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Study design
MG-ADL
QMG
MG-ADL responders
Anti-AChR
Anti-MuSK
Post hoc analyses

VIVACITY-MG3 Phase 3 design summary1–4

The primary endpoint for IMAAVY was evaluated to Weeks 22, 23,
and 24, which is the longest of any FcRn pivotal trial for the treatment of gMG.1,2

The primary efficacy endpoint was the mean change from baseline to Weeks 22, 23, and 24 in the MG-ADL total score.1

VIVACITY Phase 3 design summaryVIVACITY Phase 3 design summary

*VIVACITY is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 24-week study that assessed the efficacy and safety of IMAAVY + SOC administered via IV infusion in adult patients with gMG that was inadequately controlled (MGFA Clinical Classification Class II-IV for gMG with stable MG therapy and MG-ADL scores ≥6 at screening and baseline) vs placebo + SOC. Patients in the primary efficacy analysis set were seropositive per protocol (including anti-AChR+ or anti-MuSK+). The primary efficacy endpoint was the mean change from baseline in MG-ADL total score to Weeks 22, 23, and 24.2

†This trial included patients with the 2 most common subtypes of gMG, AChR+ and MuSK+. Eighty-eight percent (n=134) of patients were positive for anti-AChR antibodies and 10% (n=16) were positive for anti-MuSK antibodies. These subtypes account for ~90% of all patients living with gMG.1,2

‡SOC therapies included AChEIs, steroids, or NSISTs, either in combination or alone. At pivotal trial double-blind baseline, in each group, 85% of patients received AChE inhibitors, 66% of patients received steroids, and 54% of patients received NSISTs at stable doses.1

The pivotal study assessed IMAAVY + SOC therapy compared with placebo + SOC therapy. 153 antibody-positive adult patients with gMG (including anti-AChR+ or anti-MuSK+) were included in the efficacy analysis, and 196 patients were included in the safety profile analysis.1

All study participants who completed the pivotal trial period were eligible to continue into the OLE.1

Key inclusion criteria1,4:

  • Adults (aged ≥18 years)
  • MGFA Clinical Classification Class II a/b, III a/b, or IV a/b for gMG that was not well controlled with stable MG therapy (or for those who discontinued MG therapy due to intolerance or lack of efficacy)
  • MG-ADL score ≥6 at screening and baseline

Key exclusion criteria3:

  • MGFA Class I disease or presence of MG crisis (MGFA Class V)
  • Certain concomitant medications or coexisting/past medical conditions (eg, hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension)
  • Infections/immunodeficiency
  • Patients who are lactating or pregnant
  • Other (hypersensitivity to IMAAVY, suicidal ideation, severe substance or alcohol use disorder, etc)
IMAAVY + SOCPlacebo + SOCTotal
N
N7776153
Age
Mean years (SD)
Mean years (SD)52.5 (15.66)52.3 (16.37)52.4 (15.97)
Range
Range20-8120-8120-81
Sex, n (%)
Female
Female50 (65%)42 (55%)92 (60%)
Male
Male27 (35%)34 (45%)61 (40%)
Race, n (%)
American Indian or
Alaska Native
American Indian or
Alaska Native		1 (1%)01 (1%)
Asian
Asian24 (31%)25 (33%)49 (32%)
Black or African American
Black or African American1 (1%)1 (1%)2 (1%)
White
White49 (64%)47 (62%)96 (63%)
Not reported
Not reported2 (3%)3 (4%)5 (4%)
Antibody status at screening
N
N7776153
Seropositive, n (%)§
Seropositive, n (%)§77 (100%)76 (100%)153 (100%)
Anti-AChR+, n (%)
Anti-AChR+, n (%)63 (82%)71 (93%)134 (88%)
Anti-MuSK+, n (%)
Anti-MuSK+, n (%)12 (16%)4 (5%)16 (10%)
Baseline MG-ADL score
N
N7776153
Mean (SD)
Mean (SD)9.4 (2.73)9.0 (1.97)9.2 (2.38)
Range
Range6–186–136–18
≤9, n (%)
≤9, n (%)48 (62%)45 (59%)93 (61%)
>9, n (%)
>9, n (%)29 (38%)31 (41%)60 (39%)
Baseline QMG score
N
N7776149
Mean (SD)
Mean (SD)15.1 (4.78)15.7 (4.92)15.4 (4.85)
Range
Range7-285-285-28
MGFA class
N
N7776153
I, n (%)
I, n (%)1 (1%)||01 (1%)
lla, n (%)
lla, n (%)7 (9%)10 (13%)17 (11%)
llb, n (%)
llb, n (%)11 (14%)10 (13%)21 (14%)
llla, n (%)
llla, n (%)34 (44%)29 (38%)63 (41%)
lllb, n (%)
lllb, n (%)17 (22%)15 (20%)32 (21%)
lVa, n (%)
lVa, n (%)3 (4%)10 (13%)13 (9%)
lVb, n (%)
lVb, n (%)4 (5%)2 (3%)6 (4%)

