Takeda’s HYQVIA reduces CIDP relapse rates, Phase 3 trial reveals
Takeda Pharmaceutical Company has disclosed successful outcomes from its critical Phase 3 ADVANCE-CIDP 1 trial, focused on evaluating HYQVIA as a maintenance therapy for adults suffering from chronic inflammatory demyelinating polyneuropathy (CIDP).
The study found a substantial decrease in relapse rates in patients treated with HYQVIA compared to those given a placebo (9.7% vs 31.4%, respectively; p = 0.0045). Additionally, the time to relapse was also prolonged for the HYQVIA group compared to the placebo group.
The data, alongside other beneficial results, were presented at the Peripheral Nerve Society (PNS) Annual Meeting 2023, and published concurrently in the Journal of the Peripheral Nervous System (JPNS).
Chronic inflammatory demyelinating polyneuropathy is a progressively debilitating immune-mediated condition that disrupts the peripheral nervous system and causes weakness and sensory impairment. Standard treatments include immunoglobulin (IG) therapy, which has broad immunomodulatory and anti-inflammatory effects. However, the sheer volume and frequency of treatment required make it a burden for both patients and healthcare providers.
The ADVANCE-CIDP 1 Phase 3 study, a randomized, double-blind, and placebo-controlled investigation, involved adult CIDP patients who were previously on intravenous immunoglobulin (IVIG). These patients were either switched to HYQVIA or given a placebo for a duration of six months or until they relapsed or withdrew from the study.
The study’s primary goal was to evaluate the proportion of participants experiencing a relapse, measured by the Inflammatory Neuropathy Cause and Treatment (INCAT). Secondary endpoints included aspects such as functional worsening, time to relapse, change from pre-subcutaneous treatment baseline in Rasch-built Overall Disability Scale (R-ODS) centile score, and safety.
Key findings demonstrated that HYQVIA significantly reduced the relapse rate compared to placebo (p = 0.0045) and also delayed the time to relapse. Furthermore, functional worsening rates were lower in patients treated with HYQVIA (37.5% vs 54.4%), and change in R-ODS centile scores were also lower compared to the placebo group.
The safety profile of HYQVIA remained consistent with the EU Summary of Product Characteristics. Infusion characteristics were well-balanced between HYQVIA and placebo groups, with less than 1% of all infusions affected by intolerability or adverse effects.
Kristina Allikmets — Takeda senior vice president and head of Research & Development for Plasma-Derived Therapies Business Unit said: “The results from the ADVANCE-CIDP 1 trial are encouraging for adults with CIDP who require maintenance treatment by offering the potential for a facilitated subcutaneous IG administration option with up to once-monthly dosing (every 2 to 4 weeks).
“We are committed to expanding our portfolio of differentiated plasma therapies into new indications to further realize the tremendous therapeutic value of immunoglobulins in addressing the needs of patients with neuroimmunological disorders.”
HYQVIA, an Immune Globulin Infusion containing Recombinant Human Hyaluronidase and immunoglobulins, is presently under regulatory review in the US and European Union for use as maintenance therapy in adult patients with stable CIDP.