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NEW YORK (Reuters Health) —Psoriasis patients who are new users of infliximab and adalimumab appear to be at a greater risk of serious infection than those beginning therapy with etanercept, according to French researchers.

In an online paper in JAMA Dermatology, Dr. Emilie Sbidian of Hôpital Henri Mondor, Creteil, and colleagues note that biologics, adipex and alcohol interaction as well as targeted therapies such as apremilast, are effective in managing moderate to severe psoriasis. However, because of the fast emergence of such new therapeutic agents, long-term comparative safety studies in real-world settings are called for.

Dr. Sbidian told Reuters Health by email, “As more than 10 biologics are now available to treat psoriasis, the benefit/risk balance will help to choose the better drug for one patient taking into account the type of psoriasis and his/her comorbidities.”

Clinical trials, he and his colleagues say, are not adequately powered to assess the risk of any infection leading to hospitalization in patients with psoriasis receiving biologic therapies. In addition, observational studies have had conflicting results.

To investigate further, the researchers examined French national health data and identified patients having at least two prescriptions of topical vitamin D derivatives within a two-year period. This, they point out, is the recommended first-line treatment for psoriasis in France.

After exclusions, among them patients with HIV and a history of cancer, the researchers identified more than 44,000 patients who between 2008 and 2019 became new users of biologic agents or apremilast. The mean age was 48.4 years and median follow-up was for 12 months.

In all, 66.9% were first prescribed a tumor necrosis factor inhibitor, 15.0% received an interleukin (IL) 12/23 inhibitor, 9.3% received an IL-17 inhibitor, 1.2% were given an IL-23 inhibitor, and 7.6% received the targeted synthetic antipsoriatic agent apremilast. Most did not receive combination therapy, systemic corticosteroids, or NSAIDs at baseline or during follow-up.

Overall, there were more than 1,600 serious infections giving a total crude incidence of 25.0 per 1000 person-years. The most frequent were gastrointestinal, seen in 38.9%. Others included skin, and subcutaneous tissue and pulmonary infections.

After adjusting for time-dependent covariables, the risk of serious infections was higher for new users of adalimumab (estimated weighted hazard ratio of 1.22) or infliximab (wHR, 1.79) compared to that with etanercept. Use of ustekinumab was associated with a lower risk (wHR, 0.79).

Compared to etanercept, the risk of serious infections was not increased for new users of IL-17 and the IL-23 inhibitor guselkumab or apremilast. However the risk of serious infection was increased with concomitant use of NSAIDs (wHR, 1.47) or systemic corticosteroids (wHR, 2.32).

The study, the investigators conclude, “involved a large number of patients from a national database, with annual quality control of coding, which captures information during routine medical care.” However, they add, “Other observational studies are needed to confirm results for the most recent drugs.”

In the meantime, said Dr. Sbidian, “These results will provide physicians and patients new data to choose the right treatment.”

SOURCE: https://bit.ly/3ygnJ3V JAMA Dermatology, online July 21, 2021.

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