Efgartigimod PH20 SC Evidence: Trial Results and Peer-Reviewed Publications

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

The clinical evidence base for Efgartigimod PH20 SC comprises 40 peer-reviewed publications across 15 journals, 10 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Myasthenia Gravis, Purpura, Thrombocytopenic, Idiopathic, Post-Acute COVID-19 Syndrome, and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Most recent publication: Efgartigimod in Sjögren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO)., Ann Rheum Dis, 2026.

Top peer-reviewed publications

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

  1. Perioperative Safety and Efficacy of Efgartigimod for Thymoma-Associated Myasthenia Gravis: A Prospective, Multicenter, Phase II Clinical Trial.
    Wang S, Zhu M, Dong J, et al. · J Thorac Oncol · 2025
    PubMed: PMID 40320172 · NCT06221501 · Myasthenia Gravis
  2. Efgartigimod in Sjögren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO).
    Peene I, Verstappen GM, Arends S, et al. · Ann Rheum Dis · 2026
  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. Open-label study of efgartigimod in seronegative myasthenia gravis.
    Khateb M, Sivadasan A, Barnett-Tapia C, et al. · Ther Adv Neurol Disord · 2025
    PubMed: PMID 41180124 · NCT06587867 · Myasthenia Gravis
  5. Efficacy and Safety of Subcutaneous Efgartigimod PH20 in Adults With Primary Immune Thrombocytopenia (ADVANCE SC): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial.
    Cooper N, Broome CM, Miyakawa Y, et al. · Am J Hematol · 2026
    PubMed: PMID 41943179 · NCT04687072 (ADVANCE SC) · Purpura, Thrombocytopenic, Idiopathic
  6. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial.
    Broome CM, McDonald V, Miyakawa Y, et al. · Lancet · 2023
    PubMed: PMID 37778358 · NCT04188379 (ADVANCE) · Purpura, Thrombocytopenic, Idiopathic
  7. Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial.
    Azar AE, Sleasman JW, Steeland S, et al. · Front Immunol · 2026
  8. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial.
    Allen JA, Lin J, Basta I, et al. · Lancet Neurol · 2024
    PubMed: PMID 39304241 · NCT04281472 (ADHERE) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT04188379
ADVANCE
Purpura, Thrombocytopenic, IdiopathicPercentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial.
From Week 19 up to Week 24
Efgartigimod21.8 Percentage of participants
Placebo5.0 Percentage of participants
NCT04598451
ADDRESS
PemphigusNumber of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy
up to 30 weeks treatment period
Efgartigimod PH20 SC44 Participants
Placebo PH20 SC20 Participants
NCT04598477
ADDRESS+
PemphigusIncidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)
Up to 60 weeks
Efgartigimod-efgartigimod PH20 SC72.0 number of events x 100/PYFU
Efgartigimod-efgartigimod PH20 SC116.4 number of events x 100/PYFU
Efgartigimod-efgartigimod PH20 SC24.5 number of events x 100/PYFU
Placebo-efgartigimod PH20 SC69.3 number of events x 100/PYFU
Placebo-efgartigimod PH20 SC113.0 number of events x 100/PYFU
Placebo-efgartigimod PH20 SC14.6 number of events x 100/PYFU
NCT04687072
ADVANCE SC
Purpura, Thrombocytopenic, IdiopathicPercentage of Participants With Chronic Immune Thrombocytopenia (ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24
Up to 6 weeks (between Weeks 19 and 24)
Efgartigimod PH20 SC13.7 percentage of participants
Placebo PH20 SC16.2 percentage of participants
NCT04735432
ADAPTsc
Myasthenia GravisPercent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)
From week 0 to week 4
Efgartigimod IV-62.2 percent
Efgartigimod PH20 SC-66.4 percent
NCT04818671
ADAPTSC+
Myasthenia GravisNumber of AEs, SAEs and AESIs
Up to 3.5 years
Efgartigimod PH20 SC3325 events
Efgartigimod PH20 SC107 events
Efgartigimod PH20 SC420 events
NCT04980495
ADAPT NXT
Myasthenia GravisMean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm
Up to 21 weeks
Efgartigimod IV - Continuous Regimen-4.61 Score on a scale
Efgartigimod IV - Cyclic Regimen-5.13 Score on a scale
NCT05267600
BALLAD
Pemphigoid, BullousNumber of Participants With CRoff at Week 36
at week 36
Efgartigimod PH20 SC8 Participants
Placebo PH20 SC2 Participants
NCT05681481
BALLAD+
Pemphigoid, BullousNumber of Participants Who Discontinued Treatment Because of Safety Concerns
Up to 56 weeks
Efgartigimod PH20 SC4 Participants
NCT05681481
BALLAD+
Pemphigoid, BullousNumber of Participants With Treatment-emergent AEs, SAEs and AESIs
Up to 56 weeks
Efgartigimod PH20 SC40 Participants
Efgartigimod PH20 SC13 Participants
Efgartigimod PH20 SC25 Participants

