Transcript
Announcer:
Welcome to the Clinician’s Roundtable on ReachMD. This medical industry feature, titled “SCIg for Patient-Centric Care: Combining Experience with Innovation,” is sponsored by CSL Behring. Here’s your host, Dr. Matt Birnholz.
Dr. Birnholz:
This is ReachMD, and I’m Dr. Matt Birnholz. Today, we’ll focus on the clinical management of primary immunodeficiency, or PI for short, and take an in-depth look at the role of Hizentra®, Immune Globulin Subcutaneous (Human), 20 percent liquid in personalized treatment plans.
Joining me today is Dr. Elena Perez, an allergy and immunology specialist with extensive experience treating PI patients. Dr. Perez is a physician at the Institute for Asthma and Allergy in North Palm Beach, Florida, and has held both teaching and research positions at the University of Miami, University of South Florida, and the University of Pennsylvania.
Dr. Perez, welcome to the program.
Dr. Perez:
Thank you. Thank you for having me today.
Dr. Birnholz:
Great to have you with us.
Before we begin, let's take a moment to review some important safety information.
Announcer:
IMPORTANT SAFETY INFORMATION
Indications and Usage
Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:
- Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.
- Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.
- Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.
For subcutaneous infusion only.
WARNING: Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Please stay tuned to hear more Important Safety Information in this program.
Please see full prescribing information for Hizentra including boxed warning at Hizentra.com/HCP.
Dr. Birnholz:
So Dr. Perez, now that we’ve listened to that important safety information, let’s review PI and the patients you characteristically see in your practice. Can you briefly define PI and walk us through what your patients often experience from diagnosis to treatment?
Dr. Perez:
Yes, and that’s a great place to start. So, PI is a chronic condition where the immune system doesn’t function properly, which leaves patients more vulnerable to infections. Many patients come to me after dealing with frequent respiratory infections, sinusitis, or other complications that haven't been effectively managed by previous treatments. And these infections can range from mild to severe and often lead to persistent health issues which significantly impact patient outcomes and their quality of life. This disease often leads to hospitalizations and can be life-threatening if untreated.1,2
But even when they’re being treated for specific infections, the overarching issue of immunodeficiency can often go unrecognized and untreated for a long time, and that has far-reaching impacts on our patients’ quality of life.2 I’m often told by my patients that their journey to a PI diagnosis has been a long and challenging one.
When they do receive a diagnosis, it can be a mix of relief and anxiety: patients can finally put a name to this longstanding issue they’ve been dealing with, but they also grapple with what the future holds for managing it and how it’s going to affect their daily lives. For some, this carries a sudden adjustment to a whole new awareness that their immune system isn’t as protective as it should be.
So all of this together highlights that there’s a real sense of urgency on our part to change that pattern of delayed diagnosis and to start patients on an effective treatment as soon as possible.
Dr. Birnholz:
Totally understandable, Dr. Perez, and that does give us a good sense of what your patients are often dealing with when you’re evaluating them for treatment. So, let’s turn to that subject of treatment next and focus on Hizentra, which I mentioned earlier. First, what challenges do you see patients encountering around treatment options for PI, and how does Hizentra in particular factor into your treatment plan?
Dr. Perez:
Well, the good news is that there are several immunoglobulin treatment options available for patients with PI, which is something I reiterate for my patients to give them confidence that we can take action here. And these include both intravenous, or IVIg, and subcutaneous, or SCIg, forms of immunoglobulin replacement therapy.2 But in my practice, patients often face challenges with managing side effects and adopting the necessary lifestyle modifications to continue taking these treatments. That being said, in my experience with prescribing Hizentra 20 percent subcutaneous Ig for over a decade now, I’ve gotten to see a number of these issues being addressed effectively for a few key reasons.
