RESOURCES

RESOURCES

REMICADE® resources for your practice

Janssen IV Benefits Investigation and Prescription Form

Finding and completing the relevant Benefits Investigation (BI) form is the first step to understanding your patient’s insurance coverage. This combined BI and prescription form for REMICADE® includes a Patient Authorization Form, which is required on a per-patient basis for practices that do not have an executed Business Associate Agreement (BAA) and can be used across REMICADE® indications.

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Gastroenterology Benefits Investigation and Prescription Form

This combined BI and prescription form has prepopulated information specific to the gastroenterology indications for REMICADE® and also includes the Patient Authorization Form, which is required on a per-patient basis for practices that do not have an executed BAA.

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REMICADE® Benefits Investigation Form

This stand-alone BI form initiates a request for BI support for REMICADE® with optional prior authorization (PA) support. A separate Patient Authorization Form would be required on a per-patient basis for practices that do not have an executed BAA.

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Business Associate Agreement

Complete this BAA one time only to allow you to request verification of patients’ insurance benefits without requiring individual patient authorization.

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Patient Authorization Form

If no BAA is on file, you must secure a PA for each patient. Use this form or complete the PA portion (page 3) of the Janssen IV Benefits Investigation and Prescription Form or Gastroenterology Benefits Investigation and Prescription Form. Janssen CarePath cannot accept any patient without an executed BAA or PA on file.

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Sample Letter of Medical Necessity

This sample Letter of Medical Necessity shows you the key elements of a letter that would be submitted either with the initial claim or when requesting reconsideration of a denied claim to support the medical necessity of treatment with REMICADE®.

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Sample Letter of Medical Exception

This sample Letter of Medical Exception shows you the key elements of a letter that communicates your treatment decision for a patient based on their individual needs and explains why the treatment you are recommending is appropriate for your patient.

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Billing Guide for REMICADE®

This Billing Guide provides detailed information to assist you in obtaining reimbursement for REMICADE®, including essential coding considerations, sample claims forms, important product information, and reimbursement support resources.

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Supporting Appropriate Payer Coverage Decisions Brochure

This brochure explains what information may be required by payers for coverage of medically necessary drug therapies.

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Specialty Distributors

This list can help you identify specialty distributors who are authorized to sell REMICADE® directly to your office.

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REMICADE® Infusion Video LIBRARY

This video reinforces administration instructions found in the REMICADE® Prescribing Information; it is comprised of 6 chapters, which you can watch individually or consecutively.

  • Getting Started
  • Dose Calculation
  • Reconstitution and Dilution
  • Administration and Monitoring
  • Infusion Reactions
  • Important Safety Information

  • video

    REMICADE® resources for your Patients

    Patient Affordability Options for REMICADE®

    This flash card describes options that may be available to patients that can help make their treatment with REMICADE® more affordable.

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    REMICADE® Patient Brochure

    This brochure provides key information to support patients prescribed REMICADE®, including how to prepare for infusion therapy, affordability and support resources, and options to explore if their health plan doesn't approve treatment with REMICADE® or they are asked to switch medications.

    Download

    REMICADE® Discussion Guide

    This discussion guide was developed for patients prescribed REMICADE® who may have been asked to switch to another medicine for health plan coverage or policy reasons. It provides a list of questions patients can use to start a conversation with their provider regarding their treatment and what they can do to stay on their current therapy if REMICADE® is still right for them.

    Download

    Janssen CarePath Savings Program for REMICADE®

    This brochure describes the Janssen CarePath Savings Program available to eligible patients using commercial insurance to pay for REMICADE®.

    Download
    IMPORTANT SAFETY INFORMATION
    INDICATIONS
    IMPORTANT SAFETY INFORMATION
    SERIOUS INFECTIONS

    Patients treated with REMICADE® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.

    Reported infections include:

    • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
    • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
    • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.

    The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

    Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.

    MALIGNANCIES

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

    Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.

    In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

    Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE®.

    CONTRAINDICATIONS

    REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

    HEPATITIS B REACTIVATION

    TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.

    HEPATOTOXICITY

    Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

    HEMATOLOGIC EVENTS

    Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.

