Rheumatoid Arthritis
Conditions
Brief summary
A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
Detailed description
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.
Interventions
BIOLOGICALMavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization. * No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist
Exclusion criteria
* Subjects who have been permanently discontinued from investigational product in previous qualifying study. * Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years) | 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. |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | 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) | 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. |
| Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | 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) | 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. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 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) | 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. |
| Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | From Week 24 to Week 130 at specified 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. |
| Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | From Week 24 to Week 130 at specified 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. |
| Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | From Week 24 to Week 156 at specified 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. |
| Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | From Week 0 to Week 132 at specified time points | 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. |
| Oxygen Saturation Levels by Pulse Oximetry | From Week 0 to Week 132 at specified time points | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. |
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | From Week 12 to Week 156 at specified time points | DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide. |
Countries
Argentina, Bulgaria, Chile, Colombia, Czechia, Estonia, Germany, Greece, Hungary, Israel, Mexico, Poland, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom
Participant flow
Recruitment details
A total of 409 participants consented and 397 participants received mavrilimumab in this study.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Mavrilimumab 100 mg Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. | 397 |
| Total | 397 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study closure | 345 |
| Overall Study | Withdrawal by Subject | 39 |
Baseline characteristics
| Characteristic | Mavrilimumab 100 mg |
|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 11.2 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 29 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 364 Participants |
| Region of Enrollment ARGENTINA | 41 Participants |
| Region of Enrollment BULGARIA | 3 Participants |
| Region of Enrollment CHILE | 35 Participants |
| Region of Enrollment COLOMBIA | 25 Participants |
| Region of Enrollment CZECH REPUBLIC | 69 Participants |
| Region of Enrollment ESTONIA | 21 Participants |
| Region of Enrollment GERMANY | 8 Participants |
| Region of Enrollment GREECE | 3 Participants |
| Region of Enrollment HUNGARY | 9 Participants |
| Region of Enrollment ISRAEL | 11 Participants |
| Region of Enrollment MEXICO | 10 Participants |
| Region of Enrollment POLAND | 34 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 53 Participants |
| Region of Enrollment SERBIA | 24 Participants |
| Region of Enrollment SLOVAKIA | 1 Participants |
| Region of Enrollment SOUTH AFRICA | 2 Participants |
| Region of Enrollment SPAIN | 4 Participants |
| Region of Enrollment UKRAINE | 39 Participants |
| Region of Enrollment UNITED KINGDOM | 5 Participants |
| Sex: Female, Male Female | 339 Participants |
| Sex: Female, Male Male | 58 Participants |
| Weight | 73.25 Kilogram STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 214 / 397 |
| serious Total, serious adverse events | 46 / 397 |
Outcome results
Primary
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Time frame: From Week 12 to Week 156 at specified time points
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 104 (n=144) | 20.636 (mL/min/mmHg) | Standard Deviation 5.088 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 12 (n=80) | 21.196 (mL/min/mmHg) | Standard Deviation 5.158 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 24 (n=155) | 21.996 (mL/min/mmHg) | Standard Deviation 5.274 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 48 (n=203) | 21.135 (mL/min/mmHg) | Standard Deviation 4.873 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 78 (n=165) | 20.639 (mL/min/mmHg) | Standard Deviation 4.637 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 130 (n=52) | 20.372 (mL/min/mmHg) | Standard Deviation 4.546 |
| Mavrilimumab 100 mg | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Week 156 (n=6) | 19.265 (mL/min/mmHg) | Standard Deviation 4.131 |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | 0 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Anaemia | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Eosinophilia | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Iron deficiency anaemia | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukocytosis | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Leukopenia | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Lymphadenopathy | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutropenia | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Spontaneous haematoma | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Alanine aminotransferase increased | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Aspartate aminotransferase increased | 6 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood creatinine increased | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood glucose increased | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | C-reactive protein increased | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Chest X-ray abnormal | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Forced vital capacity abnormal | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Gamma-glutamyltransferase increased | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hepatic enzyme increased | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Liver function test abnormal | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mycobacterium tuberculosis complex test positive | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Neutrophil count decreased | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Red blood cell sedimentation rate increased | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Transaminases increased | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Diabetes mellitus | 5 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Dyslipidaemia | 4 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypercholesterolaemia | 9 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperglycaemia | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hyperlipidaemia | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertriglyceridaemia | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypoglycaemia | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Type 2 diabetes mellitus | 4 Participants |
Primary
Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
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.
