| Autor: |
Revel-Vilk, Shoshana, Mansfield, Royston, Feder-Krengel, Neta, Machtiger-Azoulay, Noya, Kuter, David, Szer, Jeff, Rosenbaum, Hanna, Ferreira, David Cavalcanti, Ruhrman-Shahar, Noa, Wajnrajch, Michael, Zimran, Ari |
| Předmět: |
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| Zdroj: |
Journal of Clinical Medicine; Sep2023, Vol. 12 Issue 18, p5913, 10p |
| Abstrakt: |
Taliglucerase alfa is an enzyme replacement therapy approved for Gaucher disease. We assessed the duration/compliance/safety of such home infusions in commercial use in four countries where home infusion programs are available. The treatment duration/compliance study included 173 patients (Israel, 58; US, 61; Brazil, 48; Australia, 6) who received ≥1 taliglucerase alfa home infusion through 6/2021. The median age at home therapy initiation was 38 (range, 2–87) years; 58% were females. The median treatment duration (at home) was 2.7 (range, 0.04–9.0) years. The annual compliance rate was stable (≥95%) throughout the study period. A search of the Pfizer global safety database (through 6/2021), identified 19 adverse events (AEs) as related to "definite home use" and 14 to "possible home use" of taliglucerase alfa; 42.4% of these AEs were serious; none were fatal. Twelve serious AEs in five separate case reports were considered treatment related: one case of chest discomfort/pain and hypertension and one case of erythema associated with a toe blister, for which causality could not be excluded; pain in extremity; projectile vomiting and chills, alongside excessive eye blinking; and an infusion-related AE (pruritus). In conclusion, this real-life global study demonstrated that taliglucerase alfa home infusions are safe with high compliance rates. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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