Trial reportArthritis research & therapy2011
Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study.
Trial report in Arthritis research & therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00507403 (Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis), which is not on this map. Cited by 13 papers, 3 of them syntheses 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.
Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Pan American League of Associations for Rheumatology recommendations for the management of axial spondyloarthritis.Nature reviews. Rheumatology · 2023Guideline
- Pooled it
- Methotrexate for ankylosing spondylitis.The Cochrane database of systematic reviews · 2013Pooled it
- Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis.British journal of clinical pharmacology · 2014Trial
- Extracellular Vesicles Derived from Ligament Tissue Transport Interleukin-17A to Mediate Ligament-To-Bone Crosstalk in Ankylosing Spondylitis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Immunogenicity of subcutaneous TNF inhibitors and its clinical significance in real-life setting in patients with spondyloarthritis.Rheumatology international · 2022Article
- Evidence-based efficacy of methotrexate in adult Crohn's disease in different intestinal and extraintestinal indications.Therapeutic advances in gastroenterology · 2022Review
- Investigation of the Mechanism of Therapeutic Protein-Drug Interaction Between Methotrexate and Golimumab, an Anti-TNFα Monoclonal Antibody.The AAPS journal · 2018Article
- Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNF α Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients.BioMed research international · 2015Article
- Article
- The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases.Rheumatology (Oxford, England) · 2014Review
- Infliximab dose reduction sustains the clinical treatment effect in active HLAB27 positive ankylosing spondylitis: a two-year pilot study.Mediators of inflammation · 2013Observational
- Developments in therapies for spondyloarthritis.Nature reviews. Rheumatology · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMethotrexate (MTX) has been shown to modify infliximab pharmacokinetics in rheumatoid arthritis. However, its combination with infliximab in the treatment of ankylosing spondylitis (AS) is not recommended. The objective of this study was to examine the influence of MTX on infliximab exposure in patients with AS.
methodsPatients with AS patients who had predominantly axial symptoms were randomised to receive infliximab alone (infusions of 5 mg/kg at weeks 0, 2, 6, 12 and 18) or infliximab combined with MTX (10 mg/week). Infliximab concentrations were measured before and 2 hours after each infusion and at 1, 3, 4, 5, 8, 10, 14 and 18 weeks. We estimated individual cumulative area under the concentration versus time curves (AUC) for infliximab concentration between baseline and week 18 (AUC(0-18)). Clinical and laboratory evaluations were performed at each visit. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was the primary end point for clinical response.
resultsTwenty-six patients were included (infliximab group: n = 12, infliximab + MTX group: n = 14), and 507 serum samples were available for measurement of infliximab concentration. The two groups did not differ with regard to AUC(0-18) or evolution of BASDAI scores and biomarkers of inflammation.
conclusionsThe combination of MTX and infliximab does not increase the exposure to infliximab over infliximab alone in patients with AS.
trial registrationClinicalTrials.gov: NCT00507403.
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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.