Publications by year

19982026: 40 publications.

1998
1
1999
1
2003
2
2005
1
2010
1
2011
1
2012
2
2013
1
2014
2
2017
4
2019
4
2021
1
2022
1
2023
3
2024
9
2025
3
2026
3

Publications by indication

Myasthenia Gravis (9)

  • Perioperative Safety and Efficacy of Efgartigimod for Thymoma-Associated Myasthenia Gravis: A Prospective, Multicenter, Phase II Clinical Trial.
    J Thorac Oncol · 2025 · PMID 40320172 · NCT06221501
  • 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
  • Open-label study of efgartigimod in seronegative myasthenia gravis.
    Ther Adv Neurol Disord · 2025 · PMID 41180124 · NCT06587867
  • Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis.
    Front Neurol · 2024 · PMID 38318236 · NCT06765161
  • Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial.
    Lancet Neurol · 2021 · PMID 34146511 · NCT06765161

Purpura, Thrombocytopenic, Idiopathic (2)

  • Efficacy and Safety of Subcutaneous Efgartigimod PH20 in Adults With Primary Immune Thrombocytopenia (ADVANCE SC): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial.
    Am J Hematol · 2026 · PMID 41943179 · NCT04687072
  • Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial.
    Lancet · 2023 · PMID 37778358 · NCT04188379

Post-Acute COVID-19 Syndrome (1)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1)

  • Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial.
    Lancet Neurol · 2024 · PMID 39304241 · NCT04281472

Publications by journal

Trial-results highlights

In studies for chronic idiopathic thrombocytopenic purpura (ITP), the ADVANCE trial (NCT04188379) reported that **21.8%** of participants receiving **efgartigimod** achieved a sustained platelet count response between Week 19 and 24, compared to 5.0% on placebo. In the ADVANCE SC trial (NCT04687072), 13.7% of participants on efgartigimod PH20 SC achieved a sustained platelet count response between Weeks 19 and 24, versus 16.2% on placebo PH20 SC. For pemphigus, the ADDRESS trial (NCT04598451) showed that **44 participants** receiving efgartigimod PH20 SC achieved complete clinical remission on minimal prednisone therapy, compared to 20 participants on placebo PH20 SC. The ADDRESS+ trial (NCT04598477) monitored safety outcomes up to 60 weeks.

  • For the **efgartigimod-efgartigimod PH20 SC

All Efgartigimod PH20 SC publications (40)

2026 (3 papers)

  1. Efgartigimod in Sjögren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO).
    Peene I, Verstappen GM, Arends S, et al. · Ann Rheum Dis · 2026 · Derived
  2. Efficacy and Safety of Subcutaneous Efgartigimod PH20 in Adults With Primary Immune Thrombocytopenia (ADVANCE SC): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial.
    Cooper N, Broome CM, Miyakawa Y, et al. · Am J Hematol · 2026 · Derived
    PubMed: PMID 41943179 · NCT04687072 (ADVANCE SC) · Purpura, Thrombocytopenic, Idiopathic
  3. Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial.
    Azar AE, Sleasman JW, Steeland S, et al. · Front Immunol · 2026 · Derived

