title: Impact of natalizumab on patient-reported outcomes in a clinical practice setting: a cross-sectional survey.
abstract: OBJECTIVE
  : To assess multiple sclerosis (MS) patients' experience with natalizumab (TYSABRI, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.) in a clinical practice setting.
  
  
  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.
  
  
  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'.
  
  
  CONCLUSIONS
  : 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.
authors.affiliation: 1 HealthCore Inc., Wilmington, Delaware, USA 2 Biogen Idec, Cambridge, Massachusetts, USA.
authors.forename: Siddhesh A
authors.initials: SA
authors.lastname: Kamat
authors.forename: Krithika
authors.initials: K
authors.lastname: Rajagopalan
authors.forename: Judith J
authors.initials: JJ
authors.lastname: Stephenson
authors.forename: Sonalee
authors.initials: S
authors.lastname: Agarwal