Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics

Abstract

BackgroundPatients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients.MethodsPatients eligible for, or receiving conventional systemic and biologic agents for psoriasis were followed prospectively using PSOLAR. Cohorts included: ustekinumab, tumor necrosis factor (TNF) inhibitors; infliximab; etanercept; adalimumab; non-biologic/methotrexate (MTX) (reference group); and non-biologic/non-MTX. Multivariate analyses using Cox hazard regression were used to identify factors associated with time to first SI. Rates of SI in PSOLAR psoriasis patients with self-reported PsA and possible risks with biologic therapy were evaluated.ResultsPSOLAR enrolled 4315 psoriasis patients with self-reported PsA. The overall population (N = 2401) included patients (n): 628 ustekinumab; 1413 TNF inhibitors; 258 infliximab; 481 etanercept; 674 adalimumab; 54 other biologics, 98 non-biologic/MTX; 208 non-biologic/non-MTX. Overall, 138 SI were reported with incidence rates per 100 patient-years as follows: a) ustekinumab: 1.00; b) TNF inhibitors: 2.22; c) infliximab: 2.12; d) etanercept: 2.58; e) adalimumab: 1.99; f) non-biologic/MTX: 3.01; g) and non-biologic/non-MTX: 2.31. Age, time-dependent disease activity Physician’s Global Assessment (PGA) of 4, 5, history of infection, and diabetes were associated with increased risk for SI (p < 0.05) in self-reported PsA patients. Biologic groups, other than ustekinumab, had numerically higher rates of SI.ConclusionsPSOLAR psoriasis patients with self-reported PsA in the TNF inhibitors, infliximab, adalimumab, etanercept, and MTX cohorts had numerically higher SI rates than the ustekinumab cohort, although not statistically significant. Age, PGA 4, 5, history of infection, and diabetes were associated with an increased risk for SI, irrespective of biologic exposure.Trial registrationNCT00508547; Registered July 30, 2007.

Should patients stop their biologic treatment during the COVID-19 pandemic

“…There is little difference in general infection rates between drug and placebo groups in IL-17 and IL-23 antagonist studies (15). In the Psoriasis Longitudinal Assessment and Registry (PSOLAR), rates of serious infection were lower for ustekinumab than for psoriasis patients not on a biologic (16,17). For herpes zoster, in particular, rates were slightly higher, but there were few cases, and differences were not statistically significant (18).…”

Monitoring and long-term management of giant cell arteritis and polymyalgia rheumatica

“…In this record-linkage study, however, no effort was made to adjust the results for confounding by indication. This approach is necessary because glucocorticoid doses are linked to clinical activity, and increased disease activity is associated with an increased risk of infections in several rheumatic diseases [142][143][144][145][146][147] .…”

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“…Eder et al [ 101 ] reported that patients with PsA showed an increased risk of infection that required antibiotics (OR: 1.7; 95% CI: 1.00–2.77). As patients with PsA tend to receive more biologics than patients with psoriasis, they are at an increased risk of developing adverse events including infections [ 102 ]. The study by Haddad et al [ 103 ] also found that patients with PsA showed an increased incidence of infection than patients with psoriasis.…”