Immunoglobulin Therapy Hyqvia Continues to Show Positive Results on Chronic Inflammatory Demyelinating Polyneuropathy

Kristina Allikmets, MD, PhD

Recently presented data from the phase 3 ADVANCE-CIDP 1 trial (NCT02549170) showed that treatment with Hyqvia (Takeda Pharmaceuticals), a liquid medicine containing recombinant human hyaluronidase and immunoglobulins (IgG), outperformed placebo and resulted in lower probability of functional worsening rates in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Hyqvia remains under review in the US and European Union for use as a maintenance therapy in adult patients with stable CIDP.

The prospective, randomized, double-blind, placebo-controlled study randomly assigned adults with stable CIDP on intravenous IgG (IVIG) 1:1 to be switched to either Hyqvia (n = 62) or placebo (n = 70) for a 6-month period or until relapse or study withdrawal. Relapse rate, the primary end point measured by Inflammatory Neuropathy Cause and Treatment (INCAT), was significantly reduced following treatment with Hyqvia in relation to placebo (9.7% vs 31.4%; P = .0045).

"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)," Kristina Allikmets, MD, PhD, senior vice president and head of Research & Development at Takeda’s Plasma-Derived Therapies Business Unit, said in a statement.¹ "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 is approved by the European Medicines Agency as a replacement therapy in adults, children, and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure of serum IgG level of less than 4 g/L. It is also approved in the US to treat adults and children 2 years of age and older with PI.

Presented at the 2023 Peripheral Nerve Society (PNS) Annual Meeting in Copenhagen, Denmark, on June 20, 2023, data from ADVANCE-CIDP 1 also showed a lower probability of functional worsening rates with Hyqvia in comparison with placebo (37.5% vs 54.4%; 95% CI, ­–33.02 to 0.69). Patients on active therapy experienced longer time to relapse compared with those on placebo, with Kaplan-Meier estimate curves separating early, at approximately week 4. Changes on Rasch-built Overall Disability Scale centile score, a secondary end point, also continued to favor the Hyqvia group (least squares mean difference, ­–6.1 [SD, 1.64] vs –0.9 [SD, 1.69], respectively).

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The safety profile of Hyqvia was generally consistent with the existing EU Summary of Product Characteristics, with the most common casually-related local adverse events (AEs) being injection and infusion site pain and erythema, and infusion site edema and pruritis. The most common causally-related systemic AEs included headache, nausea, fatigue, and pruritus. Throughout the trial, the majority (88.7%) of patients receiving active drug were on a 4-week dosing interval with a mean time to deliver treatment of 125.9 minutes. The majority (86.3%) of patients received study treatment using 2 infusion sites per treatment, while 9.6% and 3.7% used 1 and 3 infusion sites, respectively.

"For patients with CIDP who need immunoglobulin treatment, the ADVANCE-CIDP 1 study results are encouraging,” Robert Hadden, a consultant neurologist in the Department of Neurology at King’s College Hospital, London, said in a statement.¹ "If approved as a maintenance therapy for CIDP, this treatment may combine the ability to have subcutaneous treatment at home with less frequent infusions."

Hyqvia is a dual vial unit consisting of 1 vial of 10% human normal IgG and 1 vial of recombinant human hyaluronidase. The medication is infused under the skin into the fatty subcutaneous tissue. The hyaluronidase part of Hyqvia helps more of the Ig get absorbed into the body.

REFERENCE
1. Takeda presents full data set from phase 3 ADVANCE-CIDP 1 clinical trial investigating Hyqvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy at PNS Annual Meeting. News release. June 20, 2023. Accessed July 5, 2023. https://www.takeda.com/en-us/newsroom/news-releases/2023/takeda-presents-full-data-set-from-phase-3-ADVANCE-CIDP-1-clinical-trial-investigating-HYQVIA%C2%AE-as-a-maintenance-therapy-for-chronic-inflammatory-demyelinating-polyneuropathy-CIDP-at-PNS-annual-meeting/