Privigen is proven safe and effective for the treatment of PI, CIDP, and chronic ITP

Clinical trial results in patients with:

PI

CIDP

Chronic ITP

Proven protection
Designed for stability Efficacy and safety – PI patient

PRIVIGEN EXPERIENCE

950,000+ patient-years of therapy in 14+ years of clinical use¹

PROVEN EFFICACY

Annual rate of serious bacterial infections* in the extension study was 0.02¹⁴

DEMONSTRATED TOLERABILITY

97% of adverse reactions were non-serious in the pivotal trial^†, and 96% were non-serious in the extension trial^‡14

In the US pivotal phase III trial (n=80)¹⁵
- 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)¹⁴
- 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.

*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.

Improves functional ability
Featuring proline for Ig stability

PROVEN EFFICACY

Overall response rates to Privigen were 61% and 73% in PRIMA and PATH,* respectively^†

RAPID RESPONSE

Almost all who responded^† to Privigen did so after 1–2 maintenance treatments at Weeks 4 and 7*

DEMONSTRATED TOLERABILITY

In both studies,* 97% of adverse reactions were mild or moderate in intensity with 2 and 8 subjects experiencing serious adverse reactions in PRIMA and PATH, respectively^‡

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.

Privigen response rates among responders graph

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.

Proven efficacy
Designed for stability

Efficacy and safety – Chronic ITP patient

PROVEN EFFICACY

80.7% had a 150% platelet count increase within 7 days^*12

RAPID RESPONSE

Mean platelet count rose above 50 x 10⁹/L in 1 day^*12

LONG LASTING

Duration of response was at least 8.8 days in 75% of patients^*12

In the ITP clinical trial,* 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/L¹²
Platelet counts rose rapidly—the mean platelet count increased from 13 x 10⁹/L to 52 x 10⁹/L in only 1 day, before the second infusion¹²
Response was both quick and lasting—the duration of response was at least 8.8 days in 75% of patients¹²

Adverse events were generally mild or moderate¹²

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. A serious adverse reaction was 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

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