CRYSVITA was effective in treating adults with TIO
Two clinical studies of adults with TIO showed that CRYSVITA may help by:
Increasing and maintaining phosphorus levels in the blood
Helping to heal soft or weak bone (osteomalacia)
How CRYSVITA was studied
The benefits and risks of treatment with CRYSVITA were looked at in a total of 27 adults with TIO
Phosphorus level results
CRYSVITA increased phosphorus levels in adults with TIO
In studies of CRYSVITA, adults with TIO had the level of phosphorus in their blood measured through week 144 (Study 6) and week 88 (Study 7).
CRYSVITA helped to increase and maintain phosphorus levels in the blood within or near the normal range
This chart shows the increase in average phosphorus levels in the blood for people in Study 6 (14 adults, ages 33-68 years).
Phosphorus levels in the blood increased from an average of 1.60 mg/dL at baseline to 2.64 mg/dL averaged across the midpoint of dose intervals through week 24 and were sustained near or within the normal range through week 144
CRYSVITA
7 out of 14 people had serum phosphorus levels in the normal range averaged across the midpoint of dose intervals through week 24
Phosphorus levels in the blood increased from an average of 1.62 mg/dL at baseline to 2.63 mg/dL averaged across the midpoint of dose intervals through week 24 and were sustained through week 88
CRYSVITA
9 out of 13 people had serum phosphorus levels in the normal range averaged across the midpoint of dose intervals through week 24
Osteomalacia results
CRYSVITA helped heal osteomalacia in adults with TIO
Under normal circumstances, minerals like phosphorus are continuously added to bones. This process, called mineralization, helps keep bones hard. People with TIO 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.
CRYSVITA helped improve bone mineralization in people with TIO
CRYSVITA
reduction in unmineralized or soft bone
In Study 6, a study of 14 adults with TIO aged 33-68 years, 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.
Study 7 also showed improvement in bone mineralization with CRYSVITA
- Study 7: 3 patients had bone samples taken both before and after treatment with CRYSVITA. In these patients, OV/BV was reduced by 34% after 48 weeks of CRYSVITA treatment
CRYSVITA reduced bone abnormalities caused by osteomalacia.
Bone scans taken during Study 6 showed that some people receiving CRYSVITA saw healing in their bone abnormalities at week 48 through week 144.