Biologics better than other systemics?

That was the message Kenneth Gordon, M.D., associate professor of dermatology at Loyola University Medical Center in Chicago shared at the American Academy of Dermatology's Academy '05 here.

Dr. Gordon says a number of means of testing the safety of biologics - or any medication - exist, but none are perfect.

Experience

With biologics, Dr. Gordon says the best way to determine the long-term safety is through experience. As physicians use the treatments over a longer period of time, the more comfortable they will become with the safety profiles.

What we've seen so far, however, is promising, he says.

"When talking about the immuno- modulation for all biologics - and it is constant across the structure of it - the two big areas of concern are infection and malignancy."

Dr. Gordon says the good news is that in trials of anti-TNF therapy and anti T-cell therapy, no evidence of any increased risk of malignancy or serious infection seems to exist.

There is one condition, physicians should watch for, Dr. Gordon says.

"With anti-TNF agents there is a concern about the reccurrence of txxuberculosis and atypical forms of tuberculosis."

That risk can be almost eliminated, however, by prescreening with the TB test. I recommend all patients being treated with an anti-TNF or any immunomodulators, in general, should be given a PPD test. That will tell us if they've had previous exposure to TB which the anti-TNF therapy could potentially aggravate."

But even with the potential aggravation of atypical TB, Dr. Gordon says the risks of side effects appear to be so low as to be almost negligible.

"There is a difference between statistical risk and clinical risk. Something can be so incredibly rare that even if you double the risk, it is still an incredibly rare event.

"Certain events are extremely rare, that while you might have a statistical risk of histoplasmosis, it is so rare you would not alter your therapeutic decision based on that."

Dr. Gordon points out that when a biologic is chosen, it is chosen for a patient whose condition warrants systemic therapy.

"You would not put a patient on a biologic who does not need systemic therapy. Oftentimes we express side effect profiles in comparison to a patient's reaction to a placebo, in clinical trials in particular, and that's not an appropriate comparison.

"The appropriate comparison considers the side effects as compared to other systemic therapies," Dr. Gordon explains.