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[Related PubMed/MEDLINE] Total Number of Papers: 343
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Abbreviation |
: ADA |
Long Form |
: anti-drug antibodies |
|
No. |
Year |
Title |
Co-occurring Abbreviation |
1 |
2020 |
A capillary electrophoresis based approach for the identification of anti-drug antibodies against camelid VHH biologics (Nanobodies). |
--- |
2 |
2020 |
A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains. |
--- |
3 |
2020 |
An innovative method for characterizing neutralizing antibodies against antibody-derived therapeutics. |
ANP, CDRs, NAb, NECA |
4 |
2020 |
Anti drug antibodies monitoring in biologics use: clinical implications. |
--- |
5 |
2020 |
Anti-infliximab antibodies: How to compare old and new data? |
--- |
6 |
2020 |
Assessment of the effects of immunogenicity on the pharmacokinetics, efficacy and safety of tildrakizumab. |
ADAs, NAbs, TE-POS |
7 |
2020 |
Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody. |
mAb, PD, PK, RA |
8 |
2020 |
Clinical trial of laronidase in Hurler syndrome after hematopoietic cell transplantation. |
6MWT, HCT, MPS IH |
9 |
2020 |
Comparative Pharmacokinetics, Bioequivalence and Safety Study of Two Recombinant Human Chorionic Gonadotropin Injections in Healthy Chinese Subjects. |
ADAs, AEs, AUC, CIs, GMR, PK, rhCG |
10 |
2020 |
Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays. |
--- |
11 |
2020 |
Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population. |
--- |
12 |
2020 |
Detailed epitope mapping of neutralizing anti-drug antibodies against recombinant alpha-galactosidase A in patients with Fabry disease. |
AGAL, ERT, FD |
13 |
2020 |
Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies. |
ELISA, IgE, IgG, IgM |
14 |
2020 |
Development and validation of a novel immunogenicity assay to detect anti-drug and anti-PEG antibodies simultaneously with high sensitivity. |
ACE, PEG |
15 |
2020 |
Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence. |
FSGS, NAb |
16 |
2020 |
Drug Tolerant Anti-drug Antibody Assay for Infliximab Treatment in Clinical Practice Identifies Positive Cases Earlier. |
RA, sIFX |
17 |
2020 |
Effect of inclisiran, the siRNA against PCSK9, on platelets, immune cells and immunological biomarkers - a pre-specified analysis from ORION-1. |
DD, IL-6, SD, TNF-alpha |
18 |
2020 |
Effects of successive switches to different biosimilars infliximab on immunogenicity in chronic inflammatory diseases in daily clinical practice. |
cohort-2 |
19 |
2020 |
First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. |
IBD, MAD, NAb, s.c, SAD, TL1A |
20 |
2020 |
High ionic strength dissociation assay (HISDA) for high drug tolerant immunogenicity testing. |
HISDA |
21 |
2020 |
Host cell proteins induce inflammation and immunogenicity as adjuvants in an integrated analysis of in vivo and in vitro assay systems. |
HCPs |
22 |
2020 |
Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta in healthy subjects: A randomized, double-blind trial. |
CI |
23 |
2020 |
Immunogenicity and toxicokinetics assessment of the mono-PEGylated recombinant human interleukin-11 in cynomolgus monkeys. |
ELISA, PEG-IL11, rhIL-11 |
24 |
2020 |
Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis. |
DB, OLE, RP |
25 |
2020 |
Immunogenicity of biologic therapies in psoriasis Myths, facts and a suggested approach. |
--- |
26 |
2020 |
Immunogenicity of TNF-Inhibitors. |
TNFi |
27 |
2020 |
Implementation of a three-tiered approach to identify and characterize anti-drug antibodies raised against HIV-specific broadly neutralizing antibodies. |
--- |
28 |
2020 |
Increased Efficacy and Tolerability of Pegloticase in Patients With Uncontrolled Gout Co-Treated With Methotrexate: A Retrospective Study. |
SUA |
29 |
2020 |
Long-Term Delivery of an Anti-SIV Monoclonal Antibody With AAV. |
AAV |
30 |
2020 |
Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. |
IFX, RA, TP |
31 |
2020 |
Mesothelin-Targeted Recombinant Immunotoxins for Solid Tumors. |
CLS, iToxs, MSLN |
32 |
2020 |
Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. |
MTX, s.c, SpA |
33 |
2020 |
Model-Informed Drug Development of the Masked Anti-PD-L1 Antibody CX-072. |
CL, PK, PopPK, QSP |
34 |
2020 |
Modelling of the Time-Varying Pharmacokinetics of Therapeutic Monoclonal Antibodies: A Literature Review. |
