Redefine your child’s XLH treatment with CRYSVITA® (burosumab-twza)

Clinical studies of children with XLH have shown that CRYSVITA can help by:

CRYSVITA helped increase and maintain phosphorus levels in the normal range

Increasing and maintaining phosphorus levels in the blood

CRYSVITA helped heal rickets and correct lower limb deformity

Healing rickets and helping to correct leg deformities

CRYSVITA helped increase height

Increasing growth

The benefits and risks of treatment with CRYSVITA were studied in a total of 65 children with XLH

Study 1

  • Number of patients: 52
  • Ages: 5-12 years old
  • Length of treatment: 64 weeks

Study 2

  • Number of patients: 13
  • Ages: 1-4 years old
  • Length of treatment: 64 weeks
CRYSVITA helped increase and maintain phosphorus levels in the normal range
CRYSVITA helped increase and maintain phosphorus levels in the normal range

Serum phosphorus

Phosphorus is a mineral that is important for healthy bones. Children with XLH have too little phosphorus, leading to weakening of their bones. In 2 CRYSVITA studies, children with XLH were given CRYSVITA every 2 weeks, and the level of phosphorus in their blood, described as “serum phosphorus,” was measured at Weeks 40 and 64.

CRYSVITA helped increase and maintain serum phosphorus in the normal range*

In Study 1, 26 children with XLH aged 5 to 12 years received CRYSVITA every 2 weeks.

Study 1

Serum Phosphorus Level (mg/dL)

In Study 2, 13 children with XLH aged 1 to 4 years received CRYSVITA every 2 weeks.

Study 2

Serum Phosphorus Level (mg/dL)

In Study 2, 13 children with XLH aged 1 to 4 years received CRYSVITA every 2 weeks.

Serum Phosphorus Level (mg/dL)

*Normal serum phosphorus levels for this group of patients ranged from 3.2 to 6.1 milligrams/deciliter (mg/dL). The normal range of serum phosphorus levels varies by age and gender.

Remember the treatment goals?

Talk to your child’s doctor about how CRYSVITA can help improve your child’s low phosphorus levels.

CRYSVITA helped heal rickets and correct lower limb deformity
CRYSVITA helped heal rickets and correct lower limb deformity

Rickets

At the beginning of a study of children with XLH aged 1 to 12 years (Studies 1 and 2), children had rickets of varying severity (as shown by X-rays). Patients were then given CRYSVITA every 2 weeks, and improvement of their rickets was examined at Weeks 40 and 64.

In these studies, 2 methods were used to assess XLH-related rickets:

  • Thacher Rickets Severity Score (RSS) is a 10-point scale used to assess the changes in the severity of rickets, and reduction in the RSS score corresponds to improvement in rickets severity
  • Radiographic Global Impression of Change (RGI-C) is a 7-point scale used to assess the healing of rickets, and an RGI-C score of ≥+2.0 means substantial healing of rickets

These scoring methods use X-rays of the wrists, legs, and knees and are assigned by independent experts.

CRYSVITA helped heal rickets

In Study 1, 26 children with XLH aged 5 to 12 years received CRYSVITA every 2 weeks.

In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to a reduction in the severity of rickets
In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to a reduction in the severity of rickets
  • *This number is from the Study 1 Week 40 least squares (LS) mean (SE) change of -1.1 (95% confidence interval [CI]: -1.28 to -0.85). LS mean is a statistic that estimates the mean after adjusting for the effect of other variables in the study, and the 95% CI is a range that includes possible values of the mean reduction in RSS.
  • †This number is from the Study 1 Week 64 LS mean (SE) change of -1.0 (95% CI: -1.2 to -0.79). Note that mean RSS (SD) at baseline was 1.9 (1.17).

In Study 1 at Week 40, 18 out of 26 (69%) patients achieved substantial healing (RGI-C ≥+2.0) of their rickets after receiving CRYSVITA every 2 weeks. This improvement was also maintained at 64 weeks.

In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to the healing of rickets
In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to the healing of rickets

*Substantial healing is defined as having an RGI-C score of ≥+2.0.

In Study 2, 13 children with XLH aged 1 to 4 years received CRYSVITA every 2 weeks.

In a study of children with XLH, aged 1 to 4 years, CRYSVITA led to the reduction in the severity of rickets
In a study of children with XLH, aged 1 to 4 years, CRYSVITA led to the reduction in the severity of rickets

*This number is from the Study 2 Week 40 least squares (LS) mean (SE) change of -1.7 (95% CI: -2.03 to -1.44). Note that mean RSS (SD) at baseline was 2.9 (1.37).

In Study 2 at Week 40, 13 out of 13 (100%) patients achieved substantial healing (RGI-C ≥+2.0) of their rickets after receiving CRYSVITA every 2 weeks. These patients also demonstrated improvements in lower limb deformities.

In a study of children with XLH, aged 1 to 4 years, CRYSVITA led to the healing of rickets
In a study of children with XLH, aged 1 to 4 years, CRYSVITA led to the healing of rickets

*Substantial healing is defined as having an RGI-C score of ≥+2.0.

Remember the treatment goals?

Talk to your child’s doctor about how CRYSVITA can help heal rickets.

CRYSVITA helped increase height
CRYSVITA helped increase height

Growth

In the study of children aged 5 to 12 years (Study 1), the majority of children with XLH were below the average height for their age. They were then given CRYSVITA every 2 weeks for a total of 64 weeks, and their height was measured again to evaluate changes.

Standing height z-score was used as a measurement of growth. This measurement is standardized according to the reference age and gender of children without XLH, as defined by guidelines from the Centers for Disease Control and Prevention (CDC).

Standing height z-score was used as a measurement of growth. This measurement is standardized according to the reference age and gender of children without XLH, as defined by guidelines from the Centers for Disease Control and Prevention (CDC).

CRYSVITA helped increase height

In Study 1, 26 children with XLH aged 5 to 12 years received CRYSVITA every 2 weeks.

In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to increased height z-score
In a study of children with XLH, aged 5 to 12 years, CRYSVITA led to increased height z-score
  • *This number is from the LS mean (SE) change of +0.19 (0.05) (95% confidence interval [CI]: 0.09 to 0.29). LS mean is a statistic that estimates the mean after adjusting for the effect of other variables in the study, and the 95% CI is a range that includes possible values for the change in height z-score.

Remember the treatment goals?

Talk to your child’s doctor about how CRYSVITA may help your child grow.