CloseClose
Find a Drug
Advanced Search

Professional

Elaprase

Clinical Pharmacology
font size

Clinical Pharmacology

Elaprase

Examination of the individual components of the composite score showed that, in the adjusted analysis, the weekly ELAPRASE-treated group experienced a 35 meter greater mean increase in the distance walked in six minutes compared to placebo. The changes in %-predicted FVC were not statistically significant (Table 2).

Table 2 - Clinical Study Results


  ELAPRASE Weekly
n=32a		 Placebo
n=32a		 ELAPRASE
Weekly -
Placebo
Baseline Week 53 Changeb Baseline Week 53 Changeb Difference in
Change
Results from the 6-Minute Walk Test (Meters)
Mean ± SD 392 ± 108 436 ± 138 44 ± 70 393 ± 106 400 ± 106 7 ± 54 37 ± 16c
35 ± 14d
(p=0.01)
Median 397 429 31 403 412 -4
Percentiles (25th, 75th) 316, 488 365, 536 0, 94 341, 469 361, 460 -30, 31
Results from the Forced Vital Capacity Test (% of Predicted)
Mean ± SD 55.3 ± 15.9 58.7 ± 19.3 3.4 ± 10.0 55.6 ± 12.3 56.3 ± 15.7 0.8 ± 9.6 2.7 ± 2.5c
4.3 ± 2.3d
(p=0.07)
Median 54.9 59.2 2.1 57.4 54.6 -2.5
Percentiles (25th, 75th) 43.6, 69.3 44.4, 70.7 -0.8, 9.5 46.9, 64.4 43.8, 67.5 -5.4, 5.0
a One patient in the placebo group and one patient in the ELAPRASE group died before Week 53; imputation wasby last observation carried forward in the intent-to-treat analysis
b Change, calculated as Week 53 minus Baseline
c Observed mean ± SE
d ANCOVA model based mean ± SE, adjusted for baseline disease severity, region, and age.

Measures of bioactivity were urinary GAG levels and changes in liver and spleen size. Urinary GAG levels were elevated in all patients at baseline. Following 53 weeks of treatment, mean urinary GAG levels were markedly reduced in the ELAPRASE weekly group, although GAG levels still remained above the upper limit of normal in half of the ELAPRASE-treated patients. Urinary GAG levels remained elevated and essentially unchanged in the placebo group. Sustained reductions in both liver and spleen volumes were observed in the ELAPRASE weekly group through Week 53 compared to placebo. There were essentially no changes in liver and spleen volumes in the placebo group.

Brand Name: Elaprase
Generic Name: Idursulfase Solution
Bookmark this page:

Privacy Policy

Women's Health

Find out what women really need.

WebMD Symptom Checker - Start Here Ringworm Slideshow: Watch and Learn

Herbal First AidHerbal First Aid
Herbal medicine is ancient, but only in recent years have many people started to take notice of its all natural healing powers. See more WebMD Videos »