    HYPERSENSITIVITY

    REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Medications for the treatment of hypersensitivity reactions should be available.

    CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

    Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

    NEUROLOGIC EVENTS

    TNF inhibitors, including REMICADE®, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.

    AUTOIMMUNITY

    Treatment with REMICADE® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

    ADVERSE REACTIONS

    In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

    USE WITH OTHER DRUGS

    Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

    LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

    Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.

    Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.

    For more information, please see the full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion.

    References: 1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161(suppl 3):S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

    cp-62063v1



    INDICATIONS
    REMICADE® is indicated for:
    Crohn’s Disease
    • Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy
    • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
    Pediatric Crohn’s Disease
    • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy
    Ulcerative Colitis
    • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
    Pediatric Ulcerative Colitis
    • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy
    Rheumatoid Arthritis
    • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
    Psoriatic Arthritis
    • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)
    Ankylosing Spondylitis
    • Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)
    Plaque Psoriasis
    • The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
    • REMICADE® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician



    IMPORTANT SAFETY INFORMATION
    INDICATIONS
    IMPORTANT SAFETY INFORMATION
    SERIOUS INFECTIONS

    Patients treated with REMICADE® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.

    Reported infections include:

    • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
    • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
    • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.

    The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

    Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.

    MALIGNANCIES

    Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

    Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.

    In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

    Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE®.

    CONTRAINDICATIONS

    REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

    HEPATITIS B REACTIVATION

    TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.

    HEPATOTOXICITY

    Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

    HEMATOLOGIC EVENTS

    Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.

    HYPERSENSITIVITY

    REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Medications for the treatment of hypersensitivity reactions should be available.

    CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

    Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

    NEUROLOGIC EVENTS

    TNF inhibitors, including REMICADE®, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.

    AUTOIMMUNITY

    Treatment with REMICADE® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

    ADVERSE REACTIONS

    In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

    USE WITH OTHER DRUGS

    Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

    LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

    Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.

    Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.

    For more information, please see the full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion.

    References: 1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161(suppl 3):S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

    cp-62063v1



    INDICATIONS
    REMICADE® is indicated for:
    Crohn’s Disease
    • Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy
    • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
    Pediatric Crohn’s Disease
    • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy
    Ulcerative Colitis
    • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
    Pediatric Ulcerative Colitis
    • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy
    Rheumatoid Arthritis
    • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
    Psoriatic Arthritis
    • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)
    Ankylosing Spondylitis
    • Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)
    Plaque Psoriasis
    • The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
    • REMICADE® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician



    TargAn study design

    Targan et al conducted a multicenter, randomized, double-blind trial in 108 patients with moderately to severely active CD (baseline CDAI 220 and 400) unresponsive to conventional therapy. Patients were randomized to receive a single infusion of placebo (n=25) or REMICADE® 5 mg/kg IV (n=27), 10 mg/kg IV (n=28), or 20 mg/kg IV (n=28). The primary endpoint was clinical response at Week 4.5

    Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn’s disease.1

    ACCENT I STUDY DESIGN

    ACCENT I is a 1-year, multicenter, randomized, double-blind trial of REMICADE® in 545 patients with moderately to severely active CD (CDAI 220 and 400). All patients received an initial dose of REMICADE® 5 mg/kg IV. Patients were then randomized based on clinical response at Week 2 to 1 of 3 treatment groups through Week 541,6:

    • The placebo maintenance group received placebo infusion at Weeks 2, 6, and every 8 weeks thereafter
    • The 5 mg/kg IV maintenance group received REMICADE® 5 mg/kg IV at Weeks 2, 6, and every 8 weeks thereafter
    • The REMICADE® 10 mg/kg IV maintenance group received REMICADE® 5 mg/kg IV at Weeks 2 and 6, followed by REMICADE® 10 mg/kg IV every 8 weeks thereafter

    The coprimary endpoints of the trial were the proportion of patients responding at Week 2 who were in remission at Week 30 and time to loss of response through Week 54.1,6

    Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn’s disease.1

    SONIC STUDY DESIGN6,9

    Results from SONIC, a multicenter, randomized, double-blind, controlled, phase IIIb trial of 508 patients with moderately to severely active CD (baseline CDAI ≥220 and ≤450). At baseline, mean CDAI score for all patients was 287; median duration of CD ranged from 2.2 to 2.4 years. Patients were randomly assigned to 1 of 3 treatment groups through Week 30. In the primary study phase, patients received REMICADE® 5 mg/kg or placebo infusions at Weeks 0, 2, 6, 14, and 22; patients also received AZA capsules at a dose of 2.5 mg/kg/day or placebo capsules daily through Week 30. Patients completing treatment through Week 30 (main study) were eligible to enter the study extension if, in the opinion of the investigator, the patient could benefit from continued treatment. Patients eligible for participation in the extension (N=280) continued to receive their initial treatment through Week 50. The Week-50 analysis included patients who did not enter the study extension. These patients were assumed nonresponders and not to be in steroid-free remission at Week 50. The primary endpoint of the study was the proportion of patients in corticosteroid-free remission at Week 26. Secondary endpoints included mucosal healing at Week 26 and corticosteroid-free remission at Week 50. Monitoring for adverse events was performed through Week 54.

    REACH study design

    REACH (A Randomized, multicenter, open-label study to Evaluate the safety and efficacy of Anti-TNF-α Chimeric monoclonal antibody in pediatric subjects with moderate to severe Crohn's disease) was a controlled trial that evaluated the safety and efficacy of REMICADE® in 112 pediatric patients aged 6 to 17 years with moderately to severely active CD. All patients received induction dosing of 5 mg/kg IV REMICADE® at Weeks 0, 2, and 6. At Week 10, 103 patients were randomized to a maintenance regimen of REMICADE® 5 mg/kg IV given either every 8 weeks or every 12 weeks. Induction of clinical response, the primary endpoint, was evaluated 10 weeks after the 3-dose induction regimen (Weeks 0, 2, and 6). At Week 54, clinical response, clinical remission, and change from baseline in average daily corticosteroid use were evaluated as secondary efficacy endpoints.5

    Note: REMICADE® 5 mg/kg IV every 12 weeks is not an approved maintenance dose for REMICADE®.1

    ACT 1 study design

    The safety and efficacy of REMICADE® were evaluated in the Active Ulcerative Colitis Trial (ACT 1) (N=364), a randomized, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active ulcerative colitis who had an inadequate response or were intolerant to conventional therapy. Patients presented with a Mayo score between 6 and 12, and an endoscopy subscore of 2. Prior failed or intolerable therapies in ACT 1 included oral corticosteroids, 6-mercaptopurine (6-MP), or azathioprine (AZA). Patients were randomized to the following treatment groups: REMICADE® 5 mg/kg IV (n=121), REMICADE® 10 mg/kg IV (n=122), or placebo (n=121). Infusions were administered at Weeks 0, 2, and 6, and every 8 weeks thereafter through Week 46.5

    Final efficacy evaluations were completed 8 weeks following the last infusion. Concomitant treatment with stable doses of aminosalicylates, corticosteroids, and/or immunomodulators was permitted throughout the study. Of patients receiving steroids at baseline, tapering was allowed beginning at Week 8. The primary efficacy endpoint was clinical response at Week 8; secondary endpoints included clinical remission and mucosal healing.5

    Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.1

    ACT 2 study design

    The safety and efficacy of REMICADE® were evaluated in ACT 2 (N=364) (ACT=Active Ulcerative Colitis Trial), a randomized, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active ulcerative colitis who had an inadequate response or were intolerant to conventional therapy. Patients presented with a Mayo score between 6 and 12, and an endoscopy subscore of 2. Prior failed or intolerable therapies in ACT 2 included oral corticosteroids, 6-mercaptopurine (6-MP), or azathioprine (AZA) and/or aminosalicylates. Patients were randomized to the following treatment groups: REMICADE® 5 mg/kg IV (n=121), REMICADE® 10 mg/kg IV (n=120), or placebo (n=123). Infusions were administered at Weeks 0, 2, and 6, and every 8 weeks thereafter through Week 22.5

