Teamwork + Trust  pg. 2

Can anti-TNF therapy reduce the risk of heart disease?

We have reason to believe that coronary artery disease is inflammatory in nature, and that the inflammation in blood vessels affected by atherosclerosis is a process that is very similar to TNF-driven inflammation in other diseases. The prediction is that anti-TNF treatment may be beneficial in patients with coronary artery disease who are not in heart failure.

Such trials haven’t yet been done, but it’s likely that we’ll get an answer from the registers that have been created to follow up patients on anti-TNF treatment...

By the way, in rheumatoid arthritis, death from coronary artery disease is increased significantly. So what we would expect to see is that the population that is receiving anti-TNF will normalize and begin to resemble more the population that doesn’t have an increased coronary artery disease.

What about cancer?

It turns out that patients with rheumatoid arthritis have an increased incidence of cancer of the lymphatic glands—lymphomas...

In clinical trial evidence, there was (an) increased incidence of lymphatic cancer compared to the normal population. The FDA actually looked at this last year and concluded that the evidence at this stage was insufficient to tell us whether the rate was as expected in this disease because of the underlying disease, or whether there was an effect of anti-TNF therapy on the incidence of lymphatic cancer. Once again, we can only hope that the registry will tell us the answer to that...

As far as any other type of cancer is concerned, epidemiological studies have not shown any increase in rheumatoid arthritis patients and so far no increase in any clinical trials or registry of any other kind of cancer. There is however some very interesting data in relation to COX inhibitors, which suggest that bowel cancer is reduced in patients that are taking regular NSAIDs…

The majority of patients with rheumatoid arthritis or most inflammatory diseases are on anti-inflammatory drugs anyway, and therefore we would expect a reduction in bowel cancer incidence in such people. So there is yet another confounding factor out there—whether anti-TNF, which is known to block COX-2 just as well as aspirin or Naprosyn or any of these kinds of agents, might have the same beneficial effect.

Is there a concern that some candidate drugs may be abandoned because they do not show significance when evaluated independently, even though they may be useful in combination with other drugs?

That’s certainly true also for anti-rheumatic treatment. Even anti-TNF has been shown to work best when used with methotrexate, rather than as monotherapy. That’s now proven for all three anti-TNF drugs. If we hadn’t done such trials, we wouldn’t know that. And it’s possible there are other drug combinations with anti-TNF, which are going to be better than anti-TNF alone...

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