Trial Outcomes & Findings for A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus (NCT NCT02041091)
NCT ID: NCT02041091
Last Updated: 2018-06-15
Results Overview
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Results posted on
2018-06-15
Participant Flow
Participants who complete the Treatment Period will have the option of participating in the Optional Safety Extension Period through Week 52.
Participant milestones
| Measure |
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
|
|---|---|---|
|
Treatment
STARTED
|
112
|
114
|
|
Treatment
Received At Least One Dose of Study Drug
|
112
|
114
|
|
Treatment
Participated in Follow Up
|
106
|
96
|
|
Treatment
COMPLETED
|
90
|
91
|
|
Treatment
NOT COMPLETED
|
22
|
23
|
|
Optional Safety Extension Period
STARTED
|
85
|
82
|
|
Optional Safety Extension Period
COMPLETED
|
0
|
0
|
|
Optional Safety Extension Period
NOT COMPLETED
|
85
|
82
|
Reasons for withdrawal
| Measure |
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
The treatment regimen from Week 12 to Week 52 is an Optional Safety Extension Period.
All participants will participate in a Post-Treatment Follow-Up Period regardless of their participation in the Optional Safety Extension Period.
|
|---|---|---|
|
Treatment
Adverse Event
|
3
|
3
|
|
Treatment
Withdrawal by Subject
|
2
|
4
|
|
Treatment
Physician Decision
|
1
|
0
|
|
Treatment
Sponsor Decision
|
15
|
16
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
|
Optional Safety Extension Period
Adverse Event
|
4
|
2
|
|
Optional Safety Extension Period
Withdrawal by Subject
|
5
|
2
|
|
Optional Safety Extension Period
Protocol Violation
|
2
|
0
|
|
Optional Safety Extension Period
Physician Decision
|
2
|
1
|
|
Optional Safety Extension Period
Sponsor Decision
|
70
|
74
|
|
Optional Safety Extension Period
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Baseline characteristics by cohort
| Measure |
Tabalumab Prefilled Syringe
n=112 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
|
Tabalumab Auto-Injector
n=114 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.03 years
STANDARD_DEVIATION 12.691 • n=5 Participants
|
44.93 years
STANDARD_DEVIATION 13.306 • n=7 Participants
|
45.97 years
STANDARD_DEVIATION 13.018 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=87 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
n=99 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
|
35.7 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 53.2
|
34.1 microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 46.5
|
PRIMARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=87 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
n=99 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
|
8390 microgram*hour per milliliter (ug*hr/mL)
Geometric Coefficient of Variation 44.0
|
8170 microgram*hour per milliliter (ug*hr/mL)
Geometric Coefficient of Variation 41.3
|
SECONDARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low \<60 kilograms (kg), medium 60kg- 100kg, high \>100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=186 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
Low
|
47.8 μg/mL
Geometric Coefficient of Variation 40.5
|
—
|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
Medium
|
34.7 μg/mL
Geometric Coefficient of Variation 42.5
|
—
|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
High
|
25.4 μg/mL
Geometric Coefficient of Variation 40.1
|
—
|
SECONDARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low \<60 kilograms (kg), medium 60kg- 100kg, high \>100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=186 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
Low
|
10800 ug*hr/mL
Geometric Coefficient of Variation 31.9
|
—
|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
Medium
|
8450 ug*hr/mL
Geometric Coefficient of Variation 35.5
|
—
|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
High
|
6160 ug*hr/mL
Geometric Coefficient of Variation 36.7
|
—
|
SECONDARY outcome
Timeframe: Week 0 through Week 12Population: Safety population: all randomized patients who received at least 1 dose of study treatment.
Participants reporting incomplete dose administration from the study drug administration log.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=112 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
n=114 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Number of Participants Reporting Incomplete Tabalumab Dose Administration
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 12Population: Safety population: all randomized participants who received at least 1 dose of study treatment. Participants with a baseline sample and at least 1 evaluable sample after administration of study drug OR participants with no baseline sample and all evaluable post-baseline samples.
Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)\*100.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=111 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
n=112 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Number of Participants Developing Anti-Tabalumab Antibodies
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and Week 8Population: Safety population: all randomized patients who received at least 1 dose of study treatment.
