Infliximab

Infliximab binds with high affinity to both soluble and transmembrane bound TNF-α, but does not act against lymphotoxin α (TNF-β).

Cells expressing transmembrane TNF-α are lysed after binding infliximab either by the complement cascade or cell-mediated effector mechanisms.

Infliximab inhibits the bioactivity of human TNF-α by forming stable antigen-antibody complexes. After formation of the complex with infliximab, TNF-α is no longer recognized by its TNF receptors and therefore cannot elicit effects. The inflammation in rheumatoid arthritis is thus prevented.

• Psoriatic arthritis in adults if their response to previous disease-modifying, anti-rheumatic drug therapy has been inadequate.
• Psoriasis vulgaris (moderate to severe plaque-type psoriasis in adults who have not responded to other systemic therapy, including ciclosporin, methotrexate or PUVA, for whom such therapy is contraindicated or is not tolerated.
• rheumatoid arthritis
• Crohn's disease
• moderate to severe active ulcerative colitis.

No sufficient data available on use during pregnancy and lactation. Should not be prescribed during pregnancy and lactation.

• Women of childbearing potential should use adequate contraception (preferably at least one mechanical method) and continue it for at least 6 months after the last infliximab application.
• Due to secretion of immunoglobulins into breast milk, women should not breastfeed for at least 6 months after the last infliximab application.

Infants exposed to infliximab in utero may be at increased risk of infection, including serious disseminated fatal infections. They should not receive live vaccines during the first 12 months of life.

If there is a clear benefit, live vaccine may be given if there is evidence of a negative infliximab serum level in the infant, as well as if infliximab was limited to the first trimester of pregnancy.

Infants who have been exposed to infliximab through breast milk should not receive live vaccine unless there is an undetectable serum infliximab level.

(Red Hand Letter, 03/07/2022)

• Psoriatic arthritis and psoriasis vulgaris: 5 mg/kg bw i.v. over 2 hours, additional infusion of 5 mg/kg bw 2 and 6 weeks after the initial infusion, then every 8 weeks.
• Rheumatoid arthritis: 3 mg/kg bw i.v. over 2 hours, additional infusion of 3 mg/kg bw 2 and 6 weeks after the initial infusion, then every 8 weeks. Infliximab must be administered together with methotrexate!

Caution! Infliximab therapy must be administered under the supervision of a physician experienced in the diagnosis and treatment of rheumatoid arthritis or inflammatory bowel disease. The infusion duration must be at least 2 hours. In addition, patients must be monitored for side effects during and at least 1 hour after the infusion. Emergency equipment (drugs, a tube and other suitable material) must be available for the emergency treatment of acute infusion-related reactions!

• In general, it should be noted that substances that inhibit tumour necrosis factor-alpha also weaken the body's own defence against infections and against cancer cells. An increased incidence of infections and cancer is therefore possible.
• Frequent: among others, skin changes such as urticaria, hyperhidrosis, dry skin, pruritus, lupoid rosacea. Also viral infections (e.g. influenza, HHV), fever, headaches, dizziness, hot flushes, infections of the upper and lower respiratory tract, dyspnoea, sinusitis, nausea, diarrhoea, abdominal pain, dyspepsia, liver dysfunction, fatigue.
• Immunogenicity: Anti-Infliximab antibodies occur in 5-44% of patients. However, this does not exclude a good clinical response (Hsu L et al. (2014).

Remember! Exclusion of tuberculosis before the start of therapy is recommended (tuberculin test and chest X-ray)!

1. Baert F et al (2003) Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 348: 601-608.
2. De Rycke L et al (2003) Antinuclear antibodies following infliximab treatment in patients with rheumatoid arthritis or spondyloarthropathy. Arthritis Rheum 48: 1015-1023
3. Gottlieb AB et al (2003) Pharmacodynamic and pharmacokinetic response to anti-tumor necrosis factor-alpha monoclonal antibody (infliximab) treatment of moderate to severe psoriasis vulgaris. J Am Acad Dermatol 48: 68-75.
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11. Fritzsche J et al (2012) Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol 46: 718-719.
12. Julsgaard M et al (2016) Concentrations of adalimumab an infliximab in mothers and newborns, and effects on infection. Gastroenterology 151: 110-119