Prescrire International - Free Special Edition - 2022

MARKETING AUTHORISATIONS

EDITORS’ OPINION

Negligence

The evaluation data for a new drug, or for an existing drug in a new clinical situation, are cru cial in determining its harm-benefit balance. The results available, however, usually leave a great er or lesser degree of ongoing uncertainty. This is particularly true when a drug, which is already being used in adults, is proposed for use in children. Evaluation in children is often less extensive and leaves numerous questions unanswered. Evaluation of the benefit provided by the drug in children requires certain factors to be taken into account, in particular: the natural history of the disease during child development; the adverse effects and potentially unrecognised long-term consequences at each age; and the expected duration of exposure to the drug, which will be greater the earlier long-term treatment is initiated. For example, dupilumab (Dupixent°) has a favourable harm-benefit balance in some adults affected by atopic eczema, despite unknowns with long-term use, in particular the risk of can

cer (see “Dupilumab in adults with atopic derma- titis: an option for very troublesome eczema after failure of ciclosporin” Prescrire Int n° 204). In adolescents, specific evaluation data along with extrapolation from data in adults, also show that dupiluma b can sometimes be useful (see Rev Prescrire n° 442). However, in children, such extrapolation is much less reliable, and the harm-benefit balance of dupiluma b is uncertain for them (see “Dupilumab in severe atopic ecze ma from 6 years of age” opposite). First, because atopic eczema most often regresses or disappears before adolescence and also because no data are available on the potential consequences of such treatment on their development. In the field of drugs and therapeutics, as in other fields, it would be negligent to consider children as just small adults. Prescrire

▶ Translated from Rev Prescrire January 2022 Volume 42 N° 459 • Page 4

Prescrire Int • April 2022

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