Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry

Dávila‐Seijo, P.; Daudén, E.; Descalzo, M.Á.; Carretero, G.; Carrascosa, J.M.; Vanaclocha, F.; Gómez-García, Francisco; Cueva‐Dobao, P. de la; Herrera‐Ceballos, Enrique; Belinchón, Isabel; López-Estebaranz, J.L.; Alsina, M.; Sánchez‐Carazo, J.L.; Ferrán, Marta; Torrado, R.; Ferrándiz, Carlos; Rivera, R.; Llamas, M.; Jiménez‐Puya, R.; García‐Doval, I.; Zafrilla, Beatriz Pérez; Muñoz‐Santos, Carlos; Mendiola-Fernández, Victoria; Roldán, Cristina Sánchez; Ruíz‐Genao, Diana; Echeverría, Begoña; Mejías, S. Galiano

doi:10.1016/j.jid.2016.08.034

Cited by 101 publications

(102 citation statements)

References 27 publications

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“…20,[24][25][26] Cellulitis and pneumonia were the most commonly reported serious infections with adalimumab, consistent with clinical trial experience. [24][25][26]32 When assessed by indication, psoriasis has one of the lowest rates of TNF inhibitorassociated serious infection, whereas rheumatoid arthritis and Crohn's disease have the highest. Of note, among TNF inhibitors, infliximab demonstrated the highest rate of serious infection.…”

Section: Discussionmentioning

confidence: 53%

“…16,18,30,31 In this registry analysis of patients with psoriasis treated with adalimumab, rates of infection ranged from 7.7 to 14.7/ 100 PY. [24][25][26]32 The overall infection rates reported in the realworld registries were considerably lower than that reported in adalimumab clinical trials in patients with psoriasis (88.8/100 PY). [24][25][26]32 The overall infection rates reported in the realworld registries were considerably lower than that reported in adalimumab clinical trials in patients with psoriasis (88.8/100 PY).…”

Section: Discussionmentioning

confidence: 99%

“…[24][25][26]32 The overall infection rates reported in the realworld registries were considerably lower than that reported in adalimumab clinical trials in patients with psoriasis (88.8/100 PY). 20,[24][25][26] Cellulitis and pneumonia were the most commonly reported serious infections with adalimumab, consistent with clinical trial experience. 20,[24][25][26] Cellulitis and pneumonia were the most commonly reported serious infections with adalimumab, consistent with clinical trial experience.…”

Section: Discussionmentioning

confidence: 99%

“…25 The rates of infections Adalimumab safety in psoriasis registries (<9.0/100 PY) and serious infections (<0.6/100 PY) were lower in the PsoBest psoriasis registry, which showed similar rates across all biologics and anti-TNF agents. Higher rates were observed for a subgroup of patients who received adalimumab and methotrexate combination therapy (n = 130; 472.9 PY); the crude rates were 19.6/100 PY, 2.3/ 100 PY and 8.0/100 PY, respectively.…”

Section: Infections and Serious Infectionsmentioning

confidence: 94%

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Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Strober

Crowley

Langley

et al. 2018

Acad Dermatol Venereol

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Long-term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real-world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practice. Databases (BIOSIS Previews, Current Contents Search, Derwent Drug File, EMBASE, EMBASE Alert, EMCare, MEDLINE, SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient-years [PY]) of adverse events (AEs), serious AEs (SAEs) and AEs of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n = 10; no safety data, n = 2; no on-treatment data, n = 1; not English, n = 1), and 10 selected. Overall rates of AEs (4273 [22.2/100PY]) and SAEs (827 [4.3/100PY]) were reported in the ESPRIT registry (N = 6059). Rates of infections (7.7-14.7/100PY) and serious infections (<0.6-2.0/100PY) were reported in four studies. Cardiovascular-related events were reported in three studies: ≤0.1/100PY per major cardiac event in ESPRIT, <0.5/100PY major cardiac events in PsoBest and serious cardiovascular events in two patients (<1%) in DERMBIO. Malignancies were reported in three studies (any malignancy, 0.9/100PY; malignancies excluding non-melanoma skin cancer [NMSC], <0.6/100PY; NMSC, 0.6-<0.5/100PY). These findings suggest that real-world safety of adalimumab is consistent across different psoriasis registries, which supports the existing long-term safety profile of adalimumab from clinical studies.

