IMAAVY™ + SOC:
superior disease
control that
didn’t fade1,2*

Primary endpoint

IMAAVY + SOC demonstrated superior disease control† that didn’t fade1,2

vs placebo + SOC through Week 24

Patients taking IMAAVY + SOC therapy experienced a 4.7-point mean improvement in total MG-ADL score to Weeks 22, 23, and 24 while patients taking placebo + SOC therapy saw a 3.3-point mean improvement (P=0.002).1,2

†As measured by mean change from baseline to Weeks 22, 23, and 24 in MG-ADL total score.

View study design
mg-adl-chart
mg-adl-improvement
mg-adl-chart

Secondary endpoint

IMAAVY + SOC demonstrated significant improvement in muscle weakness‡ that didn’t fade1,2

vs placebo + SOC through Week 24

Patients taking IMAAVY + SOC therapy demonstrated a 4.9-point mean improvement in total QMG score to Weeks 22 and 24, while patients taking placebo + SOC therapy saw a 2.1-point mean improvement (P<0.001).1,2‡

‡As measured by mean change from baseline to Weeks 22 and 24 in QMG total score.

View study design
mg-adl-chart
mg-adl-improvement
mg-adl-chart

Other secondary endpoints

Percentage of MG-ADL responders was an additional
secondary endpoint2§

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.2

69% of patients taking IMAAVY + SOC (n=53/77)

69% of patients taking IMAAVY + SOC (n=53/77) were MG-ADL responders vs 53% for placebo +
SOC (n=40/76; P=0.021).2

§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. Among patients taking IMAAVY, 69% were considered MG-ADL responders; among patients taking placebo, 53% were considered responders (P=0.021). 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.2

In a post hoc analysis, Week 2 responders maintained response
to Week 243

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

88% of patients taking IMAAVY + SOC (n=36/41)

88% of patients taking IMAAVY + SOC (n=36/41) who were MG-ADL responders at Week 2
continued to have that response at Week 24.3

Limitations: This post hoc analysis is exploratory and descriptive; as such, it should be interpreted with caution.3

A subgroup analysis evaluated MG-ADL reduction in patients with anti-AChR and anti-MuSK antibody-positive gMG2,4||

In these subgroups, patients taking IMAAVY showed reduction in MG-ADL consistent with the overall study population.2,4

5.06-point MG-ADL reduction

AChR+

Patients with anti-AChR antibody-positive gMG (n=63) taking IMAAVY experienced a 5.06-point mean improvement from baseline in MG-ADL total score to Weeks 22, 23, and 24, while patients taking placebo (n=70) had a 3.44-point mean improvement from baseline.2,4

The between-group difference was -1.62 (95% CI: -2.62 to -0.62).4

3.79-point MG-ADL reduction

MuSK+

Patients with anti-MuSK antibody-positive gMG (n=12) taking IMAAVY experienced a 3.79-point mean improvement from baseline in MG-ADL total score to Weeks 22, 23, and 24, while patients taking placebo (n=4) had a 0.25-point mean improvement from baseline.2,4

The between-group difference was -3.54 (95% CI: -6.78 to -0.30).4

Limitations included the smaller population for both anti-AChR+ and anti-MuSK+ subgroups2,4

||Subgroup analyses of change from baseline in MG-ADL total score to Weeks 22, 23, and 24, based on specific antibody status (anti-AChR+ or anti-MuSK+), were performed using the full analysis set.2,4

Safety

Common adverse reactions

Adverse reactions (≥5%) of patients treated with IMAAVY and more frequently than with placebo1

The most common adverse reactions (≥10% of patients) for patients taking IMAAVY + SOC were respiratory tract infections, peripheral edema, and muscle spasms.1

Adverse reactionIMAAVY (n=98), %Placebo (n=98), %
Infection
Respiratory tract infection1813
Urinary tract infection#63
Herpes zoster and Herpes simplex62
Oral infection**53
Peripheral edema122
Muscle spasm123
Hypersensitivity reaction††87
Abdominal pain83
Back pain85
Pyrexia71
Diarrhea73
Cough73
Anemia#64
Dizziness51
Nausea52
Hypertension52
Insomnia52

Includes the following reported in patients treated with IMAAVY:

COVID-19 (and other related terms), pneumonia, bronchitis, pneumonia bacteria.

#Other related terms.

**Glossitis, oral candidiasis, pericoronitis, pulpitis dental, tooth abscess, tooth infection.

††Angioedema, dermatitis atopic, eczema, gingival swelling, rash (and other related terms), urticaria.

Rates of serious AEs,
AEs leading to discontinuation, and infection-related AEs were also reported in the
24-week pivotal trial

  • 9% of patients taking IMAAVY + SOC (n=9/98) experienced a serious AE vs 14% for patients taking placebo + SOC (n=14/98)2
  • 5% of patients taking IMAAVY + SOC (n=5/98) experienced an AE that led to permanent treatment discontinuation vs 7% for patients taking placebo + SOC (n=7/98)2
  • 43% of patients in each arm (n=42/98 for each) experienced an infection-related AE2
The safety of IMAAVY was evaluated in a broad population of antibody-positive adult patients with gMG (including women of childbearing age) and pediatric patients age 12 to 16 years with gMG who were anti-AChR+.1

Open-label extension

There is an ongoing open-label extension (OLE) study

Participants who completed the phase 3, double-blind VIVACITY trial were eligible to continue in this phase5

Study design5

view ole-enpoint-data

view ole-enpoint-data

137 antibody-positive participants in the OLE phase received IMAAVY every 2 weeks.4,5

Eligible participants for the OLE were4,5:

  • Patients who took IMAAVY + SOC in the pivotal trial and continued on IMAAVY in the OLE
  • Patients who took placebo + SOC in the pivotal trial and started IMAAVY on Day 1 of the OLE