AChEI=acetylcholinesterase inhibitor; AChR=acetylcholine receptor; AE=adverse event; DB=double blind; FcRn=neonatal fragment crystallizable receptor; gMG=generalized myasthenia gravis; IV=intravenous; MACE=major adverse cardiovascular event; MG=myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; MOA=mechanism of action; MuSK=muscle-specific tyrosine kinase; NSIST=non-steroidal immunosuppressive therapy; OLE=open-label extension; Q2W=every 2 weeks; QMG=Quantitative Myasthenia Gravis; SD=standard deviation; SE=standard error; SOC, standard of care.

§Eighty-eight percent (n=134) of patients were positive for AChR antibodies and 10% (n=16) were positive for MuSK antibodies. These subtypes account for ~90% of all patients living with gMG.1,2

||Patient had MGFA Class IIa at screening and MG-ADL of 8 at both screening and baseline.

References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8 3. Data on file. Janssen Biotech, Inc. 4. Antozzi C, Vu T, Ramchandren S, et al. Supplement to: Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S14N4-4422(24)00498-8

In the primary endpoint, IMAAVY® + SOC demonstrated superior disease control that lasts* vs placebo + SOC in a 24-week clinical trial1,2

IMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADLIMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADL

SE=standard error.

IMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADLIMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADL
View safety data

References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/
S1474-4422(24)00498-8

In the key secondary endpoint, IMAAVY® + SOC demonstrated superior disease control that lasts* vs placebo + SOC in a 24-week clinical trial1,2

IMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADLIMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADL

SE=standard error.

IMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADLIMAAVY + SOC vs placebo + SOC mean change from baseline in MG-ADL
View safety data

References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8

Percentage of MG-ADL responders was a prespecified secondary endpoint1*

The percentage of patients who achieved ≥2-point average reduction in MG-ADL to Weeks 22, 23, and 24 was a prespecified secondary endpoint in the pivotal trial for IMAAVY.1

MG-ADL responders were defined as patients with an average total MG-ADL score to Weeks 22, 23, and 24 of ≥2-point improvement compared with baseline.

69% of patients taking IMAAVY + SOC were MG-ADL responders
vs
53% of patients taking placebo + SOC were MG-ADL responders

*The P value is based on the Cochran-Mantel-Haenszel test for difference between treatments, adjusting for the baseline MG-ADL total score randomization strata (≤9, >9), antibody status (as randomized), and region.1

Reference: 1. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8

Subgroup analyses* evaluated MG-ADL and QMG reduction in patients with anti-AChR antibody-positive gMG1,2

In this subgroup, patients taking IMAAVY + SOC showed reduction in MG-ADL and QMG consistent with the overall study population.1,2

MG-ADL: 3.79-PT average reduction in MG-ADL total score to Weeks 22, 23, and 24 with IMAAVY + SOC (n=63) vs QMG: 4.89-PT average reduction in QMG total score to Weeks 22 and 24 with IMAAVY + SOC (n=11)
vs
MG-ADL: 3.44-PT average reduction in MG-ADL total score to Weeks 22, 23, and 24 with placebo + SOC (n=70) vs QMG: 1.73-PT average reduction in QMG total score to Weeks 22 and 24 with placebo + SOC (n=70)

These prespecified endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*Subgroup analyses of change from baseline in MG-ADL total score to Weeks 22, 23, and 24, and change from baseline in QMG total score to Weeks 22 and 24, based on specific antibody status (anti-AChR+ or anti-MuSK+), were performed using the full analysis set.1,2

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8 2. Antozzi C, Vu T, Ramchandren S, et al. Supplement to: Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/
S1474-4422(24)00498-8

Subgroup analyses* evaluated MG-ADL and QMG reduction in patients with anti-MuSK antibody-positive gMG1,2

In this subgroup, patients taking IMAAVY + SOC showed reduction in MG-ADL and QMG consistent with the overall study population.1,2

