Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry

Daudén, E.; Carretero, G.; Rivera, R.; Ferrándiz, Carlos; Llamas‐Velasco, Mar; Cueva, Pablo de la; Belinchón, Isabel; Herrera‐Acosta, Enrique; Ruíz‐Genao, Diana; Ferrán-Farrés, Marta; Alsina, M.; Baniandrés‐Rodríguez, Ofelia; Sánchez‐Carazo, J.L.; Sahuquillo‐Torralba, Antonio; Fernández‐Freire, Lourdes Rodríguez; Vilar-Alejo, Jaime; García‐Donoso, Carmen; Carrascosa, J.M.; Herrera‐Ceballos, Enrique; López‐Estebaranz, José Luis; Botella‐Estrada, Rafael; Segovia-Muñoz, Eva; Descalzo, M.Á.; García‐Doval, I.; Ballescá, F.; Gómez-García, Francisco; Jiménez, Rafael; Farres, M.; Baniandrés, Ofelia; Nieto, Lula; Marco, Conrad Pujol; Puchades, Almudena Mateu; Menéndez, Ángeles Flórez; Salgado, L.; Sixto, Beatriz González; Eirís, Noemí; Descalzo, Miguel Ángel; Martínez, Marina de Vega

doi:10.1016/j.jaad.2020.03.033

Cited by 42 publications

(50 citation statements)

References 27 publications

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“…14 In a prospective safety study on the long-term safety of different medications for psoriasis, authors reported that apremilast patients had a lower risk of infections and infestations. 15 Apremilast does not affect B cells, T cells, or immunoglobulin (Ig) G and IgM secretion, but partially inhibits TNFα, interferon gamma, IL-17, and IL-23. 16 Given its immunomodulatory properties and its specific mechanism of action, 12,14,16 apremilast does not favor neither the infections nor the cytokines storm, and it will not increase the risk of pulmonary fibrosis, one of the COVID-19's mortality factors.…”

Section: Discussionmentioning

confidence: 99%

COVID ‐19 patients with psoriasis and psoriatic arthritis on biologic immunosuppressant therapy vs apremilast in North Spain

Queiró

Armesto

Vela

et al. 2020

Dermatologic Therapy

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Immunosuppressive and immunomodulatory treatments are critical for the management of inflammatory and autoimmune conditions such as psoriasis or psoriatic arthritis. Like in those illnesses, the lung injury and acute respiratory distress shown in COVID‐19 patients are the result of a disruption in the balance of pro‐ and anti‐inflammatory cytokines. This hyperinflammatory response to SARS‐CoV‐2, associated with the severity of the coronavirus disease, is called the cytokine storm. There is a growing concern regarding how patients on immunosuppressant biologic therapies might be at higher risk of being infected and whether they need to discontinue their treatment preemptively. Clinical data on COVID‐19 infected patients with psoriasis or psoriatic arthritis are still scarce. Here, we presented seven cases of this type of patients. The patient infected with COVID‐19 on apremilast and the one on apremilast with infected spouse showed the best safety profile and mildest symptoms. One of the secukinumab patients also presented a relatively good outcome. Infliximab patients and the one with serious comorbidities showed the worst outcome. Even though more clinical data are yet needed to draw strong conclusions, apremilast could be a safer alternative for dermatology and rheumatology patients in case of clinically important active infection. This article is protected by copyright. All rights reserved.

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Section: Discussionmentioning

confidence: 99%

COVID ‐19 patients with psoriasis and psoriatic arthritis on biologic immunosuppressant therapy vs apremilast in North Spain

Queiró

Armesto

Vela

et al. 2020

Dermatologic Therapy

View full text Add to dashboard Cite

show abstract

“…In addition, acitretin also reversed Th1 and Th17 preponderance in psoriasis patients to some degree (52). But the blood lipid must be monitored during therapy with acitretin and the infection must be paid attention to when using methotrexate (6). The therapeutic effect of topical calcipotriol was achieved by attenuating the T17 cell accumulation in both treated areas and draining lymph nodes.…”

