Long-Term Phase III Trial Data Show Safety, Efficacy of HyQvia for Chronic Inflammatory Demyelinating Polyneuropathy

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Data from the Phase III ADVANCE-CIDP 3 clinical trial (NCT02955355) demonstrated long-term safety and a low relapse rate with HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).¹ Earlier this year, the FDA approved HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with CIDP based on findings from the randomized, double-blind, placebo-controlled ADVANCE-CIDP 1 trial, as well as ADVANCE-CIDP 3, a single-arm, open-label, extension study.²

“Results of the ADVANCE-CIDP 3 study help provide additional confidence to those living with CIDP and their healthcare providers regarding the potential for extended maintenance of their condition with a facilitated subcutaneous immunoglobulin,” presenting author Robert Hadden, MD, consultant neurologist, Neurology Department, King’s College Hospital, London, UK and Department of Basic & Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK, said in a press release. “This treatment allows the convenience of potential self-treatment at home, typically only once every four weeks.”

HyQvia, the only subcutaneous immune globulin infusion that can be administered once monthly, was initially approved by the FDA in 2014 for the treatment of primary immunodeficiency in adults. HyQvia is a liquid medication that is infused under the skin into fatty subcutaneous tissue. It contains immunoglobulins collected from the human plasma that maintains the body’s immune system.³

The hyaluronidase in HyQvia enables more immunoglobulin to be absorbed into the body. The drug derives its therapeutic effect from immune globulin infusion. The recombinant human hyaluronidase of HyQvia increases the dispersion and absorption of immunoglobulins. HyQvia provides a broad spectrum of opsonizing and neutralizing IgG antibodies that act against an array of bacterial and viral agents.³

Investigators enrolled 122 patients from ADVANCE-CIDP 1 with a confirmed diagnosis of CIDP and who remained on a stable dosing treatment regimen of intravenous immunoglobulin (IVIG) for at least three months before screening. Patients were randomly assigned to receive HyQvia or placebo at the same dose and infusion frequency as their IVIG regimen of every two, three, or four weeks for six months or until withdrawal or relapse. Patients who did not experience a relapse were given the opportunity to continue treatment with HyQvia as part of ADVANCE-CIDP 3. The open-label extension study assessed the long-term safety, tolerability, and immunogenicity of the medication in patients with CIDP who completed ADVANCE-CIDP 1.

ADVANCE-CIDP 3 is the longest extension study to be conducted within the context of a clinical trial of patients with CIDP to date, according to Takeda. In total, 85 patients continued from ADVANCE-CIDP 1 to ADVANCE-CIDP 3 to analyze the safety and immunogenicity of Hyqvia.

Median duration of treatment with HyQvia in the trial was 33 months, ranging from zero to 77 months, with a cumulative overall follow-up time of 220 patient years. The safety and tolerability profile of the medication was consistent with prior findings and no new safety signals were identified.

Adverse events (AEs) were reported by 89.4% of patients in the trial, with 60% of patients administered HyQvia reporting AEs, most of which were mild or moderate and self-limiting. The most frequently reported AEs per infusion (≥0.02 events per infusion) were headache, infusion site erythema, pyrexia, nausea, erythema, infusion site pruritis, fatigue, and infusion site pain.

Serious AEs potentially associated with HyQvia were identified in three patients, including infusion site infection, exacerbation of migraine and fibromyalgia following infusion, and exacerbation of heart failure that resolved after treatment. Investigators found that HyQvia maintained a stable disease course in patients with CIDP, as 13% of patients with data available suffered a relapse during the entire observation period, which translates to an annualized relapse rate of 4.5%.

“The long-term data from the ADVANCE-CIDP 3 clinical trial allow us to further characterize the safety, efficacy and tolerability profile of HyQvia and reinforces its role as a long-term, up-to once monthly maintenance treatment for this complex, chronic condition,” Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit, said in a press release. “These results reflect our continued commitment to bringing the benefits of our differentiated immunoglobulin therapies to patients with neuroimmunological disorders, and providing a range of effective treatment options that address the individual needs of a broad range of patients.”¹

References

1. Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting. News release. Takeda. June 18, 2024. Accessed June 18, 2024. https://www.takeda.com/newsroom/newsreleases/2024/takeda-presents-long-term-data-from-phase-3-advance-cidp-3-clinical-trial-of-hyqvia/

2. U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Takeda. News release. January 16, 2024. Accessed June 18, 2024. https://www.takeda.com/en-us/newsroom/news-releases/2024/us-fda-approves-takedas-hyqvia-as-maintenance-therapy-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp

3. Package Insert – HYQVIA. Takeda. Accessed June 18, 2024.