Michael Borte, Germany

Hospital for Children and Adolescents, St. Georg Hospital Immunology

Presenter of 2 Presentations

Poster Display Therapy

FACILITATED IMMUNOGLOBULIN ADMINISTRATION REGISTRY AND OUTCOMES STUDY (FIGARO): INTERIM RESULTS

Lecture Time
10:12 - 10:13
Room
Poster Area
Date
20.09.2019, Friday
Session Time
10:00 - 17:00
Board Number
160
Presentation Topic
Therapy

Abstract

Background and Aims

HyQvia (facilitated subcutaneous immunoglobulin [fSCIG]) is a dual-vial unit of recombinant human hyaluronidase (rHuPH20) and 10% normal immunoglobulin (IgG) solution. In the registration study, fSCIG was effective, safe, and bioequivalent to intravenous IgG at the same administration intervals, with fewer systemic reactions. FIGARO will provide real-world data about fSCIG usage in routine administration.

Methods

In this multicenter, prospective, observational study in Europe under the auspices of ESID (NCT03054181), patients are eligible for documentation if they receive treatment for primary or secondary immunodeficiency disease and provide informed consent. Planned enrolment is 100 patients. The cut-off for this interim analysis was February 18, 2019.

Results

Patient characteristics (n=85) are shown in the Table. For most patients, average time between infusions was every 4 (68.3%) or every 3 (22.0%) weeks. Median dose of the last fSCIG infusion was 30g (interquartile range: 20–35g), median maximum infusion rate was 300 ml/hr, and thus, median volume infused was 300 ml; most patients used one application site (91.9%; most commonly abdomen) and an infusion pump (97.4%). The most recent fSCIG administration was most commonly given at home (80.5%), followed by doctor’s office (12.2%) and hospital (7.3%) by self-administration (84.0%) or by nurse/physician (16.0%). Technical problems occurred twice. In all cases, the full planned dose of fSCIG was administered.

Conclusions

fSCIG offers the flexibility of infusions performed at home by the patient or in the hospital. Dosing schedule allows variability; however, most infusions are administered every 4 weeks into 1 site. The study is recruiting, and patient observation continues.

Table 1

figaro.jpg

Hide
Poster Display Therapy

RATIONALE AND DESIGN OF A NONINTERVENTIONAL STUDY ON THE USAGE AND OUTCOMES OF CUVITRU IN PATIENTS OF ANY AGE WITH PRIMARY IMMUNODEFICIENCY DISEASE: CORE STUDY

Lecture Time
10:14 - 10:15
Room
Poster Area
Date
20.09.2019, Friday
Session Time
10:00 - 17:00
Board Number
162
Presentation Topic
Therapy

Abstract

Background and Aims

The highly concentrated immunoglobulin (IG) formulationimmune globulin subcutaneous (human) 20% solution (Ig20Gly/Cuvitru)was designed to allow for subcutaneous (SC) infusion of IG in small infusion volumes and to reduce infusion times compared with less-concentrated products. The CORE study will collect representative real-world information about the utilisation, safety, tolerability, and patient experience of Ig20Gly.

Methods

CORE is a noninterventional, prospective, longitudinal study being conducted in Germany and Switzerland (DRKS00014562). Patients of all ages are eligible for participation if they provide written informed consent, have primary humoral immunodeficiency disease requiring gamma globulin replacement, received any SCIG therapy (for at least 3 months at a stable dose) prior to Ig20Gly, received Ig20Gly according to drug-label specifications, and are expected to continue treatment with Ig20Gly. Planned enrolment size is 150 patients at 30 sites who will be followed for 1 year (3 visits). Patient and usage data including maximum infusion rate and volume, number of infusion sites, infusion duration, dose and dosing schedule, number and reason for discontinued, slowed, or interrupted infusions, patient experience including satisfaction, and healthcare utilization will be collected during respective visits. Adverse drug reactions will be recorded according to regulatory requirements.

Results

13 patients have started the study to date, and enrolment is ongoing. The first patient was enrolled on 26 November 2018 and study completion is expected in March 2021.

Conclusions

The CORE study is expected to provide a detailed and complete description of Ig20Gly usage under real-life conditions and to describe the patient experience after switching from other SCIG therapies.

Hide