Trial Outcomes & Findings for A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis (NCT NCT01712399)
NCT ID: NCT01712399
Last Updated: 2017-06-01
Results Overview
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
409 participants
Primary outcome timeframe
From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Results posted on
2017-06-01
Participant Flow
A total of 409 participants consented and 397 participants received mavrilimumab in this study.
A total of 442 participants who received at least one dose of mavrilimumab provided a pooled analysis of safety and efficacy data from this open-label extension study (CD-IA-CAM-3001-1109) together with the qualifying studies (CD IA CAM 3001 1071 and CD IA CAM 3001 1107).
Participant milestones
| Measure |
Mavrilimumab 100 mg
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Overall Study
STARTED
|
397
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
397
|
Reasons for withdrawal
| Measure |
Mavrilimumab 100 mg
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
39
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Study closure
|
345
|
Baseline Characteristics
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Age, Continuous
|
51.1 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
339 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
364 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
BULGARIA
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
CHILE
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
COLOMBIA
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
ESTONIA
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
GERMANY
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
GREECE
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
HUNGARY
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
ISRAEL
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
MEXICO
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
SERBIA
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
SLOVAKIA
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
SPAIN
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
5 Participants
n=5 Participants
|
|
Weight
|
73.25 Kilogram
STANDARD_DEVIATION 16.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)Population: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
288 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
46 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)Population: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Anaemia
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Eosinophilia
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Iron deficiency anaemia
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Leukocytosis
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Leukopenia
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Lymphadenopathy
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Neutropenia
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Spontaneous haematoma
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Alanine aminotransferase increased
|
8 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Aspartate aminotransferase increased
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood creatinine increased
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood glucose increased
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood pressure increased
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
C-reactive protein increased
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Chest X-ray abnormal
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Forced vital capacity abnormal
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Gamma-glutamyltransferase increased
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hepatic enzyme increased
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Liver function test abnormal
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Mycobacterium tuberculosis complex test positive
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Neutrophil count decreased
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Red blood cell sedimentation rate increased
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Transaminases increased
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Diabetes mellitus
|
5 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Dyslipidaemia
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypercholesterolaemia
|
9 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hyperglycaemia
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hyperlipidaemia
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertriglyceridaemia
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypoglycaemia
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Type 2 diabetes mellitus
|
4 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)Population: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Pyrexia
|
3 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
26 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Blood pressure increased
|
3 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Atrial fibrillation
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Palpitations
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Sinus tachycardia
|
1 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)Population: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 24 to Week 130 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=\<)15% reduction from baseline, greater than (\>)15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 48:>20% to <80%
|
8 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 24:=<15% reduction
|
208 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 78:>15% to =<20%
|
8 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 24:>15% to =<20%
|
12 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 24:>20% reduction
|
16 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 24:>20% to <80%
|
13 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 48:=<15% reduction
|
208 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 48: >15% to =<20%
|
10 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 48: >20% reduction
|
13 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 78:=<15% reduction
|
154 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 78:>20% reduction
|
16 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 78:>20% to <80%
|
11 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 104:=<15% reduction
|
28 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 104:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 104:>20% reduction
|
1 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 104:>20% to <80%
|
1 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 130:=<15% reduction
|
3 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 130:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 130:>20% reduction
|
0 Participants
|
|
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Week 130:>20% to <80%
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 24 to Week 130 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =\<15% reduction from baseline, \>15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 24:=<15% reduction
|
195 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 24:>15% to =<20%
|
14 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 24:>20% reduction
|
13 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 24:>20% to <80%
|
9 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 48:=<15% reduction
|
201 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 48:>15% to =<20%
|
13 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 48:>20% reduction
|
8 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 48:>20% to <80%
|
4 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 78:=<15% reduction
|
150 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 78:>15% to =<20%
|
8 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 78:>20% reduction
|
14 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 78:>20% to <80%
|
5 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 104:=<15% reduction
|
27 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 104:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 104:>20% reduction
|
1 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 104:>20% to <80%
|
1 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 130:=<15% reduction
|
1 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 130:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 130:>20% reduction
|
2 Participants
|
|
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Week 130:>20% to <80%
|
2 Participants
|
PRIMARY outcome
Timeframe: From Week 24 to Week 156 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =\<15% reduction from baseline, \>15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 24 :=<15% reduction
|
209 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 24:>15% to =<20%
|
13 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 24:>20% reduction
|
11 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 24:>20% to <80%
|
7 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 48:=<15% reduction
|
218 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 48:>15% to =<20%
|
10 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 48:>20% reduction
|
11 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 48:>20% to <80%
|
7 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 78:=<15% reduction
|
160 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 78:>15% to =<20%
|
4 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 78:>20% reduction
|
13 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 78:>20% to <80%
|
6 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 104:=<15% reduction
|
32 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 104:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 104:>20% reduction
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 104:>20% to <80%
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 130:=<15% reduction
|
4 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 130:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 130:>20% reduction
|
1 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 130:>20% to <80%
|
1 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 156:=<15% reduction
|
2 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 156:>15% to =<20%
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 156:>20% reduction
|
0 Participants
|
|
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Week 156:>20% to <80%
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 0 to Week 132 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=394 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 0 to Week 132 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 0 (n=397)
|
97.6 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 12 (n=384)
|
97.6 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 24 (n=1)
|
98.0 Percent saturation
Standard Error NA
Standard error was not calculated due to limited sample size.
