Trial reportArthritis & rheumatology (Hoboken, N.J.)2022
Phase IIa Global Study Evaluating Rituximab for the Treatment of Pediatric Patients With Granulomatosis With Polyangiitis or Microscopic Polyangiitis.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Emerging treatments for dermatologic diseases in infants, children, and adolescents: a systematic review of clinical trials on biologics and small molecule inhibitors.Inflammopharmacology · 2025Pooled it
- Rituximab pediatric drug development: Pharmacokinetic and pharmacodynamic modeling to inform regulatory approval for rituximab treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis.Clinical and translational science · 2022Trial
- Severe acute kidney failure due to double-seropositive anti-GBM glomerulonephritis in a child: a case for rituximab therapy.Pediatric nephrology (Berlin, Germany) · 2026Article
- Infection prophylaxis following anti-CD20 monoclonal antibodies in childhood kidney diseases.Pediatric nephrology (Berlin, Germany) · 2026Review
- Severe Reactions to Rituximab in Children: A Cohort Study of Rituximab-Induced Serum Sickness and Anaphylaxis.Children (Basel, Switzerland) · 2026Article
- The evolving landscape of rheumatic drugs and their indications in paediatric and adolescent care.Rheumatology (Oxford, England) · 2025Review
- Pharmacokinetic Characterization of Rituximab in Patients with Glomerular Diseases.Therapeutic drug monitoring · 2025Article
- Comparing Rituximab and Cyclophosphamide in Induction Therapy for Childhood-Onset Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: An ARChiVe Registry Cohort Study.Arthritis care & research · 2025Article
- Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors.The AAPS journal · 2025Article
- Single-arm clinical trials: design, ethics, principles.BMJ supportive & palliative care · 2024Review
- Childhood-Onset ANCA-Associated Vasculitis: From Genetic Studies to Advances in Pathogenesis, Classification and Novel Therapeutic Approaches.International journal of molecular sciences · 2024Review
- Impact of Rituximab on Remission Rates in Granulomatosis With Polyangiitis: A Systematic Review.Cureus · 2024Review
- Risk of Severe Infections Secondary to the Use of Targeted Therapies in Hematological Malignancies.Cureus · 2024Review
- The Association Between Age at Diagnosis and Disease Characteristics and Damage in Patients With ANCA-Associated Vasculitis.Arthritis & rheumatology (Hoboken, N.J.) · 2023Article
- Risk of Infections Secondary to the Use of Targeted Therapies in Hematological Malignancies.Life (Basel, Switzerland) · 2023Review
- Granulomatosis with Polyangiitis following COVID-19 in an Adolescent.Internal medicine (Tokyo, Japan) · 2023Article
- The Efficacy and Safety of Rituximab in ANCA-Associated Vasculitis: A Systematic Review.Biology · 2022Review
- Second and Third Generational Advances in Therapies of the Immune-Mediated Kidney Diseases in Children and Adolescents.Children (Basel, Switzerland) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 16 institutions in 7 countries.
Funding
Abstract
objectiveTo assess the safety, tolerability, pharmacokinetics, and efficacy of rituximab (RTX) in pediatric patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
methodsThe Pediatric Polyangiitis Rituximab Study was a phase IIa, international, open-label, single-arm study. During the initial 6-month remission-induction phase, patients received intravenous infusions of RTX (375 mg/m
resultsTwenty-five pediatric patients with new-onset or relapsing disease were enrolled at 11 centers (19 with GPA [76%] and 6 with MPA [24%]). The median age was 14 years (range 6-17 years). All patients completed the remission-induction phase. During the overall study period (≤4.5 years), patients received between 4 and 28 infusions of RTX. All patients experienced ≥1 adverse event (AE), mostly grade 1 or grade 2 primarily infusion-related reactions. Seven patients experienced 10 serious AEs, and 17 patients experienced 31 infection-related AEs. No deaths were reported. RTX clearance correlated with body surface area. The body surface area-adjusted RTX dosing regimen resulted in similar exposure in both pediatric and adult patients with GPA or MPA. Remission, according to the Pediatric Vasculitis Activity Score, was achieved in 56%, 92%, and 100% of patients by months 6, 12, and 18, respectively.
conclusionIn pediatric patients with GPA or MPA, RTX is well tolerated and effective, with an overall safety profile comparable to that observed in adult patients with GPA or MPA who receive treatment with RTX. RTX is associated with a positive risk/benefit profile in pediatric patients with active GPA or MPA.
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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.