Trial reportInflammatory bowel diseases2017
Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease.
Trial report in Inflammatory bowel diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00686374 (A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- Adalimumab for maintenance of remission in Crohn's disease.The Cochrane database of systematic reviews · 2020Pooled it
- Trial
- Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2.Journal of Crohn's & colitis · 2018Trial
- Recent Advances in the Pharmacological Management of Pediatric Spondyloarthritis.Paediatric drugs · 2026Review
- Switching Between Anti-TNFs and Other Biologic Drugs in Paediatric Inflammatory Bowel Disease: A Narrative Review and Practical Clinical Guide.Journal of inflammation research · 2026Review
- Biologics in the management of pediatric inflammatory bowel disease: When and what to choose.World journal of clinical pediatrics · 2025Review
- Effectiveness and safety of biosimilars in pediatric inflammatory bowel diseases: an observational longitudinal study on the French National Health Data System.World journal of pediatrics : WJP · 2025Observational
- The role of proactive therapeutic drug monitoring in guiding infliximab therapeutic optimization in pediatric patients with Crohn's disease: A retrospective study.Pediatric discovery · 2024Article
- Recent advances and research progress regarding monoclonal antibodies for chronic graft-versus-host disease.Heliyon · 2024Review
- Biosimilars in Pediatric IBD: Updated Considerations for Disease Management.Biologics : targets & therapy · 2022Review
- Pediatric uveitis: Role of the pediatrician.Frontiers in pediatrics · 2022Review
- Risk of consecutive immunogenic failure in switchers of anti-tumor necrosis factor alpha among patients with inflammatory bowel diseases.Therapeutic advances in gastroenterology · 2022Article
- Adalimumab in Pediatric Inflammatory Bowel Disease.Frontiers in pediatrics · 2022Review
- Pharmacogenetic variants of infliximab response in young patients with inflammatory bowel disease.Clinical and translational science · 2021Article
- Dietary Management in Pediatric Patients with Crohn's Disease.Nutrients · 2021Review
- Favorable Outcomes and Anti-TNF Durability After Addition of an Immunomodulator for Anti-Drug Antibodies in Pediatric IBD Patients.Inflammatory bowel diseases · 2021Article
- Similarities and Differences Between Juvenile and Adult Spondyloarthropathies.Frontiers in medicine · 2021Review
- Positioning Biologic Therapies in the Management of Pediatric Inflammatory Bowel Disease.Gastroenterology & hepatology · 2020Article
- The Treatment of Pediatric Inflammatory Bowel Disease with Biologic Therapies.Current gastroenterology reports · 2020Review
- Hypersensitivity Reactions to Monoclonal Antibodies in Children.Medicina (Kaunas, Lithuania) · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported.
methodsPatients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015.
resultsOf 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified.
conclusionsEfficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.