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Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Infections and Serious Infectionsmentioning

confidence: 94%

See 2 more Smart Citations

Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Strober

Crowley

Langley

et al. 2018

Acad Dermatol Venereol

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“…Biologicals are effective not only for psoriasis but also for co‐morbid cardiovascular and metabolic diseases . In addition, monitoring of infection is mandatory to avoid serious consequences . The emergence of antidrug antibodies is another important issue that reduces the treatment response and promotes treatment failure during biological therapy …”

Section: Current Pathogenesis Of Psoriasis and Its Treatmentsmentioning

confidence: 99%

Autoimmunity and autoimmune co‐morbidities in psoriasis

et al. 2018

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SummaryPsoriasis is characterized by widespread scaly erythematous plaques that cause significant physical and psychological burdens for the affected individuals. Accelerated inflammation driven by the tumour necrosis factor-a/ interleukin-23/interleukin-17 axis is now known to be the major mechanism in the development of psoriasis. In addition, psoriasis has an autoimmune nature that manifests as autoreactive T cells and is comorbid with other autoimmune diseases, such as autoimmune bullous diseases, vitiligo, alopecia and thyroiditis. In this article, we review the recent topics on autoimmunity and autoimmune co-morbidities in psoriasis.

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Safety of Systemic Agents for the Treatment of Pediatric Psoriasis

et al. 2017

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IMPORTANCE Use of systemic therapies for moderate to severe psoriasis in children is increasing, but comparative data on their use and toxicities are limited.OBJECTIVE To assess patterns of use and relative risks of systemic agents for moderate to severe psoriasis in children. DESIGN, SETTING, AND PARTICIPANTSA retrospective review was conducted at 20 centers in North America and Europe, and included all consecutive children with moderate to severe psoriasis who used systemic medications or phototherapy for at least 3 months from December 1, 1990, to September 16, 2014. MAIN OUTCOMES AND MEASURESThe minimal core data set included age, sex, severity of psoriasis, systemic interventions, monitoring, adverse events (AEs), and reason for discontinuation.RESULTS For 390 children (203 girls and 187 boys; mean [SD] age at diagnosis, 8.4 [3.7] years) with psoriasis who used 1 or more systemic medications, the mean interval between diagnosis and starting systemic therapy was 3.0 years. Methotrexate was used by 270 patients (69.2%), biologic agents (primarily etanercept) by 106 (27.2%), acitretin by 57 (14.6%), cyclosporine by 30 (7.7%), fumaric acid esters by 19 (4.9%), and more than 1 medication was used by 73 (18.7%). Of 270 children taking methotrexate, 130 (48.1%) reported 1 or more AEs associated with methotrexate, primarily gastrointestinal (67 [24.8%]). Folic acid 6 days per week (odds ratio, 0.16; 95% CI, 0.06-0.41; P < .001) or 7 days per week (OR, 0.21; 95% CI, 0.08-0.58; P = .003) protected against gastrointestinal AEs more than once-weekly folic acid, regardless of the total weekly dosage. Methotrexate-associated hepatic transaminase elevations were associated with obesity (35 of 270 patients [13.0%]), but a folic acid regimen was not. Injection site reactions occurred in 20 of 106 patients (18.9%) treated with tumor necrosis factor inhibitors, but did not lead to discontinuation of treatment. Having 1 or more AEs related to medication, gastrointestinal AE, laboratory abnormality, or AE leading to discontinuation of the drug was more likely with methotrexate than tumor necrosis factor inhibitors, but having 1 or more infections related to medication (predominantly upper airway) was less likely. Six patients developed a serious treatment-related AE (methotrexate, 3; fumaric acid esters, 2; and adalimumab, 1), but methotrexate and biologic agents were taken for a mean duration that was 2-fold greater than the mean duration for cyclosporine or fumaric acid esters. No patient developed tuberculosis or a malignant neoplasm.CONCLUSIONS AND RELEVANCE Medication-related AEs occur less often with tumor necrosis factor inhibitors than with methotrexate. Folic acid administration 6 or 7 times per week protected more against methotrexate-induced gastrointestinal AEs than did weekly administration. A prospective registry is needed to track the long-term risks of systemic agents for pediatric psoriasis.

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Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry

Cited by 101 publications

References 27 publications

Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries

Autoimmunity and autoimmune co‐morbidities in psoriasis

Safety of Systemic Agents for the Treatment of Pediatric Psoriasis

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