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First FDA-Approved Subcutaneous Ig for CIDP maintenance

CIDP Efficacy and Safety

Proven in the largest Ig clinical trial in CIDP and further evaluated in an extension study

CIDP Path Logo

Largest Ig Study in CIDP (n=172)

See the study design of PATH and the PATH Extension Study1,2

CIDP Pivotal Trial and Open-Label Extension Study Chart CIDP Pivotal Trial and Open-Label Extension Study Chart

The percentage of CIDP patients who relapsed or withdrew for any other reason during SCIg treatment was significantly lower with Hizentra than with placebo.1*

*

PATH Study Design: Data from a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase III study of 2 doses of weekly Hizentra versus placebo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)—the PATH Study. Subjects who relapsed during the post-randomization phase were to receive IVIg as a rescue medication within 1 week. CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score compared with baseline.

†

Extension Study Design: 48-week, open-label, prospective extension study to PATH. 82 patients were enrolled: 62 patients were started on 0.4 g/kg weekly infusion of Hizentra, and 20 patients were started on 0.2 g/kg weekly. If clinically stable, patients on 0.4 g/kg were switched to 0.2 g/kg after 24 weeks. Upon CIDP relapse on 0.2 g/kg dose, 0.4 g/kg was either initiated or reinitiated. CIDP relapse defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score compared with baseline.

As demonstrated in the PATH Study

Proven effective in maintaining CIDP control

Relapse or withdrawal was significantly reduced with Hizentra vs placebo1

  • Relapse or withdrawal rate: 38.6% Hizentra 0.2 g/kg, 32.8% Hizentra 0.4 g/kg vs 63.2% placebo (p=0.007, p<0.001, respectively)
  • Absolute risk reduction compared to placebo: 25% Hizentra 0.2 g/kg, 30% Hizentra 0.4 g/kg

Hizentra was proven to keep patients relapse-free1

CIDP Relapse or Withdrawal chart
*
Data shown only consider CIDP relapse based on the adjusted INCAT score (relapse sensitivity analysis). All patients who withdrew for reasons other than relapse were assumed not to have had a relapse.
†
ARR=absolute risk reduction compared to placebo.

As demonstrated in the PATH Study

Hizentra maintained functional ability across multiple secondary endpoints1

CIDP Patient graphic showing Stable MRC score, INCAT score and Stable Grip Strength

Hizentra also demonstrated better Inflammatory Neuropathy-Rasch-built Overall Disability Scale (I-RODS) scores vs placebo1‡

  • Median change from baseline to last postdose observation was −3.0 points for the placebo group, −2.0 points for the 0.2 g/kg Hizentra group, and 0.0 for the 0.4 g/kg Hizentra group (p=0.0002 for all)§
*
Statistically significant vs placebo at the last postdose observation. The MRC (Medical Research Council) sum score was assessed in the following 8 bilateral muscle pairs: shoulder abduction, elbow flexion, wrist extension, index finger abduction, hip flexion, knee extension, foot dorsiflexion, and great toe dorsiflexion. The INCAT score is a 10-point scale that covers the functionality of legs and arms. Grip strength was measured in both hands by the Martin Vigorimeter. Grip strength change was for dominant hand.
†
Overall p-values are based on both Hizentra dosing groups compared to placebo.
‡
The I-RODS measures a patient’s ability to perform a wide range of activities ranging from easy tasks, like reading a book, eating, and brushing teeth, to more difficult tasks such as standing for extended periods of time or running.
§
The difference between the 0.2 g/kg Hizentra group and the placebo group was not significant.

As demonstrated in the PATH Extension Study

Adjustable dosing to optimize patient outcomes

Most patients remained relapse-free with either dosing option, with the 0.4 g/kg dose showing a lower rate of relapse2

Patient replace free

Most patients who relapsed on the low dose recovered after reinitiating on the high dose2

Patient dose
*
Approximately 68% of patients who completed the PATH Study without relapse were able to remain relapse-free after dose reduction to 0.2 g/kg. Statistical tests comparing relapse rates between the 2 doses were not conducted.
†
After 52 patients down-titrated from high to low dose, most patients who relapsed on the low dose recovered after reinitiating on the high dose.

Consistent safety and tolerability shown in the PATH and PATH Extension Studies

In the PATH Study, patients stabilized on IVIg reported a 3.6-fold lower rate of systemic adverse reactions per infusion when switched to Hizentra1*

Rate of Systematic Adverse Reaction (ARs) chart

ZERO cases of thrombosis or hemolysis were observed in Hizentra patients in the PATH Study.1 Thrombosis or hemolysis may occur with Ig products, including Hizentra. Please see the boxed warning and section 5 of the full prescribing information for more details.

PATH Extension Study tolerability was similar to the PATH Study. The most frequent ARs in the PATH Extension Study were local infusion site reactions, which occurred more frequently in subjects who received the 0.4 g/kg dose than in subjects who received the 0.2 g/kg dose (18.1% and 9.6%, respectively).

*
Data represent systemic side effects reported during the 13-week, single-arm, restabilization phase compared to those reported in the 2 Hizentra groups during the 24-week post-randomized phase. However, this difference should be interpreted with caution as there was no parallel group of subjects receiving placebo in the IVIg restabilization phase.
†
2 g/kg induction dose followed by 1 g/kg every 3 weeks.

ARs occurring in ≥5% of subjects treated with Hizentra and at a higher frequency than placebo-treated subjects

Placebo
(n=57)		 0.2 g/kg Hizentra
(n=57)		 0.4 g/kg Hizentra
(n=58)
Local Reactions‡ 7.0% 19.3% 29.3%
Headache 3.5% 7.0% 6.9%
Nasopharyngitis 1.8% 7.0% 3.4%
Fatigue 1.8% 8.8% 0.0%
Upper Respiratory Tract Infection 3.5% 5.3% 3.4%
Fall 0.0% 5.3% 1.7%
Back Pain 1.8% 5.3% 1.7%
Arthralgia 1.8% 5.3% 1.7%
Pain in Extremity 0.0% 1.8% 5.2%
‡
Includes the following infusion-site reactions: erythema, swelling, pain, induration, warmth, hematoma, and pruritus.

As demonstrated in the PATH Study

More than 7 of 10 CIDP patients on Hizentra did not report local reactions

7 out of 10 Local Reactions graphic
  • Local reactions were the most commonly reported ARs
  • Reports of infusion-site reactions decreased in frequency over time
  • No subject withdrew because of local reactions§

Mild = does not interfere with routine activities.
Moderate = interferes somewhat with routine activities.
Severe = impossible to perform routine activities.

93% of 4225 total Hizentra infusions were free of any ARs1
§
One Hizentra patient reported a serious adverse reaction of allergic dermatitis, which led to discontinuation of treatment. One other subject withdrew due to a non-serious adverse reaction (fatigue).

Dosing

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Administration

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References: 1. van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46. 2. van Schaik IN, Orell M, Bril V, et al. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP. Neurol Neuroimmunol Neuroinflamm. 2019;6:e590.
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