2025 (3 papers)

  1. Perioperative Safety and Efficacy of Efgartigimod for Thymoma-Associated Myasthenia Gravis: A Prospective, Multicenter, Phase II Clinical Trial.
    Wang S, Zhu M, Dong J, et al. · J Thorac Oncol · 2025 · Derived
    PubMed: PMID 40320172 · NCT06221501 · Myasthenia Gravis
  2. 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
  3. Open-label study of efgartigimod in seronegative myasthenia gravis.
    Khateb M, Sivadasan A, Barnett-Tapia C, et al. · Ther Adv Neurol Disord · 2025 · Derived
    PubMed: PMID 41180124 · NCT06587867 · Myasthenia Gravis

2024 (9 papers)

  1. Tackling POTS Needs More Than Just a Sympathetic Approach.
    Dani M, Fedorowski A · Hypertension · 2024 · Derived
    PubMed: PMID 39413203 · NCT05633407 (POTS) · Post-Acute COVID-19 Syndrome
  2. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial.
    Allen JA, Lin J, Basta I, et al. · Lancet Neurol · 2024 · Derived
    PubMed: PMID 39304241 · NCT04281472 (ADHERE) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
  3. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis.
    Vu T, Meisel A, Mantegazza R, et al. · NEJM Evid · 2024 · Background
  4. Understanding the burden of refractory myasthenia gravis.
    Schneider-Gold C, Hagenacker T, Melzer N, et al. · Ther Adv Neurol Disord · 2024 · Background
  5. Therapeutic Plasma Exchange in Myasthenia Gravis: A Systematic Literature Review and Meta-Analysis of Comparative Evidence.
    Ipe TS, Davis AR, Raval JS, et al. · Front Neurol · 2024 · Background
  6. Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis.
    Howard JF, Bril V, Vu T, et al. · Front Neurol · 2024 · Background
    PubMed: PMID 38318236 · NCT06765161 · Myasthenia Gravis
  7. Hospitalizations and Mortality From Myasthenia Gravis: Trends From 2 US National Datasets.
    Habib AA, Sacks N, Cool C, et al. · Neurology · 2024 · Background
  8. How should newer therapeutic agents be incorporated into the treatment of patients with myasthenia gravis?
    Gwathmey KG, Ding H, Hehir M, et al. · Muscle Nerve · 2024 · Background
  9. Adverse Events and Infectious Complications in the Critically Ill Treated by Plasma Exchange: A Five-Year Multicenter Cohort Study.
    François M, Daubin D, Menouche D, et al. · Crit Care Explor · 2024 · Background

2023 (3 papers)

  1. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial.
    Broome CM, McDonald V, Miyakawa Y, et al. · Lancet · 2023 · Derived
    PubMed: PMID 37778358 · NCT04188379 (ADVANCE) · Purpura, Thrombocytopenic, Idiopathic
  2. Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis.
    Bril V, Szczudlik A, Vaitkus A, et al. · Neurology · 2023 · Background
  3. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study.
    Bril V, Drużdż A, Grosskreutz J, et al. · Lancet Neurol · 2023 · Background

2022 (1 paper)

  1. Comparison of Corticosteroid Tapering Regimens in Myasthenia Gravis: A Randomized Clinical Trial.
    Sharshar T, Porcher R, Demeret S, et al. · JAMA Neurol · 2022 · Background

2021 (1 paper)

  1. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial.
    Howard JF, Bril V, Vu T, et al. · Lancet Neurol · 2021 · Background
    PubMed: PMID 34146511 · NCT06765161 · Myasthenia Gravis

2019 (4 papers)