Section: Discussionmentioning

confidence: 99%

“…This allowed for the specific targeting of parts of the immune system, rather than suppression of the entire immune system, leading to a favorable efficacy and safety profile (53,54). However, some studies revealed that they might cause adverse events like infection and idiopathic psoriasis (6,55). Moreover, a single drug was unable to meet the treatment of complex diseases such as psoriasis, while the combination might have an increasing risk of AEs.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, about 57% of patients are plagued by anxiety and depression (5). Conventional therapies of western medicine with psoriasis are systematically using of retinoic acid, immunosuppressant, biological agents and topical glucocorticoids or vitamin D3 derivatives (1,2), which may add patients' economic burden or present unstable curative efficacy along with adverse reactions like intolerability (6). Therefore, it is urgent to establish an effective strategy for PV management.…”

Section: Introductionmentioning

confidence: 99%

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Evidence and potential mechanisms of traditional Chinese medicine for the treatment of psoriasis vulgaris: a systematic review and meta-analysis

Dai

et al. 2020

Journal of Dermatological Treatment

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Psoriasis vulgaris (PV) not only affects patients' skin health but also increases the risk of coronary heart disease and diabetes, which brings both physical and mental harms. Its pathogenesis is complex, and the multitarget effect of traditional Chinese medicine (TCM) is especially advantageous. Because a considerable number of randomized controlled trials related to TCM exhibit design defects, small sample size, or inadequate intervention time, so the status of TCM in the treatment of PV cannot be fully clarified. We reviewed the controlled clinical trials published over the past decade and selected 17 high-quality articles from over 2000 papers. The results suggest that TCM might be beneficial for decrease in PASI scores, thus, TCM might be an effective alternative therapy for PV management. The safety of TCM on PV was also assessed in our analysis. The more strictly designed and long-term observations of TCM for PV are supposed to be conducted in the future.

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“…The most common infectious side effects from cyclosporine were flu‐like symptoms seen in 15% of patients enrolled in an RCT for chronic idiopathic urticaria 54 . Psoriasis registries examining cyclosporine reported infection rates of 8.1–17.7 infections per 100 patient‐years 55‐57 with severe or serious infection rates of 1.4 and 2.0 per 100 patient‐years, slightly higher than comparators 56,57 . Of note, cyclosporine has been shown to inhibit the replication of diverse coronaviruses including SARS as demonstrated by in vitro experiments 58,59 …”

Section: Introductionmentioning

confidence: 99%

Infection risk of dermatologic therapeutics during the COVID‐19 pandemic: an evidence‐based recalibration

et al. 2020

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Recommendations were made recently to limit or stop the use of oral and systemic immunotherapies for skin diseases due to potential risks to the patients during the current severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) COVID‐19 pandemic. Herein, we attempt to identify potentially safe immunotherapies that may be used in the treatment of cutaneous diseases during the current COVID‐19 pandemic. We performed a literature review to approximate the risk of SARS‐CoV‐2 infection, including available data on the roles of relevant cytokines, cell subsets, and their mediators in eliciting an optimal immune response against respiratory viruses in murine gene deletion models and humans with congenital deficiencies were reviewed for viral infections risk and if possible coronaviruses specifically. Furthermore, reported risk of infections of biologic and non‐biologic therapeutics for skin diseases from clinical trials and drug data registries were evaluated. Many of the immunotherapies used in dermatology have data to support their safe use during the COVID‐19 pandemic including the biologics that target IgE, IL‐4/13, TNF‐α, IL‐17, IL‐12, and IL‐23. Furthermore, we provide evidence to show that oral immunosuppressive medications such as methotrexate and cyclosporine do not significantly increase the risk to patients. Most biologic and conventional immunotherapies, based on doses and indications in dermatology, do not appear to increase risk of viral susceptibility and are most likely safe for use during the COVID‐19 pandemic. The limitation of this study is availability of data on COVID‐19.

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Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry

Cited by 42 publications

References 27 publications

COVID ‐19 patients with psoriasis and psoriatic arthritis on biologic immunosuppressant therapy vs apremilast in North Spain

COVID ‐19 patients with psoriasis and psoriatic arthritis on biologic immunosuppressant therapy vs apremilast in North Spain

Evidence and potential mechanisms of traditional Chinese medicine for the treatment of psoriasis vulgaris: a systematic review and meta-analysis

Infection risk of dermatologic therapeutics during the COVID‐19 pandemic: an evidence‐based recalibration

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