Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry

Fiorentino, David; Ho, Vincent; Lebwohl, Mark; Leite, Luíz; Hopkins, Lori; Galindo, Claudia; Goyal, Kavitha; Langholff, Wayne; Fakharzadeh, Steven; Bhaskar, Suryanarayanan; Langley, Richard

doi:10.1016/j.jaad.2017.07.013

Cited by 142 publications

(124 citation statements)

References 28 publications

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“…TNF antagonists have been associated with increased risk of serious bacterial, viral and fungal infections in patients with psoriasis, including active tuberculosis and reactivation of latent tuberculosis infection . The data on malignancy risk with long‐term exposure to TNF antagonists are conflicting, with some studies and recent registry data suggesting a potential increased risk . Rare cases of new onset or exacerbation of demyelinating disorders have also been reported during treatment with TNF antagonists…”

Section: Introductionmentioning

confidence: 99%

“…[5][6][7][8][9] The data on malignancy risk with long-term exposure to TNF antagonists are conflicting, with some studies and recent registry data suggesting a potential increased risk. [5][6][7][8]10 Rare cases of new onset or exacerbation of demyelinating disorders have also been reported during treatment with TNF antagonists. [5][6][7][8] As understanding of psoriasis disease mechanisms has advanced, more targeted therapies have become available with the potential for improved safety and tolerability.…”

Section: Introductionmentioning

confidence: 99%

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Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Crowley

Warren

Cather³

2019

Acad Dermatol Venereol

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Psoriasis is a chronic disease that requires long‐term treatment. Consequently, understanding the safety and tolerability of any potential treatment over time is critical to effective prescribing. The biologic agents currently available for the treatment of psoriasis target a number of different inflammatory cytokines involved in psoriasis disease pathogenesis. The monoclonal antibodies tildrakizumab, guselkumab and risankizumab target the p19 subunit that is specific to interleukin (IL)‐23. This article reviews published data on the safety of these IL‐23p19 inhibitors in patients with psoriasis compared with other currently available biologic therapies. Data from randomized, placebo‐ and active‐controlled phase 3 clinical trials show tildrakizumab, guselkumab and risankizumab to have a favourable risk–benefit profile in patients with moderate to severe psoriasis. No significant safety concerns have been observed for any of these IL‐23p19 inhibitors in the data published to date. The most commonly reported adverse events (AEs) associated with these agents in phase 3 studies were upper respiratory tract infections. No increase was seen in rates of serious infections, malignancies or major adverse cardiovascular events, with no signals suggestive of an elevated risk of opportunistic infections, active tuberculosis or reactivation of latent tuberculosis infection, mucocutaneous Candida infections, triggering or worsening of inflammatory bowel disease, demyelinating disorders or suicidal ideation. Selectively targeting IL‐23p19 may help avoid AEs that have been associated with biologic agents with other mechanisms of action. Data from long‐term extension studies and patient registries will further establish the safety profile of IL‐23p19 inhibitors for the treatment of moderate to severe psoriasis in routine practice.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Crowley

Warren

Cather³

2019

Acad Dermatol Venereol

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“…Because of the fact that patients with a history of malignancy are usually excluded from clinical trials, data on the effect of a treatment with biologics on a possible tumor recurrence are rather limited . Although long‐term exposure (≥12 months) to TNF inhibitors may be generally associated with a higher risk of malignancy, such as lymphomas and nonmelanocytic skin cancer (NMSC), there are only limited large scale data on the aspect of tumor recurrence under these agents . A recent Swedish population‐based study on 467 patients with a history of solid cancer and rheumatoid arthritis (RA), that were treated with TNF inhibitors, showed no increased risk for cancer recurrence in these patients, although clinically meaningful risk increases could not be ruled out completely .…”

Section: Resultsmentioning

confidence: 99%

Challenges in the treatment of psoriasis with biologics: vaccination, history of malignancy, human immunodeficiency virus (HIV) infection, and pediatric psoriasis

Plachouri

Georgiou

2019

Int J Dermatology

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Biologics are potent immunomodulatory drugs, whose application in the treatment of psoriasis has shown extremely good therapeutic results and a satisfactory safety profile. The administration of these agents in special cases, such as in patients with HIV infection, previous malignancy, unclear vaccination status as well as children, can be challenging. This report is an updated systematic review of the use of biologics in the above‐mentioned groups. Articles derived from the databases PubMed, EMBASE, and SCOPUS, and published between 1989 and 2018, were analyzed for this study. The existing evidence is not in all cases sufficient in order to provide adequate insight on the management of these complex situations. The aim of this report is to present a summarized update on the knowledge of this special topic so far and to draw into attention the need to conduct more systematic studies so as to clarify the best therapeutic strategies for these special patient groups when it comes to the use of biologics.

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“…17 A second analysis of PSOLAR (n=12,090) suggested that treatment with an anti-TNF agent for 12 months or longer (but not shorter term exposure) may be associated with an increased risk of malignancy compared with non-treatment; neither ustekinumab nor methotrexate were associated with an increased risk. 18 An analysis of a US claims database of 42,981 patients found that infection was the most frequent adverse event with psoriasis treatments and this was less common with ustekinumab, adalimumab and etanercept than with conventional systemic and topical therapy. 19 Adalimumab was associated with a significantly lower risk of malignancy.…”

Section: An Analysis Of Rates Of Serious Infection Among Patients On mentioning

confidence: 99%

Monoclonal antibodies for the treatment of plaque psoriasis

Chaplin¹

2019

Prescriber

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Risk of malignancy with systemic psoriasis treatment in the Psoriasis Longitudinal Assessment Registry

Abstract: Long-term (≥12 months) treatment with a TNF-α inhibitor, but not methotrexate and ustekinumab, may increase risk for malignancy in patients with psoriasis.

Cited by 142 publications

References 28 publications

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Safety of selective IL‐23p19 inhibitors for the treatment of psoriasis

Challenges in the treatment of psoriasis with biologics: vaccination, history of malignancy, human immunodeficiency virus (HIV) infection, and pediatric psoriasis

Monoclonal antibodies for the treatment of plaque psoriasis

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