Tapering of SOC therapy in the OLE was allowed if patients’ gMG was stable in the prior 4 weeks as reflected by MG-ADL and investigator discretion.5

All patients were observed for safety 1 hour post infusion for the first 3 IMAAVY infusions.4
‡‡All participants enrolling in the OLE phase were to receive IMAAVY 15 mg/kg given every 2 weeks by IV infusion, starting on Day 1 of the OLE phase. Assessment done at the Week 24 visit of the double-blind, placebo-controlled phases served as baseline (first visit) of the OLE phase, and participants received their first infusion of open-label IMAAVY during the same visit after completion of the Week 24 visit assessments. There were 2 arms: patients who had taken IMAAVY in the phase 3 trial and continued taking IMAAVY in the OLE study (n=88) and patients who had taken placebo in the VIVACITY trial and switched to IMAAVY for the OLE phase (n=88).4

In an interim analysis from the OLE study

IMAAVY was evaluated out to an additional 60 weeks5

  • At OLE Week 60, mean change (standard error) from baseline (end of double-blind phase) in MG-ADL total score ranged from −5.64 (0.621) in the IMAAVY to IMAAVY group to −6.01 (0.503) in the placebo to IMAAVY group (P<0.001)5
  • These results are consistent with those seen in the double-blind phase5
  • 45% (40/89) of patients receiving steroids at OLE baseline were able to decrease or discontinue steroid use. The mean dose of prednisone milligram equivalent per day decreased from 23 mg to 10 mg. In these patients, MG-ADL improvement was maintained throughout the OLE phase##

Data past 24 weeks were based on a post hoc analysis and not adjusted for multiplicity. No statistical or clinical significance can be assumed, and comparisons cannot be made. Limitations of this study included the open-label design and the lack of a placebo comparator. P value for comparison of MG-ADL total score change from baseline was significantly different from zero using a 1-sample t test.5

##Tapering one of the subject’s concomitant MG medications Q4W was allowed in the OLE phase if disease was stable over the previous 4 weeks based on MG-ADL scores and on investigator’s discretion. When decision was made to taper a concomitant corticosteroid medication, the following occurred: 1) For subjects on corticosteroid dose >30 mg per day, the dose was decreased by ≤10 mg Q4W, until a dose of ≤30 mg per day was reached. 2) For subjects on a corticosteroid dose of ≤30 mg per day, the dose was decreased by ≤5 mg Q4W. Once the investigator considered the corticosteroid taper completed, the subject remained on current dosing regimen for IMAAVY and the concomitant MG medications for at least 4 weeks before considering tapering another concomitant gMG medication.4,5

view ole-enpoint-data

OLE study safety data

Adverse events observed in an interim analysis from the OLE study5

  • There were no unexpected adverse events during the OLE phase5
  • Adverse event rates including MACE were generally similar in the placebo + SOC and IMAAVY + SOC groups5
  • No new safety signals have been observed in the OLE phase to date. Safety monitoring will be continued through the duration of the ongoing trial and findings will be reported5
Double-blind phaseOpen-label phase
Placebo + SOCIMAAVY + SOCOLE all IMAAVY
Analysis set: Seropositive7677137
Avg duration of
follow-up, weeks		22.9223.1368.96
Participant-years***33.434.1181.1
No. of events (rate, measured as events per patient year)***
All AEs233 (6.98) 287 (8.41)924 (5.10)
Serious AEs19 (0.57)12 (0.35)51 (0.28)
Fatal AEs2 (0.06)†††1 (0.03)†††3 (0.02)†††‡‡‡
Tx discontinuation due to AE§§§6 (0.18)6 (0.18)11 (0.06)
Infection and infestations44 (1.32)58 (1.70) 217 (1.20)
Infusion-related reaction0 (0)1 (0.03)2 (0.01)
Adjudicated MACE, fatal2 (0.06)0 (0)2 (0.01)
Adjudicated MACE, not fatal1 (0.03)0 (0)7 (0.04)
mg-adl-chart

***Participant-years of observation is calculated as the total duration of follow-up in days divided by 365.25.

†††Investigator assessed death(s) as unrelated to treatment.

‡‡‡Investigator assessed 1 death as related to treatment (hemophagocytic lymphohistiocytosis).

§§§Permanent discontinuation of treatment.

Study design

IMAAVY was studied in a 24-week, multicenter, randomized, double-blind, placebo-controlled pivotal trial1–4

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.2,6–8

The primary efficacy endpoint was the average change from baseline to Weeks 22, 23, and 24 in MG-ADL total score.1,2

Vivacity-graph

‖‖‖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

¶¶¶

Eighty-eight percent (n=134) of patients were positive for anti-AChR antibodies and 10% (n=16) were positive for anti-MuSK antibodies.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 analysis.1

  • SOC therapies included AChEIs, steroids, or NSISTs, either in combination or alone1

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 + SOC Total
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
l, n (%)
l, 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.1

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

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References: 1. IMAAVY™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Antozzi A, 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 A, 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
5. Antozzi C, Vu T, Ramchandren S, et al. Long-term safety and efficacy of nipocalimab in generalized myasthenia gravis: Vivacity-MG3 open-label extension phase results. Poster presented at: American Academy of Neurology (AAN) Annual Meeting; April 5-9, 2025; San Diego, CA. Janssen Biotech, Inc. 6. Vyvgart® [Prescribing Information]. Boston, MA: argenx US, Inc. 2024. 7. Vyvgart® Hytrulo [Prescribing Information]. Boston, MA: argenx US, Inc. 2025. 8. Rystiggo® [Prescribing Information]. Smyrna, GA: UCB, Inc. 2024.