Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)
Johnson & Johnson (NYSE: JNJ) has announced promising results from their Phase 3 Vivacity-MG3 study and open-label extension (OLE) for nipocalimab in treating generalized myasthenia gravis (gMG). The data shows sustained disease control over 84 weeks with significant improvements in patient outcomes.
Key findings include:
- 45% of patients on steroids were able to reduce or discontinue their use, with mean prednisone doses decreasing from 23 to 10 mg daily
- Patients treated with nipocalimab plus standard of care showed 4x greater odds of symptom improvement
- 36.4% of nipocalimab-treated patients versus 10.5% on placebo maintained improved muscle strength for over 75% of the study duration
- The treatment demonstrated sustained reduction in immunoglobulin G antibodies and maintained improvements in MG-ADL and QMG scores
The study included up to 128 weeks and 180 patient years of follow-up, confirming a consistent safety profile.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati promettenti dal loro studio di Fase 3 Vivacity-MG3 e dall'estensione in aperto (OLE) per nipocalimab nel trattamento della miastenia gravis generalizzata (gMG). I dati mostrano un controllo sostenuto della malattia per 84 settimane con significativi miglioramenti negli esiti dei pazienti.
I risultati chiave includono:
- Il 45% dei pazienti in terapia steroidea è stato in grado di ridurre o interrompere l'uso, con dosi medie di prednisone che sono diminuite da 23 a 10 mg al giorno
- I pazienti trattati con nipocalimab più il trattamento standard hanno mostrato 4 volte maggiori probabilità di miglioramento dei sintomi
- Il 36,4% dei pazienti trattati con nipocalimab rispetto al 10,5% in placebo ha mantenuto una forza muscolare migliorata per oltre il 75% della durata dello studio
- Il trattamento ha dimostrato una riduzione sostenuta degli anticorpi immunoglobulina G e ha mantenuto miglioramenti nei punteggi MG-ADL e QMG
Lo studio ha incluso fino a 128 settimane e 180 anni paziente di follow-up, confermando un profilo di sicurezza coerente.
Johnson & Johnson (NYSE: JNJ) ha anunciado resultados prometedores de su estudio de Fase 3 Vivacity-MG3 y la extensión en abierto (OLE) para nipocalimab en el tratamiento de la miastenia gravis generalizada (gMG). Los datos muestran un control sostenido de la enfermedad durante 84 semanas con mejoras significativas en los resultados de los pacientes.
Los hallazgos clave incluyen:
- El 45% de los pacientes que estaban en tratamiento con esteroides pudo reducir o interrumpir su uso, con dosis medias de prednisona disminuyendo de 23 a 10 mg diarios
- Los pacientes tratados con nipocalimab más el tratamiento estándar mostraron 4 veces más probabilidades de mejorar los síntomas
- El 36,4% de los pacientes tratados con nipocalimab en comparación con el 10,5% en placebo mantuvo una mejoría de la fuerza muscular durante más del 75% de la duración del estudio
- El tratamiento demostró una reducción sostenida de los anticuerpos IgG y mantuvo mejoras en las puntuaciones de MG-ADL y QMG
El estudio incluyó hasta 128 semanas y 180 años-paciente de seguimiento, confirmando un perfil de seguridad consistente.
존슨앤존슨 (NYSE: JNJ)는 일반화된 중증 근무력증(gMG) 치료를 위한 니포칼리맙의 3상 비바시티-MG3 연구 및 개방형 확장(OLE)에서 유망한 결과를 발표했습니다. 데이터는 84주 동안 지속적인 질병 조절을 보여주며 환자 결과의 중요한 개선을 나타냅니다.
주요 발견 사항은 다음과 같습니다:
- 스테로이드를 복용 중인 환자의 45%가 사용을 줄이거나 중단할 수 있었으며, 평균 프레드니손 복용량이 하루 23mg에서 10mg으로 감소했습니다.
- 니포칼리맙과 표준 치료를 받은 환자들은 증상 개선의 가능성이 4배 더 높았습니다.
- 니포칼리맙 치료를 받은 환자의 36.4%가 위약의 10.5%에 비해 연구 기간의 75% 이상 동안 개선된 근력 유지했습니다.
- 치료는 면역글로불린 G 항체의 지속적인 감소를 보여주었고 MG-ADL 및 QMG 점수의 개선을 유지했습니다.
이 연구는 최대 128주와 180 환자 연도의 추적 조사를 포함하여 일관된 안전성 프로필을 확인했습니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats prometteurs de leur étude de Phase 3 Vivacity-MG3 et de l'extension en ouvert (OLE) pour le nipocalimab dans le traitement de la myasthénie grave généralisée (gMG). Les données montrent un contrôle durable de la maladie sur 84 semaines avec des améliorations significatives des résultats des patients.
Les résultats clés incluent:
- 45% des patients sous stéroïdes ont pu réduire ou interrompre leur utilisation, avec des doses moyennes de prednisone diminuant de 23 à 10 mg par jour
- Les patients traités avec nipocalimab plus le traitement standard ont montré 4 fois plus de chances d'amélioration des symptômes
- 36,4% des patients traités avec nipocalimab contre 10,5% sous placebo ont maintenu une force musculaire améliorée pendant plus de 75% de la durée de l'étude
- Le traitement a montré une réduction durable des anticorps immunoglobuline G et a maintenu des améliorations dans les scores MG-ADL et QMG
L'étude a inclus jusqu'à 128 semaines et 180 années-patients de suivi, confirmant un profil de sécurité cohérent.