MG-ADL: 3.79-PT average reduction in MG-ADL total score to Weeks 22, 23, and 24 with IMAAVY + SOC (n=12) vs QMG: 5.50-PT average reduction in QMG total score to Weeks 22 and 24 with IMAAVY + SOC (n=11)
vs
MG-ADL: 0.25-PT average reduction in MG-ADL total score to Weeks 22, 23, and 24 with placebo + SOC (n=4) vs QMG: 1.73-PT average reduction in QMG total score to Weeks 22 and 24 with placebo + SOC (n=11)

Anti-MuSK+ subgroups included a smaller population. These prespecified endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.1,2

*Subgroup analyses of change from baseline in MG-ADL total score to Weeks 22, 23, and 24, and change from baseline in QMG total score to Weeks 22 and 24, based on specific antibody status (anti-AChR+ or anti-MuSK+), were performed using the full analysis set.1,2

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8 2. Antozzi C, Vu T, Ramchandren S, et al. Supplement to: Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/
S14N4-4422(24)00498-8

In an exploratory post hoc analysis1-3

In a post hoc exploratory and descriptive analysis of the VIVACITY-MG3 phase 3 trial (primary efficacy population):

41/77 patients receiving IMAAVY + SOC were MG-ADL responders* vs 30/76 patients receiving placebo + SOC2,341/77 patients receiving IMAAVY + SOC were MG-ADL responders* vs 30/76 patients receiving placebo + SOC2,3
88% of patients taking IMAAVY + SOC who were Week 2 responders maintained response to Week 24

*Responders were defined as patients who achieved ≥2-point average reduction in MG-ADL score.3

This post hoc analysis is exploratory and descriptive, and was not adjusted for multiplicity. Therefore, statistical significance has not been established.

Change in MG-ADL domain-level symptoms across all muscle function groups was evaluated with IMAAVY® + SOC vs
placebo + SOC4

IMAAVY + SOC vs placebo + SOC MG-ADL domain mean change from baseline at Week 24IMAAVY + SOC vs placebo + SOC MG-ADL domain mean change from baseline at Week 24

This post hoc analysis is exploratory and descriptive, therefore, statistical significance has not been established.

Methodology: This post hoc analysis was based on the primary efficacy analysis set of the VIVACITY-MG3 trial and evaluated the differences between IMAAVY + SOC and placebo + groups in mean change from baseline in MG-ADL domains at Week 24, which were analyzed using analysis of covariance (ANCOVA) models, with fixed effects for​ treatment group, autoantibody status, and region, and the corresponding baseline value as a covariate.​4

ANCOVA=analysis of covariance; MG-ADL, Myasthenia Gravis Activities of Daily Living; SOC, standard of care.

*Domains include respiratory (breathing), ocular (double vision, eyelid droop), limb function (brushing teeth or hair, arising from chair), and bulbar (talking, chewing, swallowing).4

Observed changes in moderate to severe ocular manifestations were evaluated for IMAAVY + SOC5

In a subgroup of patients with moderate to severe ocular manifestations from the primary efficacy analysis set with a baseline score ≥2 points on either diplopia or ptosis items of MG-ADL scale5:

IMAAVY vs placebo mean change from baseline at Week 24 in MD-ADL ocular domain scoreIMAAVY vs placebo mean change from baseline at Week 24 in MD-ADL ocular domain score
A greater proportion of patients showed a meaningful within-person improvement in ocular symptoms at Week 24 with IMAAVY + SOC vs placebo + SOC

This post hoc analysis was exploratory and not adjusted for multiplicity; therefore, statistical significance has not been established.

LSM=least squares mean.

References: 1. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8 2. Data on file. Janssen Biotech, Inc. 3. Vu T, Beydoun SR, Nowak RJ, et al. Evaluation of sustained disease control with nipocalimab versus placebo in the phase 3 Vivacity-MG3 study. Eur J Neurol. 2026;33:e70599. doi:10.1111/ene.70599 4. Farmakidis C, Gandhi K, Ait-Tihyaty M, et al. Symptom severity assessment in using MG-ADL items and domains in a 24-week, phase 3 study (Vivacity) of nipocalimab in generalized myasthenia gravis. Poster presented at: American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting: October 15-18, 2024; Savannah, GA. 5. Claeys KG, Gandhi K, Ait-Tihyaty M, et al. Efficacy of nipocalimab in adult patients with moderate-to-severe ocular manifestations of generalized myasthenia gravis in phase 3 Vivacity-MG3 study. Poster presented at: American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting: October 29-November 1, 2025; San Francisco, CA.