    Final efficacy evaluations were completed 8 weeks following the last infusion. Concomitant treatment with stable doses of aminosalicylates, corticosteroids, and/or immunomodulators was permitted throughout the study. Of patients receiving steroids at baseline, tapering was allowed beginning at Week 8. The primary efficacy endpoint was clinical response at Week 8; secondary endpoints included clinical remission and mucosal healing.5

    Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.1

    Pediatric Ulcerative Colitis Trial study design

    The REMICADE® Pediatric Ulcerative Colitis (UC) trial was a multicenter, phase 3, randomized, open-label, parallel-group trial to evaluate the safety and efficacy of REMICADE® in pediatric patients aged 6 to 17 years with moderately to severely active UC (N=60; Mayo score of 6 to 12; endoscopic subscore 2) and an inadequate response to conventional therapies. The primary objectives of the study were to evaluate clinical response after a 3-dose induction regimen of REMICADE® 5 mg/kg IV and the safety of REMICADE® during induction and maintenance regimens. Secondary objectives included the evaluation of 2 REMICADE® maintenance dosing regimens (every 8 weeks and every 12 weeks) in maintaining remission, as measured on the Pediatric Ulcerative Colitis Activity Index (PUCAI); the efficacy of a 3-dose regimen of REMICADE® in the induction of clinical remission, as measured by the Mayo score; and the induction of remission, as measured on the PUCAI.1,5

    All patients received induction dosing of REMICADE® 5 mg/kg IV at Weeks 0, 2, and 6. Patients who did not respond to REMICADE® at Week 8 received no further REMICADE® and returned for safety follow-up. At Week 8, 45 patients were randomized to a maintenance regimen of REMICADE® 5 mg/kg IV given either every 8 weeks through Week 46 or every 12 weeks through Week 42.1,5

    Note: REMICADE® 5 mg/kg IV every 12 weeks is not an FDA-approved maintenance dosing regimen for REMICADE® in the treatment of pediatric patients with moderately to severely active UC.1

    express study design1,5

    EXPRESS evaluated 378 patients with moderate to severe plaque psoriasis. These patients had 10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 12, and were candidates for systemic or phototherapy. Patients were randomized to placebo or REMICADE® (infliximab) at a dose of 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy), followed by maintenance therapy (5 mg/kg IV) every 8 weeks. At Week 24, the placebo group crossed over to REMICADE® induction (5 mg/kg IV), followed by maintenance therapy (5 mg/kg IV) every 8 weeks. Patients randomized to REMICADE® continued to receive REMICADE® 5 mg/kg IV every 8 weeks through Week 46. The primary endpoint was the proportion of patients achieving 75% improvement in PASI from baseline to Week 10.

    express II STUDY DESIGN1,6

    EXPRESS II evaluated 835 patients with moderate to severe plaque psoriasis. These patients had 10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 12, and were candidates for systemic therapy or phototherapy. Patients were randomized to placebo or REMICADE® (infliximab) at doses of 3 mg/kg IV or 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy). At Week 14, patients in the REMICADE® arms continued on their original dose but were randomized to either an every 8 week scheduled maintenance therapy or an as needed (PRN) maintenance therapy through Week 46. Patients randomized to the PRN maintenance therapy group received their original REMICADE® dose when baseline improvement in PASI was <75% and received placebo if PASI improvement was 75%. Maintenance visits occurred monthly. At Week 16, the placebo group crossed over to REMICADE® induction therapy (5 mg/kg IV), followed by a maintenance therapy every 8 weeks. The primary endpoint was proportion of patients achieving PASI 75 at Week 10.

    spirit STUDY DESIGN1,7

    SPIRIT evaluated 249 patients with plaque psoriasis. These patients had 10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 12, and had previously received either psoralen plus ultraviolet A treatment (PUVA) or other systemic therapy for their psoriasis. Patients were randomized to either placebo or REMICADE® (infliximab) at doses of 3 mg/kg IV or 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy). At Week 26, patients with a static physician’s global assessment (sPGA) score of moderate or worse (3 on a scale of 0 to 5) received an additional dose of the randomized treatment. The primary endpoint was the proportion of patients achieving 75% improvement in PASI from baseline at Week 10.