mAbs, PK |
35 |
2020 |
Neutralising anti-drug antibodies in Fabry disease can inhibit endothelial enzyme uptake and activity. |
AGAL, ERT, FD |
36 |
2020 |
Ocrelizumab in a case of refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) with antibodies anti Rituximab. |
CIDP, OCR, RTX |
37 |
2020 |
Optimization and qualification of a functional anti-drug antibody assay for HIV-1 bnAbs. |
GCLP |
38 |
2020 |
Overcoming multimeric target interference in a bridging immunogenicity assay with soluble target receptor, target immunodepletion and mild acidic assay pH. |
--- |
39 |
2020 |
Phase I, first-in-human trial of programmed cell death receptor-1 (PD-1) inhibitor, JTX-4014, in adult patients with advanced, refractory, solid tumors. |
MTD, PD-1, PK |
40 |
2020 |
Reversal of anti-drug antibodies against tumor necrosis factor inhibitors with addition of immunomodulators: A systematic review and meta-analysis. |
CI, IBD |
41 |
2020 |
Specificity of the T Cell Response to Protein Biopharmaceuticals. |
BPs |
42 |
2020 |
T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation-Updated Consensus and Review 2020. |
--- |
43 |
2020 |
The Irony of Humanization: Alemtuzumab, the First, But One of the Most Immunogenic, Humanized Monoclonal Antibodies. |
PwMS |
44 |
2020 |
Using Serum Metabolomics to Predict Development of Anti-drug Antibodies in Multiple Sclerosis Patients Treated With IFNbeta. |
MS |
45 |
2020 |
Validation of a de-immunization strategy for monoclonal antibodies using cynomolgus macaque as a surrogate for human. |
--- |
46 |
2019 |
A differential sex-specific pattern of IgG2 and IgG4 subclasses of anti-drug antibodies (ADAs) induced by glatiramer acetate in relapsing-remitting multiple sclerosis patients. |
ADAs, GA, MS |
47 |
2019 |
A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance. |
Abs, ECL, FFP, HSP47, LNP, MRD, PEG, QCs, siRNA |
48 |
2019 |
A generic method for the detection of polyethylene glycol specific IgG and IgM antibodies in human serum. |
CV, OTC, PEG |
49 |
2019 |
A Model-Based Approach to Quantify the Time-Course of Anti-Drug Antibodies for Therapeutic Proteins. |
--- |
50 |
2019 |
A Multicenter Phase IV Study to Investigate the Immunogenicity of Recombinant Human Follicle-Stimulating Hormone and Its Impact on Clinical Outcomes in Females Undergoing Controlled Ovarian Stimulation. |
AEs, COS, IUI, IVF, rhFSH |
51 |
2019 |
Addressing soluble target interference in the development of a functional assay for the detection of neutralizing antibodies against a BCMA-CD3 bispecific antibody. |
BCMA, NAb, sBCMA |
52 |
2019 |
Adeno-Associated Virus Delivery of Anti-HIV Monoclonal Antibodies Can Drive Long-Term Virologic Suppression. |
AAV, mAbs |
53 |
2019 |
An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. |
DAS28-CRP, OLE, RA, RP, SAEs, TEAEs |
54 |
2019 |
Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points. |
PC, SCP |
55 |
2019 |
Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis. |
PC |
56 |
2019 |
Antidrug antibody detection for adalimumab depends on the type of assay used: an experimental approach to help clinicians interpret diagnostic data. |
ABT, All-neg, All-pos, ARIA, AS, ELISA |
57 |
2019 |
Antidrug antibody formation during tumor necrosis factor alpha inhibitor treatment of severe psoriatic patients in the real-life practice. |
TNF-alpha |
58 |
2019 |
Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases. |
anti-TNF, IBD, TDM |
59 |
2019 |
Appropriateness of Biologics in the Management of Crohn's Disease Using RAND/UCLA Appropriateness Methodology. |
--- |
60 |
2019 |
Assessing the long-term stability of anti-drug antibodies in method validation: what is the added value? |
--- |
61 |
2019 |
Clinical relevance of monitoring serum adalimumab levels in axial spondyloarthritis. |
AUC, DMARDs, ROC, SpA |
62 |
2019 |
CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial. |
CBR, DCR, DOR, mCRC, ORR, OS, PFS |
63 |
2019 |
Depletion of interfering IgG and IgM is critical to determine the role of IgE in pegvaliase-associated hypersensitivity. |
CIC, HAEs, Phe, PKU |
64 |
2019 |
Detection and kinetics of persistent neutralizing anti-interferon-beta antibodies in patients with multiple sclerosis. Results from the ABIRISK prospective cohort study. |
IFN-beta |
