Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial

Brunner, Hermine I.; Foeldvari, Ivan; Alexeeva, Е.I.; Ayaz, Nuray Aktay; Penadés, Inmaculada Calvo; Kasapçopur, Özgür; Chasnyk, Vyacheslav; Hufnagel, Markus; Żuber, Zbigniew; Schulert, Grant S.; Özen, Seza; Rakhimyanova, Adelina; Ramanan, Athimalaipet V; Scott, Christiaan; Sözeri, Betül; Жолобова, Елена; Martin, Ruvie; Zhu, Xuan; Whelan, Sarah; Pricop, Luminita; Martini, Alberto; Lovell, Daniel J.; Ruperto, Nicolino

doi:10.1136/ard-2022-222849

Cited by 37 publications

(34 citation statements)

References 32 publications

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“…Currently, results of phase 3 clinical trials with secukinumab in the juvenile idiopathic arthritis including juvenile psoriatic arthritis patients were published, showing significantly longer time to disease flare when compared with placebo-treated patients. 64 Majority of the site effects were similar to those observed in adult patients treatment, with nasopharyngitis, nausea, upper respiratory tract infections, oropharyngeal pain, headache, fever and diarrhea being the most common ones. In one patient Crohn’s disease was diagnosed during the study.…”

Section: Psoriasis and Pediatric Psoriasis - Introductionsupporting

confidence: 53%

Secukinumab for the Treatment of Psoriasis in Pediatrics: Patient Selection and Acceptability

Niedźwiedź¹,

Lesiak²,

Ceryn³

et al. 2023

PPA

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Psoriasis (PsO) is a chronic, systemic, immune-mediated inflammatory skin disease affecting 1% to 5% population worldwide. In one-third of patients, the first symptoms of PsO manifest in childhood, with a mean age of nine years. Psoriasis in children under 16 years of age constitutes 4% of dermatological problems in this age group. Chronic inflammation of the skin observed in PsO is associated with a development of potentially serious comorbidities, including psoriatic arthritis, hypertension, metabolic syndrome, cardiovascular diseases, inflammatory bowel disease, depression and anxiety. It is reported that among children with psoriasis between 5 and 16 years of age health-related quality of life is reduced by 30.5%. Early diagnosis and effective treatment are crucial in pediatric psoriatic patients to avoid future complications and stigmatization. Treatment for psoriasis consists of a range of topical medications, phototherapy and non-biologic and biologic systemic therapies. Approved biologics for PsO in pediatric patients include etanercept, adalimumab, ustekinumab, ixekizumab and secukinumab. Secukinumab, a recombinant, fully human monoclonal antibody targeting IL-17A, was approved by the EMA (2020) and FDA (2021) in pediatric patients above 6 years of age for the treatment of moderate to severe plaque psoriasis who are candidates for systemic therapy. This review discusses the selection and acceptability of secukinumab in children with psoriasis.

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Section: Psoriasis and Pediatric Psoriasis - Introductionsupporting

confidence: 53%

Secukinumab for the Treatment of Psoriasis in Pediatrics: Patient Selection and Acceptability

Niedźwiedź¹,

Lesiak²,

Ceryn³

et al. 2023

PPA

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“…In a retrospective study that analyzed patients who had already been treated using biologics with other mechanisms of action, it was found that patients with JIA showed significant improvements in signs and symptoms in different disease domains [123]. In a recent phase-three study [124], the administration of this biologic was shown to reduce the frequency of disease flare-ups in children with JIA compared with control subjects. In more detail, the 2-year, randomized-withdrawal, double-blind, placebo-controlled JUNIPERA trial included 86 patients and consisted of three treatment periods.…”

Section: The Role Of Anti-il-17a Blocking Antibodies In Jpsa and Era ...mentioning

confidence: 99%

The Role of Interleukin-17 in Juvenile Idiopathic Arthritis: From Pathogenesis to Treatment

et al. 2022

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Background and Objectives: Interleukin-17 (IL-17) is a cytokine family consisting of six members and five specific receptors. IL-17A was the first member to be identified in 1993. Since then, several studies have elucidated that IL-17 has predominantly pro-inflammatory activity and that its production is involved in both the defense against pathogens and the genesis of autoimmune processes. Materials and Methods: In this review, we provide an overview of the role of interleukin-17 in the pathogenesis of juvenile idiopathic arthritis (JIA) and its relationship with IL-23, the so-called IL-23–IL-17 axis, by reporting updated findings from the scientific literature. Results: Strong evidence supports the role of interleukin-17A in the pathogenesis of JIA after the deregulated production of this interleukin by both T helper 17 (Th17) cells and cells of innate immunity. The blocking of IL-17A was found to improve the course of JIA, leading to the approval of the use of the human anti-IL17A monoclonal antibody secukinumab in the treatment of the JIA subtypes juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA). Conclusions: IL-17A plays a central role in the pathogenesis of JIA. Blocking its production with specific biologic drugs enables the effective treatment of this disabling childhood rheumatic disease.

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“…In the second period, responders received secukinumab or placebo. Secukinumab demonstrated a significantly longer time to disease flare and a consistent safety profile similar to adults (170). Moreover, there are ongoing clinical trials for ixekizumab (NCT04527380).…”

Section: Treatment and Outcomementioning

confidence: 90%

Spondyloarthritides: Theories and beyond

et al. 2022

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Spondyloarthritides (SpA) are a family of interrelated rheumatic disorders with a typical disease onset ranging from childhood to middle age. If left untreated, they lead to a severe decrease in patients' quality of life. A succesfull treatment strategy starts with an accurate diagnosis which is achieved through careful analysis of medical symptoms. Classification criterias are used to this process and are updated on a regular basis. Although there is a lack of definite knowledge on the disease etiology of SpA, several studies have paved the way for understanding plausible risk factors and developing treatment strategies. The significant increase of HLA-B27 positivity in SpA patients makes it a strong candidate as a predisposing factor and several theories have been proposed to explain HLA-B27 driven disease progression. However, the presence of HLA-B27 negative patients underlines the presence of additional risk factors. The current treatment options for SpAs are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), TNF inhibitors (TNFis), Disease-Modifying Anti-Rheumatic Drugs (DMARDs) and physiotherapy yet there are ongoing clinical trials. Anti IL17 drugs and targeted synthetic DMARDs such as JAK inhibitors are also emerging as treatment alternatives. This review discusses the current diagnosis criteria, treatment options and gives an overview of the previous findings and theories to clarify the possible contributors to SpA pathogenesis with a focus on Ankylosing Spondylitis (AS) and enthesitis-related arthritis (ERA).

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Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial

Cited by 37 publications

References 32 publications

Secukinumab for the Treatment of Psoriasis in Pediatrics: Patient Selection and Acceptability

Secukinumab for the Treatment of Psoriasis in Pediatrics: Patient Selection and Acceptability

The Role of Interleukin-17 in Juvenile Idiopathic Arthritis: From Pathogenesis to Treatment

Spondyloarthritides: Theories and beyond

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