    ASSERT study design5,6

    ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy), a 24-week, multicenter, double-blind, placebo-controlled, randomized, phase 3 study in 279 adult patients with active ankylosing spondylitis according to the modified New York criteria for 3 months, with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 4, and spinal pain assessment score 4 on a Visual Analog Scale (VAS), each on a scale of 0-10. The primary endpoint was the proportion of patients with a 20% improvement response according to the criteria of the ASAS International Working Group. Patients were randomized to 1 of 2 treatment groups in a 3:8 ratio: placebo (n=78) or REMICADE® 5 mg/kg (n=201) infused at Weeks 0, 2, 6, 12, and 18. Concurrent stable treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and tramadol was permitted during the study. Patients were not permitted to be on any disease-modifying antirheumatic drugs (DMARDs) or systemic corticosteroids.

    IMPACT 2 study design5,6

    IMPACT 2 (Induction and Maintenance Psoriatic Arthritis Clinical Trial 2): a randomized, double-blind, placebo-controlled, multicenter, phase 3, parallel-group study of REMICADE® in 200 adult patients with active PsA for at least 6 months who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or nonsteroidal anti-inflammatory drugs (NSAIDs). Patients had active articular disease (5 swollen and tender joints each), psoriatic target skin lesion (≥2 cm in diameter), and either C-reactive protein (CRP) 1.5 mg/dL or morning stiffness lasting 45 minutes. Stable methotrexate (MTX) doses of 25 mg/week at study entry and stable oral corticosteroid doses equivalent to 10 mg/day of prednisone were permitted. During the 24-week, double-blind phase, patients received either REMICADE® 5 mg/kg IV (n=100) or placebo (n=100) at Weeks 0, 2, 6, 14, and 22. At Week 16, placebo patients with <10% improvement in swollen and tender joint counts were switched to active treatment and received REMICADE® 5 mg/kg IV at Weeks 16, 18, 22, 30, 38, and 46. At Week 24, all patients receiving placebo crossed over to active treatment and received REMICADE® 5 mg/kg IV (n=91) at Weeks 24, 26, 30, 38, and 46. Primary endpoints included the proportion of patients with ACR20 response at Week 14 and the change from baseline in total modified van der Heijde-Sharp (vdH-S) score at Week 24. Improvement in Psoriasis Area and Severity Index (PASI) was evaluated in psoriatic arthritis patients with baseline body surface area (BSA) 3% (n=87, placebo; n=83, REMICADE®).

    start study design3

    START (Safety Trial for Rheumatoid Arthritis with REMICADE® Therapy): a 54-week, randomized, multicenter, double-blind, 3-arm, parallel-group, phase 3 study of the safety of REMICADE® in combination with methotrexate (MTX) in adult patients with moderately to severely active RA. Moderately to severely active RA was defined as 6 swollen (out of 66 total) and 6 tender joints (out of 68 total) for 3 months prior to screening. Patients were receiving MTX for 3 months before randomization and at a stable dose (25 mg/week) for 4 weeks before randomization. Patients could continue receiving other conventional disease-modifying antirheumatic drugs (DMARDs) as long as doses had been stable for 4 weeks. Doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids must have been stable for ≥4 weeks prior to screening.

    The primary objective was to assess the relative risk of serious infection within 22 weeks of initiating therapy with REMICADE® + MTX in subjects matching clinical practice demographics (including severity of disease, background DMARD use, and concomitant disease). Secondary objectives measured the safety and efficacy of dose-escalation regimens in patients with an incomplete response to the initial dose of REMICADE® 3 mg/kg every 8 weeks and the safety of REMICADE® + MTX after 1 year.

