Patient Profiles

  • Female, 40 years of age

    Diagnosed with moderately to severely active RA and still experiencing RA symptoms that deal with daily living

    • Age at diagnosis: mid 30s
    • Weight: 125 lb (<65 kg)
    • Current medication: prednisone
    • CRP: (≥2 mg/dL)
    • ≥10 swollen and ≥12 tender joints
    • Erosions observed on X-ray

    REMICADE®: Rapid Response to Signs and Symptoms1*

    In some patients, ACR responses were achieved as early as 2 weeks in moderately to severely active RA1*

    Click here for a complete study design of ATTRACT

    SELECTED IMPORTANT SAFETY INFORMATION

    Serious and sometimes fatal side effects have been reported with REMICADE® (infliximab). Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma, and other malignancies have been reported, including in children and young adult patients. REMICADE® is contraindicated in patients with severe hypersensitivity reactions to REMICADE® and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome. Please see related and other Important Safety Information.

     

  • Female, 55 years of age

    Adjustable Dosing for Your Patients2*

    • Years diagnosed: 2
    • Weight: 155 lb (≥65 and <80 kg)
    • Current medications: leflunomide and prednisone
    • High DAS score (≥6.5)
    • Elevated and rapidly changing CRP (≥2 mg/dL)
    • ≥10 swollen joints and ≥12 tender joints
    • RF positive

    REMICADE® allows for dose adjustment based on individual patient weight2*

    The recommended dose of REMICADE® is 3 mg/kg given as an intravenous induction regimen at 0, 2, and 6 weeks, followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. REMICADE® should be given in combination with methotrexate. For patients who have incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks, bearing in mind that the risk of serious infections is increased at higher doses.

    Weight-based dosing was demonstrated in a range of patients (<65 kg, ≥65 to <80 kg, and ≥80 kg)1*

    Safety data through Week 54Safety data through Week 54
     
      n Placebo + MTX
    Mean VW
    Score
    n REMICADE® + MTX
    Mean VW
    Score
    Diff P Value
    All Subjects 282 0.323 722 -0.126 0.449 <0.001
    Weight            
    <65 kg 71 0.382 161 -0.168 0.550 <0.001
    ≥65 kg to <80 kg 100 0.309 264 -0.117 0.427 <0.001
    ≥80 kg 109 0.271 294 -0.100 0.371 <0.001
     
     
    • Assessments of continuous variables were determined by comparing results among treatment groups by using analyses of variance of van der Waerden (VW) normal scores. Consistent treatment benefit was observed for subgroups based on body weight§
    • Weight-based dosing demonstrated in a range of patients (<65 kg, ≥65 kg to <80 kg, and ≥80 kg)
    • Among patients treated with REMICADE®, vdH-S score at 1 year was maintained across a broad weight range of RA patients

    Click here for a complete study design of ASPIRE

    SELECTED IMPORTANT SAFETY INFORMATION

    Serious and sometimes fatal side effects have been reported with REMICADE® (infliximab). Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma, and other malignancies have been reported, including in children and young adult patients. REMICADE® is contraindicated in patients with severe hypersensitivity reactions to REMICADE® and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome. Please see related and other Important Safety Information.

     

  • Male, 65 years of age

    Patient presents with moderately to severely active RA with evidence of structural damage

    • Years diagnosed: 9
    • Weight: 200 lb (≥80 kg)
    • Current medication: methotrexate
    • Failed 2 DMARDs in the last 6 months
    • ESR: Elevated ESR (≥28 mm/hr)
    • Morning stiffness ≥45 minutes
    • ≥6 swollen and tender joints
    • Evidence of structural damage

    Inhibition of radiographic progression maintained

    Results from ATTRACT

    Inhibition of structural damage maintained through 102 weeks2-4

    • REMICADE® (infliximab) 3 mg/kg (n=71) demonstrated a mean change in vdH–S score from baseline––1.3 vs 6.9 for MTX alone (n=64) at 1 year (P<0.001)
    • Among patients treated with REMICADE®, the change in vdH-S scores from baseline at 1 year were consistent, regardless of body weight at baseline
    • 53.7% of all patients treated with all REMICADE® regimens had no worsening of erosions (≤0 change from baseline at Week 102 in vdH-S erosion score) vs placebo (19.6%; P<0.001)4II
    SELECTED IMPORTANT SAFETY INFORMATION

    Serious and sometimes fatal side effects have been reported with REMICADE® (infliximab). Infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens (e.g., TB, histoplasmosis) have been reported. Lymphoma, including cases of fatal hepatosplenic T-cell lymphoma, and other malignancies have been reported, including in children and young adult patients. REMICADE® is contraindicated in patients with severe hypersensitivity reactions to REMICADE® and certain patients with congestive heart failure. Other serious side effects reported include melanoma and Merkel cell carcinoma, hepatitis B reactivation, hepatotoxicity, hematological events, hypersensitivity, neurological events, and lupus-like syndrome. Please see related and other Important Safety Information.

     

*
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 RA. Primary endpoints: reduction of signs and symptoms, inhibition of structural damage, and improvement in physical function. Nearly 50% of patients had advanced disease; all were on stable doses of MTX (no washout period). NSAIDs and corticosteroids (≤10 mg/day) permitted at stable doses; no other DMARDs allowed. Four REMICADE® groups: 3 mg/kg q 8 weeks (n=86), 3 mg/kg q 4 weeks (n=86), 10 mg/kg q 8 weeks (n=87), and 10 mg/kg q 4 weeks (n=81); patients randomized to MTX + placebo (n=88).
 
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-naive patients with moderately to severely active early rheumatoid arthritis (RA) (≥3 months and ≤3 years from the date of diagnosis). The coprimary endpoints were reduction of signs and symptoms and inhibition of structural damage at Week 54, and improvement in physical function from Week 30 to Week 54. Patients were randomized into 1 of 3 treatment groups in a 5:5:4 ratio: 3 mg/kg REMICADE® + MTX (n=359), 6 mg/kg REMICADE® + 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.
 
The total modified van der Heijde-Sharp (vdH-S) score (0-448) is a composite score of structural damage that measures the number and size of joint erosions and the degree of joint space narrowing (JSN) in the hands and feet.
 
§
Analyses of continuous variables were performed by comparing results among treatment groups using analyses of variance of van der Waerden (VW) normal scores. Consistent treatment benefit was observed for subgroups based on body weight.
 
II
In a subset of all patients in the ATTRACT study, fewer patients in the combined REMICADE® + MTX (53.7%; 144/268) group developed no new erosions, compared to MTX alone (19.6%; 10/51). Results from ATTRACT trial in patients with moderately to severely active RA.
 
References:
  1. Data on file. Janssen Biotech, Inc.
  2. REMICADE® (infliximab) Prescribing Information. Janssen Biotech, Inc.
  3. Lipsky PE, van der Heijde DMFM, St. Clair EW, et al; for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med. 2000;343:1594-1602.
  4. Maini RN, Breedveld FC, Kalden JR, et al; for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004;50:1051-1065.

 

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 or 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

 

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 and pneumocystosis. 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 and Listeria.

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.

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. All reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. 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.

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 rarely 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. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.

NEUROLOGIC EVENTS

TNF inhibitors, including REMICADE®, have been associated in rare cases 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, rarely, in 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®. Exercise caution in the administration of live vaccines to infants born to female patients treated with REMICADE® during pregnancy.

For more information, please see full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion. (Requires Adobe® Reader®. Click here to download.)

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:S221-S247.

2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.