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Abbreviation : ADA
Long Form : anti-drug antibodies
No. Year Title Co-occurring Abbreviation
2020 A capillary electrophoresis based approach for the identification of anti-drug antibodies against camelid VHH biologics (Nanobodies). ---
2020 A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains. ---
2020 An innovative method for characterizing neutralizing antibodies against antibody-derived therapeutics. ANP, CDRs, NAb, NECA
2020 Anti drug antibodies monitoring in biologics use: clinical implications. ---
2020 Anti-infliximab antibodies: How to compare old and new data? ---
2020 Assessment of the effects of immunogenicity on the pharmacokinetics, efficacy and safety of tildrakizumab. ADAs, NAbs, TE-POS
2020 Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody. mAb, PD, PK, RA
2020 Clinical trial of laronidase in Hurler syndrome after hematopoietic cell transplantation. 6MWT, HCT, MPS IH
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