Findings show that convenience of treatment and flexibility of administration, such as at-home treatment options, are of high importance to patients

KING OF PRUSSIA, Pa., Jan. 16, 2024 /PRNewswire/ — CSL Behring, a business unit of global biotechnology leader CSL, today announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment options (n=98, 82%) and that administering treatment at home is extremely/very important to them (n=100, 72%). However, less than half of people surveyed said they discuss potential new treatment options or switching treatments with a physician (n=100, 47% and 43% respectively). The CSL Behring-sponsored Harris Poll survey included 100 people living with CIDP, 98 of whom were currently on treatment for their CIDP, and 100 neurologists/neuromuscular specialists who regularly see at least one patient with CIDP.

CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. CIDP symptoms can worsen over time, leading to significant activity limitations.

In the survey (n=100), 57% of patients said they wish their physicians better understood what they think is important in a CIDP treatment with the majority listing efficacy (95%), minimal side effects (97%), condition maintenance (96%), at-home administration (72%) and flexible dosing options (70%), among their top priorities when thinking about a treatment option. Additionally, less than half of patients surveyed said they are very/somewhat knowledgeable about how different CIDP treatment options work (40%) or about how different CIDP treatment options are administered (45%).

“We know that people living with rare diseases benefit from shared decision-making with their physician about their treatment options, including how and where they receive treatment,” said Dr. Jeffrey Allen, MD, Associate professor of neurology at the University of Minnesota Medical School. “Having regular open discussions about the different options available, including self-administered treatment at home for CIDP maintenance for example, is particularly important for people who may find it difficult or burdensome to travel to an infusion center.”

CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human] 20 percent Liquid) is the first and only self-administered, subcutaneous immunoglobulin (SCIg) for the treatment of CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment. As Hizentra is infused under the skin and not into a vein, people with CIDP can use Hizentra at home and don’t have to worry about finding a vein, which is especially important for those who may have venous access issues. For additional convenience, Hizentra is available in vials or a wide range of prefilled syringe sizes, including 1g, 2g, 4g and a 10g size that will be available in early 2024.

“As part of Our Promise, we are committed to listening to and understanding the concerns of people living with rare diseases and developing treatment options that address unmet needs,” said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. “We are proud to be at the forefront of delivering both effective and convenient treatment options like Hizentra, which may allow those living with CIDP more flexibility by allowing them to self-administer their treatment at home. Furthermore, to help improve the treatment experience, we are proud to offer Hizentra in a range of prefilled syringe sizes, including a soon to be available 10g prefilled syringe.”

 

About the Survey

The survey was conducted on behalf of CSL Behring with 100 people living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and 100 neurologists/neuromuscular specialists. The survey took place between February 27, 2023 and March 15, 2023. Patients were identified and recruited directly by treating physicians. Both patients and physicians were fully screened for eligibility. The survey qualification criteria for patients included being age 18+, residency in the U.S. and CIDP diagnosis. The survey qualification criteria for physicians included that they practice in the U.S., are duly licensed, are neurologists/neuromuscular specialists and regularly see at least one patient with CIDP.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP symptoms can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30 percent of CIDP patients progress to wheelchair dependence if not treated. The GBS|CIDP Foundation estimates that the incidence of CIDP in the U.S. is as high as two in 100,000 people each year, with the accumulation of cases over time resulting in prevalence as high as nine in 100,000 in some areas.

 

About Hizentra®

Registered in more than 60 countries, Hizentra is the most prescribed subcutaneous immunoglobulin for primary immunodeficiency (PI) in the U.S. It has a proven track record of safety, efficacy, and tolerability. Hizentra was first approved by the U.S. FDA in March 2010 for the treatment of patients with PI and was approved in March 2018 for the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.

 

Important Safety Information (ISI)

WARNING: Thrombosis (blood clots) can occur with immune globulin products, including Hizentra. Risk factors can include: advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (blood thickness), use of estrogens, installed vascular catheters, and cardiovascular risk factors.

If you are at high risk of blood clots, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor for signs of clotting events and hyperviscosity. Always drink sufficient fluids before infusing Hizentra.

See your doctor for a full explanation, and the full prescribing information for complete boxed warning.

Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is a prescription medicine used to treat:

  • Primary immune deficiency (PI) in patients 2 years and older
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

 

Treatment with Hizentra might not be possible if your doctor determines you have hyperprolinemia (too much proline in the blood), or are IgA-deficient with antibodies to IgA and a history of hypersensitivity. Tell your doctor if you have previously had a severe allergic reaction (including anaphylaxis) to the administration of human immune globulin. Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Inform your doctor of any medications you are taking, as well as any medical conditions you may have had, especially if you have a history of diseases related to the heart or blood vessels, or have been immobile for some time. Inform your physician if you are pregnant or nursing, or plan to become pregnant.

Infuse Hizentra under your skin only; do not inject into a blood vessel. Self-administer Hizentra only after having been taught to do so by your doctor or other healthcare professional, and having received dosing instructions for treating your condition.

Immediately report to your physician any of the following symptoms, which could be signs of serious adverse reactions to Hizentra:

  • Reduced urination, sudden weight gain, or swelling in your legs (possible signs of a kidney problem).
  • Pain and/or swelling or discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, or numbness/weakness on one side of the body (possible signs of a blood clot).
  • Bad headache with nausea; vomiting; stiff neck; fever; and sensitivity to light (possible signs of meningitis).
  • Brown or red urine; rapid heart rate; yellowing of the skin or eyes; chest pains or breathing trouble; fever over 100°F (possible symptoms of other conditions that require prompt treatment).

 

Hizentra is made from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

The most common side effects in the clinical trials for Hizentra include redness, swelling, itching, and/or bruising at the infusion site; headache; chest, joint or back pain; diarrhea; tiredness; cough; rash; itching; fever, nausea, and vomiting. These are not the only side effects possible. Tell your doctor about any side effect that bothers you or does not go away.

Before receiving any vaccine, tell immunizing physician if you have had recent therapy with Hizentra, as effectiveness of the vaccine could be compromised.

Please see full prescribing information for Hizentra, including boxed warning and the patient product information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.

 

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

Source:
https://www.prnewswire.com/news-releases/harris-poll-survey-finds-people-receiving-treatment-for-cidp-are-interested-in-exploring-more-convenient-treatment-options-302034782.html
About PackGene

PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

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