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Abbreviation : ADA
Long Form : anti-drug antibodies
No. Year Title Co-occurring Abbreviation
2020 A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains. ---
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 trial of laronidase in Hurler syndrome after hematopoietic cell transplantation. 6MWT, HCT, MPS IH
2020 Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population. ---
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
2020 Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. MTX, s.c, SpA
2020 Optimization and qualification of a functional anti-drug antibody assay for HIV-1 bnAbs. GCLP
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
10  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
11  2019 A generic method for the detection of polyethylene glycol specific IgG and IgM antibodies in human serum. CV, OTC, PEG
12  2019 A Model-Based Approach to Quantify the Time-Course of Anti-Drug Antibodies for Therapeutic Proteins. ---
13  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
14  2019 Adeno-Associated Virus Delivery of Anti-HIV Monoclonal Antibodies Can Drive Long-Term Virologic Suppression. AAV, mAbs
15  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
16  2019 Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points. PC, SCP
17  2019 Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis. PC
18  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
19  2019 Antidrug antibody formation during tumor necrosis factor alpha inhibitor treatment of severe psoriatic patients in the real-life practice. TNF-alpha
20  2019 Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases. anti-TNF, IBD, TDM
21  2019 Appropriateness of Biologics in the Management of Crohn's Disease Using RAND/UCLA Appropriateness Methodology. ---
22  2019 Assessing the long-term stability of anti-drug antibodies in method validation: what is the added value? ---
23  2019 Clinical relevance of monitoring serum adalimumab levels in axial spondyloarthritis. AUC, DMARDs, ROC, SpA
24  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
25  2019 Depletion of interfering IgG and IgM is critical to determine the role of IgE in pegvaliase-associated hypersensitivity. CIC, HAEs, Phe, PKU
26  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
27  2019 Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar. CIs, PK
28  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
29  2019 Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study. ---
30  2019 Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1. PD, PK, Treg
31  2019 Evaluation of in vitro Assays to Assess the Modulation of Dendritic Cells Functions by Therapeutic Antibodies and Aggregates. DC, MoDC
32  2019 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
33  2019 Formation and glomerular deposition of immune complexes in mice administered bovine serum albumin: Evaluation of dose, frequency, and biomarkers. BSA, cCIC, CIC, IC
34  2019 Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies. ICs, PK
35  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
36  2019 Immunogenicity assay development and validation for biological therapy as exemplified by ustekinumab. ELISA, IL, nADA, SPR, UST
37  2019 Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. DT-EIA
38  2019 Immunogenicity of Golimumab and its Clinical Relevance in Patients With Ulcerative Colitis. DT-EIA, EIA
39  2019 Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics. APC, CAR, IMD, MOA, PD-1
40  2019 In vitro human helper T-cell assay to screen antibody drug candidates for immunogenicity. hA33, mAb
41  2019 Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis. RA
42  2019 Infliximab and adalimumab concentrations and anti-drug antibodies in inflammatory bowel disease control using New Zealand assays. CD, ELISA, HMSA, TNF, UC
43  2019 Investigation of pre-existing reactivity to biotherapeutics can uncover potential immunogenic epitopes and predict immunogenicity risk. TE-ADA
44  2019 Mitigating target interference in bridging immunogenicity assay with target-blocking reagents and mild basic pH. ---
45  2019 Modelling of the Time-Varying Pharmacokinetics of Therapeutic Monoclonal Antibodies: A Literature Review. mAbs, PK
46  2019 Molecular Landscape of Anti-Drug Antibodies Reveals the Mechanism of the Immune Response Following Treatment With TNFalpha Antagonists. mAbs
47  2019 Monoclonal antibodies for severe asthma: Pharmacokinetic profiles. mAbs
48  2019 Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity. ---
49  2019 Neutralising anti-drug antibodies in Fabry disease can inhibit endothelial enzyme uptake and activity. AGAL, ERT, FD
50  2019 Neutralizing Antibody Assay Development with High Drug and Target Tolerance to Support Clinical Development of an Anti-TFPI Therapeutic Monoclonal Antibody. CLB, NAb
51  2019 New insights on critical reagent optimization for antidrug antibody assays. ---
52  2019 Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing. LBA
53  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
54  2019 Pharmacodynamics, safety, and immunogenicity of Pelmeg, a pegfilgrastim biosimilar in healthy subjects. ANC, PD
55  2019 Pharmacokinetics of Human Recombinant Anti-Botulinum Toxin Antibodies in Rats. BoNT, IgG1
