Trial Outcomes & Findings for Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children (NCT NCT01955109)
NCT ID: NCT01955109
Last Updated: 2022-06-30
Results Overview
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
171 participants
Primary outcome timeframe
Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study
Results posted on
2022-06-30
Participant Flow
Children, adolescent and adult participants who were previously randomized in and completed the VIPES study (V712-202; NCT01675882) were eligible to enroll in this Phase II open-label follow-up study to receive an additional 24 months of Viaskin® Peanut (DBV712) Epicutaneous Immunotherapy (EPIT). Participants were enrolled in 21 study centers in 4 countries in France, the Netherlands, Canada and the USA from 30 August 2013 and the last participant completed 29 September 2016.
Participants who received 50, 100 or 250 micrograms (μg) Viaskin Peanut in VIPES continued on same dose in OLFUS-VIPES; those receiving placebo were re-randomized 1:1:1 to 50, 100 or 250 μg Viaskin Peanut. After protocol amendment 1, all participants received 250 μg dose from start of OLFUS-VIPES; those already enrolled were switched to 250 μg at Month 6 visit.
Participant milestones
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
48
|
|
Overall Study
Completed Study Until Month 12
|
103
|
46
|
|
Overall Study
COMPLETED
|
78
|
39
|
|
Overall Study
NOT COMPLETED
|
45
|
9
|
Reasons for withdrawal
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Participant unwilling to continue
|
35
|
7
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Non-compliance
|
3
|
1
|
Baseline Characteristics
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
Baseline characteristics by cohort
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 6.64 • n=99 Participants
|
13.0 years
STANDARD_DEVIATION 6.59 • n=107 Participants
|
13.5 years
STANDARD_DEVIATION 6.61 • n=206 Participants
|
|
Age, Customized
Children (6-11 years)
|
60 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
34 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Customized
Adults (18-55 years)
|
29 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Customized
Adolescents and Adults (12-55 years)
|
63 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
80 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not applicable
|
18 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=99 Participants
|
14 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
24 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Region of Enrollment
France
|
18 participants
n=99 Participants
|
9 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Percentage of Treatment Responders at Months 12 and 24
Month 12
|
64.1 percentage of participants
Interval 54.0 to 73.3
|
50.0 percentage of participants
Interval 34.9 to 65.1
|
|
Percentage of Treatment Responders at Months 12 and 24
Month 24
|
67.5 percentage of participants
Interval 56.3 to 77.4
|
58.5 percentage of participants
Interval 42.1 to 73.7
|
SECONDARY outcome
Timeframe: Month 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Month 24 DBPCFC performed.
Participants were considered unresponsive if they showed no objective symptoms leading to stopping the challenge during the Month 24 DBPCFC with a cumulative dose of at least 1440 mg of peanut protein, up to a cumulative dose of 5044 mg peanut protein. The percentage of unresponsive participants is presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=83 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=41 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24
|
31.3 percentage of participants
Interval 21.6 to 42.4
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
SECONDARY outcome
Timeframe: Month 26 (2 months post-treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for participants who had the Month 26 DBPCFC performed.
Participants who were unresponsive to a cumulative dose of 1440 mg of peanut protein or above at the Month 24 DBPCFC, had an additional 2-month period without treatment and continued on a peanut-free diet to assess for sustained unresponsiveness by a DBPCFC at Month 26. The percentage of participants with this sustained unresponsiveness, i.e, who showed no objective symptoms leading to stopping the challenge during the DBPCFC to a cumulative dose of 1440 mg of peanut protein or above at Month 26, are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=22 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=3 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26
|
77.3 percentage of participants
Interval 54.6 to 92.2
|
100 percentage of participants
Interval 29.2 to 100.0
|
SECONDARY outcome
Timeframe: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The median cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Month 12
|
480.0 mg
Interval 140.0 to 2240.0
|
365.0 mg
Interval 140.0 to 1440.0
|
|
Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Month 24
|
440.0 mg
Interval 160.0 to 3040.0
|
440.0 mg
Interval 140.0 to 1440.0
|
SECONDARY outcome
Timeframe: Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 12 and 24 DBPCFC performed.
