NEW YORK (Reuters Health)—Real-world psoriasis patients receiving biologic therapies rarely stop taking the drugs because of adverse effects, researchers say.
Although data from long-term registries have shown similar results, “the demographics of patients in registries are somewhat different than those of patients in real-world practices,” Dr. Jensen Yeung told Reuters Health by email.
“I have treated many patients with biological therapies for psoriasis and I must say that an adverse event leading to discontinuation of treatment is not a common occurrence,” said Dr. Yeung of Women’s College Hospital and Sunnybrook Health Sciences Centre at the University of Toronto, Canada.
“This study confirmed that other dermatologists have similar experiences,” he said.
Dr. Yeung and colleagues reviewed data on 398 adults who received 545 treatments with etanercept, infliximab, adalimumab, or ustekinumab, in varying combinations and doses.
As reported online May 28 in the Journal of the American Academy of Dermatology, their average psoriasis duration was 19.4 years, and roughly two thirds were male. Common comorbidities included psoriatic arthritis in 38%, hypertension in 18%, dyslipidemia in 12%, and diabetes in 11%.
The median duration of therapy until withdrawal because of an AE was 23.5 months.
AEs leading to withdrawal were uncommon, however. Overall, 22 AEs (4%) led to withdrawal of biologic therapy, for an incidence rate of 1.97 events/100 patient-years. More specifically, the incidence rates per 100 patient-years were 1.13 (2.29%) for etanercept, 4.96 (15%) for infliximab, 2.38 (2.99%) for adalimumab, and 1.38 (2.84%) for ustekinumab.
“Infections and malignancy associated with withdrawal of therapy accounted for 1.65% of all biologic treatments and around 5% of all discontinued biologic treatments,” the authors reported.
By comparison, in two previous multicenter observational studies, 4.02% and 6.14% of AEs had led to discontinuation, they noted.
“Our study provides data to complement existing safety profiles based on clinical trials, and shows that biologic therapies are associated with a low rate of withdrawal-related AEs in real-world clinical practice,” they wrote.
Dr. Colby Evans, chair-elect of the National Psoriasis Foundation board of directors, told Reuters Health by email, “This study is interesting . . . because it focuses specifically on adverse reactions to the medications without concern for efficacy.”
“The design is retrospective, which is easier to accomplish but limits its power to detect subtle trends,” said Dr. Evans, who was not involved in the study.
“It is helpful to confirm that biologic medications for psoriasis seem relatively safe and that the rates of side effects that lead to discontinuation are low overall and not any higher than in the original studies used to approve the drugs.”
In assessing the safety of drugs, “every bit of information is helpful,” said Dr. Mark Lebwohl, president of the American Academy of Dermatology, in email to Reuters Health. “Data from randomized, controlled clinical trials, large registries, postmarketing surveillance, retrospective chart reviews, and many other sources add to the body of knowledge that tells us if a drug is safe.”
Dr. Yeung has been a speaker, consultant, and investigator for Abbvie, Amgen, and Janssen, all of which make psoriasis drugs.
