Infliximab Approved Indications
Infliximab (Remicade) is FDA-approved for eight distinct indications across inflammatory conditions, including both adult and pediatric populations. 1
FDA-Approved Indications
Gastrointestinal Indications
Adult Crohn's Disease:
- Reducing signs and symptoms, inducing and maintaining clinical remission in moderately to severely active disease with inadequate response to conventional therapy
- Reducing draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in fistulizing disease 1
Pediatric Crohn's Disease (≥6 years):
- Reducing signs and symptoms, inducing and maintaining clinical remission in moderately to severely active disease with inadequate response to conventional therapy 1
Adult Ulcerative Colitis:
- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in moderately to severely active disease with inadequate response to conventional therapy 1
Pediatric Ulcerative Colitis (≥6 years):
- Reducing signs and symptoms, inducing and maintaining clinical remission in moderately to severely active disease with inadequate response to conventional therapy 1
Rheumatologic Indications
Rheumatoid Arthritis:
- Must be used in combination with methotrexate
- Reducing signs and symptoms, inhibiting progression of structural damage, and improving physical function in moderately to severely active disease 1
Ankylosing Spondylitis:
- Reducing signs and symptoms in active disease 1
Psoriatic Arthritis:
- Reducing signs and symptoms of active arthritis, inhibiting progression of structural damage, and improving physical function 1
Dermatologic Indication
Plaque Psoriasis:
- Treatment of chronic severe (extensive and/or disabling) plaque psoriasis in patients who are candidates for systemic therapy when other systemic therapies are medically less appropriate 1
Guideline-Supported Use
The 2024 ECCO guidelines strongly recommend infliximab for both induction and maintenance therapy in moderate-to-severe Crohn's disease, with combination therapy (infliximab plus thiopurine) recommended for the first 6-12 months to improve efficacy and reduce immunogenicity 2. Similarly, the 2024 AGA guidelines recommend infliximab for moderate-to-severe ulcerative colitis, classifying it as a higher-efficacy medication in treatment-naïve patients 3.
Critical Contraindications
- Doses >5 mg/kg in moderate or severe heart failure
- Previous severe hypersensitivity reaction to infliximab or murine proteins 1
Important Safety Warnings
Black Box Warnings include:
- Serious infections (tuberculosis, bacterial sepsis, invasive fungal infections) leading to hospitalization or death
- Lymphoma and other malignancies in children and adolescents
- Hepatosplenic T-cell lymphoma (HSTCL), particularly in young males with Crohn's disease or ulcerative colitis receiving concomitant azathioprine or 6-mercaptopurine 1