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HomeAboutDMDMTrial design and efficacySafety and tolerabilityDosing and infusion ratesPatient profilescITPcITPTrial design and efficacySafety and tolerabilityDosing and infusion ratesMaterialsSupportSupportOCTAGAM 10% Co-Pay ProgramPfizer IGuide™FAQsRequest a RepresentativeIg CompanionCoverage
Prescribing Information, including BOXED WARNINGIndicationsPatient SiteOCTAGAM 5%
Trial design and efficacyDM trial designPhase 3, prospective, randomized, double-blind, placebo-controlled, 95-patient trial design1,2

10-month study consisting of 4-month placebo-controlled period and 6-month open-label extension period1,2

 DM trial endpoints PRIMARY ENDPOINT1,2 Total Improvement Score (TIS)§
  • Proportion of TIS responders in the OCTAGAM 10% and placebo arms at week 16 (end of the placebo-controlled period)
    • A responder was defined as a patient with a TIS improvement of ≥20 points (at least minimal improvement)||
  • TIS is a composite score of 6 core set measures that assesses improvement on a scale of 0-100 with a higher score indicating greater improvement
 SECONDARY ENDPOINTS1,2 Total Improvement Score (TIS)
  • Proportion of TIS responders with moderate and major improvement at week 16
  • Mean TIS at the end of placebo-controlled period (week 16) and at the end of open-label extension period (40 weeks)
  • Median time to response (at least minimal improvement in TIS)
 Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
  • Mean change at week 16 from baseline
Median age was 55 years in the OCTAGAM 10% arm and 51.5 years in the placebo arm.2MMT-8 score: <142; ≥2 other abnormal core set measures (VAS of patient global activity ≥2 cm, physician GDA ≥2 cm, extramuscular activity ≥2cm, at least 1 muscle enzyme >1.5 times ULT, or HAQ ≥0.25).2The OCTAGAM 10% DM clinical trial was designed as a crossover trial. Thirty-four patients completed the trial in the OCTAGAM 10% arm and 35 patients in the placebo-switch arm. Two patients in the OCTAGAM 10% group and 1 in the placebo group had an AE leading to discontinuation, and 1 patient in the placebo group withdrew for other reasons.2TIS improvement is measured on a scale from 0-100 with responders classified as at least minimal (≥20 points), moderate (≥40 points), and major (≥60 points) based on change from baseline.1,2Responders were also defined as not meeting “confirmed deterioration” criteria at 2 consecutive visits up to and including week 16.2The TIS clinical endpoint studied adults only. Any mentions of TIS throughout this piece is in an adult patient context.2AE=adverse event; GDA=physician’s global assessment (PhGA) of disease activity; HAQ=health assessment questionnaire; MMT-8=Manual Muscle Testing-8; ULT=upper limit of normal; VAS=visual analog scale.TIS overviewTIS is a composite score of 6 core set measures assessed on a 0-100 point scale1,2 Definitions of minimal, moderate, and major thresholds ALT=alanine aminotransferase; AST=aspartate aminotransferase; CK=creatine kinase; LDH=lactate dehydrogenase.TIS efficacy resultsOCTAGAM 10% demonstrated a higher responder* rate vs placebo in all 3 categories of TIS improvement at week 161,2 A responder was defined as a patient with a TIS improvement of ≥20 points (at least minimal improvement), ≥40 points (at least moderate improvement), and ≥60 points (at least major improvement) who had not met criteria for confirmed deterioration at 2 consecutive visits up to and including week 16.1,2 TIS improvement resultsMean TIS† improvement during the placebo-controlled period (weeks 0-16)2

Limitations: The trial was not designed to make comparisons between treatment groups at 4, 8, 12, and 16 weeks. No statistical conclusions may be drawn.

 TIS improvement is measured on a scale from 0-100 with responders classified as minimal (≥20 points), moderate (≥40 points), and major (≥60 points) based on change from baseline.2Mean TIS improvement during the open-label extension period (weeks 16-40)2

Limitations: The trial was not designed to make comparisons between treatment groups from week 16 to week 40. No statistical conclusions may be drawn.

