Safety in Generalized Myasthenia Gravis | IMAAVY® (nipocalimab-aahu) HCP

IMAAVY demonstrated a proven safety profile¹

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

Adverse reactions observed in ≥5% of patients taking IMAAVY and at a higher rate than with placebo¹

Adverse
reactions

IMAAVY + SOC (n=98),%

Placebo + SOC (n=98),%

Infection

Respiratory tract infection*

Urinary tract infection^†

Herpes zoster and Herpes simplex

Oral infection^‡

Peripheral edema

Muscle spasm

Hypersensitivity reaction^§

Abdominal pain

Back pain

Pyrexia

Diarrhea

Cough

Anemia^†

Dizziness

Nausea

Hypertension

Insomnia

^*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 trial²

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

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

Adverse events from the VIVACITY-MG3 trial including the ongoing OLE phase¹

There were no unexpected adverse events during the OLE phase¹
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 reported¹

Safety analysis set	Double-blind phase						Open-label phase
Safety analysis set	PBO + SOC (n=98)			IMAAVY + SOC (n=98)			IMAAVY Combined (n=176)
Average duration of follow-up, weeks	23			23			70.53
Participant-years^*	43.3			43.2			237.9
	Events/ P-Y*	Events, n	Patients, n^†	Events/ P-Y*	Events, n	Patients, n^†	Events/ P-Y*	Events, n	Patients, n^†
All AEs	7.54	326	82	8.73	377	82	5.59	1331	159
Serious AEs	0.60	26	14	0.42	18	9	0.31	74	46
Fatal AEs	0.05	2	2	0.02	1	1	0.02	4	4
Tx discontinuation due to AE^‡	0.25	11	7	0.16	7	5	0.05	13	13
Infection and infestations	1.14	61	42	1.64	71	42	1.39	330	125
Infusion-related reactions^§	0.62	27	11	0.37	16	10	0.07	17	10
Adjudicated MACE, fatal	0.05	2	2	0	0	0	0.01	3	3
Adjudicated MACE, not fatal	0.02	1	1	0	0	0	0.03	7	1

Safety analysis set	Double-blind phase
Safety analysis set	PBO + SOC (n=98)
Average duration of follow-up, weeks	23
Participants -years*	43.3
	Events/ P-Y*	Events, n	Patients, n^†
All AEs	7.54	326	82
Serious AEs	0.60	26	14
Fatal AEs	0.05	2	2
Tx dis-continuation due to AE^‡	0.25	11	7
Infection and infestations	1.14	61	42
Infusion-related reactions^§	0.62	27	11
Adjudicated MACE, fatal	0.05	2	2
Adjudicated MACE, not fatal	0.02	1	1

Safety analysis set	Double-blind phase
Safety analysis set	IMAAVY + SOC (n=98)
Average duration of follow-up, weeks	23
Participants -years*	43.2
	Events/ P-Y*	Events, n	Patients, n^†
All AEs	8.73	377	82
Serious AEs	0.42	18	9
Fatal AEs	0.02	1	1
Tx dis-continuation due to AE^‡	0.16	7	5
Infection and infestations	1.64	71	42
Infusion-related reactions^§	0.37	16	10
Adjudicated MACE, fatal	0	0	0
Adjudicated MACE, not fatal	0	0	0

Safety analysis set	Open-label phase
Safety analysis set	IMAAVY Combined (n=176)
Average duration of follow-up, weeks	70.53
Participants -years*	237.9
	Events/ P-Y*	Events, n	Patients, n^†
All AEs	5.59	1331	159
Serious AEs	0.31	74	46
Fatal AEs	0.02	4	4
Tx dis-continuation due to AE^‡	0.05	13	13
Infection and infestations	1.39	330	125
Infusion-related reactions^§	0.07	17	10
Adjudicated MACE, fatal	0.01	3	3
Adjudicated MACE, not fatal	0.03	7	1

AE=adverse event; DB=double blind; eCRF=electronic case report form; MACE=major adverse cardiovascular event; OLE=open-label extension; PBO=placebo; P-Y=participant-year; SOC=standard of care; Tx=treatment.

*P-Y is calculated as the total duration of follow-up in days/365.25.

^†Patients with ≥1 AE are shown.

^‡Permanent discontinuation of Tx. Tx discontinuation for an AE with onset in DB (or OLE) occurred in DB (or OLE).

^§Indicated as infusion reaction by investigator on eCRF and relationship to study intervention = “Related”.

Reference: 1. Katzberg H, Ait-Tihyaty M, Turkoz I, et al. Safety profile of nipocalimab, a new neonatal fragment crystallizable receptor blocker in the phase 3 Vivacity study. Poster presented at: 15th Myasthenia Gravis Foundation of America (MGFA) International Conference 2025; May 13-15, 2025; The Hague, The Netherlands.

Pediatric study safety data¹

There were no serious adverse events (SAEs) or adverse events (AEs) leading to discontinuation, or AEs of special interest through Week 24 in the pediatric participants taking IMAAVY + SOC in the VIBRANCE-MG study.¹

Analysis set: Safety N=7

Pediatric participants (aged 12 to <18 years) n (%)

Average duration of follow-up, weeks

18.37

Average exposure, number of administrations

8.86

Participants with ≥1 AE

5 (71.4)

Related AEs

2 (28.6)

Participants with ≥1 AE leading to death

Participants with ≥1 SAE

AEs leading to temporary discontinuation of study treatment

AEs leading to permanent discontinuation of study treatment

AEs leading to termination of study participation

COVID-19-associated AE

1(14.3)

COVID-19-associated SAE

Participants with ≥1 AE

5 (71.4)

Nasopharyngitis

3 (42.9)

COVID-19

1 (14.3)

Bacterial vaginosis

1 (14.3)

Upper respiratory tract infection

1 (14.3)

Headache

1 (14.3)

Migraine

1 (14.3)

Somnolence

1 (14.3)

Abdominal pain upper

1 (14.3)

Diarrhea

1 (14.3)

Glossitis

1 (14.3)

Anemia

1 (14.3)

Face edema

1 (14.3)

Blood cholesterol increased

1 (14.3)

Hyper-cholesterolemiaHypercholesterolemia

1 (14.3)

Muscle spasms

1 (14.3)

Reference: 1. Strober J, Black S, Fitzgibbon M, et al. Safety and effectiveness of nipocalimab in adolescent participants in the open-label phase 2/3 Vibrance-MG clinical study. Poster presented at: American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting; October 15-18, 2024; Savannah, GA.

IMAAVY® (nipocalimab-aahu) safety results

IMAAVY demonstrated a proven safety profile1

Adverse reactions observed in ≥5% of patients taking IMAAVY and at a higher rate than with placebo1

Rates of serious AEs, AEs leading to discontinuation, and infection-related AEs were also reported in the 24-week pivotal trial2

Adverse events from the VIVACITY-MG3 trial including the ongoing OLE phase1

Pediatric study safety data1

IMAAVY®
(nipocalimab-aahu) safety results

IMAAVY demonstrated a proven safety profile¹

Adverse reactions observed in ≥5% of patients taking IMAAVY and at a higher rate than with placebo¹

Rates of serious AEs, AEs leading to discontinuation, and
infection-related AEs were also reported in the 24-week pivotal trial²

Adverse events from the VIVACITY-MG3 trial including the ongoing OLE phase¹

Pediatric study safety data¹