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

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

CRYSVITA led to increased and maintained serum phosphorus levels within the normal range

Increasing and maintaining phosphorus levels in the blood

CRYSVITA led to the healing of fractures and osteomalacia

Healing fractures and osteomalacia

CRYSVITA improved joint stiffness

Decreasing XLH-related joint stiffness

The risks and benefits of treatment with CRYSVITA were studied in a total of 148 adults with XLH

Study 4

  • Number of patients: 134
  • Ages: 19 to 66 years
  • Length of treatment: 48 weeks

Study 5

  • Number of patients: 14
  • Ages: 25 to 52 years
  • Length of treatment: 48 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. Adults with XLH have too little phosphorus, leading to weakening of their bones. In Study 4, adults with XLH were given either CRYSVITA or a placebo (an injection that did not contain any active medicine) every 4 weeks for 24 weeks, and the amount of phosphorus in their blood, described as “serum phosphorus,” was measured. At Week 24, adults who were given placebo were switched to CRYSVITA every 4 weeks, and both groups were re-evaluated at Week 48.

CRYSVITA helped increase and maintain serum phosphorus levels within the normal range*

In a study of adults with XLH aged 19 to 66 years (Study 4), 68 adults received CRYSVITA and 66 adults received placebo every 4 weeks for 24 weeks, followed by 24 weeks with all 134 adults on CRYSVITA.

CRYSVITA increasd the percentage of patients who achieved serum phosphorus levels in the normal range
CRYSVITA increasd the percentage of patients who achieved serum phosphorus levels in the normal range
  • *Normal levels of serum phosphorus for this group of patients ranged from 2.5 to 4.5 milligrams/deciliter (mg/dL). The normal range of serum phosphorus varies by age and gender.

At baseline, both patients in the CRYSVITA and placebo groups had phosphorus levels below the normal range. At 24 weeks of treatment with CRYSVITA or placebo every 4 weeks, there were more patients who achieved phosphorus levels within the normal range in the CRYSVITA group than in the placebo group. After 24 weeks of treatment, all patients were placed on CRYSVITA. Serum phosphorus levels were maintained through Week 48 with CRYSVITA treatment.

Remember the treatment goals?

Talk to your doctor about how CRYSVITA can help increase and maintain normal serum phosphorus levels.

CRYSVITA led to the healing of fractures
CRYSVITA led to the healing of fractures

Fractures

In adults with XLH, ongoing osteomalacia can result in what’s called “low trauma” fractures or pseudofractures. Pseudofracture is a kind of fracture where the bone thickens at the site of an injury but is not completely broken. These symptoms can manifest as a result of bearing weight on weak bones.

CRYSVITA healed fractures

In a study of adults with XLH aged 19 to 66 years (Study 4), 68 adults received CRYSVITA and 66 adults received placebo every 4 weeks for 24 weeks, followed by 24 weeks during which all patients received CRYSVITA. At the beginning of the study, there were 65 total fractures in the CRYSVITA group and 91 total fractures in the placebo group.

CRYSVITA helped heal a greater percentage of fractures than placebo
CRYSVITA helped heal a greater percentage of fractures than placebo

During treatment through Week 24, a total of 6 new fractures or pseudofractures appeared in 68 patients in the CRYSVITA group, compared with 8 new abnormalities in 66 patients in the placebo group.

Remember the treatment goals?

Talk to your doctor about how CRYSVITA can help with fracture healing.

CRYSVITA led to the healing of osteomalacia and fractures
CRYSVITA led to the healing of osteomalacia and fractures

Osteomalacia

Under normal conditions, minerals like phosphorus are continuously added to bones. This process, called “mineralization,” helps to keep bones hard. People with XLH don’t have enough phosphorus for bones to properly mineralize, which causes some parts of the bone to become “soft” and more likely to break. “Softening” and weakening of the bones is called osteomalacia.

In a study of adults with XLH aged 25 to 52 years (Study 5), small samples of bone were taken and examined for signs of healing of osteomalacia. Bone samples were taken before patients started treatment with CRYSVITA and then again after the patients were treated with CRYSVITA every 4 weeks for 48 weeks.

CRYSVITA helped heal osteomalacia

In Study 5, 14 adults with XLH aged 25 to 52 years received CRYSVITA every 4 weeks.

71% of patients on CRYSVITA showed healing of osteomalacia
71% of patients on CRYSVITA showed healing of osteomalacia

Healing of osteomalacia was observed in 10 out of 14 (71%) patients. Their bone biopsies showed a 57% reduction in osteoid volume to bone volume, which is a measurement of unmineralized bone.

Remember the treatment goals?

Talk to your doctor about how CRYSVITA can help heal osteomalacia.

CRYSVITA improved joint stiffness
CRYSVITA improved joint stiffness

Joint stiffness

Osteomalacia and deformities of the bones and joints can lead to several physical symptoms of disease. Adults with XLH often report joint stiffness, pain, and impaired physical function as part of their disease symptoms.

CRYSVITA improved XLH-related joint stiffness in adults

In a study of adults with XLH aged 19 to 66 years (Study 4), 68 adults received CRYSVITA and 66 adults received placebo every 4 weeks for 24 weeks.

CRYSVITA improved patient-reported joint stiffness vs placebo
CRYSVITA improved patient-reported joint stiffness vs placebo
  • In Study 4, patient-reported joint stiffness was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). At Week 24, CRYSVITA showed improvement from baseline (-7.9), compared with placebo (+0.3) in the stiffness severity score (range 0 to 100; lower scores reflect symptom improvement).

No significant difference between CRYSVITA and placebo was observed in patient-reported pain intensity or physical function

Remember the treatment goals?

Talk to your doctor about how CRYSVITA may help decrease XLH-related joint stiffness.