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NAGLAZYME® (galsulfase) improved endurance: 12-minute walk test

NAGLAZYME 12-minute walk test

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  • Week 24: Patients treated with NAGLAZYME demonstrated statistically and clinically significant improvement compared to placebo in endurance as measured by a 12-minute walk test at week 24.7

- Patients in the group treated with NAGLAZYME experienced a 92±40 m increase (model-derived group mean difference adjusted for baseline) in mean distance walked at 12 minutes relative to those in the placebo group after 24 weeks of treatment in the double-blind study. This improvement was statistically significant (P=0.025, model-based mean difference).7,1

  • Week 96: In the group originally treated with NAGLAZYME, improvement in the 12-minute walk test was sustained through week 96.16,1

- At week 96, the group treated with NAGLAZYME showed a 183±26 m improvement from baseline.16 Additionally, there was an increase in distance walked at week 96 compared with week 72 for this group.20

  • Crossover: The placebo group began taking NAGLAZYME at week 24. After 72 weeks on NAGLAZYME therapy, this crossover group showed a 117±25 m increase from the beginning of the open-label extension period.16

  • Week 240: In an additional open-label extension study, patients receiving NAGLAZYME showed maintenance of initial improvement in endurance for approximately 240 weeks.16

*Fitted values.16
†By week 96, patients in the drug group had been taking NAGLAZYME for 96 weeks; patients in the placebo group had only been taking NAGLAZYME for the 72-week open-label extension period.
‡One patient in the placebo group left the study for reasons unrelated to treatment. Patients receiving placebo were switched to NAGLAZYME in the trial extension period.7
§One patient failed to complete the assessment.16

Next: Improved endurance - stair climb

References

  1. Harmatz P, Giugliani R, Schwartz I, et al. Enzyme replacement therapy for mucopolysaccharidosis VI: a Phase 3, randomized, double-blind, placebo-controlled, multinational study of recombinant human N-acetylgalactosamine 4-sulfatase (recombinant human arylsulfatase B or rhASB) and follow-on, open-label extension study. J Pediatr. 2006;148:533-539.
  1. Wraith JE. The mucopolysaccharidoses: a clinical review and guide to management. Arch Dis Childhood. 1995;72:263–267.
  1. Harmatz RP. Mucopolysaccharidosis type VI. Emedicine. December 18, 2006. Available at: http://www.Emedicine.com/PED/topic1373.htm Accessed: November 4, 2008.