Protocol of a dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy (DRIP study)

Krista Kuitwaard*, Willem-Jan R. Fokkink, Esther Brusse, Alexander F. J. E. Vrancken, Filip Eftimov, Nicolette C. Notermans, Anneke J. van der Kooi, Ingemar S. J. Merkies, Bart C. Jacobs, Pieter A. van Doorn

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

9 Citations (Web of Science)

Abstract

High peak levels of serum IgG may not be needed for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) with intravenous immunoglobulin (IVIg). More frequent dosing of IVIg leads to more stable IgG levels and higher trough levels which may be related with improved clinical efficacy. More frequent lower dosing leads to lower peak levels and may induce less systemic side-effects. The DRIP study is a double-blind randomized controlled cross-over intervention study. CIDP patients 18years old, proven IVIg dependent and receiving an individually established but stable maintenance dose and interval of IVIg (Kiovig) can be included. One group (A) will be treated with their normal dosage and interval of IVIg and receive a placebo (albumin 0.5%) infusion in between their regular IVIg infusions, for a total of four infusions. The other group (B) will be treated with half their normal IVIg dosage (with the same volume of placebo to maintain the total volume) at half their interval (double their frequency) for four infusions. After a wash-out phase (2 infusions), patients will cross-over to the other treatment group. During the study the total dose of IVIg administered will remain unchanged as before start of the trial. The main objective is to investigate whether high frequent low dosage IVIg treatment is more effective than low frequent high dosage IVIg treatment as maintenance treatment for CIDP. Hand grip strength, as measured by the Martin Vigorimeter, will be used as the primary outcome measure. Secondary objective is to investigate whether high frequent low dosage of IVIg results in less adverse events compared to low frequent high dosage treatment. The DRIP study is currently ongoing and the protocol is presented.
Original languageEnglish
Pages (from-to)5-10
Number of pages6
JournalJournal of the Peripheral Nervous System
Volume23
Issue number1
DOIs
Publication statusPublished - 1 Mar 2018

Keywords

  • chronic inflammatory demyelinating polyradiculoneuropathy
  • intravenous immunoglobulin
  • IVIg
  • maintenance treatment
  • protocol
  • RCT
  • IMMUNE-MEDIATED POLYNEUROPATHIES
  • GUILLAIN-BARRE-SYNDROME
  • MULTIFOCAL MOTOR NEUROPATHY
  • RANDOMIZED CONTROLLED-TRIAL
  • PERIPHERAL-NERVE-SOCIETY
  • JOINT TASK-FORCE
  • INTRAVENOUS IMMUNOGLOBULIN
  • INTEROBSERVER AGREEMENT
  • NEUROLOGICAL-SOCIETIES
  • EUROPEAN-FEDERATION

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