Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis

Paller, Amy S.; Seyger, M.M.B.; Magariños, Gabriel; Pinter, Andreas; Cather, Jennifer Clay; Rodriguez-Capriles, Claudia; Zhu, Danting; Somani, Najwa; Garrelts, Alyssa; Papp, Kim

doi:10.1001/jamadermatol.2022.0655

Cited by 23 publications

(11 citation statements)

References 31 publications

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“… 18 Furthermore, a randomized controlled trial (RCT) of 139 pediatric patients with plaque psoriasis who completed ixekizumab (<25 kg: 40 mg at week 0, 20 mg every 4 weeks; 25-50 kg: 80 mg at week 0, 40 mg every 4 weeks; ≥50 kg: 160 mg at week 0, 80 mg every 4 weeks) showed that improvements were sustained through week 108, with patients achieving PASI 75 (91.7%), PASI 90 (79.0%), PASI 100 (55.1%), static Physician’s Global Assessment (sPGA) 0 or 1 (78.3%), and sPGA 0 (52.4%). 19 This trial reported the safety profile of ixekizumab to be consistent with previously reported data, with common side effects including injection site reactions (20%), and infections. Inflammatory bowel disease (IBD) was reported in 2% of the all-ixekizumab exposed group (adjudicated as Crohn’s disease) but no cases of candidiasis were reported during the study.…”

Section: Psoriasissupporting

confidence: 85%

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A Practical Guide to Using Biologics in Pediatric Dermatology

George,

Lansang,

Lansang

et al. 2024

J Cutan Med Surg

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Psoriasis, hidradenitis suppurativa (HS), atopic dermatitis (AD), and chronic spontaneous urticaria (CSU), are common, immune-mediated, chronic, inflammatory skin diseases that can affect the pediatric population. While there is adequate evidence supporting the use of biologics in pediatric patients, concerns regarding safety and efficacy amongst healthcare providers are not uncommon. However, new emerging evidence in this population highlights the safety of biologic therapy, making it crucial to review and establish a practical guide for their use. This article describes a methodological framework for initiating biologics in the management of pediatric psoriasis, HS, AD, and CSU, with a special focus on baseline work-up, monitoring, dosing, and considerations in this population.

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Section: Psoriasissupporting

confidence: 85%

“…Inflammatory bowel disease (IBD) was reported in 2% of the all-ixekizumab exposed group (adjudicated as Crohn’s disease) but no cases of candidiasis were reported during the study. 19 …”

Section: Psoriasismentioning

confidence: 99%

A Practical Guide to Using Biologics in Pediatric Dermatology

George,

Lansang,

Lansang

et al. 2024

J Cutan Med Surg

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“…The aims of the present study were to compare and review efficacy and safety data at 12 weeks, which is the standard timepoint for the pivotal trials leading to approval. Long-term safety outcomes could therefore not be assessed beyond 2 years in this study as investigated RCTs reported safety data up to 2 years only ( 74 ). It should be noted that several prior registries have focused on long-term observations in children treated with biologics ( 75 , 76 ).…”

