The interim analysis is from ESPRIT, a 10-year multinational post-marketing registry.
“Clinical trials are not the real world,” in part because patients with comorbidities are screened out of such trials, which is why postmarketing studies are so important, said lead author Dr. Alan Menter, of Baylor University Medical Center, Dallas, Texas, in a telephone interview.
He noted that the risk of treatment-emergent adverse events (TEAEs) decreased over time, while the drug’s effectiveness increased over time. This was particularly noteworthy, Menter said, given that the types and mix of psoriasis symptoms seen in ESPRIT “are very similar to what we see in clinical practice.”
Psoriasis patients are already at higher risk for lymphoma and myocardial infarction, he said, and they’re often worried about long-term adverse effects of immune suppression. Given the review’s findings, Menter said, patients who ask if there’s an increased lymphoma risk from long-term adalimumab can be told, “The answer definitively is ‘No.'”
Registry participants, all age 18 or over, either initiated adalimumab within four weeks before entry into the registry, or had previously initiated adalimumab and were not off the drug more than 70 consecutive days.
Overall, the researchers had data on 6,059 patients collected from 2008 to 2013. Close to a third of patients (30.2%) had a Physician Global Assessment (PGA) of 3 (Moderate) on a psoriasis severity scale of 0-5.
PGA of 0 or 1 was achieved by more than 50% of patients at years 1 and 2 of registry participation and by more than 60% at years 3 to 5.
With a median registry exposure of 765 days for the overall group, the rates of events for 100 patient-years of total adalimumab exposure came to 4.3 for serious treatment emergent adverse events, 1.0 for serious infection, 0.9 for malignancies, and <0.1 for melanomas, the authors reported online July 16 in the Journal of the American Academy of Dermatology.
Adalimumab was dosed according to local product labeling. Patients were allowed other treatment at their physicians’ discretion, but concurrent anakinra, abatacept, or other biologic agents were prohibited.
Overall, the authors wrote, “rates of any serious TEAE and serious TEAEs of special interest (such as cardiovascular-related, infection-related and malignancies) were low, and rates of serious TEAEs and serious infections decreased with increasing adalimumab exposure.”