Am J Gastroenterol 2011.
There is some evidence that immunosuppressive drugs can help prevent relapse of inflammatory bowel disease (IBD), but it's not conclusive, a new meta-analysis shows.
Immunosuppressives are favored by patients and doctors, but "many of the clinical trials are small, the summary effect is modest, and in some cases not statistically significant," said lead author Dr. Khurram J. Khan, of Ontario's McMaster University, in email to Reuters Health. "We still need to evaluate efficacy in more conclusive, large, randomized controlled trials."
Dr. Khan and colleagues do say that if Crohn's disease (CD) and ulcerative colitis (UC) can't be controlled with 5-aminosalicylic acid therapy and steroids, a trial of immunosuppressive therapy is appropriate.
In a study reported online March 15th in the American Journal of Gastroenterology, the researchers reviewed outcomes from parallel group randomized controlled trials of immunosuppressive therapy. They say it reflects poorly on GI research that "we only have 897 CD patients and 268 UC patients" in such trials.
Information on methotrexate and cyclosporine was particularly limited although there were some data to support the use of IM methotrexate in CD but not UC.
Five trials of azathioprine or 6-mercaptopurine in 380 patients with active CD did not show any effect on remission. In two trials involving 198 patients with quiescent CD, azathioprine had no significant effect on relapse. In further withdrawal trials, continuing on azathioprine didn't help.
Two studies of 130 patients with active UC suggested a trend toward a benefit from azathioprine. And in three trials involving 127 patients with quiescent UC, azathioprine did significantly lower the rate of relapse (relative risk, 0.60).
The investigators did not find more adverse events in patients taking immunosuppressive therapy, but they say "this simply reflects the small numbers involved."
"Immunosuppressive therapy," they conclude, "is not without risk and therefore it is imperative that the benefits of these agents are rigorously defined so that the risk-benefit ratio of these drugs can be established."
There is some evidence that immunosuppressive drugs can help prevent relapse of inflammatory bowel disease (IBD), but it's not conclusive, a new meta-analysis shows.
Immunosuppressives are favored by patients and doctors, but "many of the clinical trials are small, the summary effect is modest, and in some cases not statistically significant," said lead author Dr. Khurram J. Khan, of Ontario's McMaster University, in email to Reuters Health. "We still need to evaluate efficacy in more conclusive, large, randomized controlled trials."
Dr. Khan and colleagues do say that if Crohn's disease (CD) and ulcerative colitis (UC) can't be controlled with 5-aminosalicylic acid therapy and steroids, a trial of immunosuppressive therapy is appropriate.
In a study reported online March 15th in the American Journal of Gastroenterology, the researchers reviewed outcomes from parallel group randomized controlled trials of immunosuppressive therapy. They say it reflects poorly on GI research that "we only have 897 CD patients and 268 UC patients" in such trials.
Information on methotrexate and cyclosporine was particularly limited although there were some data to support the use of IM methotrexate in CD but not UC.
Five trials of azathioprine or 6-mercaptopurine in 380 patients with active CD did not show any effect on remission. In two trials involving 198 patients with quiescent CD, azathioprine had no significant effect on relapse. In further withdrawal trials, continuing on azathioprine didn't help.
Two studies of 130 patients with active UC suggested a trend toward a benefit from azathioprine. And in three trials involving 127 patients with quiescent UC, azathioprine did significantly lower the rate of relapse (relative risk, 0.60).
The investigators did not find more adverse events in patients taking immunosuppressive therapy, but they say "this simply reflects the small numbers involved."
"Immunosuppressive therapy," they conclude, "is not without risk and therefore it is imperative that the benefits of these agents are rigorously defined so that the risk-benefit ratio of these drugs can be established."