    Patients (N=1084) were randomized in a 1:1:1 ratio to 1 of 3 treatment groups: placebo infusions through Week 14, followed by REMICADE® 3 mg/kg infusions every 8 weeks through Week 46 (Group 1, n=363); REMICADE® 3 mg/kg infusions every 8 weeks through Week 46, with dose escalation from Week 22 to 46 by 1.5 mg/kg increments, if the patient had an inadequate response (Group 2, n=360); and REMICADE® 10 mg/kg infusions every 8 weeks through Week 46 (Group 3, n=361). At Week 26, Group 2 and Group 3 patients received a placebo infusion in order to maintain treatment blind. The median dose of MTX was 15 mg/week.

    attract study design1,5

    ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy): a 2-year, multicenter, double-blind, placebo-controlled, randomized, phase 3 study of REMICADE® with methotrexate (MTX) in 428 patients with moderately to severely active MTX-refractory established RA (MTX use 3 months). Moderately to severely active RA was defined as 6 swollen joints (out of 66 total) and 6 tender joints (out of 68 total) and 2 of the following:

    1. ≥45 minutes of morning stiffness
    2. Erythrocyte sedimentation rate (ESR) 28 mm/h
    3. C-reactive protein (CRP) 20 mg/L despite treatment with stable doses of MTX (12.5 mg/wk of MTX)

    Primary endpoints: reduction of signs and symptoms at 30 weeks, inhibition of structural damage at 54 weeks, and improvement in physical function at 102 weeks. Nearly 50% of patients had advanced disease. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (10 mg/day) permitted at stable doses; no other disease-modifying antirheumatic drugs (DMARDs) allowed. There were 4 REMICADE® groups: 3 mg/kg IV q8 weeks + MTX (n=86), 3 mg/kg IV q4 weeks + MTX (n=86), 10 mg/kg IV q8 weeks + MTX (n=87), and 10 mg/kg IV q4 weeks + MTX (n=81); patients randomized to placebo + MTX (n=88).

    Aspire study design1,5

    ASPIRE (Active-controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset): a 54-week, multicenter, double-blind, active treatment-controlled, randomized, phase 3 study of REMICADE® with methotrexate (MTX) in 1004 MTX-naïve adult patients with moderately to severely active early RA (3 months and 3 years from date of diagnosis). Moderately to severely active RA was defined as 10 swollen joints (out of 66 total) and 12 tender joints (out of 68 total) and 1 of the following:

    1. Rheumatoid factor (RF)-positive
    2. Radiographic evidence of erosive RA
    3. C-reactive protein (CRP) levels 2 mg/dL

    Concurrent stable treatment with corticosteroids (equivalent to ≤10 mg prednisone per day) and usual doses of nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted. The coprimary endpoints were reduction of signs and symptoms, inhibition of structural damage, and improvement in physical function from baseline to Week 54. Patients were randomized into 1 of 3 treatment groups in a 5:5:4 ratio: REMICADE® 3 mg/kg IV + MTX (n=359), REMICADE® 6 mg/kg IV + MTX (n=363), and placebo + MTX (n=282). REMICADE® or placebo was infused at Weeks 0, 2, and 6, and every 8 weeks thereafter. MTX was started at 7.5 mg/week and gradually increased to 20 mg/week by Week 8. All patients were to maintain a target MTX dose of 20 mg/week for the duration of the trial, whenever possible.

    DOSING FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen


    If response is lost, consider treatment with 10 mg/kg IV1


    Patients who do not respond by Week 14 are unlikely to respond, and consideration should be given to discontinuing REMICADE® in these patients1

    DOSING FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    DOSING FOR PEDIATRIC PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    DOSING FOR PEDIATRIC PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    DOSING FOR CHRONIC SEVERE PLAQUE PSORIASIS

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    DOSING FOR MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    3 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    3 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    REMICADE® should be given in combination with methotrexate.

    For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg IV or treating as often as every 4 weeks, bearing in mind that risk of serious infections is increased at higher doses.

    DOSING FOR ACTIVE PSORIATIC ARTHRITIS

    Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 8 weeks thereafter
    as a maintenance regimen

    REMICADE® can be used with or without methotrexate in active PsA.

    DOSING FOR ACTIVE ANKYLOSING SPONDYLITIS

    Infusions every 6 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1

    Induction dosing

    5 mg/kg IV given at 0, 2, and 6 weeks
    as an induction regimen

    Maintenance dosing

    5 mg/kg IV given every 6 weeks thereafter
    as a maintenance regimen