Call for shake-up of biologic regulations for psoriasis

by | 4th Mar 2008 | News

Patients in many countries are being denied effective new biologic therapies for psoriasis due to old fashioned clinical thinking and needlessly complex prescribing and reimbursement restrictions, say leading dermatologists.

Patients in many countries are being denied effective new biologic therapies for psoriasis due to old fashioned clinical thinking and needlessly complex prescribing and reimbursement restrictions, say leading dermatologists.

Disease severity at which biologics can be prescribed v
aries from country to country, as do strictures about prior therapies that patients must have failed before a biologic can be introduced. However, “not enough patients are getting access to these drugs – there are so many regulatory barriers,” said Wayne Gulliver, Chairman of Dermatology, Memo
rial University of Newfoundland. “Patients should not have to jump through these hoops.”

Speaking at the “Treating psoriasis as a chronic inflammatory systemic disease” in Athens, Greece, Prof Gulliver called for international harmonisation of prescribing guidelines and regulatory strictu
res on use of biologics. He added that use of biologics would be boosted if more doctors stopped treating psoriasis as simple skin disease, and considered its true nature as a skin manifestation of an underlying chronic inflammatory condition.

Recent research by his department has shown that
people with psoriasis die ten years younger than people without psoriasis and that psoriatics are more likely to die from cardiovascular disease than the general population.

“Why do psoriasis patients have such a high rate of associated co-morbidities? The answer may lie in the fact that fo
r years dermatologists have under-treated psoriasis. As we know, less that half of severe patients are on systemic treatment but we know that treating the immune-mediated inflammation may decrease the risk of co-morbidities such as cardiovascular disease,” he said.

Christopher Griffiths of
the University of Manchester, UK said that psoriasis should now be regarded as a systemic disease, no different from arthritis or inflammatory bowel disease. Targeted biological therapies could offer long term safe control of psoriasis.

According to Enno Christophers of the University of Kiel, Germany, it should be mandatory for dermatologists to monitor patients with psoriasis for signs of systemic disease and for the metabolic syndrome which drives heart disease.

Biologic therapies for psoriasis include alefacept (LFA-3-TIP, Amevive, Biogen), efalizumab (anti-CD11a, Raptiva, Genentec, Xoma, Merck/Serono), etanercept (Enbrel, Amgen, Wyeth), infliximab (Remicade, Centocor) and adalimumab (Humira, Abbott). Long term (three-year) efficacy data on efalizumab is expected to be published later this week.

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