Humira released in USA

As expected, the new biologic medicine Humira has been approved by the FDA for adult use. According to the Wikipedia it may come in preloaded pen devices , which do sound like an improvement on the old manual syringe.

The story appeared in the Chicago Tribune's business pages:

"Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade therapy," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.

Abbott's drug also could be more convenient, the company and analysts say. Unlike Remicade, which has to be infused by a physician in the doctor's office, Humira is the only new Crohn's treatment that can be injected by the patient on his own.

Better surgery for Crohn's

Newswise has an excerpt from an article in the Journal of Surgery which contains interesting research into the long-term success of surgery that avoids removing parts of the bowel.

Among other findings, the study supports the notion that strictureplasty -- a bowel-sparing surgical procedure commonly used to correct Crohn's-related strictures -- is less likely to lead to stricture recurrence later on, compared to surgical excision ("resection") of the stricture.

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In decades past, Crohn's patients typically underwent surgical removal of the bowel at the point of stricture, although in recent years, corrective, bowel-sparing "strictureplasties" have become much more common. Dr. Michelassi has been a pioneer in developing new strictureplasty techniques. But he says that, up till now, surgeons lacked good information on the long-term consequences of these operations compared with resection.

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The study also found that up to a third of recurrences occur away from the site of the original operation. Furthermore, the type and site of prior surgery appears to influence the pattern of recurrence, the researchers found. The study also provides new guidance on what surgeons call "prophylactic strictureplasty" -- procedures aimed at preventing stricture-related trouble.

"Sometimes we encounter a stricture that isn't giving the Crohn's patient any symptoms right now. We know, though, that these strictures can lead to trouble in about 25 percent of cases," Dr. Michelassi explains. "Based on our findings, we would now advise that if an asymptomatic stricture can be fixed using bowel-sparing strictureplasty, then the surgeon should go ahead and perform that type of prophylactic procedure," the NewYork-Presbyterian/Weill Cornell expert says. "However, if fixing the problem requires bowel resection, then we would advise leaving the stricture alone, because there's still a 75 percent chance it will not cause the patient any harm."

Humira nears US release for Crohn's

The Boston Globe has an update on new medication that is expected to be released to US consumers soon. Crohn's afflicted people outside the US will probably welcome this news, as it will introduce a large new population for the drugs to be tested on. It'll be interesting to see if Humira lives up to its promise of providing longer-term remission than infliximab (Remicade).

Within days, Illinois-based Abbott Laboratories expects to win federal approval to sell its drug, Humira , currently used to treat rheumatoid arthritis, psoriatic arthritis, and a disease that causes arthritis of the spine, to combat the intestinal disorder.

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In clinical trials, 21 percent of patients who had stopped responding to Remicade were coaxed into remission by week four on Humira, compared with 7 percent who achieved remission on a placebo. Those results were impressive enough for the FDA to speed its handling of the drug -- trimming the review from 10 months to six months and indicating that an approval decision could come by the end of February.