329 - Ustekinumab Responders versus Non-Responders in Refractory Pediatric Inflammatory Bowel Disease

Fusillo, Steven J.; Chang, Vivian Y.; Stein, Ronen; Maxwell, Elizabeth C.; Conrad, Máire A.; Albenberg, Lindsey; Grossman, Andrew B.; Mamula, Petar; Piccoli, David A.; Baldassano, Robert N.; Kelsen, Judith R.

doi:10.1016/s0016-5085(18)30724-8

Cited by 6 publications

(4 citation statements)

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“…of 28 pediatric patients (10). Similar 12-month outcomes were described in a cohort of 44 pediatric patients (11).…”

Section: What Is Newsupporting

confidence: 62%

“…There remains limited data on the effectiveness of ustekinumab in the pediatric population. There are few published case reports showing clinical response in 50% of children (7–9) and Fusillo et al most recently described clinical response in 50%, 36%, and 35% of patients at weeks 6, 26, and 52, respectively, in a cohort of 28 pediatric patients (10). Similar 12‐month outcomes were described in a cohort of 44 pediatric patients (11).…”

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confidence: 99%

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Real World Experience With Ustekinumab in Children and Young Adults at a Tertiary Care Pediatric Inflammatory Bowel Disease Center

Dayan

Dolinger²,

Benkov³

et al. 2019

J. pediatr. gastroenterol. nutr.

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Background: Ustekinumab is an effective therapy for Crohn disease currently approved for adults. Off-label use in the pediatric population is increasing, but its effectiveness in this age group has not been reported. Aims: The aim of the study was to describe real-world experience with ustekinumab at a tertiary care pediatric inflammatory bowel disease (IBD) center. Methods: As part of an ongoing observational cohort study of biologic-treated pediatric IBD patients initiated in October 2014, data on demographics, disease behavior, location and activity, treatment, and surgical history were collected for all patients receiving ustekinumab. Disease activity was assessed using the Harvey Bradshaw index or partial Mayo score. Primary outcome was steroid-free remission at 52 weeks. Descriptive statistics summarized the safety and efficacy outcomes, and univariate analyses were performed to examine associations of clinical characteristics with efficacy. Results: Fifty-two children and young adults initiating ustekinumab were analyzed; 81% Crohn Disease, 8% ulcerative colitis, and 11% IBD-unspecified. Median [IQR] age at induction was 16.8 [14–18] years. Patients were followed for a minimum of 12 months. Most patients (81%) failed >1 anti-TNF, and 37% failed anti-TNF and vedolizumab; 10 patients were biologic-naïve. At week 52, 75% were still on ustekinumab, and 50% (bio-exposed) and 90% (bio-naïve) were in steroid-free remission. Two infusion reactions and neither serious adverse events nor serious infections were observed. Conclusions: Our results suggest that ustekinumab is efficacious and safe in pediatric patients with IBD. Controlled clinical trial data are needed to confirm these observations.

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“…of 28 pediatric patients (10). Similar 12-month outcomes were described in a cohort of 44 pediatric patients (11).…”

Section: What Is Newsupporting

confidence: 62%

mentioning

confidence: 99%

Real World Experience With Ustekinumab in Children and Young Adults at a Tertiary Care Pediatric Inflammatory Bowel Disease Center

Dayan

Dolinger²,

Benkov³

et al. 2019

J. pediatr. gastroenterol. nutr.

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“…Even though ustekinumab has already demonstrated clinical efficacy in the induction and the maintenance of remission in adult refractory patients (16)(17)(18), the data in pediatric IBD is scarce. Few multicenter retrospective studies have showed an effective response to ustekinumab therapy, approaching 50% (19,20). Chavannes et al (21), in a multicenter retrospective study of 44 pediatric patients, reported clinical remission in 38.6% of the patients and clinical response in 47.8%, at 12 months.…”

Section: Discussionmentioning

confidence: 99%

Ustekinumab Use in Pediatric Inflammatory Bowel Disease: A French Multicenter Study From the Pediatric GETAID

KOUDSI

Martinez-Vinson

Pigneur

et al. 2023

Journal of Pediatric Gastroenterology &Amp; Nutrition

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Objectives: Ustekinumab is known to be efficient in adult patients suffering from moderate to severe Crohn disease (CD) and ulcerative colitis (UC) resistant to anti-tumor necrosis factor-alpha (TNF-α). Here, we described the clinical course of treatment with ustekinumab in French pediatric inflammatory bowel disease (IBD) patients treated with ustekinumab. Methods: This study includes all pediatric patients treated by ustekinumab injection for IBD (CD and UC), between January 2016 and December 2019. Results: Fifty-three patients were enrolled, 15 males and 38 females. Forty-eight patients (90%) had a diagnosis of CD and 5 (9.4%) had UC. Sixty-five percent of CD patients presented an ileocolitis. Perineal disease was observed in 20 out of 48 CD patients (41.7%), among them 9 were treated surgically. All patients included were resistant to anti-TNF-α treatment. Fifty-one percent had presented side effects linked to anti-TNF-α, including psoriasis and anaphylactic reaction. The average Pediatric Crohn Disease Activity Index (PCDAI) at induction was 28.7 (5–85), 18.7 (0–75) at 3 months of treatment and 10 (0–35) at the last follow-up. The average Pediatric Ulcerative Colitis Activity Index at induction was 47 (25–65), 25 (15–40) at 3 months of treatment and 18.3 (0–35) at the last follow-up. No severe side effects were observed. Conclusion: In this retrospective, multicentral study, ustekinumab proved to be efficient in pediatric patients resistant to anti-TNF-α. PCDAI has been significantly improved in patients with severe disease, treated with ustekinumab.

