Telitacicept Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Telitacicept comprises 39 peer-reviewed publications across 15 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Lupus Erythematosus, Systemic, Nephrotic Syndrome, Arthritis, Rheumatoid, and Glomerulonephritis, IGA. Most recent publication: The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial., Front Immunol, 2025.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases.
    Zeng L, Yang K, Wu Y, et al. · J Autoimmun · 2024
    PubMed: PMID 39146891 · NCT06979271 · Arthritis, Rheumatoid
  2. Non-immunosuppressive treatment for IgA nephropathy.
    Tunnicliffe DJ, Reid S, Craig JC, et al. · Cochrane Database Syst Rev · 2024
    PubMed: PMID 38299639 · NCT04905212 · Glomerulonephritis, IGA
  3. The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial.
    Li J, Zhang Y, Deng Y, et al. · Front Immunol · 2025
    PubMed: PMID 41200184 · NCT06827587 · Myasthenia Gravis
  4. Targeting B Cells and Plasma Cells in Glomerular Disease.
    Ahmad SB, Jefferson JA · J Am Soc Nephrol · 2025
    PubMed: PMID 40465397 · NCT05680480 · Lupus Nephritis
  5. Gelsolin: a new biomarker of disease activity in SLE patients associated with HDL-c.
    Parra S, Heras M, Herrero P, et al. · Rheumatology (Oxford) · 2020
    PubMed: PMID 31504936 · NCT05666336 · Lupus Erythematosus, Systemic
  6. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study.
    Merrill JT, Wallace DJ, Wax S, et al. · Arthritis Rheumatol · 2019
    PubMed: PMID 29073347 · NCT05666336 · Lupus Erythematosus, Systemic
  7. Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL.
    Gordon C, Wofsy D, Wax S, et al. · Arthritis Rheumatol · 2017
    PubMed: PMID 27390168 · NCT05666336 · Lupus Erythematosus, Systemic
  8. A panel of urinary proteins predicts active lupus nephritis and response to rituximab treatment.
    Davies JC, Carlsson E, Midgley A, et al. · Rheumatology (Oxford) · 2021
    PubMed: PMID 33313921 · NCT05666336 · Lupus Erythematosus, Systemic

Publications by year

19972025: 39 publications.

1997
1
2003
1
2004
1
2009
1
2010
1
2012
2
2013
2
2016
2
2017
1
2018
2
2019
4
2020
3
2021
6
2022
3
2023
4
2024
3
2025
2

Publications by indication

Lupus Erythematosus, Systemic (25)

  • Glycosphingolipid Levels in Urine Extracellular Vesicles Enhance Prediction of Therapeutic Response in Lupus Nephritis.
    Metabolites · 2024 · PMID 35208209 · NCT05666336
  • Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus.
    Drugs Today (Barc) · 2022 · PMID 35107091 · NCT05666336
  • Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis.
    Eur J Pharm Sci · 2021 · PMID 33440243 · NCT05666336
  • Characterization of B- and T-Cell Compartment and B-Cell Related Factors Belonging to the TNF/TNFR Superfamily in Patients With Clinically Active Systemic Lupus Erythematosus: Baseline BAFF Serum Levels Are the Strongest Predictor of Response to Belimumab after Twelve Months of Therapy.
    Front Pharmacol · 2021 · PMID 34093196 · NCT05666336
  • Proposal and validation of a method to classify genetic subtypes of diffuse large B cell lymphoma.
    Sci Rep · 2021 · PMID 33479306 · NCT05666336

Nephrotic Syndrome (10)

  • Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria.
    Kidney Int Rep · 2023 · PMID 36938094 · NCT06125405
  • Telitacicept for minimal change disease.
    Kaohsiung J Med Sci · 2023 · PMID 37440467 · NCT06125405
  • The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study.
    Lupus · 2023 · PMID 36416639 · NCT06125405
  • Telitacicept for autoimmune nephropathy.
    Front Immunol · 2023 · PMID 37342346 · NCT06125405
  • Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease.
    Immunopharmacol Immunotoxicol · 2022 · PMID 34519594 · NCT06125405

Arthritis, Rheumatoid (1)

  • Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases.
    J Autoimmun · 2024 · PMID 39146891 · NCT06979271

Glomerulonephritis, IGA (1)

Myasthenia Gravis (1)

  • The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial.
    Front Immunol · 2025 · PMID 41200184 · NCT06827587

Lupus Nephritis (1)

Publications by journal

All Telitacicept publications (39)

2025 (2 papers)

  1. The efficacy, safety, and pharmacokinetics/pharmacodynamics of telitacicept following efgartigimod in generalized myasthenia gravis: protocol of a randomized controlled trial.
    Li J, Zhang Y, Deng Y, et al. · Front Immunol · 2025 · Derived
    PubMed: PMID 41200184 · NCT06827587 · Myasthenia Gravis
  2. Targeting B Cells and Plasma Cells in Glomerular Disease.
    Ahmad SB, Jefferson JA · J Am Soc Nephrol · 2025 · Derived
    PubMed: PMID 40465397 · NCT05680480 · Lupus Nephritis

2024 (3 papers)

  1. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases.
    Zeng L, Yang K, Wu Y, et al. · J Autoimmun · 2024 · Trial result
    PubMed: PMID 39146891 · NCT06979271 · Arthritis, Rheumatoid
  2. Non-immunosuppressive treatment for IgA nephropathy.
    Tunnicliffe DJ, Reid S, Craig JC, et al. · Cochrane Database Syst Rev · 2024 · Derived
    PubMed: PMID 38299639 · NCT04905212 · Glomerulonephritis, IGA
  3. Glycosphingolipid Levels in Urine Extracellular Vesicles Enhance Prediction of Therapeutic Response in Lupus Nephritis.
    Troyer B, Rodgers J, Wolf BJ, et al. · Metabolites · 2024 · Background
    PubMed: PMID 35208209 · NCT05666336 · Lupus Erythematosus, Systemic

2023 (4 papers)

  1. Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria.
    Lv J, Liu L, Hao C, et al. · Kidney Int Rep · 2023 · Background
  2. Telitacicept for minimal change disease.
    Li S, Ding L, Yang YJ, et al. · Kaohsiung J Med Sci · 2023 · Background
  3. The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study.
    Chen R, Fu R, Lin Z, et al. · Lupus · 2023 · Background
  4. Telitacicept for autoimmune nephropathy.
    Cai J, Gao D, Liu D, et al. · Front Immunol · 2023 · Background

2022 (3 papers)

  1. Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease.
    Shi F, Xue R, Zhou X, et al. · Immunopharmacol Immunotoxicol · 2022 · Background
  2. Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus.
    Fan Y, Gao D, Zhang Z, et al. · Drugs Today (Barc) · 2022 · Background
    PubMed: PMID 35107091 · NCT05666336 · Lupus Erythematosus, Systemic
  3. Telitacicept: First Approval.
    Dhillon S · Drugs · 2022 · Background

2021 (6 papers)

  1. Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis.
    Yao X, Ren Y, Zhao Q, et al. · Eur J Pharm Sci · 2021 · Background
    PubMed: PMID 33440243 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Incidence and Relapse of Idiopathic Nephrotic Syndrome: Meta-analysis.
    Veltkamp F, Rensma LR, Bouts AHM, et al. · Pediatrics · 2021 · Background
  3. Characterization of B- and T-Cell Compartment and B-Cell Related Factors Belonging to the TNF/TNFR Superfamily in Patients With Clinically Active Systemic Lupus Erythematosus: Baseline BAFF Serum Levels Are the Strongest Predictor of Response to Belimumab after Twelve Months of Therapy.
    Piantoni S, Regola F, Masneri S, et al. · Front Pharmacol · 2021 · Background
    PubMed: PMID 34093196 · NCT05666336 · Lupus Erythematosus, Systemic
  4. Proposal and validation of a method to classify genetic subtypes of diffuse large B cell lymphoma.
    Pedrosa L, Fernández-Miranda I, Pérez-Callejo D, et al. · Sci Rep · 2021 · Background
    PubMed: PMID 33479306 · NCT05666336 · Lupus Erythematosus, Systemic
  5. Urine and serum S100A8/A9 and S100A12 associate with active lupus nephritis and may predict response to rituximab treatment.
    Davies JC, Midgley A, Carlsson E, et al. · RMD Open · 2021 · Background
    PubMed: PMID 32723832 · NCT05666336 · Lupus Erythematosus, Systemic
  6. A panel of urinary proteins predicts active lupus nephritis and response to rituximab treatment.
    Davies JC, Carlsson E, Midgley A, et al. · Rheumatology (Oxford) · 2021 · Background
    PubMed: PMID 33313921 · NCT05666336 · Lupus Erythematosus, Systemic

2020 (3 papers)

  1. Lymphocyte phenotype and its application to precision medicine in systemic autoimmune diseases✰.
    Tanaka Y, Kubo S, Miyagawa I, et al. · Semin Arthritis Rheum · 2020 · Background
    PubMed: PMID 31079846 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Gelsolin: a new biomarker of disease activity in SLE patients associated with HDL-c.
    Parra S, Heras M, Herrero P, et al. · Rheumatology (Oxford) · 2020 · Background
    PubMed: PMID 31504936 · NCT05666336 · Lupus Erythematosus, Systemic
  3. Circulating microRNAs as potential biomarkers for monitoring the response to in vivo treatment with Rituximab in systemic lupus erythematosus patients.
    Cecchi I, Perez-Sanchez C, Sciascia S, et al. · Autoimmun Rev · 2020 · Background
    PubMed: PMID 32062026 · NCT05666336 · Lupus Erythematosus, Systemic