  1. Neonatal Fc receptor antagonist efgartigimod safely and sustainably reduces IgGs in humans.
    Ulrichts P, Guglietta A, Dreier T, et al. · J Clin Invest · 2019 · Background
  2. Randomized phase 2 study of FcRn antagonist efgartigimod in generalized myasthenia gravis.
    Howard JF, Bril V, Burns TM, et al. · Neurology · 2019 · Background
  3. Adverse Effects of Immunoglobulin Therapy.
    Guo Y, Tian X, Wang X, et al. · Front Immunol · 2019 · Background
  4. Treatment of Myasthenia Gravis.
    Farmakidis C, Pasnoor M, Dimachkie MM, et al. · Neurol Clin · 2019 · Background

2017 (4 papers)

  1. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study.
    Howard JF, Utsugisawa K, Benatar M, et al. · Lancet Neurol · 2017 · Background
  2. Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis.
    Guptill JT, Juel VC, Massey JM, et al. · Autoimmunity · 2017 · Background
  3. Myasthenia Gravis.
    Gilhus NE · N Engl J Med · 2017 · Background
  4. International clinimetric evaluation of the MG-QOL15, resulting in slight revision and subsequent validation of the MG-QOL15r.
    Burns TM, Sadjadi R, Utsugisawa K, et al. · Muscle Nerve · 2017 · Background
    PubMed: PMID 27220659 · NCT06765161 · Myasthenia Gravis

2014 (2 papers)

  1. Therapeutic plasma exchange in patients with neurological diseases: multicenter retrospective analysis.
    Kaya E, Keklik M, Sencan M, et al. · Transfus Apher Sci · 2014 · Background
  2. Minimal clinically important difference in myasthenia gravis: outcomes from a randomized trial.
    Katzberg HD, Barnett C, Merkies IS, et al. · Muscle Nerve · 2014 · Background

2013 (1 paper)

  1. Intravenous immunoglobulin for myasthenia gravis.
    Gajdos P, Chevret S, Toyka KV, et al. · Cochrane Database Syst Rev · 2013 · Background

2012 (2 papers)

  1. Intravenous immune globulin in autoimmune and inflammatory diseases.
    Gelfand EW · N Engl J Med · 2012 · Background
  2. The quantitative myasthenia gravis score: comparison with clinical, electrophysiological, and laboratory markers.
    Barnett C, Katzberg H, Nabavi M, et al. · J Clin Neuromuscul Dis · 2012 · Background
    PubMed: PMID 22622164 · NCT06765161 · Myasthenia Gravis

2011 (1 paper)

  1. Comparison of IVIg and PLEX in patients with myasthenia gravis.
    Barth D, Nabavi Nouri M, Ng E, et al. · Neurology · 2011 · Background

2010 (1 paper)

  1. The neonatal Fc receptor as therapeutic target in IgG-mediated autoimmune diseases.
    Sesarman A, Vidarsson G, Sitaru C, et al. · Cell Mol Life Sci · 2010 · Background
    PubMed: PMID 20217455 · NCT06765161 · Myasthenia Gravis

2005 (1 paper)

  1. Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin: a randomized double-blind clinical trial.
    Gajdos P, Tranchant C, Clair B, et al. · Arch Neurol · 2005 · Background

2003 (2 papers)

  1. The epidemiology of myasthenia gravis.
    Phillips LH · Ann N Y Acad Sci · 2003 · Background
  2. Therapeutic apheresis in Sweden: update of epidemiology and adverse events.
    Norda R, Stegmayr BG, Swedish Apheresis Group, et al. · Transfus Apher Sci · 2003 · Background

1999 (1 paper)

  1. Myasthenia gravis activities of daily living profile.
    Wolfe GI, Herbelin L, Nations SP, et al. · Neurology · 1999 · Background
    PubMed: PMID 10227640 · NCT06765161 · Myasthenia Gravis

1998 (1 paper)

  1. Reliability testing of the quantitative myasthenia gravis score.
    Barohn RJ, McIntire D, Herbelin L, et al. · Ann N Y Acad Sci · 1998 · Background

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).