Naltrexone shows positive results

Penn State Live reports that a pilot study has shown encouraging results in using naltrexone to treat Crohn's disease.

In the study, patients with diagnosed Crohn's disease were treated with a low dose of naltrexone, an FDA-approved drug used to ease symptoms of withdrawal from substance abuse, and monitored for improvement of symptoms for 12 weeks. Quality of life surveys were given every four weeks for 16 weeks.

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The results showed that 89 percent of participants showed an improvement with therapy, while 67 percent achieved remission of symptoms. The only side effect to treatment was sleep disturbance in some patients.

In addition to combatting drug and alcohol addiction, naltrexone is also used to treat multiple sclerosis (though its effectiveness has yet to be proven), which like Crohn's is a disease of the immune system.

Good results for Humira

Abbott has announced that a trial has shown that people for whom Humira (adalimumab) is effective after four weeks who then take Humira either weekly or fortnightly for a year are much more likely to be in remission after six months and after year than those taking a placebo. There's a lot more detail in the press release.

In addition they include interesting news for users of infliximab (Remicade), mentioning:

Abbott has received FDA approval to initiate a Treatment Protocol to study the use of adalimumab in patients no longer responding to or intolerant to infliximab, an approved therapy for Crohn's disease.

Self-medication with hookworm

Kuro5hin has an intruiging first-hand tale of a person who cured his asthma by deliberately gaining and maintaining a hookworm infestation. Although this has been proposed as a possible treatment for Crohn's and other auto-immune diseases, the necessary extensive research has not yet been done. In addition, if it is found to be effective, then the particular mechanism that the hookworms use would be analysed and, if possible, turned into a much safer medicine than being a host for parasitic organisms.

Based upon what I read, and what I learned about the hookworm I decided that I was going to try and infest myself with hookworm in an attempt to cure my asthma. I was not willing to wait ten or more years for the drug companies to bring a drug to market. It was obvious to me that hookworm, for a healthy adult with a good diet, are quite benign.
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At this point I came to the conclusion that short of bribing a research assistant or stealing samples from a lab I would have to go to the tropics and walk around barefoot in human excrement. Not an attractive proposition, but then neither is not being able to breathe, and the breathing thing was going to last the rest of my life.

But where to go to find these hookworm?

Intensive searches of the WHO website turned up just one map showing hookworm distribution in only one country: Cameroon.

Remicade for children with Crohn’s Disease

The FDA's priority review program has lived up to its name, as only a month since being accepted into that program the Food and Drug Administration has approved the use of Remicade (Infliximab) for children with Crohn's Disease. The trial they examined showed that the medicine was as effective in children as in adults, and that it had the same side-effects.

Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumor necrosis factor-alpha (TNF-α), that was initially approved in 1998 to treat Crohn's disease in adults.
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The safety and effectiveness of Remicade in pediatric Crohn's disease were assessed in a randomized study in 112 children who were 6 to 17 years old with moderately to severely active Crohn's disease who had an inadequate response to conventional therapies. The proportion of these patients who achieved clinical response compared favorably with the proportion of adults in an earlier Remicade study in adult Crohn's disease, and the pediatric trial's results showed no new safety concerns not already expressed in the product's current label.

In other news relating to Remicade and its sibling Humira, the Washington Post notes that serious side-effects have recently been reported in adults:

Approval comes after Wednesday's publication in the Journal of the American Medical Association of a study in which researchers said they found an apparent link between Remicade and a second drug, Humira, and some types of cancer in rheumatoid arthritis patients. Those cancers include skin, gastrointestinal, breast and lung tumors.

The FDA-approved labeling for Remicade, also called infliximab, already mentions the drug's association with an increased risk of lymphoma and other cancers, including skin, breast and colorectal, the regulatory agency and the drug's manufacturer both said. The label also mentions an increased risk of serious and sometimes fatal infections, as well as disorders of the blood and central nervous system.

Update 23-May-2006: Abbott, the manufacturer of Humira, has responded:

The conclusion in the JAMA article regarding risk of infection in those taking anti-TNF agents restates what has already been observed in the clinical trials of all three anti-TNFs. These data have been reviewed in a U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee meeting in March 2003, and routinely since that time. The information in the JAMA article on infections is well documented in the labeling of all three anti-TNF agents, including HUMIRA (adalimumab).

Abbott disagrees with the authors' conclusions that their analysis establishes an increased risk of malignancies attributable to the anti-TNF agents included in their meta-analysis. The potential role, if any, of TNF-blocking therapy in the development of malignancies is not known, and this is reflected in the labeling of all three agents.

NACC - Ongoing research

While there's a lull in research results being announced it's an opportune time to point out one of the sources of the research.

The UK's National Association for Colitis and Crohn's Disease (NACC) has been funding research for a number of years, and the targets of their recent research funding are succintly described in plain English on their research pages. In addition there is a comprehensive summary of NACC research since 1984 which is well worth reading.

Other national Crohn's and Colitis associations distribute research funding, but none are as successful as the NACC in communicating the relevant details to the general public.