First, its safety and efficacy have been consistently reassuring for me. Hizentra has a long record of proven safety and efficacy, dating back to 2010, with more than 14.9 million doses delivered worldwide.3 And it’s this proven track record that has helped make Hizentra a preferred option when discussing personalized treatment plans with my patients.4,5
Another important factor that I bring up with patients is Hizentra's ability to provide disease control without the need for venous access or regular clinic visits for infusions. In fact, Hizentra delivers consistent steady-state IgG levels versus IVIg regardless of dosing frequency.6
So, with those aspects in mind, I commonly hear from my patients that their treatment course with Hizentra offers much more flexibility in that they can administer it themselves at home and on their own schedules, which gives them the freedom to manage their treatment in a way that fits into their lives, rather than the other way around. And in turn, that gives me more confidence in the therapy, because when my patients tell me that it’s integrating much better with their lifestyles, I may get to see this translate into better adherence.
Dr. Birnholz:
Those are interesting points of feedback you’re getting from your patients, Dr. Perez, but let’s come back to that note about maintaining steady-state IgG levels. What do patients make of that based on your experience?
Dr. Perez:
Sure. The steady IgG levels that are achieved using Hizentra mirrors the normal levels seen in healthy individuals, and this avoids the peaks and the troughs that are often seen with monthly IVIg dosing.6 And this may reduce the “wear-off” effects that have been reported toward the end of IVIg dosing cycles, which many of my patients bring up as a comparative benefit with Hizentra.6
Just to be clear, though, no clinical difference between IVIg and Hizentra SCIg has been demonstrated,6 but patients do often report to me that they appreciate knowing that their immune system is continuously supported with steady state Ig levels and personalized dosing schedules that can be anywhere from daily to up to every two weeks. And I consider it another positive impact for my patients’ well-being where they appreciate knowing it reduces the risk of potential infections between infusions.
Dr. Birnholz:
For those just tuning in, you’re listening to the Clinician’s Roundtable on ReachMD. I’m Dr. Matt Birnholz, and today I’m speaking with allergy and immunology specialist Dr. Elena Perez about her experience treating Primary immunodeficiency with Hizentra SCIg.
So, Dr. Perez, let’s continue on this track of the patient experience with Hizentra and get a better sense of what you’re seeing and hearing from your patients in practice. What aspects about this treatment get brought up by these patients the most?
Dr. Perez:
Well first I want to mention that, in my experience, it’s not uncommon for patients to feel some anxiety about starting the self-infusion process with Hizentra. So, it’s important to have honest conversations with patients who have questions or concerns about the changes in their treatment, and it can also be a good opportunity to promote support and training services.
But, in my clinic, one of the most significant innovations of Hizentra has been the pre-filled syringes, which gets highlighted all the time by my patients as a standout feature.
I hear so often from them about the simplified infusion process that eliminates the need for vial transfers, which can be really challenging for some people. The pre-filled syringes may make it easier for them to stay consistent with their therapy since they don’t have to worry about handling vials, and that may reduce errors and save preparation time. On top of that, Hizentra four gram and 10 gram prefilled syringe doses fit directly into common infusion pumps.7 So, as I mentioned before, factors like that can translate into a smoother patient experience in my practice.
Dr. Birnholz:
And Dr. Perez, I assume this, in turn, adds to that theme of empowering patients to personalize their own Ig treatment, is that correct?
Dr. Perez:
Exactly. Patients have other treatment options for PI and some prefer IVIg but in my experience, patients tend to prioritize accessibility and how the treatment will impact their way of life.
That’s one of the big benefits of Hizentra for my patients, how well it integrates into their lives. The ease and flexibility offered through the pre-filled syringes is a big deal to them. And because they can do their infusions at home, my patients don't have to schedule clinic visits as frequently. I think this kind of autonomy is really empowering—it lets my patients manage their treatment on their own terms and keep up with their daily routines, which in turn creates a sense of normalcy while actively treating their disease. So, I look at accessibility factors like these as ones that make a big difference in how satisfied my patients feel overall with their treatment experience.
Dr. Birnholz:
So, if we consider patient preferences and satisfaction reporting more broadly, do you think the experiences of your patients reflect what other practices may be seeing and within the PI patient population?
Dr. Perez
Absolutely. My patients’ experiences generally mirror the findings of a CSL sponsored Harris Poll survey that was conducted on patient preference and satisfaction.8 According to that survey, four out of five patients who had used SCIg and IVIg preferred SCIg. And among those who used SCIg in pre-filled syringes and vials, respectively, 86 percent favored the pre-filled syringes. In fact, almost all patients surveyed were satisfied with factors related to self-infusing their Ig therapy, citing the ability to personalize treatment, convenience, ease of administration, and how well it fits into their lifestyle as key benefits.8
Dr. Birnholz:
Well Dr. Perez, before we wrap up today’s discussion, do you have any other thoughts you'd like to add for our audience to take away from today’s discussion?
Dr. Perez:
Definitely. Over the past 10-plus years, I’ve witnessed firsthand Hizentra’s impacts on two levels: first by managing the clinical aspects of PI and also by improving treatment experience for my patients. It’s this combination of safety, efficacy, the ability to personalize treatment, and now the added flexibility of the pre-filled syringe delivery system, altogether making this a standout therapy option for my patients who are dealing with this chronic disease state. It’s a treatment that aligns well with my patients’ needs and helps them regain control over their lives, and that, in turn, makes it a trusted therapy in my practice.
Dr. Birnholz:
Well, that’s a great way to round out our discussion on this topic. And I very much want to thank my guest, Dr. Elena Perez, for sharing her experience and expertise in managing patients with PI using Hizentra SCIg.
Dr. Perez, it was great speaking with you today. Thanks so much.
Dr. Perez:
Thank you. And it was wonderful being here. Thank you.
Dr. Birnholz:
For ReachMD, I’m Dr. Matt Birnholz. Before we close, let’s take a moment to review some Important Safety Information.
Announcer:
Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (e.g., polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.
IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.
Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).
Hizentra is derived 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 adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.
The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results.
Please see accompanying full prescribing information for Hizentra, including boxed warning.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This medical industry feature was sponsored by CSL Behring. If you missed any part of this discussion or to find others in this series, visit Clinician’s Roundtable on ReachMD.com, where you can Be Part of the Knowledge.
References:
- Guaní-Guerra E, Jiménez-Romero AI, García-Ramírez UN, et al. Disease burden for patients with primary immunodeficiency diseases identified at reference hospitals in Guanajuato, Mexico. PLoS One. 2017;12(4):e0175867. doi:10.1371/journal.pone.0175867
- Anderson JT, Cowan J, Condino-Neto A, Levy D, Prusty S. Health-related quality of life in primary immunodeficiencies: Impact of delayed diagnosis and treatment burden. Clin Immunol. 2022;236:108931. doi:10.1016/j.clim.2022.108931
- Data on File. Available from CSL Behring as DOF HIZ-005. 2024.
- Jolles S, Borte M, Nelson RP Jr, et al. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol. 2014;150(2):161-169. doi:10.1016/j.clim.2013.10.008. Accessed June 26, 2024. https://www.sciencedirect.com/science/article/pii/S1521661613002738?via%3Dihub
- Hagan JB, Fasano MB, Spector S, et al. Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency. J Clin Immunol. 2010;30(5):734-745. doi:10.1007/s10875-010-9423-4
- Wasserman RL, Melamed I, Nelson RP, et al. Pharmacokinetics of Subcutaneous IgPro20 in Patients with Primary Immunodeficiency. Clin Pharmacokinet. 2011;50(6):405-414. doi:10.2165/11587030-000000000-00000
- Data on File. Available from CSL Behring as DOF HIZ-017. 2023.
- Data on File. Available from CSL Behring as DOF HIZ-013. 2023.
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