Trial Outcomes & Findings for Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP (NCT NCT02955355)
NCT ID: NCT02955355
Last Updated: 2024-08-28
Results Overview
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Treatment emergent adverse events (TEAEs) were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
COMPLETED
PHASE3
85 participants
From the first dose of study drug up to end of study (up to 6.6 years)
2024-08-28
Participant Flow
Participants took part in the study at 39 investigative sites worldwide from 14 November 2016 to 04 July 2023.
A total of 85 participants with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) who completed Study 161403 (NCT02549170) without CIDP worsening were enrolled in this Extension Study to receive HYQVIA/HyQvia.
Participant milestones
| Measure |
HYQVIA/HyQvia
Participants received HYQVIA/HyQvia (recombinant human hyaluronidase \[rHuPH20\] at a dose of 80 units per gram (U/g) immunoglobulin G \[IgG\], followed by subcutaneous \[SC\] immune globulin infusion \[IGI\] 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
85
|
Reasons for withdrawal
| Measure |
HYQVIA/HyQvia
Participants received HYQVIA/HyQvia (recombinant human hyaluronidase \[rHuPH20\] at a dose of 80 units per gram (U/g) immunoglobulin G \[IgG\], followed by subcutaneous \[SC\] immune globulin infusion \[IGI\] 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
21
|
|
Overall Study
Site Terminated by Sponsor
|
35
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Reason Not Specified
|
5
|
Baseline Characteristics
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Baseline characteristics by cohort
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|
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Age, Continuous
|
54.3 years
STANDARD_DEVIATION 13.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Height
|
171.5 centimeters (cm)
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Weight
|
80.89 kilograms (kg)
STANDARD_DEVIATION 18.856 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.42 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 5.587 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Treatment emergent adverse events (TEAEs) were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
|
Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality
Any TEAE
|
76 Participants
|
—
|
|
Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality
Any Serious TEAE
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
|
Number of Participants With Causally Related Treatment-emergent SAEs and AEs
Any IP-Related TEAE
|
51 Participants
|
—
|
|
Number of Participants With Causally Related Treatment-emergent SAEs and AEs
Any IP-Related Serious TEAE
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
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Number of Participants With Adverse Reactions (ARs) or Suspected Adverse Reactions (SARs) Categorized as Serious and Non-serious
Any Serious AR/SAR
|
7 Participants
|
—
|
|
Number of Participants With Adverse Reactions (ARs) or Suspected Adverse Reactions (SARs) Categorized as Serious and Non-serious
Any Non-serious AR/SAR
|
57 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
Percentage of participants with TEAEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events were assessed. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. The percentage was rounded off to the nearest decimal.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
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Percentage of Participants With Treatment-Emergent Adverse Events That May be a Result of Immune-Mediated Responses
|
7.1 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Participants can have more than one TEAE associated with infusion.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
|
Number of Treatment-Emergent SAEs and AEs Associated With Infusions, Regardless of Causality
Serious TEAEs
|
30 events in participants
|
—
|
|
Number of Treatment-Emergent SAEs and AEs Associated With Infusions, Regardless of Causality
TEAEs
|
1406 events in participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
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|---|---|---|
|
Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions
IP-Related Serious TEAEs
|
3 events in participants
|
—
|
|
Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions
IP-Related TEAEs
|
798 events in participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs that occurred during infusion or within 72 hours post-infusion were considered to be temporally associated with infusions. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Participants can have more than one TEAE temporally associated with infusion.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of TEAEs Temporally Associated With Infusions
|
857 events in participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AR/SAR=any AE that meets any of following criteria: AE considered by either investigator and/or sponsor to be possibly or probably related to IP administration, begins during infusion of IP or within 72 hours following end of IP infusion,or AE for which causality assessment is missing or indeterminate. ARs/SARs associated with an infusion=AEs considered by the investigator to be occurring after administration of IP. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria. Participants can have more than one AR/SAR associated with infusion.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Serious and Non-Serious ARs or SARs Associated With Infusions
Serious ARs/SARs
|
8 events in participants
|
—
|
|
Number of Serious and Non-Serious ARs or SARs Associated With Infusions
Non-Serious ARs/SARs
|
913 events in participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Infusions Associated With One or More Systemic TEAEs
|
50 infusions
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Infusions Associated With One or More Local TEAEs
|
17 infusions
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or TEAEs
|
3 infusions
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Infusion
Systemic TEAEs
|
0.25 AEs/infusion
|
—
|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Infusion
Local TEAEs
|
0.15 AEs/infusion
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Participant
Systemic TEAEs
|
10.38 AEs/participant
|
—
|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Participant
Local TEAEs
|
6.16 AEs/participant
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
Systemic TEAEs
|
4000.23 AEs/1000 participant-year
|
—
|
|
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
Local TEAEs
|
2376.55 AEs/1000 participant-year
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Infusion
Systemic IP-Related TEAEs
|
0.08 AEs/infusion
|
—
|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Infusion
Local IP-Related TEAEs
|
0.15 AEs/infusion
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Participant
Systemic IP-Related TEAEs
|
3.38 AEs/participant
|
—
|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Participant
Local IP-Related TEAEs
|
6.01 AEs/participant
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per 1000 Participant-year
Systemic IP-Related TEAEs
|
1301.66 AEs/1000 participant-year
|
—
|
|
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per 1000 Participant-year
Local IP-Related TEAEs
|
2317.59 AEs/1000 participant-year
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Infusion
Systemic ARs/SARs
|
0.11 reactions/infusion
|
—
|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Infusion
Local ARs/SARs
|
0.15 reactions/infusion
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Participant
Systemic ARs/SARs
|
4.58 reactions/participant
|
—
|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Participant
Local ARs/SARs
|
6.16 reactions/participant
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per 1000 Participant-year
Systemic ARs/SARs
|
1764.27 reactions/1000 participant-year
|
—
|
|
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per 1000 Participant-year
Local ARs/SARs
|
2376.55 reactions/1000 participant-year
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With a TEAE That Led to Discontinuation From Study
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events. The severity of each AE was assessed by the investigator using clinical expertise based on the following description: moderate=AE produces limited impairment of function and may require therapeutic intervention and produces no sequela/sequelae; severe=AE results in a marked impairment of function and may lead to temporary inability to resume usual life pattern and produces sequela/sequelae, which require (prolonged) therapeutic intervention.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other concomitant medications. The severity of each AE was assessed by the investigator using clinical expertise. Data for number of events per 100 infusions was assessed at the group level calculated by dividing number of events by total number of infusions and multiplying that by 100.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=3487 infusions
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Rate of Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses, Expressed as Number of Events Per 100 Infusions
|
0.0860 AEs/100 infusions
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. All local infusion site treatment-emergent AEs were reported as adverse reactions.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants That Experienced Treatment-Emergent Local Infusion Site Reactions
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: During the ramp-up (8 weeks)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. As prespecified in the statistical analysis plan (SAP), comparative local tolerability data for the ramp-up of 8 weeks from studies 161403 (for participants originally randomized to HYQVIA in double-blind) and 161505 were reported in the results of study 161505.
