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The results of a cohort study of patients with psoriasis suggest that new users of adalimumab or infliximab may be at an increased risk of serious infection compared to users of etanercept.
The data also showed that the risk of infection was lower for ustekinumab while remaining comparable for secukinumab, ixekizumab, brodalumab, guselkumab or apremilast compared to etanercept.
A team of investigators from France, led by Laetitia Penso, MSc, assessed patient data from the National Health Data System in order to comprehensively capture the real risk of serious infection associated with the use of biologics.
“All adults with psoriasis, defined as having received at least 2 prescriptions of a topical vitamin D derivative over a 2-year period, recorded in the database between January 1, 2008 and May 31, 2019, were eligible, “said Penso and his colleagues. .
They included those who had not had or used a prescription for a biologic or apremilast in the previous year.
The study
Investigators defined severe infection as infection resulting in hospitalization.
As such, the primary endpoint sought was the occurrence of severe infection as well as the time to first onset. They also evaluated the results of serious infections, such as gastrointestinal, skin, eye, ear-nose-throat, musculoskeletal, pulmonary and nervous system, among others.
They also took note of the socio-demographic characteristics of the patients as well as any past or current use of non-biological anti-psoriatic agents, non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
Results
A total of 44,239 patients were new users of a targeted biologic / biosimilar or synthetic antipsoriatic agent.
Of this population, 29,618 (66.9%) first received a tumor necrosis factor inhibitor, 6,658 (15.0%) an interleukin (IL) 12/23 inhibitor, 4093 (9, 3%) an IL-17 inhibitor, 526 (1.2%) an IL-23 inhibitor and 3344 (7.6%) apremilast.
The Penso team reported that 1656 serious infections occurred in the entire population assessed, gastrointestinal infections (38.9%) being the most frequently observed type of infection, followed by skin infections. (19.6%) and pulmonary (14.8%).
The overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1000 person-years, and the median time to event was 9 months.
“After adjusting for time-dependent covariates, the risk of serious infections was higher for new users of adalimumab ([hazard ratio] RH, 1.22; 95% CI, 1.07-1.38) or infliximab (HR, 1.79; 95% CI 1.49-2.16) compared to etanercept, whereas ustekinumab was combined with lower risk of having severe infection (HR, 0.79; 95% CI, 0.67-0.94), ”wrote Penso and his team.
Patients who used guselkumab or apremilast did not show an increased risk of serious infection compared to new users of etancercept. However, the risk was higher in those who used NSAIDs concomitantly (HR, 1.47; 95% CI, 1.25-1.73) or systemic corticosteroids (HR, 2.32; 95% CI, 1.95 to 2.76).
Conclusion
“The results of this study are important because recent biological agents, including secukizumab, ixekizumab, brodalumab and guselkumab, have been compared with each other,” wrote Penso and colleagues.
They noted that observational studies have produced conflicting results regarding biological use and the risk of infections. One potential explanation proposed by the investigators was the differences between the populations studied, namely the condition treated by the biological and inclusion / exclusion criteria.
Nevertheless, they recognized that additional observational studies to confirm these results in patients with psoriasis are warranted.
The study, “Association between the use of biologics and the risk of serious infection in patients with psoriasis,” has been published online in JAMA Dermatology.
This article was originally published by our sister publication HCP Live
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