In the 2-year AFFIRM pivotal trial:

Relapsing MS patients received 300 mg TYSABRI every 28 days (n=627) or placebo (n=315). Patients with PPMS, SPMS, and PRMS were excluded.

83% of patients taking TYSABRI had no sustained disability progression for 12 weeks vs 71% with placebo (primary endpoint: 17% vs 29%; p<0.001)1,2


In 2 separate studies, patients taking TYSABRI reported statistically significant improvements in quality of life, with regard to health-related quality of life (HRQoL) and Quality of Life in Neurological Disorders (Neuro-QoL) scores

In an exploratory analysis of the pivotal trials, TYSABRI patients reported improved health-related quality of life (HRQoL) scores as early as 6 months after starting treatment3

Study description: A retrospective, exploratory analysis of the pivotal trials was performed to report the effects of TYSABRI on HRQoL as measured by the Short Form-36 (SF-36). Results shown below are exploratory outcomes of the AFFIRM trial.3,a

  • The SF-36 is a widely used, general HRQoL instrument that contains 36 items used to assess patients’ health status and its impact on their lives

aSF-36 HRQoL results are patient-reported.3

Study limitations:

  • Results are exploratory outcomes of the AFFIRM trial, and a number of calculations were made to evaluate data trends; therefore, marginal p values should be interpreted with caution
  • The standard minimally important difference cutoff of 5 points was derived from a disease-free population, thus it may be preferable to establish a minimally important difference in patients with RMS
  • Significance level for testing the difference between treatment groups was set at 0.05 with no correction for multiple analyses
  • HRQoL measures were completed at baseline and Weeks 24, 52, and 104. Earlier measures would have allowed better understanding of when patients might expect improvement after they start therapy, and testing between Weeks 52 and 104 would have provided insight into the stability of HRQoL benefits during the second year of treatment
  • HRQoL for 9% (8% TYSABRI, 10% placebo) of patients who withdrew from the study was not known. Reasons for discontinuation of TYSABRI were not collected

HRQoL improvements were observed with TYSABRI as early as 6 months after starting treatment and sustained out to 2 years3

Adapted from the American Medical Association by Wiley-Liss, Inc.

Bold rows with highlighted values: statistically significant compared with placebo.

Baseline scores and changes from baseline at Weeks 24, 52, and 104 are shown for all SF-36 scales.




Physical Function score was significantly greater at 6 months, 1 year, and 2 years (p<0.01) along with significant improvements in 6 of 8 individual HRQoL scales

Patients treated with TYSABRI reported mean improvements relative to placebo in a majority of scales by Year 2 (Week 104)3

Patients taking TYSABRI achieved significant improvements in the Physical Function, Role-Physical, General Health, Vitality, Social Function, and Role-Emotional scales at 2 years3

This study was funded by Biogen.

TYSABRI can produce clinically meaningful improvements in mental and social health4

Study description: MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions) is an ongoing, multinational, multicenter study to generate and collect standardized patient data during routine office visits from a large real-world cohort of MS patients. The study investigated the experiences reported by patients after starting natalizumab (n=164) using standard Neuro-QoL assessments of 12 domains related to physical, mental, and social health.5,6

  • Data were collected at routine visits from the large, real-world cohort of MS patients known as MS PATHS using the previously validated Multiple Sclerosis Performance Test (MSPT)
  • Neuro-QoL scores from visits following natalizumab initiation were compared with baseline Neuro-QoL scores to calculate the annualized rate of change
    • Patients completed the Neuro QoL, a comprehensive, self-reported, computer-adaptive battery of assessments for 12 domains
    • In the Neuro QoL, standardized T-scores for each domain are derived from patient responses on a 5-point scale related to their feelings or functioning in the prior 7 days
  • To evaluate the clinical relevance of changes, analyses were also conducted in patients with impairment in Neuro-QoL domains at baseline, defined as a T-score ≥55 for each of the negatively worded domains or ≤45 for each of the positively worded domains
  • A clinically meaningful change for each domain was defined as ≥5-point change (≥0.5 standard deviation [SD]) in T-score from baseline, previously identified as the threshold of discrimination of a minimally important difference using different quality-of-life tools in chronic diseases

Study limitations:

  • This is a real-world study that lacks randomization, and the results thus may be impacted by unconsidered variables or incomplete adjustment
  • The specific contribution of expectation bias—where patients have the expectation of benefit with study treatment—cannot be parsed in this study
  • The standard cutoff of ≥5 points or half of standard deviation in T-score from baseline was used to establish clinically meaningful change. The cutoff was based on the estimated effect size from several studies that included a mixed population of patients with diverse chronic diseases as well as some patients with MS5,6

Adjusted annualized rates of change in Neuro-QoL T-scores across all domains4

Bold rows with highlighted values are statistically significant.

eDue to reconfiguration of the Multiple Sclerosis Performance Test during the course of this study, 14 of the 164 patients did not provide responses to two of the Neuro-QoL domains—(1) positive affect and well-being and (2) emotional and behavioral dyscontrol—resulting in a total of 150 individual patient responses for these two domains.

fRate and CI are based on a multivariate-adjusted mixed-effects regression model.

Patients treated with TYSABRI in the overall population improved in 8 of 12 Neuro-QoL domains vs baseline4

Patients treated with TYSABRI who had baseline Neuro-QoL impairment improved in 10 of 12 domains4

Clinically meaningful change in Neuro-QoL T-Scores (Overall Population)4

Bold rows indicate that more patients achieved clinically meaningful improvement than worsening.

  • More than 75% of patients treated with TYSABRI remained stable or improved in each of the assessed domains
  • A greater proportion of patients treated with TYSABRI reported clinically meaningful improvement than worsening for all domains except lower extremity function and participation in social roles and activities, for which an equal number of patients worsened and improved

TYSABRI was shown to produce clinically meaningful improvements in mental and social health4