Positive Results in Phase 3 Chronic Inflammatory Demyelinating Polyneuropathy Trial

According to a story from Business Wire, the pharmaceutical company Takeda recently presented results from its phase 3 clinical trial evaluating HYQVIA (Human Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare disease. The drug was evaluated as a maintenance treatment for the disease. Results were presented on June 20th at the 2023 annual meeting of the Peripheral Nerve Society, which took place in Copenhagen, Denmark. The results were also published in the Journal of the Peripheral Nervous System.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a disorder which is most characterized by inflammation of the peripheral nervous system. It is closely related to Guillain-Barré syndrome, and in effect is a long-term, chronic form of that disease. Chronic inflammatory demyelinating polyneuropathy is an autoimmune disorder in which the immune system attacks healthy body tissue by mistake. Symptoms of the disorder include difficulty walking, tingling or numbness, nerve pain, muscle weakness, muscle cramps, loss of reflexes, and poor balance. Treatment for the disease often includes corticosteroids, intravenous immunoglobulin, plasmapharesis, or other drugs that can suppress the immune system. Physical therapy can produce improved muscle strength; when immune system suppressants are not effective, stem cell transplant may be considered. The disease tends to relapse and remit sporadically. To learn more about chronic inflammatory demyelinating polyneuropathy, click here.

Trial Results

Intravenous immunoglobulin (IVIG) has been an established standard of care for this disease. 132 adult patients with confirmed diagnoses participated in the trial. These patients had been receiving a stable IVIG treatment dose for at least three months prior to the trial. Patients were randomly selected to receive HYQVIA at the same dose and frequency as IVIG for a six-month period or until disease relapse, and were also compared with a placebo group.

As a maintenance therapy, HYQVIA is not intended to induce remission, but to ‘maintain’ remission after it has been reached. Patients using HYQVIA saw a substantially lowered relapse rate (9.7%) when compared to placebo (31.4%). These patients also had a lower probability of functional worsening (37.5%) versus placebo (54.4%). In the patients that were using HYQVIA that did experience relapse, it took longer for them to do so than the placebo group.

Overall, the findings from this study are encouraging, with the drug showing good efficacy. If approved, it will also allow patients to dose IVIG subcutaneously in the home setting with less frequency than traditional IVIG.

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