Participants with local tolerability events were those for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs. These events were assessed during the initial ramp-up for each participant i.e., during the first 8 weeks of open-label extension study 161505 \[NCT02955355\] among participants originally randomized to placebo (as being in the placebo arm, they had no ramp-up during the 161403 \[NCT02549170\] study) versus during the 8-week ramp-up for participants originally randomized to active HYQVIA in double-blind 161403 study. Thus, the data for this outcome measure are presented per the bifurcation of participants in the study 161403.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=42 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
n=43 Participants
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Local Tolerability Events During Ramp-up
|
6 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. Overall number analyzed is the number of participants with local infusion reactions.
Local infusion reactions were defined as local (administration site-related) adverse events. Median infusion rate per site was derived as the median value across all participants, per participant's average infusion rate, by site: actual volume infused / duration in hours of infusion / number of sites. Median infusion volume per site was derived as the median value across all participants, per participant's average actual volume infused, by site: actual volume infused / number of sites. Number of participants with local infusion reactions as a function of each of the categories are presented below.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=30 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
3 Week Dosing Interval
|
8 Participants
|
—
|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
4 Week Dosing Interval
|
22 Participants
|
—
|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
< Median Infusion Rate per Site
|
15 Participants
|
—
|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
≥ Median Infusion Rate per Site
|
15 Participants
|
—
|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
< Median Infusion Volume per Site
|
15 Participants
|
—
|
|
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
≥ Median Infusion Volume per Site
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, up to 6.6 yearsPopulation: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
Number of participants whose anti-hyaluronidase antibody titers rose by ≥4 fold from the baseline value at any point during the study was assessed.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants Whose Anti-Hyaluronidase Binding Antibody Titers Rose by ≥4-fold From Baseline
|
16 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. Overall number analyzed is the number of participants with data available for analyses.
Binding antibodies were defined as anti-rHuPH20 titer ≥1:160.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=84 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With Binding Antibodies to rHuPH20
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. Overall number analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=84 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With Neutralizing Antibodies Binding to rHuPH20
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=85 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants With a Decline of Anti-rHuPH20 Binding Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or to <1:160 Antibody Titer Level at the Study Completion or Early Discontinuation
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. Overall number analyzed is the number of participants who had \>1:10,000 anti-rHuPH20 antibody titers.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=8 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers With Neutralizing Antibodies
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to end of study (up to 6.6 years)Population: Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication. Overall number analyzed is the number of participants who had \>1:10,000 anti-rHuPH20 antibody titers.
Outcome measures
| Measure |
HYQVIA/HyQvia
n=8 Participants
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
HYQVIA/HyQvia Then HYQVIA/HyQvia
Participants received HYQVIA/HyQvia in the study 161403 and received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|---|
|
Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers Showing Cross Reactivity With Hyaluronidase (Hyal)-1,2 and 4
|
0 Participants
|
—
|
Adverse Events
HYQVIA/HyQvia
Serious adverse events
| Measure |
HYQVIA/HyQvia
n=85 participants at risk
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Nervous system disorders
Conus medullaris syndrome
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.4%
2/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Eye disorders
Papilloedema
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Pulmonary tuberculoma
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Tuberculosis
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal polyp
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.2%
1/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
Other adverse events
| Measure |
HYQVIA/HyQvia
n=85 participants at risk
Participants received HYQVIA/HyQvia (rHuPH20 at a dose of 80 U/g IgG, followed by SC IGI 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
7/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.1%
12/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
6/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
21.2%
18/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
11/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
14.1%
12/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
27.1%
23/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
9.4%
8/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
9.4%
8/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
General disorders
Infusion site erythema
|
15.3%
13/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
General disorders
Infusion site pain
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
General disorders
Infusion site pruritus
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
12.9%
11/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
5/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
6/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
20.0%
17/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
7/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
7/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
8/85 • From the first dose of study drug up to end of study (up to 6.6 years)
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place