2019 (4 papers)

  1. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study.
    Merrill JT, Wallace DJ, Wax S, et al. · Arthritis Rheumatol · 2019 · Background
    PubMed: PMID 29073347 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study.
    Iaccarino L, Andreoli L, Bocci EB, et al. · J Autoimmun · 2019 · Background
    PubMed: PMID 28935492 · NCT05666336 · Lupus Erythematosus, Systemic
  3. Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus.
    Hruskova Z, Tesar V · Expert Opin Biol Ther · 2019 · Background
    PubMed: PMID 30040494 · NCT05666336 · Lupus Erythematosus, Systemic
  4. NMR-Based Serum Metabolomics Reveals Reprogramming of Lipid Dysregulation Following Cyclophosphamide-Based Induction Therapy in Lupus Nephritis.
    Guleria A, Phatak S, Dubey D, et al. · J Proteome Res · 2019 · Background
    PubMed: PMID 29877087 · NCT05666336 · Lupus Erythematosus, Systemic

2018 (2 papers)

  1. Diagnostic and prognostic tests in systemic lupus erythematosus.
    Vasquez-Canizares N, Wahezi D, Putterman C, et al. · Best Pract Res Clin Rheumatol · 2018 · Background
    PubMed: PMID 29224677 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Predictive and prognostic factors influencing outcomes of rituximab therapy in systemic lupus erythematosus (SLE): A systematic review.
    Pirone C, Mendoza-Pinto C, van der Windt DA, et al. · Semin Arthritis Rheum · 2018 · Background
    PubMed: PMID 28602359 · NCT05666336 · Lupus Erythematosus, Systemic

2017 (1 paper)

  1. Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL.
    Gordon C, Wofsy D, Wax S, et al. · Arthritis Rheumatol · 2017 · Background
    PubMed: PMID 27390168 · NCT05666336 · Lupus Erythematosus, Systemic

2016 (2 papers)

  1. Genetic markers in CYP2C19 and CYP2B6 for prediction of cyclophosphamide's 4-hydroxylation, efficacy and side effects in Chinese patients with systemic lupus erythematosus.
    Shu W, Guan S, Yang X, et al. · Br J Clin Pharmacol · 2016 · Background
    PubMed: PMID 26456622 · NCT05666336 · Lupus Erythematosus, Systemic
  2. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE).
    Kalunian KC, Merrill JT, Maciuca R, et al. · Ann Rheum Dis · 2016 · Background
    PubMed: PMID 26038091 · NCT05666336 · Lupus Erythematosus, Systemic

2013 (2 papers)

  1. B cell biomarkers of rituximab responses in systemic lupus erythematosus.
    Vital EM, Dass S, Buch MH, et al. · Arthritis Rheum · 2013 · Background
    PubMed: PMID 21618204 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study.
    McBride JM, Jiang J, Abbas AR, et al. · Arthritis Rheum · 2013 · Background
    PubMed: PMID 22833362 · NCT05666336 · Lupus Erythematosus, Systemic

2012 (2 papers)

  1. The discovery and development of belimumab: the anti-BLyS-lupus connection.
    Stohl W, Hilbert DM · Nat Biotechnol · 2012 · Background
    PubMed: PMID 22231104 · NCT05666336 · Lupus Erythematosus, Systemic
  2. Identification of urinary metabolites that distinguish membranous lupus nephritis from proliferative lupus nephritis and focal segmental glomerulosclerosis.
    Romick-Rosendale LE, Brunner HI, Bennett MR, et al. · Arthritis Res Ther · 2012 · Background
    PubMed: PMID 22152586 · NCT05666336 · Lupus Erythematosus, Systemic

2010 (1 paper)

  1. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial.
    Merrill JT, Neuwelt CM, Wallace DJ, et al. · Arthritis Rheum · 2010 · Background
    PubMed: PMID 20039413 · NCT05666336 · Lupus Erythematosus, Systemic

2009 (1 paper)

  1. Biomarkers of lupus nephritis determined by serial urine proteomics.
    Zhang X, Jin M, Wu H, et al. · Kidney Int · 2009 · Background
    PubMed: PMID 18596723 · NCT05666336 · Lupus Erythematosus, Systemic

2004 (1 paper)

  1. Is there really an increase in non-minimal change nephrotic syndrome in children?
    Filler G, Young E, Geier P, et al. · Am J Kidney Dis · 2004 · Background

2003 (1 paper)

  1. Nephrotic syndrome in childhood.
    Eddy AA, Symons JM · Lancet · 2003 · Background

1997 (1 paper)

  1. Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children.
    Tarshish P, Tobin JN, Bernstein J, et al. · J Am Soc Nephrol · 1997 · Background
    PubMed: PMID 9176846 · NCT06125405 (STERN) · Nephrotic Syndrome

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).