas Neurology Consultants, University of Texas Medical Branch, Round Rock, TX

Gilles Edan, MD , CHU-Hôpital Pontchaillou, Rennes, France

Mark S Freedman, MD , University of Ottawa and Ottawa Hospital Research Institute, Ottawa, ON, Canada

Xavier Montalbán, MD, PhD , Hospital Universitari Vall d’Hebron, Barcelona, Spain

Hans-Peter Hartung, MD, FRCP, FAAN, FANA , Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

Bernhard Hemmer, MD, PhD , Munich Cluster for Systems Neurology (SyNergy), Munich, Germany

Frederik Barkhof, MD, PhD , Department of Radiology & Nuclear Medicine, VU University Medical Center, Amsterdam, Netherlands

Sven Schippling, MD , University Hospital Zurich, Zurich, Switzerland

Andrea Schulze, PhD , PAREXEL International, Berlin, GA, Germany

Dirk Pleimes, MD , Myelo Therapeutics GmbH, Berlin, Germany

Christoph Pohl, MD , Department of Neurology, University Hospital of Bonn, Bonn, Germany

Rupert Sandbrink, MD , Heinrich-Heine University, Düsseldorf, Germany

Gustavo Suarez, MD , Bayer HealthCare Pharmaceuticals, Whippany, NJ

Eva-Maria Wicklein, MD , Bayer Pharma AG, Berlin, Germany

Ludwig Kappos, MD, PhD , University Hospital Basel, University of Basel, Basel, Switzerland

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Background: The BENEFIT trial demonstrated improved clinical outcomes in patients with a first event suggestive of MS (a clinically-isolated syndrome [CIS]) who had early treatment with interferon beta-1b up to 11 years after randomization.

Objectives: To describe employment status, resource use, and escalation to 2nd-line therapy 11 years after CIS to establish the long-term effects of early treatment with interferon beta-1b.

Methods: Patients with CIS had been randomly assigned to receive interferon beta-1b 250 μg (early treatment) or placebo (delayed treatment). After conversion to clinically definite MS or a maximum of 2 years, patients receiving placebo were offered active treatment. 11 years after the initial randomization, all patients from participating study centers were approached to participate in the study.

Results: 278 of the 468 patients originally enrolled in BENEFIT were evaluated (median age at onset 30 years). Both treatment groups had similar levels of resource use and employment status at Year 11. Most patients lived either with a partner or family (239 [86.0%]). 204 patients (73.4%) were employed at Year 11 compared with 81.3% at study entry. Of those, 64.4% were working >20 hours/week and 9.0% <20 hours/week (vs 75.9% and 5.4% respectively at study entry). 26 patients (9.4%) were retired at Year 11 (22 [7.9%] retired early), compared with 7 (2.5%) at study entry. 12 patients (4.3%) were on long-term disability. In the 12 months prior to the Year 11 assessment, 178 patients (64.0%) reported that they did not take any days off work (including school and housework) due to MS and 254 (91.4%) did not need hospitalization. 21 (7.6%) had home, car, or work adaptations. 14.3% of patients required escalation to 2nd-line therapies (including natalizumab, cyclophosphamide, mitoxantrone, alemtuzumab, cyclosporine, methotrexate, mycophenolate mofetil/mycophenolate sodium, cladribine, daclizumab, rituximab, sirolimus, tacrolimus, temsirolimus, or fingolimod).

Conclusions: Employment rate at study start reflected European averages and at Year 11 remained comparatively high while resource use was relatively low. Findings suggest that early treatment with interferon beta-1b can stabilize the disease enough to allow the majority of patients to remain employed, minimize their resource use over the long term, and avoid escalation to a 2nd-line therapy.

DX22 Resource Use, Employment Status, and Escalation to Second Line Therapy in Patients from the Benefit Study 11 Years after Onset of MS Symptoms

DX22
Resource Use, Employment Status, and Escalation to Second Line Therapy in Patients from the Benefit Study 11 Years after Onset of MS Symptoms