Abstract
Serious infection is a concern for patients with psoriasis receiving biologic therapies. We assessed the risk of serious infections for biologics used to treat psoriasis by comparison with a cohort receiving non-biologic systemic therapies in a propensity score-weighted Cox proportional hazards model using data from the British Association of Dermatologists Biologic Interventions Register. Overall, 1,352; 3,271; and 994 participants were included in the etanercept, adalimumab, ustekinumab cohorts, respectively, and 3,421 participants were in the non-biologic cohort. A total of 283 patients had a serious infection; the incidence rates with 95% confidence intervals (CI) per 1,000 person-years were as follows: non-biologic, 14.2 (11.5–17.4); etanercept, 15.3 (11.6–20.1); adalimumab, 13.9 (11.4–16.6); and ustekinumab, 15.1 (10.8–21.1). No significant increases in the risk of serious infection were observed for etanercept (hazard ratio [HR] = 1.10, 95% CI = 0.75–1.60), adalimumab (HR = 0.93, 95% CI = 0.69–1.26), or ustekinumab (HR = 0.92, 95% CI = 0.60–1.41) compared with non-biologic systemic therapies or methotrexate-only (etanercept: HR = 1.47, 95% CI = 0.95–2.28; adalimumab: HR = 1.26, 95% CI = 0.86–1.84; ustekinumab: HR = 1.22, 95% CI = 0.75–1.99). The risk of serious infection should not be a key discriminator for patients and clinicians when choosing between non-biologic systemic therapies, etanercept, adalimumab, and ustekinumab for the treatment of psoriasis.
Highlights
Moderate to severe psoriasis is increasingly managed by biologic, immune-modulating therapies
ustekinumab compared with non-biologic therapies for patients
There was no difference in the risk of serious infections
Summary
Moderate to severe psoriasis is increasingly managed by biologic, immune-modulating therapies. The main adverse event leading to discontinuation of biologic therapies in patients with psoriasis is infection (Warren et al, 2015). The risk of serious infection for biologic therapies in the real world has been hard to ascertain, because clinical trials have limited external validity (Garcia-Doval et al, 2012) and are not powered to assess this outcome (Yiu et al, 2016). The risk of serious infections in patients with psoriasis on biologic therapies is not well-quantified. One showed no increased risk of serious infection with tumor necrosis factor inhibitors (TNFIs) compared with acitretin, methotrexate, or cyclosporine (Garcia-Doval et al, 2017b), and the two other studies showed no significant increased risk with TNFIs or ustekinumab versus methotrexate
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