Trial reportArthritis research & therapy2012
Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial.
Trial report in Arthritis research & therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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
22 citing papers in PubMed, 37 citations in OpenAlex.
- Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor Fusion Protein, in Primary Sjögren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2018Trial
- Efficacy and safety of pateclizumab (anti-lymphotoxin-α) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study).Arthritis research & therapy · 2014Trial
- Tertiary Lymphoid Structure: A Potential Therapeutic Target Affecting Immune Response in Autoimmune Diseases.Clinical reviews in allergy & immunology · 2026Review
- Generation of aptamers for the selective detection and neutralization of soluble lymphotoxin alpha.Molecular therapy. Nucleic acids · 2026Article
- Combination antagonism of TNF superfamily signaling for T cell immunosuppression.Frontiers in immunology · 2026Article
- Inter-Antibody Variability in the Clinical Pharmacokinetics of Monoclonal Antibodies Characterized Using Population Physiologically Based Pharmacokinetic Modeling.Antibodies (Basel, Switzerland) · 2024Article
- Integrated mRNA-miRNA transcriptome profiling of blood immune responses potentially related to pulmonary fibrosis in forest musk deer.Frontiers in immunology · 2024Article
- Meningeal inflammation as a driver of cortical grey matter pathology and clinical progression in multiple sclerosis.Nature reviews. Neurology · 2023Review
- Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Prediction of Drug Targets for Specific Diseases Leveraging Gene Perturbation Data: A Machine Learning Approach.Pharmaceutics · 2022Article
- A systematic review of CXCL13 as a biomarker of disease and treatment response in rheumatoid arthritis.BMC rheumatology · 2020Article
- Chronic Inflammation: A Common Promoter in Tertiary Lymphoid Organ Neogenesis.Frontiers in immunology · 2019Review
- The role of lymphotoxin-α in rheumatoid arthritis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2018Review
- Strategies for clinical development of monoclonal antibodies beyond first-in-human trials: tested doses and rationale for dose selection.British journal of cancer · 2018Article
- Lymphotoxin signalling in tertiary lymphoid structures and immunotherapy.Cellular & molecular immunology · 2017Review
- Non-canonical NF-κB signaling in rheumatoid arthritis: Dr Jekyll and Mr Hyde?Arthritis research & therapy · 2015Review
- Ectopic lymphoid-like structures in infection, cancer and autoimmunity.Nature reviews. Immunology · 2014Review
- Lymphotoxin and TNF: how it all began-a tribute to the travelers.Cytokine & growth factor reviews · 2014Review
- Bioavailability of IgG administered by the subcutaneous route.Journal of clinical immunology · 2013Article
- Clinical targeting of the TNF and TNFR superfamilies.Nature reviews. Drug discovery · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPateclizumab (MLTA3698A) is a humanized mAb against lymphotoxin α (LTα), a transiently expressed cytokine on activated B and T cells (Th1, Th17), which are implicated in rheumatoid arthritis (RA) pathogenesis. This study was conducted to assess the safety, tolerability, < NOTE: For clarity and per AMA/S-W Style, please restore the use of Oxford/serial commas (ie: David likes vanilla, strawberry, and chocolate ice cream) throughout. and biologic activity of single and multiple doses of intravenous (IV) or subcutaneous (SC) pateclizumab in RA patients.
methodsThe single ascending dose (SAD) phase in patients with stable RA consisted of six cohorts (4:1 active:placebo at 0.3 mg/kg IV, 1.0 mg/kg IV, 1.0 mg/kg SC, 3.0 mg/kg IV, 3.0 mg/kg SC, and 5.0 mg/kg IV; n = 5/cohort). In the multiple ascending dose (MAD) phase, patients with prespecified RA disease activity received three doses of pateclizumab or placebo (4:1) every 2 weeks (1.0 mg/kg SC, n = 10; 3.0 mg/kg SC, n = 20; or 5.0 mg/kg IV, n = 5). Safety and tolerability were assessed throughout, and clinical activity was determined after three doses (Week 6).
resultsWe observed no serious adverse events (AEs) or dose-limiting toxicities, and the majority of AEs were mild to moderate. The pharmacokinetic profiles were linear, and clearance was independent of dose. Reductions in levels of serum CXCL13 were observed, supporting the biologic activity of pateclizumab on the LTα pathway. Patients receiving pateclizumab in the 3.0 mg/kg MAD group (3.0 mg/kg SC) demonstrated ACR20, ACR50, and ACR70 response rates at week 6 of 75%, 56% and 25%, respectively, compared with 57%, 29%, and 0% in the placebo group. The median Disease Activity Score in 28 joints, C-reactive protein, reduction was 28% for pateclizumab, versus 8.4% for placebo.
conclusionsPateclizumabwas generally well-tolerated in RA patients. Preliminary evidence of clinical activity was observed in active RA patients at the dose level targeted for clinical effect.
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