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Randomized Controlled Trial
. 2023 Sep;28(3):436-449.
doi: 10.1111/jns.12573. Epub 2023 Jul 6.

Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial

Vera Bril  1 , Robert D M Hadden  2 , Thomas H Brannagan 3rd  3 , Michal Bar  4 , Elisabeth Chroni  5 , Konrad Rejdak  6 , Alberto Rivero  7 , Henning Andersen  8 , Norman Latov  9 , Todd Levine  10 , Mamatha Pasnoor  11 , Sabrina Sacconi  12 , Nizar Souayah  13 , Colin Anderson-Smits  14 , Kim Duff  14 , Erin Greco  14 , Shabbir Hasan  14 , Zhaoyang Li  14 , Leman Yel  14 , Hakan Ay  14
Affiliations
Randomized Controlled Trial

Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial

Vera Bril et al. J Peripher Nerv Syst. 2023 Sep.

Abstract

Background and aims: ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse.

Methods: ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0-7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints.

Results: Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: -21.8% [-34.5%, -7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common.

Interpretation: fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.

Keywords: ADVANCE-CIDP 1 randomized controlled trial; chronic inflammatory demyelinating polyradiculoneuropathy; efficacy; hyaluronidase-facilitated subcutaneous immunoglobulin 10%; safety.

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References

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