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“…Se informaron resultados similares a largo plazo a los 12 meses en una cohorte retrospectiva separada de 44 pacientes pediátricos. En general, estos resultados sugieren que ustekinumab es eficaz en pacientes pediátricos con EII, pero se requerirán estudios de cohortes más grandes para validar la eficacia, el perfil de seguridad y el régimen de dosificación optimizado en esta población (205)(206)(207) .…”

Section: Ustekinumabunclassified

Consenso colombiano de la enfermedad inflamatoria intestinal pediátrica

Vera Chamorro,

Sánchez Franco,

Vargas Sandoval

et al. 2023

Rev. colomb. Gastroenterol.

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Introducción: la colitis ulcerativa pediátrica (CUP), la enfermedad de Crohn pediátrica (ECP) y la enfermedad inflamatoria intestinal pediátrica no clasificable (EIIPNC) tienen particularidades clínicas y psicosociales que las diferencian de las del adulto y pueden condicionar enfoques terapéuticos distintos por las posibles repercusiones nutricionales, crecimiento y desarrollo, lo que representa un desafío para el pediatra y el gastroenterólogo. Objetivo: desarrollar recomendaciones basadas en la evidencia por consenso de expertos para el diagnóstico y el tratamiento oportunos y seguros de la enfermedad inflamatoria intestinal pediátrica (EIIP) en menores de 18 años, para los profesionales que atienden estos pacientes y los pagadores en salud. Metodología: a través de un panel de expertos del Colegio Colombiano de Gastroenterología, Hepatología y Nutrición Pediátrica (COLGAHNP) y un grupo multidisciplinario se formularon 35 preguntas en relación con el cuadro clínico, el diagnóstico y el tratamiento de la EIIP. A través de una revisión y un análisis crítico de la literatura, con especial énfasis en las principales guías de práctica clínica (GPC), estudios clínicos aleatorizados (ECA) y metaanálisis de los últimos 10 años, los expertos plantearon 77 recomendaciones que respondían a cada una de las preguntas de investigación con sus respectivos puntos prácticos. Posteriormente, cada una de las afirmaciones se sometieron a votación dentro del grupo desarrollador, incluyendo las afirmaciones que alcanzaron > 80 %. Resultados: todas las afirmaciones alcanzaron una votación > 80 %. La EIIP tiene mayor extensión, severidad y evolución hacia la estenosis, enfermedad perianal, manifestaciones extraintestinales y retraso en el crecimiento en comparación con los pacientes adultos, por lo que su manejo debe ser realizado por grupos multidisciplinarios liderados por gastroenterólogos pediatras y prepararlos para una transición a la edad adulta. Los criterios de Porto permiten una clasificación práctica de la EIIP. En la ECP, debemos usar la clasificación de París y debemos realizar ileocolonoscopia y esofagogastroduodenoscopia, ya que el 50 % tienen un compromiso superior, usando el SES-CD (UCEIS/Mayo en CUP) y tomando múltiples biopsias. Los laboratorios iniciales deben incluir marcadores de inflamación, calprotectina fecal y descartar infecciones intestinales. El tratamiento, la inducción y el mantenimiento de la EIIP deben ser individualizados y decididos según la estratificación de riesgo. En el seguimiento se debe usar el Pediatric Crohn Disease Activity Index (PCDAI) y Pediatric Ulcerative Colitis Activity Index (PUCAI) de las últimas 48 horas. Los pacientes con EIIP temprana e infantil, deben ser valorados por inmunólogos y genetistas. Conclusión: se proporciona una guía de consenso con recomendaciones basadas en la evidencia sobre el diagnóstico y los tratamientos oportunos y seguros en los pacientes con EIIP.

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329 - Ustekinumab Responders versus Non-Responders in Refractory Pediatric Inflammatory Bowel Disease

Cited by 6 publications

References 0 publications

Real World Experience With Ustekinumab in Children and Young Adults at a Tertiary Care Pediatric Inflammatory Bowel Disease Center

Real World Experience With Ustekinumab in Children and Young Adults at a Tertiary Care Pediatric Inflammatory Bowel Disease Center

Ustekinumab Use in Pediatric Inflammatory Bowel Disease: A French Multicenter Study From the Pediatric GETAID

Consenso colombiano de la enfermedad inflamatoria intestinal pediátrica

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