65 |
2019 |
Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar. |
CIs, PK |
66 |
2019 |
Efficacy, immunogenicity and cost analysis of a systematic switch from originator infliximab to biosimilar CT-P13 of all patients with inflammatory arthritis from a single center. |
ASDAS, DAS28, PsA, RA, sIFX, SpA |
67 |
2019 |
Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study. |
--- |
68 |
2019 |
Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1. |
PD, PK, Treg |
69 |
2019 |
Evaluation of in vitro Assays to Assess the Modulation of Dendritic Cells Functions by Therapeutic Antibodies and Aggregates. |
DC, MoDC |
70 |
2019 |
Formation and glomerular deposition of immune complexes in mice administered bovine serum albumin: Evaluation of dose, frequency, and biomarkers. |
BSA, cCIC, CIC, IC |
71 |
2019 |
Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies. |
ICs, PK |
72 |
2019 |
HLA- and genotype-based risk assessment model to identify infantile onset pompe disease patients at high-risk of developing significant anti-drug antibodies (ADA). |
GAA, iTEM, rhGAA |
73 |
2019 |
Immunogenicity assay development and validation for biological therapy as exemplified by ustekinumab. |
ELISA, IL, nADA, SPR, UST |
74 |
2019 |
Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. |
DT-EIA |
75 |
2019 |
Immunogenicity of Golimumab and its Clinical Relevance in Patients With Ulcerative Colitis. |
DT-EIA, EIA |
76 |
2019 |
Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics. |
APC, CAR, IMD, MOA, PD-1 |
77 |
2019 |
In vitro human helper T-cell assay to screen antibody drug candidates for immunogenicity. |
hA33, mAb |
78 |
2019 |
Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis. |
RA |
79 |
2019 |
Infliximab and adalimumab concentrations and anti-drug antibodies in inflammatory bowel disease control using New Zealand assays. |
CD, ELISA, HMSA, TNF, UC |
80 |
2019 |
Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk. |
TE-ADA |
81 |
2019 |
Major Histocompatibility Complex Binding, Eluted Ligands, and Immunogenicity: Benchmark Testing and Predictions. |
HLA, MHC |
82 |
2019 |
Mitigating target interference in bridging immunogenicity assay with target-blocking reagents and mild basic pH. |
--- |
83 |
2019 |
Molecular Landscape of Anti-Drug Antibodies Reveals the Mechanism of the Immune Response Following Treatment With TNFalpha Antagonists. |
mAbs |
84 |
2019 |
Monoclonal antibodies for severe asthma: Pharmacokinetic profiles. |
mAbs |
85 |
2019 |
Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity. |
--- |
86 |
2019 |
Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody. |
CLB, NAb |
87 |
2019 |
New insights on critical reagent optimization for antidrug antibody assays. |
--- |
88 |
2019 |
Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing. |
LBA |
89 |
2019 |
PF-06881893 (Nivestymâ„¢), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. |
ANC, AUEC, CD, HVs, PD, PK, US-Neupogen |
90 |
2019 |
Pharmacodynamics, safety, and immunogenicity of Pelmeg, a pegfilgrastim biosimilar in healthy subjects. |
ANC, PD |
91 |
2019 |
Pharmacokinetics of Human Recombinant Anti-Botulinum Toxin Antibodies in Rats. |
BoNT, IgG1 |
92 |
2019 |
Phase 1 study of MEDI3902, an investigational anti-Pseudomonas aeruginosa PcrV and Psl bispecific human monoclonal antibody, in healthy adults. |
TEAEs |
93 |
2019 |
Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. |
CL, hs-CRP, IL, s.c, Vss |
94 |
2019 |
Post-transplant laronidase augmentation for children with Hurler syndrome: biochemical outcomes. |
HCT, IV-ERT, uGAG |
95 |
2019 |
Preclinical pharmacokinetics of a novel anti-c-Met antibody-drug conjugate, SHR-A1403, in rodents and non-human primates. |
ADC, DAR, IND, PK |
96 |
2019 |
Prediction of natalizumab anti-drug antibodies persistency. |
MSD, PK |
97 |
2019 |
Quantification of neutralizing anti-drug antibodies and their neutralizing capacity using competitive displacement and tandem mass spectrometry: Infliximab as proof of principle. |
IFX, NAb, RIA, SIL |
98 |
2019 |
Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs. |
--- |
99 |
2019 |
Report on the AAPS Immunogenicity Guidance Forum. |
AAPS, FDA, PCs |
100 |
2019 |
Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. |
TE-ADAs |
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