MONDAY, June 30 (HealthDay News) -- Anti-tumor necrosis factor (TNF) agents are effective in treating both luminal and fistulizing Crohn's disease but further safety studies need to be done, according to an article published in the June issue of Clinical Gastroenterology and Hepatology.
Laurent Peyrin-Biroulet, M.D., of the Hopital Claude Huriez, Centre Hospitalier Universitaire de Lille in Lille, France, and colleagues conducted a meta-analysis of 21 placebo-controlled studies enrolling more than 5,000 patients to investigate the safety and efficacy of anti-TNF agents in the treatment of Crohn's disease.
In the 14 studies enrolling 3,995 patients with luminal Crohn's disease, anti-TNF agents effectively induced remission at week 4 (11 percent mean difference for anti-TNF versus placebo and a number needed to treat [NNT] of 9) and maintained remission at 20 to 30 weeks (23 percent mean difference for anti-TNF versus placebo and NNT of 4). In the 10 studies enrolling 776 patients and evaluating the efficacy of anti-TNF agents for fistulizing Crohn's disease, anti-TNF agents were effective for fistula closure if combined with anti-TNF for induction (16 percent mean difference anti-TNF versus placebo and NNT of 6). In 21 studies enrolling 5,356 patients, there was no increase in the risk of death, malignancy or serious infections.
"These data need to be interpreted with caution because of several limitations; patients in clinical trials might not represent patients seen in clinical practice, the control group usually had anti-TNF exposure, and follow-up might not be sufficiently long for some serious events such as malignancy to occur," the authors conclude. "Only head-to-head trials would enable direct comparison between anti-TNF agents."
Several of the study authors report financial relationships with the pharmaceutical industry.
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