56  2019 Phase 1 study of MEDI3902, an investigational anti-Pseudomonas aeruginosa PcrV and Psl bispecific human monoclonal antibody, in healthy adults. TEAEs
57  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
58  2019 Post-transplant laronidase augmentation for children with Hurler syndrome: biochemical outcomes. HCT, IV-ERT, uGAG
59  2019 Preclinical pharmacokinetics of a novel anti-c-Met antibody-drug conjugate, SHR-A1403, in rodents and non-human primates. ADC, DAR, IND, PK
60  2019 Prediction of natalizumab anti-drug antibodies persistency. MSD, PK
61  2019 Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs. ---
62  2019 Report on the AAPS Immunogenicity Guidance Forum. AAPS, FDA, PCs
63  2019 Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. TE-ADAs
64  2019 Systematic review of anti-drug antibodies of IL-17 inhibitors for psoriasis. ---
65  2019 Therapeutic drug monitoring of biologics in psoriasis. TDM
66  2019 Use of Ella to facilitate drug quantification and antidrug antibody detection in preclinical studies. ---
67  2018 A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. ACR20, PK, RA
68  2018 A simple and cost-effective assay for measuring anti-drug antibody in human patients treated with Adalimumab. LOD
69  2018 Anti-drug antibodies to LMB-100 are enhanced by mAbs targeting OX40 and CTLA4 but not by mAbs targeting PD1 or PDL-1. ---
70  2018 Antibody drug quantitation in coexistence with anti-drug antibodies on nSMOL bioanalysis. mAbs
71  2018 Assessment of the immunogenicity of residual host cell protein impurities of OsrHSA. HCPs, HSA, OsrHSA
72  2018 Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials. CIC, HAE, Ig, PEG, Phe, PKU
73  2018 Bead-extraction and heat-dissociation (BEHD): A novel way to overcome drug and matrix interference in immunogenicity testing. Ab, BEAD, BEHD, BEHD, NAb
74  2018 Collaborative study using common samples to evaluate the performance of anti-drug antibody assays constructed by different companies. ---
75  2018 Comparison of different immunoassay methods to detect human anti-drug antibody using the WHO erythropoietin antibody reference panel for analytes. BLI, ECL, EPO, SPR, WHO
76  2018 Construction of Macaque Immune-Libraries. ---
77  2018 Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay. CI-M6PR, ERTs, NAbs
78  2018 Detection of Memory B Activity Against a Therapeutic Protein in Treatment-Naive Subjects. ASC, SFU
79  2018 Development and effect of antibodies to anakinra during treatment of severe CAPS: sub-analysis of a long-term safety and efficacy study. AEs, CAPS, CRP, DSSS, PK, SAA
80  2018 Development of an anti-EPO antibody detection kit based on lab-on-a-chip and bridging antibody technologies. PRCA
81  2018 Discrimination of Anti-drug Antibodies With Neutralizing Capacity in Infliximab- and Adalimumab-Treated Patients: Comparison of the Homogeneous Mobility Shift Assay and the Affinity Capture and Elution Assay. ACE, ADAL, HMSA, IFX
82  2018 Dosing interval and diagnosis predict infliximab levels in patients with inflammatory bowel disease on maintenance treatment. CD, IBD, IFX, TL, UC
83  2018 Drug immunogenicity in patients with inflammatory arthritis and secondary failure to tumour necrosis factor inhibitor therapies: the REASON study. ADL, ETN, INF
84  2018 Drug-induced Glomerulonephritis: The Spectre of Biotherapeutic and Antisense Oligonucleotide Immune Activation in the Kidney. ASO
85  2018 Humoral Immune Response After Intravitreal But Not After Subretinal AAV8 in Primates and Patients. NHP, rAAV8, vg
86  2018 IgG4 anti-infliximab in treated patients: Clinical impact and temporal evolution. IFX
87  2018 Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab. TNF
88  2018 Immunogenicity assessment of tbo-filgrastim in cancer patients receiving chemotherapy. ---
89  2018 Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan. ---
90  2018 Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection. IC
91  2018 Immunogenicity to cerliponase alfa intracerebroventricular enzyme replacement therapy for CLN2 disease: Results from a Phase 1/2 study. CSF, ERT, i.c.v, ML, NAb
92  2018 Interferon-beta specific T cells are associated with the development of neutralizing antibodies in interferon-beta treated multiple sclerosis patients. IFN-beta, MS
93  2018 Investigation of the Mechanism of Therapeutic Protein-Drug Interaction Between Methotrexate and Golimumab, an Anti-TNFalpha Monoclonal Antibody. MTX, PsA, TP-DI
94  2018 Isolation and Characterization of Novel Phage Displayed scFv Fragment for Human Tumor Necrosis Factor Alpha and Molecular Docking Analysis of Their Interactions. TNF-alpha
95  2018 Low Percentage of Signal Regulatory Protein alpha/beta+ Memory B Cells in Blood Predicts Development of Anti-drug Antibodies (ADA) in Adalimumab-Treated Rheumatoid Arthritis Patients. AUC, DEMs, RA, ROC, SIRP, TNF
96  2018 MAPPs for the identification of immunogenic hotspots of biotherapeutics; an overview of the technology and its application to the biopharmaceutical arena. MAPPs
97  2018 Methotrexate and BAFF interaction prevents immunization against TNF inhibitors. AID, BAFFtg, MTX, TNFi, WT
98  2018 Neutralizing anti-drug antibodies in Fabry disease have no obvious clinical impact? FD
99  2018 Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects. AUC, AUC0-336, GMRs, PK
100  2018 Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. anti-CMV, PK