Red Hand Letter to ustekinumab

Red Hand Brief on ustekinumab: In the treatment of severe plaque psoriasis and psoriatic arthritis with ustekinumab, exfoliative dermatitis (erythroderma) has rarely occurred

24/11/2014

As reported by "Springer Medizin", the pharmaceutical company Janssen has informed in a red hand letter and in consultation with the Paul Ehrlich Institute and the European Medicines Agency about the occurrence of exfoliative dermatitis and skin exfoliation during therapy with ustekinumab.

Thus, it is rare in the treatment of severe plaque psoriasis and psoriatic arthritis with ustekinumab (≥ 1/100- < 1/10 000) zum Auftreten einer exfoliativen Dermatitis (Erythrodermie) gekommen. Diese trat in einigen Fällen bereits wenige Tage nach Beginn der Therapie mit Ustekinumab auf, wobei es zu einigen schweren Fällen kam, die im Krankenhaus behandelt werden mussten.

It also happened occasionally (≥ 1/1000 to < 1/100) zu Exfoliationen der Haut ohne weitere Symptome einer exfoliativen Dermatitis. Es ist jedoch zu beachten, dass eine Plaque-Psoriasis im Rahmen des natürlichen Verlaufs der Erkrankung eine erythrodermische Psoriasis entwickeln kann, deren Symptome mit denen einer exfoliativen Dermatitis identisch sind.

In this context, the company urges physicians to pay more attention to the appearance of the skin during treatment with ustekinumab and to sensitize the patients to extensive peeling of the skin and severe redness. If there is a suspicion of a drug interaction, the treatment with ustekinumab should be stopped and a skin treatment is mandatory. The information should also be included in the package leaflet and in the technical information in the future.

Due in part to the above-mentioned side effects, many psoriasis patients therefore resorted to alternative treatment methods in the field of natural medicine. Here are in particular methods of traditional Chinese medicine (TCM) - such as the acupuncture - psoriasis treatments on homeopathic basis, nutritional therapies, light therapies and fish therapy to call. In the latter, small fish eat the excess skin of psoriasis. But even with the bath therapy as well as with the electrotherapy in practice already significant treatment success against the itchy rash of psoriasis was achieved. (Sb)