Proven safety profile over 24 weeks1
Adverse reactions in ≥5% of patients treated with IMAAVY and more frequently than placebo1*
IMAAVY (n=78)Placebo (n=39)
| Adverse reaction1 | All grades1 | Grade 1 or 22 | Grade 3 or 42 | All grades1 | Grade 1 or 22 | Grade 3 or 42 |
|---|---|---|---|---|---|---|
Peripheral edema† | 12% | 12% | 0 | 3% | 3% | 0 |
Diarrhea | 12% | 12% | 0 | 8% | 8% | 0 |
Pyrexia | 10% | 10% | 0 | 3% | 3% | 0 |
Dizziness | 9% | 9% | 0 | 8% | 8% | 0 |
Urinary tract infection‡ | 9% | 9% | 0 | 5% | 3% | 3% |
Headache | 6% | 6% | 0 | 5% | 5% | 0 |
IMAAVY (n=78)
| Adverse reaction1 | All grades1 | Grade 1 or 22 | Grade 3 or 42 |
|---|---|---|---|
Peripheral edema† | 12% | 12% | 0 |
Diarrhea | 12% | 12% | 0 |
Pyrexia | 10% | 10% | 0 |
Dizziness | 9% | 9% | 0 |
Urinary tract infection‡ | 9% | 9% | 0 |
Headache | 6% | 6% | 0 |
Placebo (n=39)
| Adverse reaction1 | All grades1 | Grade 1 or 22 | Grade 3 or 42 |
|---|---|---|---|
Peripheral edema† | 3% | 3% | 0 |
Diarrhea | 8% | 8% | 0 |
Pyrexia | 3% | 3% | 0 |
Dizziness | 8% | 8% | 0 |
Urinary tract infection‡ | 5% | 3% | 3% |
Headache | 5% | 5% | 0 |
The most common AEs (≥10% of patients treated with IMAAVY) were peripheral edema, diarrhea, and
pyrexia.1
Serious infections§ & serious
AEs for IMAAVY and placebo2
Grade 1 or 2 infections
- 38% (30/78) IMAAVY
- 28% (11/39) placebo
Serious infections
- 5% (4/78) IMAAVY
- 10% (4/39) placebo
Serious AEs
- 18% (14/78) IMAAVY
- 36% (14/39) placebo
Discontinuation due
to AEs
- 9% (7/78) IMAAVY
- 3% (1/39) placebo
Additional clinically relevant adverse reactions occurring in ≤5% of patients1:
- Pneumonia (5% with IMAAVY; 5% with placebo)
- Nausea (3.8% with IMAAVY; 2.6% with placebo)
- Insomnia (1.3% with IMAAVY; 0% with placebo)
AE=adverse event.
*In the double-blind phase, 78 patients received IMAAVY across the dose regimens evaluated in the study.
†Includes edema peripheral, edema, and generalized edema.
‡Includes urinary tract infection, pyelonephritis, and urinary tract infection bacterial.
§Serious infections included pneumonia, arthritis bacterial, salmonella sepsis, spontaneous bacterial peritonitis, COVID-19, and urinary
tract infection.
tract infection.
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References: 1. IMAAVY [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.