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

Christopher T Ritchlin,Wayne Langholff,Jerry Bagel,Alice B Gottlieb,Shelly Kafka,Yves Poulin,Bhaskar Srivastava,Soumya D Chakravarty,Mona Stahle

doi:10.1186/s41927-019-0094-3

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.

Highlights

Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients
We evaluated the incidence of SIs in a subpopulation of patients with self-reported PsA enrolled in the psoriasis Psoriasis Longitudinal Assessment and Registry (PSOLAR) registry [18], and among patients receiving biologic therapies for their psoriasis with concomitant PsA compared with patients receiving nonbiologic therapies
The overall PsA population included a total of 2401 patients (7244 patient years [Patient years (PY)]), of which 628 had received ustekinumab; 1413 received tumor necrosis factor (TNF) inhibitors; 258 received infliximab; 481 received etanercept, 674 received adalimumab, 98 received non-biologic/MTX, and 208 received non-biologic/non-MTX (Table 1)

Summary

Introduction

Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients. Several studies have reported increased risk of infections with biologic use in patients with psoriasis [2, 4,5,6,7] and rheumatoid arthritis (RA) [2, 8,9,10,11,12]. Patients with PsA have been reported to have an increased risk of comorbidities and adverse events (AEs), including serious infections (SIs), compared with patients with psoriasis [13, 14]. Many investigators question whether the increased risk for AEs is due to the underlying inflammatory nature of psoriatic disease itself, or to the therapies used to treat the disease

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