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Remicade (INFLIXIMAB)

Remicade works by binding to and neutralizing tumor necrosis factor, a protein that promotes inflammation and tissue damage.

Remicade (Infliximab) is a tumor necrosis factor blocker, originally developed by Centocor Inc and currently owned by the same company. It targets tumor necrosis factor, a protein involved in inflammation, and is used to treat various autoimmune diseases such as rheumatoid arthritis, psoriasis, and Crohn's disease. Remicade was FDA-approved in 1998 and has a half-life of 7.7 to 9.5 days. The commercial status of Remicade is patented, and it is not yet available as a generic medication. Key safety considerations include increased risk of infections and allergic reactions.

At a glance

Mechanism of action

Infliximab products neutralize the biological activity of TNF by binding with high affinity to the soluble and transmembrane forms of TNF and inhibit binding of TNF with its receptors. Infliximab products do not neutralize TNF (lymphotoxin-), related cytokine that utilizes the same receptors as TNF. Biological activities attributed to TNF include: induction of pro-inflammatory cytokines such as interleukins (IL) and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNF bound by infliximab products can be lysed in vitro or in vivo. Infliximab products inhibit the functional activity of TNF in wide variety of in vitro bioassays

Approved indications

• Ankylosing spondylitis
• Behcet's disease
• Crohn's disease
• Erythrodermic psoriasis
• Plaque psoriasis
• Psoriasis with arthropathy
• Pustular psoriasis
• Rheumatoid arthritis
• Ulcerative colitis

Boxed warnings

• WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) • Discontinue INFLECTRA if a patient develops a serious infection. • Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. ( 5.2 ) • Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ( 5.2 ) SERIOUS INFECTIONS Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. INFLECTRA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before INFLECTRA use and during therapy. Treatment for latent infection should be initiated prior to INFLECTRA use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. 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 INFLECTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with INFLECTRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products [see Warnings and Precautions (5.2) ] . Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.

Common side effects

• Infusion-related reactions
• Infections
• Pneumonia
• Tuberculosis
• Serious infusion reactions
• Delayed hypersensitivity reaction
• Cardiopulmonary reactions
• Pruritus
• Urticaria
• Anaphylaxis
• Convulsions
• Erythematous rash

Key clinical trials

• Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
• Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission (NA)
• A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
• Combined Immunosuppression for Pediatric Crohn's Disease (PHASE4)
• Zymfentra (Infliximab-dyyb) REal World Cohort STudy
• Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis
• MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease (NA)
• A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Remicade CI brief — competitive landscape report
• Remicade updates RSS · CI watch RSS
• Johnson & Johnson portfolio CI