NAGLAZYME® (galsulfase) improved endurance: 3-minute stair climb
- Week 24: Patients treated with NAGLAZYME demonstrated statistically significant improvement in the rate of stair climbing compared to placebo at week 24.7
- The rate in the group treated with NAGLAZYME was 19.4±4.1 stairs/min at baseline, increasing to 26.9±4.1 stairs/min at week 24.1
- In the longitudinal analysis, the difference between the mean change in the rates for the NAGLAZYME and placebo patients was 5.7±2.9 stairs/min and approached statistical significance (P=0.053, model-based mean difference).1
- The placebo group showed a near constant rate of climb: 31.0±18.1 stairs/min at baseline and 32.6±19.6 at week 24.1
- Week 96: In the group originally treated with NAGLAZYME, improvement in the rate of stair climbing was sustained through week 96.16
- At week 96, the group treated with NAGLAZYME showed a 13.1±2.0 stairs/min improvement from baseline. Additionally, there was an increase in the rates of stair climbing at week 96 compared with week 72 for this group.16,20
- Crossover: The placebo group began taking NAGLAZYME at week 24. After 72 weeks on NAGLAZYME therapy, this crossover group showed a 11.1±10.0 stairs/min increase in stair-climbing rate from the beginning of the open-label extension period.1
*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.
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