Observational studyPloS one2015
The Association between Clinical Response to Ustekinumab and Immunogenicity to Ustekinumab and Prior Adalimumab.
Observational study in PloS one, 2015. 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
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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, 38 citations in OpenAlex.
- Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate.Rheumatology (Oxford, England) · 2023Trial
- Therapeutic Drug Monitoring of Biologics for Patients with Inflammatory Bowel Diseases: How, When, and for Whom?Gut and liver · 2022Review
- Immunogenicity of Monoclonal Antibodies and the Potential Use of HLA Haplotypes to Predict Vulnerable Patients.Frontiers in immunology · 2022Review
- Real-world use of ustekinumab therapeutic drug monitoring in moderate to severe psoriasis.Frontiers in medicine · 2022Article
- Therapeutic drug monitoring in inflammatory bowel disease: The dawn of reactive monitoring.World journal of gastroenterology · 2021Review
- Psoriasis and Gut Microbiome-Current State of Art.International journal of molecular sciences · 2021Review
- Immunogenicity of biologic agents in rheumatology.Nature reviews. Rheumatology · 2021Review
- Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults.Therapeutic advances in musculoskeletal disease · 2021Review
- Interleukin 23 and autoimmune diseases: current and possible future therapies.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2020Review
- Using Real-World Data to Guide Ustekinumab Dosing Strategies for Psoriasis: A Prospective Pharmacokinetic-Pharmacodynamic Study.Clinical and translational science · 2020Observational
- Clinical response correlates with 4-week postinjection ustekinumab concentrations in patients with moderate-to-severe psoriasis.The British journal of dermatology · 2020Article
- The Molecular Mechanisms That Underlie the Immune Biology of Anti-drug Antibody Formation Following Treatment With Monoclonal Antibodies.Frontiers in immunology · 2020Review
- Gut Microbiome in Psoriasis is Perturbed Differently During Secukinumab and Ustekinumab Therapy and Associated with Response to Treatment.Clinical drug investigation · 2019Observational
- Clinical Consequences of Antibody Formation, Serum Concentrations, and HLA-Cw6 Status in Psoriasis Patients on Ustekinumab.Therapeutic drug monitoring · 2019Article
- Immunogenicity assay development and validation for biological therapy as exemplified by ustekinumab.Clinical and experimental immunology · 2019Article
- Selenium unmasks protective iron armor: A possible defense against cutaneous inflammation and cancer.Biochimica et biophysica acta. General subjects · 2018Article
- Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications.Journal of immunology research · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmunogenicity due to antidrug antibodies (ADA) to tumor necrosis factor (TNF)-α antagonists is known to decrease treatment response. However, few studies have investigated ADA in ustekinumab, an interleukin-12 and -23 antagonist, in a clinical setting. This study aimed to investigate the immunogenicity of ustekinumab and its clinical consequences in psoriasis.
methodsThis prospective observational study enrolled 76 patients with plaque psoriasis who were treated with ustekinumab for a minimum of 7 months. Blood samples were drawn just prior to scheduled ustekinumab injection during clinic visits. Levels of anti-ustekinumab antibody (AUA) and serum ustekinumab concentration were measured respectively by radioimmunoassays and enzyme-linked immunoassays respectively, and correlated to clinical data and Psoriasis Area and Severity Index (PASI).
resultsAUA was detected in 6.5% of patients after a mean of 13 months of treatment. Patients with positive AUA had significantly lower serum ustekinumab concentrations (0.01 vs. 0.2 mg/L, p<0.001) and lower PASI 50 response than patients without AUA (0% vs. 69%, p = 0.004).The percentage of AUA formation was comparable between patients who had failed previous adalimumab with or without anti-adalimumab antibodies (AAA) (14.3% vs. 12.5%, p = 1.00). However, a higher proportion of switchers without AAA obtaining PASI50 (71.4% vs. 37.5%) and PASI75 response (42.9% vs.12.5%) within 7 months of ustekinumab treatment than with AAA though this difference did not reach statistical significance.
conclusionsOur results suggest that presence of AUA was significantly associated with treatment failure for ustekinumab, though limited by a small sample size. Also, determining the presence of ADA to antecedent TNF-α antagonists may assist in choosing an optimized subsequent treatment modality achieving treatment success.
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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.