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HomeAbout OCTAGAM 10%EfficacyEfficacyDMcITPSafety & TolerabilitySafety & TolerabilityDMcITPDosing & Infusion RatesDosing & Infusion Rates DMcITPSupportSupportMaterialsVideosPfizer OCTAGAM Co-Pay ProgramPfizer IGuide™Ig CompanionFrequently asked questionsRequest a representative

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Prescribing Information, including BOXED WARNINGIndicationsOCTAGAM 5%Patient Site
EfficacyOCTAGAM 10% [Immune Globulin Intravenous (Human)] liquid

DM study design

DM study endpoints overview

DM primary endpoint (TIS improvement)

DM secondary endpoints
(TIS & 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 1 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
  • 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
Study efficacy endpoint Primary endpoint: Total Improvement Score (TIS)
  • 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 41,2
  • TIS is a composite score of 6 core set measures that assesses improvement on a scale of 0-1001,2
Secondary endpointsTIS
  • Proportion of TIS responders by improvement category at 4 months and 10 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
LoadingReferences:Octagam 10%. Prescribing information. Octapharma USA Inc.; 2022.Data on file. Octapharma USA Inc. 
Total Improvement Score (TIS) is a validated assessment tool to quantify DM improvement1

In 2016, the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) developed validated TIS response criteria to quantify the degree of improvement in myositis clinical trials1

See TIS results from the clinical study
LoadingALT=alanine aminotransferase; AST=aspartate aminotransferase; LDH=lactate dehydrogenase.Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)—a clinician-scored outcome measure for DM2

The CDASI assesses activity and damage measures over 15 areas with a total activity score of 1-100 and total damage score of 0-32 (lower scores indicate lower disease severity)2*

See CDASI results from the clinical study 
LoadingThe 3 activity measures on the 15 anatomical locations can add up to 90 points; Gottron’s papules on the hands, periungual, and alopecia can add up to 10 points. The 2 damage measures on the 15 anatomical locations can add up to 30 points with 2 additional points for Gottron’s hands. The activity (0-100) and damage (0-32) scores make up the modified CDASI total score used in this study.References:NIH National Institute of Environmental Health Sciences. Myositis response criteria. 2016 ACR/EULAR criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis and juvenile dermatomyositis. Accessed February 8, 2022. https://www.niehs.nih.gov/research/resources/imacs/response_criteria/final_myositis_response_
criteria_508.pdfTiao J, Feng R, Bird S, Choi JK, et al. The reliability of the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) among dermatologists, rheumatologists and neurologists. Br J Dermatol. 2017;176(2):423-430. doi:10.1111/bjd.15140
OCTAGAM 10% demonstrated a higher responder rate* vs placebo in all 3 categories of TIS improvement at 4 months1

Primary endpoint met: a significantly higher proportion of patients receiving OCTAGAM 10% achieved at least the minimal category of TIS improvement vs. placebo (79% vs 44%; P=0.0008)1

  • In both the moderate and major improvement categories, there were higher proportions of responders with OCTAGAM 10% vs placebo (secondary endpoints)1
  • Median time to response in the OCTAGAM 10% treatment arm was 35 days (after 2 infusions)1
Learn more about TIS endpoint 
LoadingA responder was defined as a patient with a TIS improvement of ≥20 points (at least minimal improvement), ≥40 points (at least moderate improvement), ≥60 points (major improvement) who had not met criteria for confirmed deterioration at 2 consecutive visits up to and including week 16. The proportion of responders in the OCTAGAM 10% vs placebo arms, respectively, was 78.7% (37/47 patients) vs 43.8% (21/48 patients) for minimal TIS improvement; 68.1% (32/47 patients) vs 22.9% (11/48 patients) for moderate TIS improvement; 31.9% (15/47 patients) vs 8.3% (4/48 patients) for major TIS improvement.Reference:Octagam 10%. Prescribing information. Octapharma USA Inc.; 2022.
After patients switched from placebo to OCTAGAM 10%, both treatment arms achieved similar mean TIS at 10 months1

At 4 months, there were greater improvements in mean TIS in the OCTAGAM 10% arm vs placebo arm1

  • Mean TIS is a secondary endpoint which is different than the primary endpoint of TIS responder rate1*†
    • TIS values were collected at each visit through week 16, then at week 28, and at week 40. Mean TIS values for both treatment arms are shown in the graph1
Mean TIS is defined as the average TIS values collected from baseline to week 16, then at week 28 and week 40.TIS responder rate is the proportion of patients achieving a TIS improvement of ≥20 points (at least minimal improvement), ≥40 points (at least moderate improvement), ≥60 points (major improvement).After patients switched from placebo to OCTAGAM 10%, both treatment arms achieved similar mean CDASI total activity scores at 10 months1

At 4 months, there were greater improvements in mean CDASI total activity score in the OCTAGAM 10% arm vs placebo arm2

  • A greater improvement in mean CDASI total activity score was demonstrated with OCTAGAM 10% vs placebo at 4 months (mean change -9.4 vs -1.2)1,2
  • In the open-label extension period, patients who switched to OCTAGAM 10% achieved a similar mean CDASI total activity score vs patients who received OCTAGAM 10% throughout the entire study1
  • CDASI total activity scores of ≥15 indicate moderate-to-severe skin disease3,4 
  • In clinical studies, the target treatment difference between the study drug and placebo arms is a 5- to 10-point change from baseline4
Learn more about CDASI endpoint
LoadingThe CDASI Total Activity Score ranges from 0-100.5References:Data on file. Octapharma USA Inc.Octagam 10%. Prescribing information. Octapharma USA Inc.; 2022.Ahmed S, Chen KL, Werth VP. The validity and utility of the Cutaneous Disease Area and Severity Index (CDASI) as a clinical outcome instrument in dermatomyositis: a comprehensive review. Semin Arthritis Rheum. 2020;50(3):458-462. Brevard JA, Hurtt M, Horobin J, et al. Design considerations for clinical trials using the Cutaneous Dermatomyositis Disease Area and Severity Index as a primary endpoint. J Clin Exp Dermatol Res. 2017;8(4). doi:10.4172/2155-9554.1000401Tiao J, Feng R, Bird S, Choi JK, et al. The reliability of the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) among dermatologists, rheumatologists and neurologists. Br J Dermatol. 2017;176(2):423-430. doi:10.1111/bjd.15140
Efficacy DM safety and tolerability data for OCTAGAM 10% Review data Loading
DM dosing and infusion rates for OCTAGAM 10% See detailsLoading
OCTAGAM 10% DM clinical results video Watch hereLoading

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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.

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.
IMPORTANT SAFETY
INFORMATION 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. ContraindicationsOCTAGAM 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 PrecautionsOCTAGAM 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 receiving 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.OCTAGAM® is a registered trademark of Octapharma AG.Please click here for Full Prescribing Information, including BOXED WARNING.INDICATIONS AND USAGEOCTAGAM® 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.