Siddhesh A. Kamat (HealthCore Inc., Wilmington, Delaware, USA) Krithika Rajagopalan (Biogen Idec, Cambridge, Massachusetts, USA) Judith J. Stephenson (HealthCore Inc., Wilmington, Delaware, USA) Sonalee Agarwal (Biogen Idec, Cambridge, Massachusetts, USA)
Abstract
Objective: To assess multiple sclerosis (MS) patients' experience with natalizumab (TYSABRI, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.) in a clinical practice setting. Abstract: Methods: MS patients who were enrolled in the TOUCH (TYSABRI Outreach Unified Commitment to Health) prescribing program and who had received their third natalizumab infusion participated in this study. Patient-reported measures included an overall quality-of-life (QOL) assessment, an adapted version of the Multiple Sclerosis Impact Scale-29 (MSIS-29), and pre-/post-disease level and functional status scores. MSIS-29 responses were modified to measure patient-perceived change since initiating natalizumab. Paired t-tests assessed pre-/post- changes in disease level and functional status, where negative change indicated improvement. Abstract: Results: Results from 451 patients in this study indicated that 73% were female and, on average, were diagnosed with MS >11 years previously. Almost all (96%) patients had used one or more MS drugs prior to natalizumab initiation. After receiving natalizumab, 97% of all patients reported an improvement or remained stable in their overall QOL. Despite the short treatment duration, there were significant improvements (mean ± SD change) in disease level (-0.26 ± 0.99, paired t-test - 5.47; p < 0.001) and functional status (-0.33 ± 0.73, paired t-test - 9.40; p < 0.001) scores. More than 80% of patients reported an improvement in one or more MSIS-29 physical items. The physical item on the adapted MSIS-29 with the highest reported improvement (58%) was 'the ability to do physically demanding tasks'. The physical item with the lowest reported improvement (32%) was 'problems using transport'. Abstract: Conclusion: Overall, the experiences of MS patients with natalizumab were positive in a clinical practice setting. Patients reported improvements in overall QOL, ambulation and functional status as early as after three natalizumab infusions. While preliminary, these early results are suggestive of a beneficial effect of natalizumab in patients with MS and warrant further long-term investigation of the impact of this treatment on patient outcomes.
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