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

NAGLAZYME 12-minute walk test

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In the phase 3 trial, patients originally treated with NAGLAZYME:

  • Showed 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 (P= 0.025)7§
  • Experienced a 109±26 m improvement from baseline in mean distance walked at 12 minutes by week 24 (P<0.001)7* compared with a 25±24 m increase from baseline in the placebo group

By week 48:

  • The group treated with NAGLAZYME showed a 145±25 m improvement from baseline
  • The placebo group showed a 65±23 m increase from the beginning of the open-label extension period

* All data points shown are group mean difference from baseline. All percentages are calculated as percent change from baseline: group mean improvement as a proportion of group mean baseline value.
† Patients receiving placebo were switched to NAGLAZYME at the beginning of the open-label extension period. Patients in the drug group received NAGLAZYME for a total of 48 weeks; placebo/NAGLAZYME patients received NAGLAZYME during the 24-week open-label extension period only.
‡ One patient in the placebo/NAGLAZYME group failed to complete the assessment.
§For both measures of endurance, the baseline mean established at Week 0 was higher in the placebo group than in the group treated with NAGLAZYME.
One patient in the placebo/NAGLAZYME group left the study before Week 24 for reasons unrelated to treatment.

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.