Inflammatory bowel disease (IBD)
Chronic autoimmune intestinal diseases — Crohn disease and ulcerative colitis. Therapy depends on severity and location — mesalazine, corticosteroids, thiopurines (azathioprine), and biologics.
ICD-10 K50/K513 drugs
Also known as: Crohn, Ulcerative colitis
Drugs used for this condition
- BAzathioprineSecond line · Immunosuppressants, thiopurinesPer AGA 2021, for moderate-to-severe Crohn disease and ulcerative colitis, biologics and small molecules are now preferred first-line; azathioprine has moved to second-line, used as a combination partner with an anti-TNF agent (to reduce immunogenicity, SONIC trial) or as maintenance in milder or step-up settings. Dose 2–2.5 mg/kg/day, effect over 8–16 weeks. Reduces flare frequency, corticosteroid requirements, and hospitalizations. Azathioprine monotherapy is not first-line for active moderate-to-severe disease. TPMT activity (and where possible NUDT15) must be tested before start, with blood-count monitoring for myelosuppression. The thiopurine plus anti-TNF combination carries the highest risk of hepatosplenic T-cell lymphoma, mainly in young men, and raises the risk of lymphoma and non-melanoma skin cancer.
- BMethotrexateSecond line · Antimetabolites, folic acid analoguesIn Crohn disease, methotrexate is used as a thiopurine alternative when those agents are intolerated or ineffective per AGA 2021 and ECCO 2020. Evidence is weaker in ulcerative colitis, where methotrexate is rarely used. Dose 25 mg subcutaneously weekly.
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit