octagam(R) 10% Immune Globulin Intravenous(Human) 10% Liquid Preparation

Efficacy

Dermatomyositis (DM)

DM
Study design
DM
​​​​​​​Study endpoints overview
DM
​​​​​​​Primary endpoint  (TIS improvement)
DM
​​​​​​​Secondary endpoints (CDASI improvement)

The first and only IVIg therapy with a successful phase 3 study resulting in FDA-approval for DM in adults1

Phase 3, prospective, randomized, double-blind, placebo-controlled, 95-patient study design1,2

Patient population

  • Diagnosis of definite or probable DM with confirmed active disease*
     ⁃   Manual Muscle Testing-8 (MMT-8) score: <142   
     ⁃    ≥2 other abnormal core set measures†  
  • Age range 22-79 years; 25% male, 75% female  ​​​​​​​
  • Patient disease severity, based on the physicians’ GDA assessment was: 
     ⁃    27% mild disease     
    ​​​​​​​ ⁃    59% moderate disease  
     
    ⁃    14% severe disease ​​​​​​​​​​​​​

*According to the Bohan and Peter criteria, developed in 1975 for the diagnosis and classification of DM based on: symmetric proximal muscle weakness, muscle biopsy evidence of myositis, elevation of serum skeletal muscle enzymes, electromyographic finding consistent with myositis, and typical dermatomyositis skin rash.
VAS of patient global activity ≥2 cm, physician’s GDA ≥2 cm, extra-muscular activity ≥2 cm, at least one muscle enzyme >1.5 times ULT, or HAQ ≥0.25.
Median age was 55 years in the OCTAGAM 10% arm and 51.5 years in the placebo arm.
§The OCTAGAM 10% DM clinical study was designed as a cross-over study.
||34 patients completed the trial in the OCTAGAM 10% arm and 35 patients in the placebo-switch arm.
#For stable patients, there was an option to reduce the OCTAGAM 10% dose to 1 g/kg at Week 28.

CSM=core-set measure; GDA=global disease activity; HAQ=health assessment questionnaire; MDAAT=myositis disease activity assessment tool; ULT=upper limit of normal; VAS=visual analog scale.
 ​​​​​​​

Concomitant medication use

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  • 98.9% of patients who were taking prior DM medications on a stable dose continued those medications
  • ​​​​​​​A similar proportion of patients used concomitant medications in both treatment arms. The most common were:
    ​​​​​​​⁃    88% systemic corticosteroids
    ⁃    57% immunosuppressants
    ​​​​​​​⁃    21% anti-inflammatory and anti-rheumatic products
Get more details on TIS & CDASI endpoints

Study efficacy endpoint1,2

Primary endpoint: Total Improvement Score (TIS)

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  • Proportion of TIS responders in the OCTAGAM 10% and placebo arms at 4 months (end of the placebo-controlled period) compared to baseline1
     ​​​​​​​⁃  A responder was defined as a patient with a TIS improvement of ≥20 points (at least minimal improvement) who had not met “confirmed deterioration” criteria at 2 consecutive visits up to and including month 4
    1,2
  • TIS is a composite score of 6 core set measures that assesses improvement on a scale of 0—1001,2

 
Secondary endpoints
TIS
 

  • Proportion of TIS responders by improvement category at 4 months2*
  • Mean TIS at end of placebo-controlled period (4 months) and at end of open-label extension period (10 months)2
  • Median time to response (minimal improvement in TIS) in the OCTAGAM 10% treatment arm2

Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

  • Mean change at 4 months and mean modified CDASI total score at 10 months2​​​​​​​

*TIS improvement is measured on a scale from 0 to 100 with responders classified as at least minimal (≥20 points), moderate (≥40 points), and major (≥60 points) based on change from baseline.

Get more details on TIS & CDASI endpoints

 
References
  1. OCTAGAM 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021. 
  2. Data on file. Octapharma USA Inc. ​​​​​​​
 

 
DM safety and tolerability data 
for OCTAGAM 10%

 

Administration Video

Review data

 
DM dosing and infusion rates 
for OCTAGAM 10%
 

Resources for patients and HCPs

See details 

 
OCTAGAM 10% DM clinical 
results video
 

Resources for patients and HCPs

Watch here 

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 10% liquid. 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 OCTAGAM 10% liquid. 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. OCTAGAM 10% liquid does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 10% liquid 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.

Dosing and Administration
Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min.

Contraindications
OCTAGAM 10% liquid 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
OCTAGAM 10% liquid may cause hypersensitivity in patients with a corn allergy. OCTAGAM 10% liquid contains maltose, which is derived from corn.

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

Falsely elevated blood glucose readings may occur during and after the infusion of OCTAGAM 10% liquid with testing by some glucometers and test strip systems.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients recieving OCTAGAM 10% liquid.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 10% liquid. Risk factors for hemolysis include high doses and non–O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Aseptic meningitis syndrome may occur in patients receiving OCTAGAM 10% liquid, especially with high doses or rapid infusion.

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

OCTAGAM 10% liquid is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions
cITP - The most common adverse reactions reported in >5% of study subjects were headache, fever, and increased heart rate.

DM - The most common adverse reactions reported in >5% of study subjects were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.

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.
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OCTAGAM® is a registered trademark of Octapharma AG.

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

OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.

INDICATIONs and Usage

OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.

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