Abstract Details

Title Phase 3 Study of Facilitated Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP): Interim Analysis of Immunogenicity

Topic Autoimmune Neurology

Presentation(s) Autoimmune Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 065

Objective Provide preliminary assessment of potential immune response to recombinant human hyaluronidase (rHuPH20) in a phase 3 study of facilitated subcutaneous immunoglobulin (fSCIG; Immune Globulin Infusion [Human] 10% with rHuPH20) in CIDP.

Background ADVANCE-CIDP 1 (NCT02549170) is an ongoing placebo-controlled, randomized, double-blind, global phase 3 study evaluating fSCIG as maintenance therapy to prevent relapse in adults with CIDP. rHuPH20 allows for transient and local increase in subcutaneous tissue permeability through depolymerization of subcutaneous hyaluronan, faciliatating dispersion of large immunoglobulin volumes. fSCIG can be administered at doses and infusion rates comparable with intravenous administration. Published data suggest up to 18% of patients with primary immunodeficiency diseases may develop clinically- nonsignificant binding antibodies to rHuPH20, which are not associated with adverse events and decline over time despite continued treatment.

Design/Methods A preplanned interim analysis of ADVANCE-CIDP 1 was performed to report immunogenicity in patients with CIDP receiving rHuPH20 with immunoglobulin 10% or placebo. Patients were monitored for development of binding and neutralizing anti-rHuPH20 antibodies using anti-rHuPH20 antibody (GCL-612) and anti-rHuPH20 neutralizing activity (MN14006) assays. Antibody titers ≥1:160 were considered positive.

Results This analysis included 96 patients. Mean baseline age was 53.3 (range: 19–86) years, 55% were male, and 83% were white. Six (6.3%) patients had positive binding antibody titers (range: 1:160–1:20,480); of these, 2 patients had 2 consecutive positive binding antibody titer measurements, and 4 patients developed positive titers after ≥98 days. No adverse event was related to positive binding antibodies. No patient with positive binding antibodies developed neutralizing antibodies.

Conclusions This preliminary immunogenicity assessment showed that clinically nonsignificant, transient, non-neutralizing, binding antibodies to rHuPH20 can occasionally develop in patients with CIDP following rHuPH20 administration. These data align with findings in other disease populations.

Authors/Disclosures
Shabbir Hasan PRESENTER	Shabbir Hasan has received stock or an ownership interest from Takeda.
Hakan AY, MD (Takeda)	Dr. AY has received personal compensation for serving as an employee of Takeda.
	No disclosure on file
Shailesh Chavan	Shailesh Chavan has received personal compensation for serving as an employee of Takeda Pharmaceuticals. Shailesh Chavan has received stock or an ownership interest from Takeda Pharmaceuticals.

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