Adverse Reactions to Biologics in Psoriasis

Lockwood, Stephen J.; Prens, Lisette M.; Kimball, Alexa B.

doi:10.1159/000478072

Cited by 25 publications

(24 citation statements)

References 85 publications

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“…In agreement to literature [ 16 , 17 ], the most common AEs observed in our study belong to the general disorders and administration site conditions (mild to moderate), followed by investigations anomalies. Increased rates of infection have been reported in patients receiving TNF-α inhibitors, with upper respiratory tract infections, pharyngitis and sinusitis, most commonly reported [ 16 ], as well as an increased risk of opportunistic infections [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

et al. 2020

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Psoriasis is an inflammatory and chronic skin disorder associated with physical and psychological burden impairing patients’ quality of life. In the last decade, biologic drugs have widely changed treatment of moderate-severe psoriasis and their number is increasing overtime. To early identify expected/unexpected adverse events (AEs) with biologic treatments, pharmacovigilance programs are needed. We designed a post-marketing active pharmacovigilance program to monitor and analyse AEs and/or serious adverse events (SAEs) reports. All consecutive patients treated with one biologic drug during a two-years period and satisfying inclusion criteria have been enrolled in five Dermatology tertiary units. Demographic and clinical features of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Overall, 512 patients with a diagnosis of psoriasis (286; 55.9%) or arthropathic psoriasis (226; 44.1%) have been enrolled. Eighty-two (16%) patients with AEs and 5 (1%) with SAEs have been identified. Further, 59 (11.5%) had a primary/secondary failure (mainly on infliximab and etanercept). The adverse events and SAEs were reported with golimumab (4/12), adalimumab (32/167), infliximab (9/48), etanercept (31/175) and ustekinumab (11/73), no adverse events have occurred with secukinumab (0/37). Infliximab and etanercept were significantly associated with primary/secondary failures, whereas no differences have been highlighted for AEs insurgence. On the other hand, ustekinumab seems to be associated with a low rate of AEs (p = 0.01) and no adverse events or failures have been reported with secukinumab (p = 0.04 and 0.03, respectively). Our study, even though limited by a small sample size and a brief follow-up period , provide useful data on widely used biologic drugs and their tolerability, discontinuation rate and the incurrence of severe adverse events. Further studies are necessary to include the recently approved biologic drugs and to increase the sample size for more detailed analysis.

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Section: Discussionmentioning

confidence: 99%

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

et al. 2020

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“…Due to the broad range of receptors, potentially targeted by IL-38 and differently activated during the course of psoriasis, IL-38 manipulation could represent a valid therapeutic strategy for the treatment of acute and chronic psoriatic skin lesions, as well as of other disease subtypes. Importantly, this peculiarity of IL-38 could circumvent inherent drawbacks of the current biological drugs, targeting TNF-α or IL-17 cytokines, such as immune mechanisms of redundancy and compensation, which can lead to therapy resistance or adverse reactions, as described for anti-TNF-α or anti-IL-17A drugs [69].…”

Section: Therapeutic Potential Of Il36r-targeting In Psoriasismentioning

confidence: 99%

The Significance of IL-36 Hyperactivation and IL-36R Targeting in Psoriasis

Madonna

Girolomoni

Dinarello

et al. 2019

IJMS

110

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Psoriasis is an immune-mediated inflammatory skin disease that involves mainly T helper (Th)17, Th1 and Th22 lymphocytes, which cause hyper-proliferation of the epidermis with aberrant differentiation of keratinocytes, and local production of chemokines and cytokines. These fuel a self-amplifying loop where these products act on T cells to perpetuate cutaneous inflammatory processes. Among the various inflammatory mediators involved, interleukin (IL)-36 cytokines are important for the recruitment and activation of neutrophils and Th17 cells in psoriatic skin. In particular, IL-36s induce chemokines and cytokines interfere with differentiation/cornification programs in the epidermis, as well as promote pathological angiogenesis and endothelial cell activation. IL-36 cytokines belong to the IL-1 family, and comprise IL-36α, IL-36β, and IL-36γ agonists as well as IL-36 receptor antagonist and IL-38 antagonists. IL-36 cytokines are up-regulated in psoriatic epidermis, and their expression is strongly induced by TNF-α and IL-17. Contrarily, IL-38 antagonist is downregulated, and its impaired expression may be relevant to the dysregulated inflammatory processes induced by IL-36. Here, we discuss on the pathogenic mechanisms leading to the altered balance of IL-36 agonists/antagonists and the significance of this dysregulation in psoriasis. Collection of the information will provide a theoretical basis for the development of novel therapeutic strategies based on IL-36 agonist/antagonist manipulation in psoriasis.

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“…Die häufigste Nebenwirkung von Biologika im Allgemeinen sind leichte Infektionen, besonders des oberen Respirationstraktes [35]. Interessanterweise konnten einige der unerwünschten Wirkungen, die in klinischen Studien beobachtet wurden (z.…”

Section: C) Unerwünschte Wirkungenunclassified

“…▶ Tab. 5 Klinisch-relevante unerwünschte Arzneimittelwirkungen der Biologika (nach [7,12,14,35,38]).…”

Section: Unterbrechung Einer Biologikatherapieunclassified

Etablierung des Schwerpunktes Psoriasis an der Universitätshautklinik Rostock und eine praxisbezogene Übersicht über die Biologikatherapie der Psoriasis

Grünwald

Krebs

Troitzsch

et al. 2020

Aktuelle Dermatologie

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ZusammenfassungDie Diagnostik und Behandlung der Psoriasis stellt einen Schwerpunkt an der Universitätshautklinik Rostock dar. Aufgrund des breiten Spektrums verfügbarer Biologikatherapien für die Behandlung der Psoriasis werden in diesem Artikel praxisbezogene Ratschläge für diese Therapieform gegeben. Dabei wird aufgezeigt, wie das optimale Biologikum für einen individuellen Patienten unter Berücksichtigung möglicher Kontraindikationen, krankheitsspezifischer Aspekte und unerwünschter Wirkungen ausgewählt werden kann. Außerdem wird ein mögliches Vorgehen bei Unterbrechung, Wiederaufnahme oder Umstellung von Biologika erwähnt.

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Adverse Reactions to Biologics in Psoriasis

Cited by 25 publications

References 85 publications

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

Safety profile of biologic drugs for psoriasis in clinical practice: An Italian prospective pharmacovigilance study

The Significance of IL-36 Hyperactivation and IL-36R Targeting in Psoriasis

Etablierung des Schwerpunktes Psoriasis an der Universitätshautklinik Rostock und eine praxisbezogene Übersicht über die Biologikatherapie der Psoriasis

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