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Efficacy

Proven Efficacy in Clinical Trials Totalling 274 Patient-years of Treatment

Results

  • Height velocity increased in the first year, on average, to 8 cm/year from a baseline of 2.8 cm/year, nearly tripling the rate of growth (P<0.0001)1
  • In years 2 through 6, height velocity was sustained at approximately 5 cm/year.1
  • Change in bone age was appropriate for chronological age1

GROWTH RATE INCREASES WITH INCRELEX1*

GROWTH RATE INCREASES WITH INCRELEX

No patients dropped out of the trial due to adverse events:

  • Data shown are from individuals treated continuously in 5 clinical studies: 4 open label and 1 double blind, placebo controlled
  • Pre-treatment height velocity data were available for 58 subjects
  • 71 children 2 to 10 years old with average height SD score of -6.7 due to Primary IGFD. Mean treatment time was 3.9 years with 274 total patient-years of treatment1

*95% confidence intervals are shown


CUMULATIVE CHANGE IN HT-SDS WITH INCRELEX1

CUMULATIVE CHANGE IN HT-SDS WITH INCRELEX

Increlex improved height standard deviation scores1

  • Data shown are from individuals treated continuously in 5 clinical studies: 4 open label and 1 double blind, placebo controlled
  • Year 1 height was available for 61 subjects
  • Pre-treatment HT-SDS was -6.7 ± 1.8. By the end of the first year, the mean HT-SDS increased by 0.8 (P<0.0001), paired test, and had increased by 1.5 at year 8.

*95% confidence intervals are shown



Increlex [package insert]. Brisbane, Calif. Tercica; 2005.

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