Efficacy

CIDP

CIDP
study design
CIDP
INCAT responder rates (primary endpoint)
CIDP
​​​​​​​supporting efficacy endpoints
CIDP
​​​​​​​dose adjustments

The first and only IVIg treatment study to evaluate different maintenance dosing options for CIDP1


Prospective, double-blind, randomized, multicenter phase 3 study design1,2

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  • 18-83 years of age (25% of patients aged ≥65 years)
  • Patients with CIDP treated with IVIg or corticosteroids
  • Weakness of ≥2 limbs
  • Adjusted INCAT disability score between 2 and 9*

Washout phase: ≤12 weeks (IVIg/corticosteroids)

  • Deterioration of CIDP: decrease in PGIC score and ≥1 of the following:​​​​​​​
    • Increase in INCAT disability score of ≥1
    • Decrease in grip strength of ≥8 kPa in one hand
    • I-RODS MCID-SE (cut-off of –1.96 or less)

Patient population

DOSE-EVALUATION PHASE (INFUSIONS EVERY 3 WEEKS)†‡

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Learn about INCAT responder rates

Study efficacy endpoints1

Primary endpoint

  • Adjusted INCAT responder rate for the PANZYGA 1 g/kg treatment group at 6 months relative to baseline​​​​​​​​​​​​​​
    • Responders defined as a decrease of at least 1 point on the adjusted INCAT disability score relative to baseline

Supporting efficacy endpoints

  • Adjusted INCAT responder rate for the PANZYGA 2 g/kg treatment arm at 6 months relative to baseline
  • Time to INCAT response for PANZYGA 1 g/kg and 2 g/kg treatment arms2
  • I-RODS, Grip Strength, and MRC Sum Score responder rates for PANZYGA 1 g/kg and 2 g/kg treatment arms
Learn about supporting efficacy endpoint data

*A score of 2 comes exclusively from leg disability.2 
If patients in the 0.5 g/kg or 1 g/kg arms were either deteriorating at a 3-week interval after Week 3 and before Week 18 or not improving at Week 6, they were given 2 consecutive blinded doses of 2 g/kg 3 weeks apart. Their improvement was assessed with a Study End visit 3 weeks after the second rescue dose, and then they were discontinued. Patients in the 2 g/kg arm who were either deteriorating at a 3-week interval after Week 3 and before Week 18 or not improving at Week 6 were discontinued.2 
Since previous placebo-controlled studies have already been done, it was not considered ethically justified to conduct further placebo-controlled studies.2 
INCAT=Inflammatory Neuropathy Cause and Treatment; I-RODS=Inflammatory Rasch-built Overall Disability Scale; IVIg=intravenous immunoglobulin; MCID-SE=minimum clinically important difference related to the varying standard errors; MRC=Medical Research Council; PGIC=Patients’ Global Impression of Change. 

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References
  1. PANZYGA [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021.
  2. Data on file. Octapharma USA Inc.

CIDP dosing and infusion rates for PANZYGA

See details

CIDP safety and tolerability data for PANZYGA

Review data
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including PANZYGA. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer PANZYGA 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. [see Full Prescribing Information, Warnings and Precautions (5.2, 5.4)]

Contraindications

PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Warnings and Precautions

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving PANZYGA.

Aseptic meningitis syndrome may occur in patients receiving PANZYGA, especially with high doses or rapid infusion.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to PANZYGA treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Monitor blood pressure prior to, during, and following PANZYGA infusion.

Carefully consider the relative risks and benefits before prescribing the high dose regimen (for cITP) in patients at increased risk of volume overload.

PANZYGA is made from human plasma and may contain infectious agents, e.g. viruses and theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions

PI – The most common adverse reactions (≥5% study subjects) were headache, nausea, fever, fatigue, and abdominal pain.

cITP in adults – The most common adverse reactions (≥5% study subjects) were headache, fever, nausea, vomiting, dizziness, and anemia.

CIDP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, dermatitis, and blood pressure increase.
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The risk information provided here is not comprehensive; see full Prescribing Information and Boxed Warning for PANZYGA.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

PANZYGA® is a registered trademark of Octapharma AG.

Please click here for Full Prescribing Information, including BOXED WARNING.

PANZYGA (Immune Globulin Intravenous [Human] - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.

INDICATION AND USAGE

PANZYGA (Immune Globulin Intravenous [Human] - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.