Section: Discussionmentioning

confidence: 99%

Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis

et al. 2022

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BackgroundPsoriasis is a chronic immune-mediated inflammatory skin disease affecting both adults and children. To better understand the efficacy-safety profile of biologics in children with moderate-to-severe psoriasis, this study aimed to analyze efficacy and safety data of randomized controlled trials (RCTs) performed in pediatric psoriasis and to compare efficacy outcomes in children with those in adults.MethodsRCTs investigating biologics in children with moderate-to-severe psoriasis were identified in a systematic literature review. PASI75/90 treatment responses at weeks 11/12 were analyzed comparing biologics with control arms. Serious adverse events (SAEs) were analyzed at the end of each study. Efficacy data from RCTs in adults with psoriasis were selected for the same biologics. Risk ratios (RR) of selected RCTs were pooled together in a statistical random effects model using the inverse variance method.ResultsFor children, there were 1 etanercept, 2 secukinumab, 1 ixekizumab and 1 ustekinumab placebo-controlled RCTs and 1 adalimumab RCT using methotrexate as reference arm at weeks 11/12. For adults, out of 263 RCTs, 7 adalimumab and 15 etanercept (TNF inhibitors) and 4 ixekizumab and 12 ustekinumab (IL-17 and IL-12/23 inhibitors) RCTs reported PASI75/90 efficacy responses at weeks 11/12. Regarding efficacy, all biologics showed improved PASI responses over control arms. RRs ranges were 2.02–7.45 in PASI75 and 4.10–14.50 in PASI90. The highest PASI75 responses were seen for ustekinumab 0.375 mg/kg (RR = 7.25, 95% CI 2.83–18.58) and ustekinumab 0.75 mg/kg (RR = 7.45, 95% CI 2.91–19.06) in the CADMUS study. The highest PASI90 response was seen for ixekizumab (RR = 14.50, 95% CI 4.82–43.58) in the IXORA-PEDS study. SAE incidences in pediatric and adult arms with biologics were 0 to 3% except for a pediatric arm with adalimumab 0.40 mg/kg (8%). For adults, pooled RR also showed improved PASI responses over placebo for all biologics, with highest PASI75 response observed for ixekizumab (pooled RR = 16.18, 95% CI 11.83–22.14).ConclusionBoth adults and children with psoriasis show superior efficacy with biologics compared to control arms after 3 months of treatment with SAE incidences in the low percentages. Additional longer-term clinical studies are warranted to fully understand the overall efficacy-safety profile of biologics in children with moderate-to-severe psoriasis.

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“…Hauptgrund hierfür ist die um 5 Zulassungsjahre längere Erfahrung mit dem TNF-α-Inhibitor; Adalimumab wurde im Jahr 2015 für die kindliche Psoriasis zugelassen, die beiden genannten IL-17A-Inhibitoren erst 2020. Inzwischen liegen allerdings sowohl für Ixekizumab [ 16 ] als auch für Secukinumab [ 12 ] Studiendaten zu längerfristigen Behandlungen (108 bzw. 52 Wochen) vor, die keine neuen Sicherheitsbedenken erbracht haben.…”

Section: Systemtherapie Mit Biologikaunclassified

Psoriasis in children and adolescents

Hamm

Höger

2023

Dermatologie

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Die Psoriasis wird heute als multifaktorielle, entzündliche, immunmediierte Systemerkrankung mit vorrangiger Manifestation am Hautorgan aufgefasst. In etwa einem Drittel der Fälle beginnt sie bereits im Kindes- und Jugendalter und geht oft mit einer deutlichen Beeinträchtigung der Lebensqualität Betroffener und ihrer Eltern einher. Neben der genetischen Disposition sind Triggerfaktoren wie Streptokokkeninfektionen maßgeblich an der Manifestation und an Exazerbationen beteiligt. Auch die bereits in dieser Altersgruppe nachteilige Rolle von Komorbiditäten, allen voran die Adipositas, wurde inzwischen gut belegt. Die Behandlungsmöglichkeiten haben sich durch die Zulassung von nunmehr 5 Biologika im Kindesalter erheblich verbessert, werden aber noch unzureichend genutzt. Der vorliegende Beitrag gibt einen kurzen Überblick über den heutigen Wissensstand und die Empfehlungen der aktualisierten deutschen Leitlinie. Neben den häufigen Typen werden auch ungewöhnlichere Erscheinungsformen wie die pustulöse, die ekzematisierte und die durch TNF(Tumornekrosefaktor)-α-Inhibitoren induzierte „paradoxe“ Psoriasis thematisiert.

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Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis

Abstract: This randomized clinical trial evaluates the effect of ixekizumab on self-reported and objective measures of case severity, itch, adverse events, and other outcomes in children with plaque psoriasis.

Cited by 23 publications

References 31 publications

A Practical Guide to Using Biologics in Pediatric Dermatology

A Practical Guide to Using Biologics in Pediatric Dermatology

Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis

Psoriasis in children and adolescents

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