Background Different preparations of intravenous immunoglobulin (IVIg) are considered to have comparable clinical efficacy but this has never been formally investigated. Some patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) report that some IVIg brands are more effective than others. A liquid IVIg preparation is more user friendly and potentially can be infused at a faster rate.
Objectives The primary objective was to compare the efficacy of two different IVIg brands in CIDP. The secondary objective was to compare their safety.
Methods This was an investigator-initiated multi-centre randomised controlled double-blind trial. Twenty-seven patients with active but stable CIDP treated with their individual stable IVIg (Gammagard S/D) maintenance dose and interval were randomised to receive four infusions of freeze-dried 5% IVIg (Gammagard S/D) or the new liquid 10% IVIg (Kiovig). The overall disability sum score (ODSS) was used as the primary outcome scale. The equivalence margin was defined as a difference of ≤1 point in mean ΔODSS between treatment groups. Main secondary outcome scales were the MRC sum score and the Vigorimeter.
Results Repeated measurements analysis of variance, adjusted for baseline ODSS, showed a clinically insignificant treatment difference of 0.004 (95% CI –0.4 to 0.4). We also found no significant differences in any of the other outcome measures. Besides a lower occurrence of cold shivers in patients randomised to Kiovig (p=0.03), no significant differences were found in the occurrence of adverse events.
Conclusions This trial demonstrated equal clinical efficacy between a freeze-dried and a liquid IVIg preparation for maintenance treatment of CIDP.
- chronic inflammatory demyelinating
- clinical neurology
- peripheral neuropathology
- randomised trials
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Funding This study was supported by an unconditional grant from Baxter Healthcare BV, The Netherlands.
Competing interests K Kuitwaard was assigned to conduct a study comparing Gammagard S/D with Kiovig (this study) supported by an unrestricted departmental research grant from Baxter. L H van den Berg received fees for lecturing and consultancy from Baxter BV. W-L van der Pol received personal compensation from Baxter International for serving on a scientific advisory board. I N van Schaik received an unrestricted departmental research grant from Sanquin Blood Supply Foundation and from Actelion Pharmaceuticals Ltd; personal and departmental payments for lecturing and consultancy from Actelion Pharmaceuticals Ltd; received government research support NOW grant #940-33-024 and NOW grant #903-51-201 unrelated to subject of publication; received support from the non-profit foundation Prinses Beatrix Fonds grant #MAR01-0213 and serves as a member of the Cochrane Neuromuscular Disease Group editorial board. PA van Doorn received an unrestricted departmental research grant from Baxter to conduct a study comparing Gammagard S/D with Kiovig (this study) and to conduct a previous study comparing Gammagard S/D with or without methylprednisolone in GBS; received personal and departmental payments for consultancy/RCT trial boards fromTalecris, ZLB, Baxter and Octapharma; received government research support from ZonMW; received support from the non-profit foundations Prinses Beatrix Fonds and Janivo Foundation unrelated to this study and serves as a member of the Cochrane Neuromuscular Disease Group editorial board.
Ethics approval This study was conducted with the approval of the Erasmus MC, University Medical Center, Rotterdam, The Netherlands; University Medical Center Utrecht, Utrecht, The Netherlands; Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Provenance and peer review Not commissioned; externally peer reviewed.