Facilitated subcutaneous immunoglobulin use in pediatric patients with primary or secondary immunodeficiency diseases.
Ulrich BaumannMaria FaßhauerChristine PauschHelmut WittkowskiCorinna HermannDavid PittrowMichael BortePublished in: Immunotherapy (2021)
Aim: While facilitated subcutaneous immunoglobulin (fSCIG) has been evaluated in pediatric patients with primary immunodeficiency diseases in clinical trials, real-world data are lacking. Materials & methods: This multicenter, retrospective, chart review study assessed fSCIG utilization in 30 patients less than 18 years old, with primary or secondary immunodeficiency diseases. Medical records were reviewed at fSCIG initiation and at 6 months. Results: Most (90%) patients received their first fSCIG infusion at a medical facility; by 6 months, all fSCIG infusions were administered at home by the patient/caregiver, the majority infusing every 3-4 weeks into a single site. No serious adverse drug reactions occurred. Conclusion: This study supports the feasibility and tolerability of administering fSCIG at home to pediatric patients with immunodeficiencies. Clinical Trial Registration: DRKS00015436 (German Clinical Trials Register).
Keyphrases
- clinical trial
- end stage renal disease
- adverse drug
- newly diagnosed
- chronic kidney disease
- healthcare
- prognostic factors
- open label
- phase ii
- double blind
- peritoneal dialysis
- cross sectional
- low dose
- emergency department
- study protocol
- big data
- machine learning
- artificial intelligence
- case report
- phase iii
- gestational age
- data analysis