Examining worldwide postmarketing suicides from biologics used for psoriasis with a focus on brodalumab: A cross-sectional analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS)

Yeroushalmi, Samuel; Chung, Max; Bartholomew, Erin; Hakimi, Marwa; Koo, John

doi:10.1016/j.jdin.2022.08.010

Cited by 4 publications

(4 citation statements)

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“…94 In fact, there has only been one suicide documented worldwide after nearly half a decade of brodalumab's use. 95,96 As a preventative measure in the United States, brodalumab prescriptions can only be administered going through the SILIQ risk evaluation and mitigation strategy program, a program designed to manage the risk of suicidal thoughts and actions. 94 Brodalumab should not be prescribed to individuals with a history of suicidal thoughts.…”

Section: Il-17 Inhibitorsmentioning

confidence: 99%

“…There is no meaningful causative relationship between the use of brodalumab and suicidal ideation 94 . In fact, there has only been one suicide documented worldwide after nearly half a decade of brodalumab's use 95,96 . As a preventative measure in the United States, brodalumab prescriptions can only be administered going through the SILIQ risk evaluation and mitigation strategy program, a program designed to manage the risk of suicidal thoughts and actions 94 .…”

Section: Managementmentioning

confidence: 99%

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Current management of generalized pustular psoriasis

Kodali

Blanchard

Kunamneni

et al. 2023

Experimental Dermatology

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Generalized pustular psoriasis (GPP) is a rare subset of psoriasis involving episodes of sterile pustules accompanied by inflammation and, often, systemic involvement. The inflammatory nature of GPP has potential for severe multisystem complications including high‐output cardiac failure, infections, digestive system issues, and disfiguring or lethal acute flare episodes. The disease tends to have higher prevalence in females and Asians. The IL‐1/IL‐36 inflammatory pathway is a critical facet of GPP's pathology. Genetic mutations that are associated with GPP include modifications of Interleukin 36 Receptor Antagonist (IL36RN), Caspase Recruitment Domain Family Member 14 (CARD14), Adaptor Related Protein Complex 1 Subunit Sigma 3 (AP1S3), Myeloperoxidase (MPO) and Serpin Peptidase Inhibitor Clade A Member 3 (SERPINA3) genes. Treatment guidelines for GPP are not well‐entrenched. Currently, only one GPP‐specific treatment, the interleukin‐36 receptor antagonist (IL‐36Ra) spesolimab, has been approved for use in the United States. Additional anti‐IL‐36 pathway therapies are currently being developed. Other treatment options include other biologic therapies such as IL‐17 inhibitors, IL‐23 inhibitors and TNFα inhibitors. Non‐biologic therapeutic options include retinoids, cyclosporine and methotrexate. Treatment options differ throughout the world; most countries utilize retinoids, cyclosporine and methotrexate as first‐line non‐biologic options. China and United Kingdom have no GPP‐specific biologic therapies approved for use, while several biologic therapies are approved for use in Japan. This review aims to serve as an update on the current global management of GPP while also including relevant aspects of disease pathogenesis, diagnosis, clinical presentation, histopathology, aetiology and epidemiology.

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Section: Il-17 Inhibitorsmentioning

confidence: 99%

Section: Managementmentioning

confidence: 99%

Current management of generalized pustular psoriasis

Kodali

Blanchard

Kunamneni

et al. 2023

Experimental Dermatology

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“…The American College of Rheumatology, recommended to withhold methotrexate 1 week after each dose of vaccine for patients with well-controlled disease [48]. This recommendation is based on data from influenza and pneumococcal vaccines showing that methotrexate, but not target therapies, impair humoral responses [49].…”

Section: Efficacy Of Sars-cov-2 Vaccines In Patients With Chronic Pla...mentioning

confidence: 99%

“…There is no established mechanism. Nonetheless, patients are recommended to be counselled on this risk [46][47][48][49][50].…”

Section: Suicidementioning

confidence: 99%

Medicom Conference Report Proceedings of the 6th IFPA WPPA Conference

2021

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The ideas and opinions expressed in this publication do not necessarily reflect those of Medicom Medical Publishers. Although great care has been taken in compiling the content of this publication, Medicom is not responsible or liable in any way for the currency of the information, for any errors, omissions or inaccuracies in the original articles, or for any consequences arising from the content. Products mentioned in this report may not be covered by marketing authorisation in some countries. Product information, applicable in your country, should be reviewed before prescribing. The mention of any product, service, or therapy in this publication should not be construed as an endorsement of the products mentioned. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Readers are advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, method, and duration of administration, or contraindications. Readers are also encouraged to contact the manufacturer with questions about the features or limitations of any products. Medicom assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of PATHOGENESIS OF PSORIATIC ARTHRITIS

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Brodalumab: Six-Year US Pharmacovigilance Report

Lebwohl,

Koo,

Armstrong

et al. 2024

Dermatol Ther (Heidelb)

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Introduction Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6 years of real-world clinical practice. Methods Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries. Results Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6 years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year 6, and there were no completed suicides throughout 6 years. Conclusion Pharmacovigilance data throughout 6 years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate. Graphical Abstract

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Examining worldwide postmarketing suicides from biologics used for psoriasis with a focus on brodalumab: A cross-sectional analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS)

Cited by 4 publications

References 1 publication

Current management of generalized pustular psoriasis

Current management of generalized pustular psoriasis

Medicom Conference Report Proceedings of the 6th IFPA WPPA Conference

Brodalumab: Six-Year US Pharmacovigilance Report

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