Trial reportNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2024
Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+).
Trial report in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis
A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effectiveness and safety of efgartigimod in myasthenia gravis: A meta-analysis of different antibody subtypes.Immunologic research · 2026Pooled it
- Efficacy and safety of rituximab in anti-MuSK myasthenia Gravis: a systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Long-Term Safety and Efficacy of Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: ADHERE/ADHERE+ Trial Interim Analysis.Journal of the peripheral nervous system : JPNS · 2026Trial
- Long-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+).Frontiers in neurology · 2026Trial
- ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis.Annals of clinical and translational neurology · 2025Trial
- Investigating the Pharmacokinetics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administered with a Prefilled Syringe.Advances in therapy · 2026Article
- Perioperative Use of Efgartigimod Alfa, a Neonatal Fc Receptor Antagonist, to Reduce Antiphospholipid Antibody Titers and Thrombotic Risk in a Kidney Transplant Recipient.Kidney medicine · 2026Article
- Severe Hypogammaglobulinemia (IgG) During Efgartigimod Therapy in Neurological Practice: A Real-World Case Series.Cureus · 2026Article
- Boom or Bust: Clinical Trials in Pemphigus and Other B-Cell-Mediated Autoimmune Diseases.The Journal of investigative dermatology · 2026Review
- Italian recommendations for the diagnosis and treatment of myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Minimal Symptom Expression in Generalized Myasthenia Gravis: A Valuable Patient-Centric Treatment Goal.European journal of neurology · 2026Review
- Assessing efgartigimod dosing patterns and Myasthenia Gravis Activities of Daily Living outcomes in clinical practice: results from a large patient support program database.Frontiers in neurology · 2026Article
- Research Progress in Pharmacological Targeted Therapy for Myasthenia Gravis.Journal of inflammation research · 2026Review
- Efgartigimod for Generalized Myasthenia Gravis and Beyond: A Narrative Review of Its Pharmacological Profile, Clinical Utility, and Expanding Applications.Biomedicines · 2025Review
- Effective Subcutaneous Efgartigimod Treatment in a 90-Year-Old Female With Myasthenia Gravis.Journal of clinical neurology (Seoul, Korea) · 2025Article
- Management of Myasthenic Crisis and Emerging Roles of Molecularly Targeted Therapies: A Narrative Review.Neurology international · 2025Review
- FcRn Blockade as a Targeted Therapeutic Strategy in Antibody-Mediated Autoimmune Diseases: A Focus on Warm Autoimmune Hemolytic Anemia.Antibodies (Basel, Switzerland) · 2025Review
- Real-World Experience with FcRn Inhibitors Efgartigimod and Rozanolixizumab in Myasthenia Gravis: Administration in Multiple Cycles and Transition from Intravenous to Subcutaneous Formulation.Neurology and therapy · 2025Article
- Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- New and Emerging Biological Therapies for Myasthenia Gravis: A Focussed Review for Clinical Decision-Making.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
ADAPT-SC (NCT04735432) was designed to evaluate noninferiority of subcutaneous (SC) efgartigimod PH20 to intravenous (IV) efgartigimod in participants with generalized myasthenia gravis (gMG). ADAPT-SC+ (NCT04818671) is an open-label extension study designed to assess long-term safety, tolerability, and efficacy of efgartigimod PH20 SC. Adult participants in ADAPT-SC were randomly assigned to receive a treatment cycle of 4 once-weekly administrations of efgartigimod PH20 SC 1000 mg or efgartigimod IV 10 mg/kg, followed by 7 weeks of follow-up. Primary endpoint was percentage change from baseline in total immunoglobulin G (IgG) level at week 4 (1 week after the fourth administration). Secondary efficacy endpoints assessed number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) responders and mean change from baseline in total score for each measure. The primary endpoint was met, demonstrating noninferiority in total IgG reduction between efgartigimod PH20 SC 1000 mg and efgartigimod IV 10 mg/kg. Clinically meaningful improvements were seen as early as 1 week following the first administration in both treatment arms, with maximal improvements at week 4. Continued treatment cycles of efgartigimod PH20 SC in ADAPT-SC+ have demonstrated long-term safety and consistent improvements in MG-ADL total score. Findings from ADAPT-SC and ADAPT-SC+ demonstrate similar safety and efficacy as observed in the placebo-controlled ADAPT study. Collectively, these findings support noninferiority between efgartigimod PH20 SC 1000 mg and efgartigimod IV 10 mg/kg, as well as long-term safety, tolerability, and efficacy of efgartigimod PH20 SC for treatment of a broad population of patients with gMG.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.