The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from "Strongly Disagree" as 1 to "Strongly Agree" as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=112 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
n=114 Participants
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: L
|
6.7 units on a scale
Standard Deviation 0.81
|
6.8 units on a scale
Standard Deviation 0.51
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: A
|
6.7 units on a scale
Standard Deviation 0.59
|
6.8 units on a scale
Standard Deviation 0.71
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: B
|
6.4 units on a scale
Standard Deviation 0.94
|
6.8 units on a scale
Standard Deviation 0.64
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: A
|
6.5 units on a scale
Standard Deviation 1.14
|
6.8 units on a scale
Standard Deviation 0.60
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: B
|
5.9 units on a scale
Standard Deviation 1.39
|
6.8 units on a scale
Standard Deviation 0.60
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: C
|
6.3 units on a scale
Standard Deviation 1.24
|
6.8 units on a scale
Standard Deviation 0.55
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: D
|
6.4 units on a scale
Standard Deviation 1.12
|
6.8 units on a scale
Standard Deviation 0.45
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: E
|
6.5 units on a scale
Standard Deviation 0.92
|
6.7 units on a scale
Standard Deviation 0.56
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: F
|
6.6 units on a scale
Standard Deviation 0.82
|
6.7 units on a scale
Standard Deviation 0.70
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: G
|
6.3 units on a scale
Standard Deviation 1.31
|
6.5 units on a scale
Standard Deviation 0.74
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: H
|
6.6 units on a scale
Standard Deviation 0.82
|
6.9 units on a scale
Standard Deviation 0.35
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: I
|
6.4 units on a scale
Standard Deviation 1.06
|
6.9 units on a scale
Standard Deviation 0.39
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: J
|
6.4 units on a scale
Standard Deviation 1.12
|
6.8 units on a scale
Standard Deviation 0.47
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 0: K
|
6.6 units on a scale
Standard Deviation 0.93
|
6.9 units on a scale
Standard Deviation 0.40
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: C
|
6.5 units on a scale
Standard Deviation 0.97
|
6.8 units on a scale
Standard Deviation 0.71
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: D
|
6.5 units on a scale
Standard Deviation 0.97
|
6.8 units on a scale
Standard Deviation 0.73
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: E
|
6.5 units on a scale
Standard Deviation 0.95
|
6.7 units on a scale
Standard Deviation 0.76
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: F
|
6.6 units on a scale
Standard Deviation 0.84
|
6.8 units on a scale
Standard Deviation 0.73
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: G
|
6.5 units on a scale
Standard Deviation 0.77
|
6.5 units on a scale
Standard Deviation 1.05
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: H
|
6.7 units on a scale
Standard Deviation 0.59
|
6.8 units on a scale
Standard Deviation 0.64
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: I
|
6.5 units on a scale
Standard Deviation 0.87
|
6.8 units on a scale
Standard Deviation 0.70
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: J
|
6.5 units on a scale
Standard Deviation 0.92
|
6.7 units on a scale
Standard Deviation 0.78
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: K
|
6.6 units on a scale
Standard Deviation 0.68
|
6.8 units on a scale
Standard Deviation 0.65
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 4: L
|
6.7 units on a scale
Standard Deviation 0.82
|
6.8 units on a scale
Standard Deviation 0.77
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: A
|
6.7 units on a scale
Standard Deviation 0.58
|
6.9 units on a scale
Standard Deviation 0.30
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: B
|
6.5 units on a scale
Standard Deviation 1.07
|
6.9 units on a scale
Standard Deviation 0.28
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: C
|
6.6 units on a scale
Standard Deviation 0.86
|
6.9 units on a scale
Standard Deviation 0.37
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: D
|
6.6 units on a scale
Standard Deviation 0.96
|
6.9 units on a scale
Standard Deviation 0.31
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: E
|
6.6 units on a scale
Standard Deviation 0.86
|
6.8 units on a scale
Standard Deviation 0.74
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: F
|
6.8 units on a scale
Standard Deviation 0.73
|
6.8 units on a scale
Standard Deviation 0.74
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: G
|
6.6 units on a scale
Standard Deviation 0.89
|
6.6 units on a scale
Standard Deviation 1.06
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: H
|
6.8 units on a scale
Standard Deviation 0.48
|
6.8 units on a scale
Standard Deviation 0.68
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: I
|
6.7 units on a scale
Standard Deviation 0.81
|
6.9 units on a scale
Standard Deviation 0.67
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: J
|
6.6 units on a scale
Standard Deviation 1.03
|
6.8 units on a scale
Standard Deviation 0.74
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: K
|
6.7 units on a scale
Standard Deviation 0.82
|
6.9 units on a scale
Standard Deviation 0.67
|
|
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Week 8: L
|
6.8 units on a scale
Standard Deviation 0.58
|
6.8 units on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.
Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=33 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Arm
|
29.4 μg/mL
Geometric Coefficient of Variation 38.1
|
—
|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Abdomen
|
37 μg/mL
Geometric Coefficient of Variation 35.4
|
—
|
|
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Thigh
|
42.2 μg/mL
Geometric Coefficient of Variation 52.6
|
—
|
SECONDARY outcome
Timeframe: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumabPopulation: PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.
Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
Outcome measures
| Measure |
Tabalumab Prefilled Syringe
n=33 Participants
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe: Administered SC
|
Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector: Administered SC
|
|---|---|---|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Arm
|
7380 μg*hr/mL
Geometric Coefficient of Variation 36
|
—
|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Abdomen
|
8890 μg*hr/mL
Geometric Coefficient of Variation 27.9
|
—
|
|
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Thigh
|
10000 μg*hr/mL
Geometric Coefficient of Variation 34
|
—
|
Adverse Events
Tabalumab Prefilled Syringe Treatment
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Tabalumab Auto-Injector Treatment
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Prefilled Syringe Optional Safety Extension
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Auto-Injector Optional Safety Extension
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Prefilled Syringe Follow Up
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Auto-Injector Follow Up
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tabalumab Prefilled Syringe Treatment
n=112 participants at risk
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks.
|
Tabalumab Auto-Injector Treatment
n=114 participants at risk
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks.
|
Prefilled Syringe Optional Safety Extension
n=85 participants at risk
Tabalumab given SC every two weeks from Week 12 to Week 52.
|
Auto-Injector Optional Safety Extension
n=82 participants at risk
Tabalumab given every two weeks from Week 12 to Week 52.
|
Prefilled Syringe Follow Up
n=106 participants at risk
Follow Up 24-48 weeks post last doseTabalumab
|
Auto-Injector Follow Up
n=96 participants at risk
Follow Up 24-48 weeks post last doseTabalumab
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
1.2%
1/85 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
1.2%
1/85 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.88%
1/114 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
1.2%
1/85 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.88%
1/114 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.93%
1/108 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/81
All participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
1.0%
1/100 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/90
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.88%
1/114 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.88%
1/114 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.89%
1/112 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Sideropenic dysphagia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder cholesterolosis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
2.4%
2/82 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.89%
1/112 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tracheobronchitis
|
0.89%
1/112 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Tabalumab Prefilled Syringe Treatment
n=112 participants at risk
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks.
|
Tabalumab Auto-Injector Treatment
n=114 participants at risk
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks.
|
Prefilled Syringe Optional Safety Extension
n=85 participants at risk
Tabalumab given SC every two weeks from Week 12 to Week 52.
|
Auto-Injector Optional Safety Extension
n=82 participants at risk
Tabalumab given every two weeks from Week 12 to Week 52.
|
Prefilled Syringe Follow Up
n=106 participants at risk
Follow Up 24-48 weeks post last doseTabalumab
|
Auto-Injector Follow Up
n=96 participants at risk
Follow Up 24-48 weeks post last doseTabalumab
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.89%
1/112 • Number of events 1
All participants who received at least 1 dose of study drug.
|
2.6%
3/114 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
5/112 • Number of events 6
All participants who received at least 1 dose of study drug.
|
4.4%
5/114 • Number of events 8
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
7/112 • Number of events 7
All participants who received at least 1 dose of study drug.
|
3.5%
4/114 • Number of events 5
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
2.4%
2/82 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.8%
2/112 • Number of events 2
All participants who received at least 1 dose of study drug.
|
2.6%
3/114 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site bruising
|
2.7%
3/112 • Number of events 4
All participants who received at least 1 dose of study drug.
|
1.8%
2/114 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 3
All participants who received at least 1 dose of study drug.
|
1.2%
1/82 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
3.6%
4/112 • Number of events 5
All participants who received at least 1 dose of study drug.
|
3.5%
4/114 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
4.7%
4/85 • Number of events 8
All participants who received at least 1 dose of study drug.
|
9.8%
8/82 • Number of events 16
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
4.5%
5/112 • Number of events 7
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
General disorders
Local swelling
|
1.8%
2/112 • Number of events 2
All participants who received at least 1 dose of study drug.
|
3.5%
4/114 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
5.2%
5/96 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
2/112 • Number of events 2
All participants who received at least 1 dose of study drug.
|
3.5%
4/114 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
1.2%
1/85 • Number of events 1
All participants who received at least 1 dose of study drug.
|
3.7%
3/82 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
3.5%
3/85 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
3.5%
3/85 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
1.2%
1/82 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
5.2%
5/96 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
3.7%
3/82 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
2.4%
2/82 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
1.2%
1/82 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
1.9%
2/106 • Number of events 2
All participants who received at least 1 dose of study drug.
|
2.1%
2/96 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.94%
1/106 • Number of events 1
All participants who received at least 1 dose of study drug.
|
2.1%
2/96 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
2.1%
2/96 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
2.8%
3/106 • Number of events 3
All participants who received at least 1 dose of study drug.
|
1.0%
1/96 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.7%
3/112 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.88%
1/114 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.89%
1/112 • Number of events 1
All participants who received at least 1 dose of study drug.
|
2.6%
3/114 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/85
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/112
All participants who received at least 1 dose of study drug.
|
0.00%
0/114
All participants who received at least 1 dose of study drug.
|
2.4%
2/85 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/82
All participants who received at least 1 dose of study drug.
|
0.00%
0/106
All participants who received at least 1 dose of study drug.
|
0.00%
0/96
All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60