Takeda Shares Long-Term Phase 3 Data on HYQVIA® for CIDP at PNS Meeting

Takeda has announced promising results from the Phase 3 ADVANCE-CIDP 3 clinical trial, revealing that HYQVIA® is effective and safe for long-term treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). This study marks the longest extension in a clinical trial for CIDP, indicating HYQVIA's potential in maintaining stable disease conditions.

HYQVIA, approved by the FDA and the European Commission, is the first facilitated subcutaneous immunoglobulin (fSCIG) approved for CIDP maintenance therapy. The treatment combines immune globulin with recombinant human hyaluronidase, facilitating the rapid absorption of large volumes of immunoglobulin into subcutaneous tissue. This allows for high-volume IG administration subcutaneously, potentially reducing the frequency of infusions to once monthly. HYQVIA can be self-administered or given by healthcare professionals in various settings.

The ADVANCE-CIDP 3 trial included 85 patients from the earlier ADVANCE-CIDP 1 trial, providing a median follow-up of 33 months with a total of 220 patient-years of data. The trial primarily assessed safety, tolerability, and immunogenicity, finding that HYQVIA was well-tolerated with no new safety concerns. Key outcomes included a stable monthly dose of HYQVIA and a high rate of administration every four weeks. Only a small fraction of infusions had to be adjusted due to intolerability.

Adverse events (AEs) were reported in 89.4% of patients, but most were mild or moderate and self-limiting. Common AEs included headache, site reactions, fatigue, and nausea. Serious AEs possibly related to HYQVIA were rare and included infection at the infusion site, migraine exacerbation, and heart failure exacerbation, all of which resolved with treatment.

The study concluded that HYQVIA effectively maintained a stable disease course in CIDP patients. Only 13% of patients experienced a relapse, with an annualized relapse rate of 4.5%. These results suggest that HYQVIA provides a reliable, long-term maintenance option for CIDP patients, offering the convenience of less frequent treatments.

Dr. Robert Hadden, a consultant neurologist and the presenting author of the study, emphasized the significance of these findings for CIDP patients and their healthcare providers. He noted that HYQVIA allows for the potential of self-treatment at home, typically only once every four weeks.

CIDP is a neuroimmunological condition marked by progressive weakness and sensory dysfunction in the limbs. Immunoglobulin (IG) therapy is a well-established standard of care for this condition due to its immunomodulatory and anti-inflammatory effects. Nearly a quarter of IG therapy is utilized in treating CIDP.

HYQVIA is a liquid medicine combining immunoglobulins derived from human plasma with recombinant human hyaluronidase. It is used as a replacement therapy for primary and secondary immunodeficiencies and as maintenance therapy for CIDP. It is approved for use in both adults and children.

The ADVANCE-CIDP 3 trial followed patients from the ADVANCE-CIDP 1 trial, where all participants received open-label HYQVIA. The primary goals were to assess long-term safety, tolerability, and immunogenicity, with efficacy as an exploratory outcome.

The results of this extensive study offer hope for long-term disease management in CIDP, supporting the use of HYQVIA as a viable maintenance treatment. The data will be presented at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada, providing further validation and visibility to these significant findings.