WAIKOLOA, HAWAII – The latest update from the ongoing PSOLAR registry provides “very reassuring” evidence that the use of biologic agents to treat moderate to severe psoriasis doesn’t significantly increase malignancy risk other than for skin cancer, according to Dr. Kristina Callis Duffin.
Dr. Duffin of the department of dermatology at the University of Utah, Salt Lake City, cited a report presented by Dr. David Fiorentino, professor of dermatology at Stanford (Calif.) University, at the annual meeting of the European Academy of Dermatology and Venereology last October in Copenhagen. This update from the prospective international Psoriasis Longitudinal Assessment and Registry (PSOLAR) included 12,093 psoriasis patients deemed candidates for biologics, including 2,084 who did not go on a biologic agent while the rest did.
During 40,388 patient-years of prospective follow-up, or an average of 3.3 years, 455 patients were diagnosed with a malignancy other than skin cancer. The cumulative malignancy rate was 0.75 cases per 100 patient-years in patients on nonbiologic therapies, which was not significantly different from the rates of 0.51 per 100 patient-years in participants who started on ustekinumab (Stelara) at enrollment, 0.81 in patients on infliximab (Remicade), or 0.73 per 100 patient-years in those on other biologics, Dr. Duffin said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“These are all very low rates,” commented Dr. Duffin.
The PSOLAR data are particularly valuable because the registry was set up specifically to prospectively examine the long-term safety and efficacy of biologic agents in psoriasis patients. In contrast, the landmark epidemiologic study led by Dr. Joel M. Gelfand of the University of Pennsylvania, Philadelphia, which concluded that mild psoriasis was associated with a 34% increased risk of lymphoma and that severe psoriasis carried a 59% greater risk than in nonpsoriatic controls (J Invest Dermatol. 2006 Oct;126:2194-201), involved a retrospective analysis of the U.K. General Practice Research Database. And while that study had strength in numbers – it included more than 153,000 British psoriasis patients and nearly 800,000 controls – it wasn’t designed to look specifically at psoriasis patients.
It’s reassuring that the lymphoma rate of 0.47 cases per 100 patient-years in patients with severe psoriasis in the U.K. registry during the prebiologics era is virtually identical to the rates associated with biologic agents in PSOLAR to date, which ranged from 0.3 to 0.5 cases per 100 patient-years, Dr. Duffin said.
The PSOLAR findings are worth sharing with patients. As a result of direct-to-consumer advertising by pharmaceutical companies, psoriasis patients are typically quite concerned about the risk of cancer associated with biologic agents, she added.
“They hear the comment in the ad that serious infections and malignancies have been reported in patients on these drugs as ‘these drugs increase the risk of malignancy.’ So where I start this conversation is, ‘Actually, patients with psoriasis do have some increased risk of malignancy, but those malignancies are mostly nonmelanoma skin cancers and lymphoproliferative diseases,’” the dermatologist explained.
Much of this risk is probably related to the fact that patients with moderate to severe psoriasis often have an extensive history of exposure to immunosuppressive agents such as cyclosporine as well as UV light therapies, which increase the risk of skin cancer.
“You also have to consider the fact that psoriasis patients tend to have a lot of smoking behaviors and alcohol behaviors that increase cancer risk,” Dr. Duffin continued.
In shared decision making regarding the option of biologic therapy in psoriasis patients having a history of cancer or who develop cancer while on a biologic, she likes to pose a question: What scares you more: the risk of your cancer coming back or not being able to have a good quality of life?
“That gets them thinking,” she said.
She stressed that as part of discussions regarding the risk/benefit profile of biologic therapy in an individual with a history of cancer, or of continuing a biologic in someone diagnosed with a malignancy while on treatment, it’s important for the dermatologist to talk with the patient’s oncologist, who is best positioned to provide insight into the risk of cancer recurrence.
Dr. Duffin is a recipient of research grants from and a consultant to Janssen, which sponsors the PSOLAR registry, as well as to more than half a dozen other pharmaceutical companies. SDEF and this news organization are owned by the same parent company.