Clinical Study Results for IMAAVY® (nipocalimab-aahu)

What are the results?

A 24-week clinical study explored the effectiveness and safety of IMAAVY in adults living with warm autoimmune hemolytic anemia (

). Patients were currently receiving or had previously received treatment for wAIHA. In the study, patients received either IMAAVY or placebo.*

*Placebo: In a clinical study, this is the group that does not receive the medicine that is being tested.

They were adults who:

Had been diagnosed with wAIHA for at least 3 months and were receiving treatment or previously received treatment for wAIHA
Had active disease, meaning there were signs their body was breaking down
red blood

cells
red blood cells
at the time and their hemoglobin was less than 10 g/dL
Were allowed to keep taking their current wAIHA medicines during the study. This included steroids (90% for IMAAVY and 87% for placebo), immunosuppressants (24% for IMAAVY and 26% for placebo), or both (18% for IMAAVY and 21% for placebo)

To achieve improved

levels, patients had to reach all 4 of the following measures without the need for additional treatment,^† starting by Week 16 of the clinical study

^†No additional treatment means no rescue treatment (extra treatment) was given by a healthcare provider based on worsening signs and symptoms of wAIHA.

More patients taking IMAAVY achieved improved hemoglobin levels without the need for additional treatment vs placebo in a 24-week clinical study

IMAAVY vs placebo; percentage of patients who met the main goal in the clinical study

3 times more patients met all 4 study measures with IMAAVY vs placebo

Individual results may vary. Talk to your healthcare provider to see if IMAAVY is right for you.

In the clinical study, patients also experienced the following results:

After 1 week, some patients taking IMAAVY saw their hemoglobin levels increase. An average increase of 1 g/dL was observed in patients taking IMAAVY.

Average change in hemoglobin levels throughout the clinical study

For this graph, if a patient stopped treatment or needed additional (rescue) treatment before Week 24, their results after that time were treated as showing no improvement from the start of the study.

61% of patients taking IMAAVY had a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from the start of the study. This happened at one or more visits by Week 24 of the clinical study.

15% of patients taking placebo had this result.

These results were not the main goals of the study and cannot be given the same importance as its main goals. Not all patients may achieve these results.

Talk to your healthcare provider to see if IMAAVY is right for you.

Impact on

score‡ was studied at the end of the clinical study

IMAAVY vs placebo; average change in fatigue score at Week 24 of the clinical study

At 24 weeks, the average change in fatigue score^‡ was 2.95 points with IMAAVY and -0.56 points with placebo

^‡Average fatigue score was measured using the FACIT-Fatigue Scale. FACIT stands for Functional Assessment of Chronic Illness Therapy. It’s a 13-item questionnaire where patients indicate their level of fatigue from the past 7 days. It includes 5 statements related to fatigue symptoms and 8 statements related to the impact of fatigue on functioning. Total scores range from 0–52, with higher scores indicating less fatigue.

The fatigue data were not the main goals of the study and cannot be given the same importance as its main goals. Not all patients may achieve these results.

Talk to your healthcare provider to see if IMAAVY is right for you.

Be wAIHA wise!

If your healthcare provider has not asked about your fatigue in detail, consider bringing it up at your next appointment. You may also want to ask about the FACIT-Fatigue Scale.

Side effects and safety profile of IMAAVY

IMAAVY is a prescription medicine that may cause serious side
effects, including:

Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you get any of the following symptoms of infection:
- fever
- chills
- shivering
- cough
- sore throat
- fever blisters
- burning when you urinate
- trouble breathing

Allergic (hypersensitivity) reactions. Allergic reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:
- swelling of your face, lips, mouth, tongue, or throat
- trouble swallowing or breathing
- hives
- itchy rash
- chest pain or tightness

Infusion-related reactions
. Tell your healthcare provider right away if you get any of the following symptoms during or within a few days after your infusion of IMAAVY:
- headache
- rash
- nausea
- fatigue
- dizziness
- chills
- flu-like symptoms
- redness of skin

The most common side effects reported in people with wAIHA treated with IMAAVY were:

Swelling in the hands, ankles, or feet (peripheral edema)
Diarrhea
Fever (pyrexia)

Get personalized support tailored
to your unique needs

Once you and your healthcare provider have decided that IMAAVY is right for you, IMAAVY withMe is here for you and your loved ones with free personalized support when and where you may need it.

IMAAVY® (nipocalimab-aahu) was proven to increase hemoglobin levels in a 24-week clinical study

About the patients in the study

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IMAAVY^® (nipocalimab-aahu) was proven to increase hemoglobin levels in a 24-week clinical study

Get personalized support tailored
to your unique needs