Long-Term Safety and Low Relapse Rate Observed in Phase 3 ADVANCE-CIDP 3 Trial of Hyqvia

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A phase 3 trial showed that over time, Hyqvia is a safe and well-tolerated maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy.

Robert Hadden, MD

(Credit: LinkedIn)

Robert Hadden, MD

(Credit: LinkedIn)

New data from the phase 3 ADVANCE-CIDP 3 trial (NCT02955355) assessing immune globulin (IG) infusion 10% (human) with recombinant human hyaluronidase (Hyqvia; Takeda Pharmaceuticals) showed favorable long-term safety and tolerability as well as a low relapse rate in treated patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Presented at the 2024 Peripheral Nerve Society (PNS) Annual Meeting, held June 22-25, in Montreal, Canada, these findings support the use of Hyqvia as maintenance treatment for CIDP.1,2

Across all patients (n = 85) in ADVANCE-CIDP 3, the median monthly dose of Hyqvia was 64 (28.0 to 200.0) g/4 weeks. In the study, the mean infusion duration per dose of Hyqvia was 135.5 minutes with 88.2% of doses administered every 4 weeks and 92.3% of doses administered across 2 infusion sites. Notably, Hyqvia was well tolerated among the 3487 infusions administered, with 3 (0.1%) infusions had reduced infusion rate, were interrupted or stopped because of intolerability.

“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,” lead author Robert Hadden, MD, consultant neurologist in the department of neurology at King’s College Hospital, said in a statement.1 “This treatment allows the convenience of potential self-treatment at home, typically only once every four weeks.”

ADVANCE-CIDP 3 was a long-term extension of ADVANCE-CIDP 1 (NCT02549170), a phase 3, double-blind, randomized, placebo-controlled study that also assessed Hyqvia as maintenance therapy for CIDP.3 In ADVANCE-CIDP 3, which enrolled 85 patients from ADVANCE-CIDP 1, assessed the safety, tolerability and immunogenicity of Hyqvia. The median duration of Hyqvia treatment was 33 months (0 to 77 months) with a cumulative overall follow-up time of 220 patient years, with results that showed a consistent safety and tolerability profile with no new safety signals.2

READ MORE: Combination Therapy of Corticosteroids and Immunosuppressants Shows Efficacy in Rare Case of Overlapping CIDP and NMOSD

Top Clinical Takeaways

  • Hyqvia demonstrated favorable long-term safety and tolerability as a maintenance treatment for CIDP.
  • The trial showed a low relapse rate of 4.5% annually among patients using Hyqvia.
  • Most adverse events were mild or moderate, and consistent with the established safety profile of Hyqvia.

Most adverse events (AEs) reported by participants were mild or moderate and self-limiting. A total of 1406 AEs were reported, 48 were severe and 30 were serious. Among these, 798 AEs were related to treatment, which occurred in 51 patients (60.0%); 20 were severe and 3 were serious. Approximately two thirds of the Hyqvia–related AEs were local reactions (64.0%), such as infusion site redness and pain. Notably, 14 patients (16.7%) had at least 1 positive anti-hyaluronidase antibody titer (≥1:160). Authors noted that the antibody positivity was not associated with increased incidence of any AEs. Overall, researchers reported that relapse occurred in 10 of 77 patients (13.0%), resulting in 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 statement.1 “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.”

In January 2024, the FDA approved Hyqvia as maintenance therapy for adults with CIDP to prevent relapse of neuromuscular disability and impairment.4 Hyqvia is the only FDA-approved combination of IG and hyaluronidase, making it a facilitated subcutaneous immunoglobulin (SCIG) infusion. Patients with CIDP can infuse Hyqvia up to once monthly (every 2, 3, or 4 weeks) because of the hyaluronidase component, which can facilitate the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle. Since the treatment is delivered subcutaneously, Hyqvia can be administered by a healthcare professional in a medical office, infusion center, or at a patient’s home.

Following the news of the approval, Richard Lewis, MD, director of the electromyography laboratory and professor of neurology at Cedars-Sinai Medical Center, sat down in an interview with NeurologyLive® to share his reaction. He discussed how the approval marks a significant advancement in the field, especially since it is only FDA-approved combination of IG and hyaluronidase. He also talked about advantages Hyqvia offers over traditional intravenous immunoglobulin treatments for patients with CIDP. Lewis, also a consultant for Takeda, spoke about how the potential shift to a 20% solution might impact the future of CIDP therapy and patient convenience.

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. June 18, 2024. Accessed June 19, 2024. ttps://www.takeda.com/newsroom/newsreleases/2024/takeda-presents-long-term-data-from-phase-3-advance-cidp-3-clinical-trial-of-hyqvia/
2. Hadden R, Andersen H, Bril V, et al. Hyaluronidase-facilitated Subcutaneous Immunoglobulin 10% For CIDP: Final Results From A Long-term Safety And Tolerability Study. Presented at 2024 Peripheral Nerve Society (PNS) Annual Meeting, held June 22-25, in Montreal, Canada. Abstract P189.
3. Bril V, Hadden RDM, Brannagan TH 3rd, et al. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial. J Peripher Nerv Syst. 2023;28(3):436-449. doi:10.1111/jns.12573
4. U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). News Release. Takeda. Published January 16, 2024. Accessed June 19, 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
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