Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti–tumor necrosis factor agents versus classic therapies: Prospective meta-analysis of Psonet registries

García‐Doval, I.; Cohen, Arnon D.; Cazzaniga, Simone; Feldhamer, Ilan; Addis, Antonio; Carretero, G.; Ferrándiz, Carlos; Stern, Robert S.; Naldi, Luigi

doi:10.1016/j.jaad.2016.07.039

Cited by 82 publications

(96 citation statements)

References 24 publications

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“…8–10,15 However, previous epidemiologic studies on infectious outcomes in patients with psoriasis who were receiving biologics have yielded conflicting results. 11,12,16–20 A large, prospective cohort study discovered an elevated risk for serious infection (most commonly cellulitis and pneumonia) with the TNF-α inhibitor adalimumab compared with systemic retinoid and/or phototherapy, but this increased risk was not observed in biologic-naive subjects. 12 In contrast, meta-analyses of several registries found no increased risk for serious infection with biologics.…”

Section: Discussionmentioning

confidence: 99%

“…11,12 The contradictory results may be a result of data aggregation from multiple locations, inadequate follow-up time and sample size, variable exclusion criteria, and inconsistent definitions of serious infection. To address these concerns, we analyzed these events in patients with newly diagnosed psoriasis in a real-world, integrated practice setting with the longest follow-up time to date of any study, together allowing for greater accuracy in data capture and increased likelihood of recording these rare, but serious events.…”

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confidence: 99%

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Serious infections among a large cohort of subjects with systemically treated psoriasis

Dobry

Quesenberry

Ray

et al. 2017

Journal of the American Academy of Dermatology

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Background Biologic therapy is effective for treatment of moderate-to-severe psoriasis but may be associated with an increased risk for serious infection. Objective To estimate the serious infection rate among patients with psoriasis treated with biologic as compared with nonbiologic systemic agents within a community-based health care delivery setting. Methods We identified 5889 adult Kaiser Permanente Northern California health plan members with psoriasis who had ever been treated with systemic therapies and calculated the incidence rates and 95% confidence intervals (CIs) for serious infections over 29,717 person-years of follow-up. Adjusted hazard ratios (aHRs) were calculated using Cox regression. Results Adjusting for age, sex, race or ethnicity, and comorbidities revealed a significantly increased risk for overall serious infection among patients treated with biologics as compared with those treated with nonbiologics (aHR, 1.31; 95% CI, 1.02–1.68). More specifically, there was a significantly elevated risk for skin and soft tissue infection (aHR, 1.75; 95% CI, 1.19–2.56) and meningitis (aHR, 9.22; 95% CI, 1.77–48.10) during periods of active biologic use. Limitations Risk associated with individual drugs was not examined. Conclusion We found an increased rate of skin and soft tissue infections among patients with psoriasis treated with biologic agents. There also was a signal suggesting increased risk for meningitis. Clinicians should be aware of these potential adverse events when prescribing biologic agents.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Serious infections among a large cohort of subjects with systemically treated psoriasis

Dobry

Quesenberry

Ray

et al. 2017

Journal of the American Academy of Dermatology

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“…[8][9][10]15 However, previous epidemiologic studies on infectious outcomes in patients with psoriasis who were receiving biologics have yielded conflicting results. 11,12,[16][17][18][19][20] A large, prospective cohort study discovered an elevated risk for serious infection (most commonly cellulitis and pneumonia) with the TNF-α inhibitor adalimumab compared with systemic retinoid and/or phototherapy, but this increased risk was not observed in biologic-naive subjects. 12 In contrast, meta-analyses of several registries found no increased risk for serious infection with biologics.…”

Section: Discussionmentioning

confidence: 99%

“…12 In contrast, meta-analyses of several registries found no increased risk for serious infection with biologics. 11,21 A possible explanation for this difference is that the former study had a less restrictive definition of serious infection (ie, patients did not need to be hospitalized), which may have captured more adverse events. With regard to SSTIs, patients with psoriasis develop serious cellulitis infections at 3 times the rate at which patients without psoriasis develop them.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][10] A recent meta-analysis revealed no increased risk for serious infection, whereas a prospective cohort study observed a significantly increased risk for serious infection with specific biologic agents. 11,12 The contradictory results may be a result of data aggregation from multiple locations, inadequate follow-up time and sample size, variable exclusion criteria, and inconsistent definitions of serious infection. To address these concerns, we analyzed these events in patients with newly diagnosed psoriasis in a real-world, integrated practice setting with the longest follow-up time to date of any study, together allowing for greater accuracy in data capture and increased likelihood of recording these rare, but serious events.…”

mentioning

confidence: 99%

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399 Serious infections among a large cohort of subjects with systemically-treated psoriasis

Dobry¹

2017

Journal of Investigative Dermatology

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Risk of Serious Infection in Patients Receiving Systemic Medications for the Treatment of Psoriasis

et al. 2019

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IMPORTANCE There is a need for better understanding of the comparative safety of systemic medications used in the treatment of psoriasis. OBJECTIVE To compare the risk of serious infection associated with biologic and nonbiologic systemic medications in patients with psoriasis. DESIGN, SETTING, AND PARTICIPANTS An observational cohort study was conducted using medical and outpatient pharmacy claims from 2 large US health insurance claims databases from January 1, 2003, through September 30, 2015. We included patients with a diagnosis of psoriasis who were new users of systemic medications for psoriasis. EXPOSURES Prescription claims for acitretin, adalimumab, apremilast, etanercept, infliximab, methotrexate, or ustekinumab. MAIN OUTCOMES AND MEASURES The primary outcome was serious infection, defined by inpatient discharge diagnosis International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Cox proportional hazards regression was used to compare rates of serious infection for each exposure (acitretin, adalimumab, apremilast, etanercept, infliximab, and ustekinumab) with the referent group (methotrexate). We used pairwise 1:1 propensity score (PS) matching to adjust for potential confounders, which were assessed during a 180-day baseline period prior to study drug initiation. Results from the 2 databases were pooled via fixed-effects analysis. RESULTS The databases included 31 595 patients in the Optum Clinformatics Data Mart and 76 112 patients in Truven MarketScan who were new users of acitretin, adalimumab, apremilast, etanercept, infliximab, methotrexate, and ustekinumab. Users of acitretin, apremilast, infliximab, and methotrexate were older and had higher baseline comorbidity scores than subcutaneous biologic users (adalimumab, etanercept, and ustekinumab). The pooled PS-matched analysis yielded a decreased rate of overall serious infection in users of apremilast (hazard ratio [HR], 0.50; 95% CI, 0.26-0.94), etanercept (HR, 0.75; 95% CI, 0.61-0.93), and ustekinumab (HR, 0.65; 95% CI, 0.47-0.89) compared with methotrexate. We did not find a different rate of overall serious infection among users of acitretin, adalimumab, and infliximab compared with methotrexate. Subanalysis by type of serious infection showed a significantly increased risk of cellulitis among users of acitretin compared with methotrexate (PS-adjusted HR, 1.76; 95% CI, 1.11-2.80). CONCLUSIONS AND RELEVANCE Among patients with psoriasis treated with systemic medications in 2 large US claims databases, new users of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with methotrexate.

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Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti–tumor necrosis factor agents versus classic therapies: Prospective meta-analysis of Psonet registries

Cited by 82 publications

References 24 publications

Serious infections among a large cohort of subjects with systemically treated psoriasis

Serious infections among a large cohort of subjects with systemically treated psoriasis

399 Serious infections among a large cohort of subjects with systemically-treated psoriasis

Risk of Serious Infection in Patients Receiving Systemic Medications for the Treatment of Psoriasis

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