 Placebo crossover refers to the end of the initial placebo-controlled trial period (weeks 0-16) and the beginning of the 6-month open-label extension period (weeks 16-40), during which all subjects who were eligible to continue received OCTAGAM 10% every 4 weeks.2Modified CDASI overviewModified CDASI: 15 anatomical skin locations assessed and measured by the total activity score (0-100)6 Modified CDASI resultsPatients on OCTAGAM 10% demonstrated a greater improvement in the modified CDASI total activity score vs placebo at week 161,2

CDASI scores and minimal clinically significant change7

A decrease in modified CDASI of 5 points generally represents a minimal clinically significant change. The average score in the OCTAGAM 10% group decreased by 9.4 points and crossed this threshold, whereas the average score in the placebo group decreased by 1.2 points, and did not cross the threshold.

Average scores at 16 weeks1,2¶

  • OCTAGAM 10% group: 9.6§ (mild disease)
  • Placebo group: 17.6§ (moderate to severe disease)
Improvement in the OCTAGAM 10% DM trial is based on scores measured at 16 weeks from baseline, which is the mean score.This threshold was not defined in the clinical trial, however literature suggests a threshold of 5 points represents a minimal clinically significant change.7The CDASI score cutoff for mild disease is considered to be >14 points. While definitions of moderate-severe disease vary, generally a CDASI score of 15-19 points or higher is considered moderate to severe disease.7The OCTAGAM Co-Pay Program provides eligible patients assistance of up to $12,500 per year. Once a patient reaches the annual maximum benefit, patient is responsible for paying the remaining monthly out-of-pocket costs. The OCTAGAM Co-Pay Program is good only in the US and Puerto Rico. No membership fees. Federal and state health care beneficiaries are not eligible. Private insurance only. Eligibility and restrictions apply. See full Terms and Conditions on the Support and financial assistance page. Next page: Safety and tolerability > LoadingReferences:Octagam 10%. Prescribing Information. Octapharma USA Inc.; 2023.Aggarwal R, Charles-Schoeman C, Schessl J, et al. Trial of intravenous immune globulin in dermatomyositis. N Engl J Med. 2022;387(14):1264-1278. doi:10.1056/NEJMoa2117912Data on file. Octapharma USA Inc.Aggarwal R, Rider LG, Ruperto N, et al. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: an International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation collaborative initiative. Ann Rheum Dis. 2017;76(5):792-801. doi:10.1136/annrheumdis-2017-211400Rider LG, Werth VP, Huber AM, et al. Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: physician and patient/parent global activity, Manual Muscle Testing (MMT), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (C-HAQ), Childhood Myositis Assessment Scale (CMAS), Myositis Disease Activity Assessment Tool (MDAAT), Disease Activity Score (DAS), Short Form 36 (SF-36), Child Health Questionnaire (CHQ), physician global damage, Myositis Damage Index (MDI), Quantitative Muscle Testing (QMT), Myositis Functional Index-2 (FI-2), Myositis Activities Profile (MAP), Inclusion Body Myositis Functional Rating Scale (IBMFRS), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Cutaneous Assessment Tool (CAT), Dermatomyositis Skin Severity Index (DSSI), Skindex, and Dermatology Life Quality Index (DLQI). Arthritis Care Res (Hoboken). 2011;63(suppl 11):S118-S157. doi:10.1002/acr.20532Tiao J, Feng R, Bird S, 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.15140Anyanwu C, Fiorentino D, Chung L, et al. Validation of the Cutaneous Dermatomyositis Disease Area and Severity Index: characterizing disease severity and assessing responsiveness to clinical change. Br J Dermatol. 2015;173:969-974
OCTAGAM 10% Co-Pay Program

Eligible patients may pay as little as $0 for OCTAGAM 10%#

 Learn moreLoading
OCTAGAM 10% Co-Pay Program

With the OCTAGAM Co-Pay Program, eligible patients may pay as little as $0#

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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.
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.