IMAAVY™
(nipocalimab-aahu)
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IMAAVY™ (nipocalimab-aahu)
Medical Information
IMAAVY – Occurrence of Hypersensitivity Reactions in Patients with Generalized Myasthenia Gravis
Last Updated: 04/30/2025
SUMMARY
- Please refer to the local labeling for relevant information regarding hypersensitivity reactions with IMAAVY.
- In a 24-week, phase 3, randomized, double-blind, placebo (PBO)-controlled trial in adult patients with generalized myasthenia gravis (gMG), hypersensitivity reactions were reported as a treatment-emergent adverse event (TEAE) in 8.2% (8/98) and in 7.1% (7/98) of patients in the IMAAVY and PBO groups, respectively.1
, 2
CLINICAL DATA
VIVACITY-MG3
Antozzi et al (2025)2 evaluated the efficacy and safety of IMAAVY in adults with gMG in a phase 3, randomized, multicenter, double-blind, PBO-controlled study.
Study Design/Methods
- Patients (≥18 years of age) with anti- acetylcholine receptor (AChR), muscle-specific tyrosine kinase (MuSK) or low-density lipoprotein receptor 4 (LRP4) antibody positive or seronegative (in all countries except France) gMG (Myasthenia Gravis Foundation of America [MGFA] Class IIa–IVb) were included in the study.2,3
- The safety analysis population included all randomized patients who received ≥1 dose (partial or complete) of any study treatment in the double-blind phase.
- The study consisted of a ≤4-week screening phase, followed by a 24-week, double-blind, PBO-controlled treatment phase, a variable-duration, open-label extension phase, and a safety follow-up at 8 weeks after the last infusion.2,4
- Patients who withdrew or discontinued after receiving any amount of the study intervention were required to complete a safety follow-up assessment at 8 weeks after the last dose.3
- Eligible patients were randomized (1:1) to receive a loading dose of intravenous IMAAVY 30 mg/kg at week 0, followed by 15 mg/kg every 2 weeks (Q2W), or matching PBO through week 24 in addition to standard of care (SOC) therapy.2
Results
- A total of 196 patients (IMAAVY, n=98; PBO, n=98) were included in the safety analysis set.2
- Hypersensitivity reaction was reported as a TEAE in 8.2% (8/98) of patients in the IMAAVY group and in 7.1% (7/98) of patients in the PBO group (see Table: Incidence of Hypersensitivity Reactions).1
| n (%) | PBO n=98 | IMAAVY 30 mg/kg LD + 15 mg/kg Q2W n=98 |
|---|---|---|
| Hypersensitivity reaction | 7 (7.1) | 8 (8.2) |
| Urticaria | 0 | 2 (2.0) |
| Angioedema | 0 | 1 (1.0) |
| Dermatitis atopic | 0 | 1 (1.0) |
| Eczema | 0 | 1 (1.0) |
| Gingival swelling | 0 | 1 (1.0) |
| Rash | 3 (3.1) | 1 (1.0) |
| Rash vesicular | 1 (1.0) | 1 (1.0) |
| Anaphylactic shock | 1 (1.0) | 0 |
| Dermatitis acneiform | 1 (1.0) | 0 |
| Swelling face | 1 (1.0) | 0 |
| Note: Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.Abbreviations: AE, adverse event; LD, loading dose; PBO, placebo; Q2W, every two weeks. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Nipocalimab. Clinical Study Report MOM-M281-011. Janssen Research & Development, LLC. EDMS-RIM-1112540; 2024. |
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