Summary contentEducational objectives
Understand how to assess safety of a drug in real life practice
Understand the differences between small molecules and biologics
Understand how IBD drugs can be classified according to their safety profile
Understand how to improve IBD drug safety
Summary
Biologics differ from small molecules by many aspects, among which the chemistry, their degradation and their mechanism of action. These aspects may directly influence safety. Safety of a drug is itself difficult to quantify and qualify. The safety profile depends on the available data, strongly depending also on the time of apparition of the drug on the market and its widespread use. Most of the comparative data on safety generated through network meta-analyses or head to head trials correspond to relatively short duration of use of the drug and relatively small population compared to what would be needed to really assess safety. Therefore no or only minor differences are disclosed by these studies. If we adopt a pragmatic classification of side effects, we could classify them into mild-moderate intolerance, cumulative toxicity, major side effects that can be prevented or treated, major side effects that can hardly be prevented or treated, serious adverse events potentially lethal. When analysing the safety profiles of currently available drugs according to such classification, we find both small molecules and biologics with all these kinds of side effects. Therefore, if we can currently consider that some drugs are associated with lower or higher safety concerns, there is no difference between biologics and small molecules, the mechanism of action being sometimes closer between one small molecule and one biologic than between two biologics. Instead of safer drug or beside safer drug, we should maybe mainly aim at a safer use of these drugs.