Management of fistulas in patients with Crohn’s disease: TOLERABILITY AND SAFETY OF DRUGS Part 3

18 Apr
2012

TOLERABILITY AND SAFETY OF DRUGSIn a trial using infliximab for the treatment of fistulas, side effects occurring more frequently with the active treatment than with the placebo were abscesses (11%), upper respiratory tract infections (10%) and fatigue (10%). One of the 63 (1.6%) patients treated with infliximab discontinued therapy because of pneumonia. Concerns about infliximab relate to the development of antidoublestranded DNA antibodies, human antichimeric antibodies and the risk of autoimmune diseases, acute infusion reactions, delayed hypersensitivity reactions and lymphoma. Remission of the inflammatory disease can be maintained over one year by retreatment with repeated infusions every eight weeks for 36 weeks; there is general tolerability to this prolonged treatment, but one case of lymphoma and one case of suspected drug-induced lupus were reported in a study involving 73 patients. There is a potential for serum sickness reactions and delayed hypersensitivity reactions when treatment is repeated after long intervals (two to four years) between infliximab doses. These adverse events were not seen in other studies of infliximab involving 475 patients with rheumatoid arthritis receiving two or more subsequent infusions over eight to 38 weeks at fixed four- to 12-week intervals. A preliminary report on all patients prospectively observed up to three years after treatment in clinical trials suggested that the long term safety profile of infliximab is very good. You can find best quality treatment now – to see how cheap it is.

Toxicity reported to occur during low dose methotrexate treatment of autoimmune diseases such as psoriasis and rheumatoid arthritis includes diarrhea, mucositis, headache, central nervous system effects, hypersensitivity, pneumonitis, bone marrow suppression, hepatic fibrosis, or cirrhosis and lymphoma. In 94 patients with Crohn’s disease treated with methotrexate 25 mg administered weekly, 16 (17%) withdrew from treatment because of adverse events, including asymptomatic elevation of serum aminotransferase levels in seven (7%) and nausea in six (6%). However, a lower dose of methotrexate (15 mg/week) in a selected group of patients who most previously entered into remission after treatment with 25 mg/week was associated with a good safety profile during 40 weeks of treatment. One of the major concerns about the long term use of low dose methotrexate in IBD patients is the potential for chronic liver disease. While a meta-analysis showed a 7% overall risk of developing severe fibrosis or cirrhosis in patients with psoriasis, the risk is much lower in patients with rheumatoid arthritis, at approximately 1%. The actual risk of developing histologically advanced liver disease is not known in patients with IBD.

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