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Providing consistent Ig levels for patients with CIDP

Pharmacometric analysis and the impact of consistent Ig levels.

As demonstrated in the pharmacokinetic analysis of the PATH Study

Hizentra provided more consistent Ig levels between infusions than IVIg

Weekly dosing avoids the extreme peaks and troughs of IVIg

Median concentrations per dose and dosing regimen1*†
Median concentrations per dose and dosing regimen graph
*The 0.2 g/kg and 0.4 g/kg weekly doses of Hizentra were 40% lower and 20% higher than the IVIg weekly dose, respectively.4
†The pharmacokinetic model simulated concentration time plots for Hizentra 0.2 g/kg and 0.4 g/kg compared to IVIg 1 g/kg.1,5,6

Greater consistency in serum IgG concentrations may reduce potential for CIDP symptom return between infusions1‡

  • The simulated pharmacokinetic model of Hizentra weekly doses (0.2 g/kg and 0.4 g/kg) maintained consistent therapeutic IgG concentrations over 24 weeks

‡PATH Study Design: Data from a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase III study of 2 doses of weekly Hizentra versus placebo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)—the PATH Study. Subjects who relapsed during the post-randomization phase were to receive IVIg as a rescue medication within 1 week. CIDP relapse was defined as a≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score compared with baseline.

Consistent Ig levels can impact the lives of real patients

Arthur patient testimonial on consistent ig levels can impact the lives of real patients
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On IVIg, I experienced fatigue leading up to my infusions. With Hizentra, I'm able to maintain stable Ig levels so my strength stays more consistent and I can remain active.

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— Arthur, patient advocate on Hizentra§
§Patient advocates are not healthcare professionals or medical experts. Patient advocates are compensated by CSL Behring LLC for their time and/or expenses.

Dosing

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Efficacy and Safety

See how Hizentra was proven in the largest Ig study in CIDP and further evaluated in an extension study

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Administration

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References: 1. Tortorici MA, Yuraszeck T, Cornblath D, et al. Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy. CPT Pharma Syst Pharmacol. 2021;10:839-850. 2. Berger M. Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal dose. Curr Opin All Clin Immunol. 2011;11:532-538. 3. Berger M, Allen JA. Optimizing IgG therapy in chronic autoimmune neuropathies: a hypothesis driven approach. Muscle Nerve. 2015;51:315-326. 4. Allen JA, Gelinas DF, Freimer M, Runken MC, Wolfe GI. Immunoglobulin administration for the treatment of CIDP: IVIG or SCIG? J Neurol Sci. 2020. https://doi.org/10.1016/j.jns.2019.116497. 5. Leger JM, De Bleecker JL, Sommer C, et al. Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013;18:130-140. 6. van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46.
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