Johnson & Johnson (NYSE: JNJ) hat vielversprechende Ergebnisse aus ihrer Phase-3-Studie Vivacity-MG3 und der offenen Verlängerung (OLE) für Nipocalimab zur Behandlung der generalisierten Myasthenia gravis (gMG) angekündigt. Die Daten zeigen eine nachhaltige Krankheitskontrolle über 84 Wochen mit signifikanten Verbesserungen der Patientenergebnisse.
Wichtige Ergebnisse umfassen:
- 45% der Patienten, die Steroide einnahmen, konnten ihren Gebrauch reduzieren oder einstellen, wobei die durchschnittliche Dosis von Prednison von 23 auf 10 mg täglich gesenkt wurde
- Patienten, die mit Nipocalimab plus Standardbehandlung behandelt wurden, hatten eine 4-mal höhere Wahrscheinlichkeit für eine Verbesserung der Symptome
- 36,4% der mit Nipocalimab behandelten Patienten im Vergleich zu 10,5% in der Placebo-Gruppe hielten eine verbesserte Muskelkraft für mehr als 75% der Studiendauer aufrecht
- Die Behandlung zeigte eine nachhaltige Reduktion von Immunoglobulin G-Antikörpern und hielt die Verbesserungen in den MG-ADL- und QMG-Werten aufrecht
Die Studie umfasste bis zu 128 Wochen und 180 Patientenjahre Nachbeobachtung und bestätigte ein konsistentes Sicherheitsprofil.
- 45% of steroid-using patients reduced or discontinued their medication
- 4x higher odds of sustained symptom improvement vs placebo
- 36.4% of treated patients maintained improved muscle strength (vs 10.5% placebo)
- Consistent and tolerable safety profile throughout the extended study
- Significant QMG score improvements (-4.9 vs placebo)
- None.
Insights
The positive 84-week data for nipocalimab represents a meaningful clinical advancement in Johnson & Johnson's immunology pipeline. With sustained disease control and antibody reduction over this extended period, the drug demonstrates potential long-term efficacy critical for chronic conditions like gMG. What stands out is the impressive QMG score improvement versus placebo (-4.9 points, p<0.001) and the four-fold greater odds of sustained symptom improvement versus standard care.
Particularly compelling is that 45% of steroid-treated patients could reduce or discontinue their steroid use, with average prednisone doses decreasing from
The safety profile remains consistent with earlier findings across 180 patient years of follow-up data, which helps de-risk the asset from a regulatory perspective. For J&J's broader portfolio strategy, nipocalimab represents a potential cornerstone of their growing autoimmune franchise, where they've historically maintained strength. The drug's mechanism targeting IgG antibodies gives it potential applications beyond gMG in other autoantibody-mediated diseases, suggesting platform potential that could enhance long-term value beyond this initial indication.
These nipocalimab results represent potentially significant clinical value for gMG patients. The sustained improvements in MG-ADL scores (-5.64 points for the continuous nipocalimab group and -6.01 for crossover patients) are well above the 2-point threshold generally considered clinically meaningful. Similarly, the QMG improvements exceed the clinically significant 3-point threshold, with 36.4% of nipocalimab patients maintaining this improvement for over 75% of the study duration versus just 10.5% with placebo.
What's particularly valuable is the demonstrated efficacy across multiple antibody subtypes (AChR+, MuSK+, and LRP4+). Current approved therapies often show variable responses depending on antibody status, so this broad effectiveness addresses an important treatment gap. The steroid-reduction capability further enhances nipocalimab's clinical utility, as chronic steroid use in gMG leads to significant complications including osteoporosis, diabetes, and immunosuppression.
The functional improvements in muscle groups affecting daily activities like swallowing and speech directly address quality-of-life factors most important to patients. While we await full Phase 3 completion and potential regulatory submission, these results suggest nipocalimab could offer meaningful advantages over existing treatment options in terms of both efficacy breadth and steroid-sparing potential, potentially positioning it as an important new option in the gMG treatment armamentarium.
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase
Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study
Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMGb response versus placebo plus SOC in the 24-week double blind phase of the study
"The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalized MG and the significant burden on people living with this condition," said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Centerd. "Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies."
Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.1 In the antibody-positive population,
Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.2 Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score.2 Results show significantly more patients treated with nipocalimab (
"People living with generalized MG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time," said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG."
Editor's notes:
a. | The open-label extension (OLE) interim analysis includes 60 weeks of open-label data, totalling 84 weeks for nipocalimab-treated participants, including 24 weeks from the treatment group of the double-blind phase. Some patients have follow-up data extending to 128 weeks.1 | ||
b. | QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.3 | ||
c. | MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.3 | ||
d. | Dr. Constantine Farmakidis M.D. has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. |
ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK] or anti-low density lipoprotein-related protein 4 [LRP4]), which target proteins at the neuromuscular junction, and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.5,6,7 The disease impacts an estimated 700,000 people worldwide.5 The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.8 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.9,10,11 Approximately 10 to
Initial disease manifestations are usually ocular, but 85 percent of MG patients experience additional advancements to the disease manifestations – referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness of the skeletal muscles and difficulties in speech and swallowing.18,19,20,21,22 Approximately 100,000 individuals in the
ABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.25,26 Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.25 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).25 The primary endpoint of the study was mean change in MG-ADLb score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.26
ABOUT NIPOCALIMAB
Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.26,27,28,29,30,31,32,33,34 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.35,36
The
U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren's disease (SjD) in March 2025U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024U.S. FDA granted Priority Review in gMG in Q4 2024- EU EMA Orphan medicinal product designation for HDFN in October 2019
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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FAQ
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