Biologic therapies

Kohala Coast, HI

- In weighing the safety of biological therapies for psoriasis, one of the most fundamental concepts to consider is that psoriasis itself is unsafe, said Kim A. Papp, M.D., Ph.D., at the Winter Clinical Dermatology Conference.

"That has ramifications for helping guide our treatment decisions and our patients who are deciding what treatments they will accept," said Dr. Papp, assistant professor of dermatology, University of Western Ontario, Canada.

In discussing the safety of biological therapies, Dr. Papp first provided a definition of safety, but by inverting the issue. He proposed anything may be considered "unsafe" if it compromises an individual’s well-being.

"We know that psoriasis impacts patients physically and emotionally and as much as such serious diseases as arthritis, cancer, chronic lung disease, among others," said Dr. Papp.

Further putting the safety of psoriasis treatment with biologics in perspective, he cited statistics about the risks of accidental death from various causes, including being an occupant of an automobile.

"Perhaps the biggest risk we are going to impose on our patients is asking them to come into our clinics for regular follow-up," he said.

Data from a recent population-based study has also identified that psoriasis may be an independent risk factor for myocardial infarction. In that analysis, younger patients with severe psoriasis were four to six times more likely to suffer a myocardial infarction than controls without psoriasis, and there was even an elevated risk of myocardial infarction in younger individuals with mild psoriasis.

"Looking at health-adjusted life expectancy after adjustment for other comorbidities, patients with moderate- to-severe psoriasis live on average three to four years less than a population without psoriasis," noted Dr. Papp.

Although there is no data available to characterize the relative risks of mortality and serious diseases associated with biologic treatment of psoriasis, relevant information can be gleaned from studies in the rheumatoid arthritis population.

Citing one study comparing populations of patients treated with nonbiologics (NSAIDs and DMARDs) versus those treated with biologics (TNF-alpha antagonists), Dr. Papp noted that the patients in the biologic group had lower relative risks for cardiovascular events and solid tumors. Treatment with the biologics was not associated with any increase in mortality.

"Although these data are not specifically from patients with psoriasis, rheumatoid arthritis is a chronic inflammatory disease like psoriasis and is associated with similar patterns of comorbidity. The bottom line is that biologics as a whole appear to be beneficial to our patients. They reduce hazards and they improve many aspects of our patients’ lives," Dr. Papp concluded. DT