The cumulative reactive dose was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC. To distinguish participants who reached the highest dose of the DBPCFC without objective symptoms 1000 mg was added to the cumulative reactive dose to obtain an adjusted value. The mean cumulative reactive doses at Months 12 and 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Month 12
|
1419.6 mg
Standard Deviation 1595.92
|
895.9 mg
Standard Deviation 1329.14
|
|
Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24
Month 24
|
1751.1 mg
Standard Deviation 1962.12
|
758.4 mg
Standard Deviation 1176.38
|
SECONDARY outcome
Timeframe: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
The change from the VIPES Baseline in peanut-specific IgE values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
VIPES Baseline to Month 18
|
-1.870 kilo units per liter
Interval -1091.88 to 433.97
|
-0.710 kilo units per liter
Interval -389.03 to 716.2
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
VIPES Baseline to Month 24
|
-3.160 kilo units per liter
Interval -381.93 to 861.24
|
-10.060 kilo units per liter
Interval -384.03 to 332.83
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
VIPES Baseline to Month 6
|
2.150 kilo units per liter
Interval -306.0 to 500.12
|
18.900 kilo units per liter
Interval -72.37 to 344.79
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24
VIPES Baseline to Month 12
|
-0.370 kilo units per liter
Interval -189.17 to 1168.12
|
4.785 kilo units per liter
Interval -447.41 to 233.11
|
SECONDARY outcome
Timeframe: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
The change from the VIPES Baseline in peanut-specific IgG4 values at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
VIPES Baseline to Month 6
|
1.935 mg/L
Interval -6.82 to 28.95
|
0.775 mg/L
Interval -0.8 to 8.86
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
VIPES Baseline to Month 12
|
2.890 mg/L
Interval -7.06 to 34.8
|
1.510 mg/L
Interval -0.61 to 11.93
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
VIPES Baseline to Month 18
|
2.780 mg/L
Interval -5.04 to 21.9
|
2.370 mg/L
Interval -0.26 to 16.98
|
|
Change From VIPES Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 6, 12, 18 and 24
VIPES Baseline to Month 24
|
2.170 mg/L
Interval -5.64 to 27.51
|
1.950 mg/L
Interval -0.89 to 15.4
|
SECONDARY outcome
Timeframe: VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) in the OLFUS-VIPES studyPopulation: The full analysis set was the intent-to-treat population which consisted of all participants and results are reported for those participants who had the Months 6, 12, 18 and 24 DBPCFC performed.
The change from the VIPES Baseline in the wheal diameter from the undiluted skin prick tests at Months 6, 12, 18 and 24 of the OLFUS-VIPES study are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
Outcome measures
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 Participants
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 Participants
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
VIPES Baseline to Month 6
|
-2.30 millimeters
Interval -17.0 to 8.5
|
-1.50 millimeters
Interval -14.0 to 3.5
|
|
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
VIPES Baseline to Month 12
|
-3.00 millimeters
Interval -15.0 to 7.3
|
-1.00 millimeters
Interval -14.5 to 22.5
|
|
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
VIPES Baseline to Month 18
|
-3.00 millimeters
Interval -27.6 to 8.0
|
-1.40 millimeters
Interval -14.5 to 10.5
|
|
Change From VIPES Baseline in Wheal Diameter During Skin Prick Testing at Months 6, 12, 18 and 24
VIPES Baseline to Month 24
|
-2.00 millimeters
Interval -15.0 to 13.0
|
-1.50 millimeters
Interval -15.0 to 6.5
|
Adverse Events
VIPES Initial Treatment Group: All Viaskin Peanut Doses
Serious events: 7 serious events
Other events: 113 other events
Deaths: 0 deaths
VIPES Initial Treatment Group: Placebo
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 participants at risk
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 participants at risk
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Anaphylactic reaction
|
1.6%
2/123 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Food allergy
|
0.00%
0/123 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/123 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Pneumonia
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Viral pericarditis
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/123 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/123 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Psychiatric disorders
Anxiety
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
0.00%
0/48 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
Other adverse events
| Measure |
VIPES Initial Treatment Group: All Viaskin Peanut Doses
n=123 participants at risk
Participants were randomized in the VIPES study to receive either 50 μg, 100 μg or 250 μg Viaskin Peanut for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 36 months.
