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PROVEN PROTECTION through reliable Ig replacement
Efficacy and safety –photo of chronic ITP patients smiling
Experience_Proven_Demonstrated_PI
  • In the US pivotal phase III trial (n=80)16
    • The annual rate§ of serious bacterial infections* (SBI) was 0.08 and of other infections was 3.55
    • 97% of adverse reactions were non-serious, and 90% were rated mild or moderate in severity
  • In patients studied up to 29 months in the extension trial (n=55)15
    • The annual rate§ of SBI* was 0.02 and of other infections was 1.60
    • 96% of adverse reactions were non-serious, and 93% were rated mild or moderate in severity

In the clinical studies, the most common adverse reactions, observed in >5% of study subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature.

*SBI were defined as pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
† Serious adverse reactions in the pivotal trial included hypersensitivity, chills, fatigue, dizziness, and increased body temperature (all severe), occurring in one subject and resulting in the subject’s withdrawal from the study. Two other subjects withdrew from the study due to adverse reactions of vomiting in one subject and chills and headache in the other.
‡11 patients had serious reactions in the extension trial.
§Infections per subject year.

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RAPID IMPROVEMENTS in functional ability*
*Almost all patients who responded to Privigen did so
after 1–2 maintenance treatments at Weeks 4 and 7.
CIDP patient and wife walking in a city
Couple holding hands with Privigen vial imagery

Largest CIDP Trial

PATH, one of two clinical trials,† was the largest ever CIDP study, evaluating 207 patients

In the clinical studies, the most common reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash. A serious adverse reaction was hemolysis.

Privigen response rates among responders graph
Couple holding hands with Privigen vial imagery

Privigen improved strength in addition to functional ability

In PRIMA:

  • Privigen improved muscle strength as measured by Medical Research Council (MRC) sum score
    • Average improvement in MRC sum score was 6.9 points
    • A clinically meaningful improvement is defined as ≥3 points
  • Dominant hand grip strength improved by a mean of 14.1 kPa
    • Similar results were observed in the nondominant hand

In PATH:

  • Privigen improved muscle strength as measured by MRC sum score
    • Average improvement in MRC sum score was 3.6 points
    • A clinically meaningful improvement is defined as ≥3 points
  • Dominant hand grip strength improved by a mean of 12.2 kPa
    • Similar results were observed in the nondominant hand
†In a prospective, open-label, single-arm, multicenter clinical study (Privigen Impact on Mobility and Autonomy [PRIMA]), 28 subjects with CIDP received a Privigen loading dose of 2 g/kg followed by Privigen maintenance doses of 1 g/kg every 3 weeks for up to 21 weeks with 3-week follow-up. In a second prospective, open-label Privigen prerandomization phase of a multicenter clinical study (Polyneuropathy and Treatment with Hizentra [PATH]), 207 IVIg-pretreated subjects with CIDP received a Privigen loading dose of 2 g/kg followed by up to 4 Privigen maintenance doses of 1 g/kg every 3 weeks for up to 13 weeks.
‡Overall response rate was defined as percentage of subjects who experienced at least a 1-point decrease in adjusted INCAT score.
§Serious adverse reactions included hemolysis (2), exacerbation of CIDP (2), acute rash, diastolic increased blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine. A total of 4 patients discontinued treatment due to serious adverse reactions.

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PROVEN EFFICACY with long-lasting response
Efficacy and safety – PI Patient and Daughter Walking
Chronic ITP Patient and Wife Taking a Photograph

In the ITP clinical trial,* platelet counts rose rapidly—response was both quick and lasting

  • 80.7% of subjects (46 of 57) responded to Privigen with a 150% rise in platelet count within 7 days from ≤20 x 109/L to at least 50 x 109/L13
  • The mean platelet count increased from 13 x 109/L to 52 x 109/L in only 1 day, before the second infusion13
  • The duration of response was at least 8.8 days in 75% of patients13
  • Adverse events were generally mild or moderate13
    • In clinical trials, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. Serious adverse reactions were hemolysis and aseptic meningitis syndrome.

* Study was performed on 57 subjects with chronic ITP. Each subject had a platelet count of ≤20 x 109/L. Dose was 1 g/kg on 2 consecutive days. Primary endpoint was elevation of platelet count to at least 50 x 109/L within 7 days of infusion.

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Privigen is the first and only IVIg stabilized with proline

Find out what proline is and why it's in Privigen

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