PRODUCT LITERATURE

Efficacy and safety of Privigen® in patients with chronicinflammatory demyelinating polyneuropathy: results ofa prospective, single-arm, open-label Phase III study(the PRIMA study)

---

This prospective, multicenter, single-arm, open-label Phase III study aimed toevaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglob-ulin [IVIG], stabilized with L-proline) in patients with chronic inflammatory demyelinatingpolyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight[bw]) and up to seven maintenance doses (1 g/kg bw) at 3-week intervals. The primary effi-cacy endpoint was the responder rate at completion, defined as improvement of ≥1 point onthe adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. Thepreset success criterion was the responder rate being ≥35%. Of the 31 screened patients,28 patients were enrolled including 13 (46.4%) IVIG-pretreated patients. The overallresponder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%).IVIG-pretreated patients demonstrated a higher responder rate than IVIG-na¨ıve patients(76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5(3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standarddeviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and themedian Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5]points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mildor moderate in intensity and resolved by the end of study. Two serious AEs of hemolysiswere reported that resolved after discontinuation of treatment. Thus, Privigen providedefficacious and well-tolerated induction and maintenance treatment in patients with CID

---

Availability

Detail Information

Series Title

-

Call Number

-

Publisher

: .,

Collation

-

Language

English

ISBN/ISSN

-

Classification

NONE

Content Type

TEXTBOOK

Media Type

-

Carrier Type

-

Edition

-

Subject(s)

Privigen
chronicinflammatory demyelinating polyneuropathy
PRIMA study

Specific Detail Info

Journal of the Peripheral Nervous System 18:130–140 (2013)

Statement of Responsibility

-

Other version/related

File Attachment

Comments

---

You must be logged in to post a comment