|
VIPES Initial Treatment Group: Placebo
n=48 participants at risk
Participants were randomized in the VIPES study to receive placebo for 12 months. In the follow-up OLFUS-VIPES study, participants received 250 μg Viaskin Peanut for up to 24 months. Participants received treatment with Viaskin Peanut for a total of up to 24 months.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
4.1%
5/123 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
9/123 • Number of events 10 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
14.6%
7/48 • Number of events 14 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.1%
10/123 • Number of events 13 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 11 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
8/123 • Number of events 11 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
4.2%
2/48 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
7/123 • Number of events 8 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
12.5%
6/48 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
12/123 • Number of events 14 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
16.7%
8/48 • Number of events 8 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site dermatitis
|
7.3%
9/123 • Number of events 12 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site eczema
|
11.4%
14/123 • Number of events 18 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
14.6%
7/48 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site erythema
|
56.1%
69/123 • Number of events 238 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
58.3%
28/48 • Number of events 96 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site irritation
|
4.1%
5/123 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 8 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site oedema
|
5.7%
7/123 • Number of events 13 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site papules
|
7.3%
9/123 • Number of events 10 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
14.6%
7/48 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site pruritus
|
46.3%
57/123 • Number of events 194 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
68.8%
33/48 • Number of events 117 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site rash
|
8.1%
10/123 • Number of events 16 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
16.7%
8/48 • Number of events 16 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site swelling
|
22.8%
28/123 • Number of events 111 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
41.7%
20/48 • Number of events 67 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Application site urticaria
|
7.3%
9/123 • Number of events 27 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
General disorders
Pyrexia
|
14.6%
18/123 • Number of events 32 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
12.5%
6/48 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Allergy to animal
|
5.7%
7/123 • Number of events 12 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Food allergy
|
11.4%
14/123 • Number of events 37 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 4 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Hypersensitivity
|
4.9%
6/123 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Immune system disorders
Seasonal allergy
|
4.9%
6/123 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
14.6%
7/48 • Number of events 15 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Ear infection
|
2.4%
3/123 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
10.4%
5/48 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Influenza
|
6.5%
8/123 • Number of events 8 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 4 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
25/123 • Number of events 41 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
29.2%
14/48 • Number of events 30 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.9%
6/123 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 4 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Rhinitis
|
6.5%
8/123 • Number of events 17 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
4.2%
2/48 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Sinusitis
|
4.9%
6/123 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 4 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.8%
17/123 • Number of events 37 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
22.9%
11/48 • Number of events 26 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Viral infection
|
4.1%
5/123 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 4 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
3/123 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
2/123 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.6%
2/123 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 3 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
8/123 • Number of events 10 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
4.2%
2/48 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Nervous system disorders
Headache
|
20.3%
25/123 • Number of events 80 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
25.0%
12/48 • Number of events 44 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.3%
9/123 • Number of events 17 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
12.5%
6/48 • Number of events 10 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
21/123 • Number of events 28 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
29.2%
14/48 • Number of events 29 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
7/123 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 2 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.6%
13/123 • Number of events 26 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
16.7%
8/48 • Number of events 15 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.6%
13/123 • Number of events 19 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
20.8%
10/48 • Number of events 11 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
13.8%
17/123 • Number of events 22 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
18.8%
9/48 • Number of events 12 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.3%
9/123 • Number of events 17 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
2.1%
1/48 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.5%
8/123 • Number of events 11 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.9%
6/123 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
12.5%
6/48 • Number of events 25 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.9%
6/123 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 7 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.81%
1/123 • Number of events 1 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
6.2%
3/48 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
5/123 • Number of events 6 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
8.3%
4/48 • Number of events 5 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
13.8%
17/123 • Number of events 20 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
12.5%
6/48 • Number of events 9 • Treatment-emergent adverse events were collected from OLFUS-VIPES Baseline up to Month 24. Overall time frame of up to 24 months.
The safety analysis set included all participants who received at least 1 dose of IP during the OLFUS-VIPES study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place