The question of undesired immune responses to biologics is one of the major drug safety problems that have limited the approval and clinical use of these agents. In fact, the question may be a combination of several factors. First, the drugs are proteins, which can generate undesired immune responses in some patients.

Second, while these agents suppress immune responses, the suppression is not global but is often very specific. Global immune suppression, as in the case of patients on chemotherapy, has many undesired consequences, including a substantial risk of dying from infection. The new biologics are often developed to target a very specific part of the immune response, for example TNF production. But the immune system is nothing if not redundant, and the history of biologics is marked by agents that work very well in tissue culture but have no clinical benefit, and occasionally with agents that produce a marked fluctuation in immune response, including in some cases extreme immune reactions such as cytokine storm.

While biologics offer great promise, they are a very different class of therapeutic agents than conventional small molecules. Drug regulatory authorities, biotechnology and pharmaceutical companies are wrestling with a number of new challenges as these agents are evaluated and enter the market in increasing numbers. The next decade will, I predict, be an interesting one for the biologics.

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