The complexity of adverse event assessment and counseling for patients on biologic treatment

Figures & data

Table 1. Sources of adverse event data [1,2,7]

Method	Advantages	Disadvantages
Randomized controlled clinical trials	-Randomization and placebo arm allows a direct comparison to a similar unexposed population	-Short periods of time. -Low power. -Exclusion of subjects with common comorbidities
Registries	-Monitors large sample sizes -Longer exposure periods	-No comparable control population
Post-marketing surveillance	-Addresses rare events. -Includes patients with real life comorbidities	-No comparable control population -Incomplete reporting

Figure 1. Changing Patient Perspective Through Pictorial Aids. (a) Drug A, B, and C demonstrate the rate of occurrence of side effects per 100 of 1, 2 and 3, respectively. Drug C looks more worrisome than the rest. (b) Drug A, B and C had a rate of no occurrence of side effects per 100 of 99, 98 and 97, respectively and the difference between them is barely noticeable. (c) Pictorial aids give the perspective on why Graph A and B can be so similar in numbers but so different in context. This is because patients fear being part of the 2% (when being told the rate of side effects) but find more reassuring being part of the 98% (when being told the rate of no side effects)

Table 2. Strategies for a better patients’ understanding of biologics’ safety

Strategy	Example
Providing statistics	Using small numbers with correct perspective (i.e. 99 out of 100 will not get the adverse event)[14]
Pictorial aids	Adding pictorial aids on drug labels instead of just text[10,12,14]
Putting risks in the context of more common risks	Telling a patient that for a specific treatment will need x3 injections a year instead of x3 injections a month with a different treatment[14]
Anchoring	Telling a patient the risk for a specific adverse event while on a specific treatment is less common than getting hit by a lightning[14]
Message-framing^[11]	Gain-frame message: By wearing sunscreen the risk of skin cancer decreases[11,14] Loss-frame message: By not wearing sunscreen the risk of sun-damaged skin and actinic lentigos (liver spots) increase[11,13,14]
Default Option	Telling a patient with psoriasis that a specific biologic is the default treatment option so they will make the best decision[14]

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