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 36 (n=357)
|
97.5 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 48 (n=327)
|
97.8 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 60 (n=281)
|
97.8 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 72 (n=233)
|
97.7 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 84 (n=222)
|
97.7 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 96 (n=188)
|
97.9 Percent saturation
Standard Error 0.1
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 108 (n=58)
|
97.8 Percent saturation
Standard Error 0.2
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 120 (n=18)
|
97.6 Percent saturation
Standard Error 0.3
|
|
Oxygen Saturation Levels by Pulse Oximetry
Week 132 (n=7)
|
97.9 Percent saturation
Standard Error 0.5
|
PRIMARY outcome
Timeframe: From Week 12 to Week 156 at specified time pointsPopulation: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Outcome measures
| Measure |
Mavrilimumab 100 mg
n=397 Participants
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 12 (n=80)
|
21.196 (mL/min/mmHg)
Standard Deviation 5.158
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 24 (n=155)
|
21.996 (mL/min/mmHg)
Standard Deviation 5.274
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 48 (n=203)
|
21.135 (mL/min/mmHg)
Standard Deviation 4.873
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 78 (n=165)
|
20.639 (mL/min/mmHg)
Standard Deviation 4.637
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 104 (n=144)
|
20.636 (mL/min/mmHg)
Standard Deviation 5.088
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 130 (n=52)
|
20.372 (mL/min/mmHg)
Standard Deviation 4.546
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Week 156 (n=6)
|
19.265 (mL/min/mmHg)
Standard Deviation 4.131
|
Adverse Events
Mavrilimumab 100 mg
Serious events: 46 serious events
Other events: 214 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mavrilimumab 100 mg
n=397 participants at risk
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
3/397 • Number of events 3 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Gastrointestinal disorders
Colitis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Appendiceal abscess
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Appendicitis perforated
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Bronchitis
|
1.0%
4/397 • Number of events 4 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Gastroenteritis
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Peritonitis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Pneumonia
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Pyomyositis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Sialoadenitis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Urinary tract infection
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
2/397 • Number of events 3 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.0%
4/397 • Number of events 5 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.50%
2/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Nervous system disorders
Myelitis transverse
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Nervous system disorders
Syncope
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Vascular disorders
Peripheral artery stenosis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.25%
1/397 • Number of events 2 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.25%
1/397 • Number of events 1 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
Other adverse events
| Measure |
Mavrilimumab 100 mg
n=397 participants at risk
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
|
|---|---|
|
Gastrointestinal disorders
Dental caries
|
2.0%
8/397 • Number of events 9 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
15/397 • Number of events 15 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Bronchitis
|
11.1%
44/397 • Number of events 59 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Gastroenteritis
|
2.8%
11/397 • Number of events 14 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Influenza
|
5.8%
23/397 • Number of events 26 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Nasopharyngitis
|
14.9%
59/397 • Number of events 90 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Oral herpes
|
2.8%
11/397 • Number of events 13 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Pharyngitis
|
4.5%
18/397 • Number of events 20 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Respiratory tract infection
|
3.3%
13/397 • Number of events 21 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Rhinitis
|
2.3%
9/397 • Number of events 10 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
31/397 • Number of events 43 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Urinary tract infection
|
8.8%
35/397 • Number of events 53 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Infections and infestations
Viral infection
|
2.0%
8/397 • Number of events 10 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
8/397 • Number of events 8 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
8/397 • Number of events 8 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.3%
9/397 • Number of events 9 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
12/397 • Number of events 13 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.0%
12/397 • Number of events 13 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
9.6%
38/397 • Number of events 78 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Nervous system disorders
Headache
|
4.3%
17/397 • Number of events 35 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
8/397 • Number of events 9 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
|
Vascular disorders
Hypertension
|
6.5%
26/397 • Number of events 27 • From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER