Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics
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 usin...
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| Format: | Article |
| Language: | English |
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BMC
2019-11-01
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| Series: | BMC Rheumatology |
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| Online Access: | https://doi.org/10.1186/s41927-019-0094-3 |
| _version_ | 1818327809787953152 |
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| author | Christopher T. Ritchlin Mona Stahle Yves Poulin Jerry Bagel Soumya D. Chakravarty Shelly Kafka Bhaskar Srivastava Wayne Langholff Alice B. Gottlieb |
| author_facet | Christopher T. Ritchlin Mona Stahle Yves Poulin Jerry Bagel Soumya D. Chakravarty Shelly Kafka Bhaskar Srivastava Wayne Langholff Alice B. Gottlieb |
| author_sort | Christopher T. Ritchlin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T12:22:10Z |
| format | Article |
| id | doaj.art-7b610315eb0d40c1a38aadfc14a63da9 |
| institution | Directory Open Access Journal |
| issn | 2520-1026 |
| language | English |
| last_indexed | 2024-12-13T12:22:10Z |
| publishDate | 2019-11-01 |
| publisher | BMC |
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| series | BMC Rheumatology |
| spelling | doaj.art-7b610315eb0d40c1a38aadfc14a63da92022-12-21T23:46:33ZengBMCBMC Rheumatology2520-10262019-11-013111310.1186/s41927-019-0094-3Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologicsChristopher T. Ritchlin0Mona Stahle1Yves Poulin2Jerry Bagel3Soumya D. Chakravarty4Shelly Kafka5Bhaskar Srivastava6Wayne Langholff7Alice B. Gottlieb8Division of Allergy, Immunology, and Rheumatology, University of Rochester Medical CenterDepartment of Medicine, Karolinska University Hospital, Karolinska InstitutetUniversité Laval and Centre de Recherche Dermatologique du Quebec métropolitainPsoriasis Treatment Center of Central New JerseyJanssen Scientific Affairs, LLCJanssen Scientific Affairs, LLCJanssen Scientific Affairs, LLCJanssen Research & DevelopmentNew York Medical College, Metropolitan HospitalAbstract 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.https://doi.org/10.1186/s41927-019-0094-3PSOLARPsoriasisPsoriatic arthritisSerious infections |
| spellingShingle | Christopher T. Ritchlin Mona Stahle Yves Poulin Jerry Bagel Soumya D. Chakravarty Shelly Kafka Bhaskar Srivastava Wayne Langholff Alice B. Gottlieb Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics BMC Rheumatology PSOLAR Psoriasis Psoriatic arthritis Serious infections |
| title | Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics |
| title_full | Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics |
| title_fullStr | Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics |
| title_full_unstemmed | Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics |
| title_short | Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics |
| title_sort | serious infections in patients with self reported psoriatic arthritis from the psoriasis longitudinal assessment and registry psolar treated with biologics |
| topic | PSOLAR Psoriasis Psoriatic arthritis Serious infections |
| url | https://doi.org/10.1186/s41927-019-0094-3 |
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