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

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

doi:10.1186/s41927-019-0094-3

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

BMC Rheumatol. 2019 Nov 28:3:52. doi: 10.1186/s41927-019-0094-3. eCollection 2019.

Authors

Christopher T Ritchlin¹, Mona Stahle², Yves Poulin³, Jerry Bagel⁴, Soumya D Chakravarty^{5

6}, Shelly Kafka⁵, Bhaskar Srivastava⁵, Wayne Langholff⁷, Alice B Gottlieb⁸

Affiliations

¹ 1Division of Allergy, Immunology, and Rheumatology, University of Rochester Medical Center, 601 Elmwood Ave., Box 695, Rochester, NY 14642 USA.
² Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
³ 3Université Laval and Centre de Recherche Dermatologique du Quebec métropolitain, Quebec, Canada.
⁴ 4Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ USA.
⁵ 5Janssen Scientific Affairs, LLC, Horsham, PA USA.
⁶ 6Drexel University College of Medicine, Philadelphia, PA USA.
⁷ 7Janssen Research & Development, Spring House, PA USA.
⁸ 8New York Medical College, Metropolitan Hospital, New York, NY USA.

Abstract

Background: Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients.

Methods: Patients 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.

Results: PSOLAR 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.

Conclusions: PSOLAR 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 registration: NCT00508547; Registered July 30, 2007.

Keywords: PSOLAR; Psoriasis; Psoriatic arthritis; Serious infections.

Associated data

ClinicalTrials.gov/NCT00508547