Time frame: From Week 0 to Week 132 at specified time points
Population: The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | 0 Participants |
Primary
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
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.
Time frame: From Week 24 to Week 130 at specified time points
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 24:=<15% reduction | 208 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 24:>15% to =<20% | 12 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 24:>20% reduction | 16 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 24:>20% to <80% | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 48:=<15% reduction | 208 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 48: >15% to =<20% | 10 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 48: >20% reduction | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 48:>20% to <80% | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 78:=<15% reduction | 154 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 78:>15% to =<20% | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 78:>20% reduction | 16 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 78:>20% to <80% | 11 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 104:=<15% reduction | 28 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 104:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 104:>20% reduction | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 104:>20% to <80% | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 130:=<15% reduction | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 130:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 130:>20% reduction | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Week 130:>20% to <80% | 0 Participants |
Primary
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
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.
Time frame: From Week 24 to Week 130 at specified time points
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 24:=<15% reduction | 195 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 24:>15% to =<20% | 14 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 24:>20% reduction | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 24:>20% to <80% | 9 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 48:=<15% reduction | 201 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 48:>15% to =<20% | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 48:>20% reduction | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 48:>20% to <80% | 4 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 78:=<15% reduction | 150 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 78:>15% to =<20% | 8 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 78:>20% reduction | 14 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 78:>20% to <80% | 5 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 104:=<15% reduction | 27 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 104:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 104:>20% reduction | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 104:>20% to <80% | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 130:=<15% reduction | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 130:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 130:>20% reduction | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Week 130:>20% to <80% | 2 Participants |
Primary
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
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.
Time frame: From Week 24 to Week 156 at specified time points
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 24 :=<15% reduction | 209 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 24:>15% to =<20% | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 24:>20% reduction | 11 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 24:>20% to <80% | 7 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 48:=<15% reduction | 218 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 48:>15% to =<20% | 10 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 48:>20% reduction | 11 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 48:>20% to <80% | 7 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 78:=<15% reduction | 160 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 78:>15% to =<20% | 4 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 78:>20% reduction | 13 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 78:>20% to <80% | 6 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 104:=<15% reduction | 32 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 104:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 104:>20% reduction | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 104:>20% to <80% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 130:=<15% reduction | 4 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 130:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 130:>20% reduction | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 130:>20% to <80% | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 156:=<15% reduction | 2 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 156:>15% to =<20% | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 156:>20% reduction | 0 Participants |
| Mavrilimumab 100 mg | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Week 156:>20% to <80% | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 288 Participants |
| Mavrilimumab 100 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 46 Participants |
Primary
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Hypertension | 26 Participants |
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Pyrexia | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Blood pressure increased | 3 Participants |
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Atrial fibrillation | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Palpitations | 1 Participants |
| Mavrilimumab 100 mg | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Sinus tachycardia | 1 Participants |
Primary
Oxygen Saturation Levels by Pulse Oximetry
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time frame: From Week 0 to Week 132 at specified time points
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 0 (n=397) | 97.6 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 12 (n=384) | 97.6 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 24 (n=1) | 98.0 Percent saturation | — |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 36 (n=357) | 97.5 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 48 (n=327) | 97.8 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 60 (n=281) | 97.8 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 72 (n=233) | 97.7 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 84 (n=222) | 97.7 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 96 (n=188) | 97.9 Percent saturation | Standard Error 0.1 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 108 (n=58) | 97.8 Percent saturation | Standard Error 0.2 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 120 (n=18) | 97.6 Percent saturation | Standard Error 0.3 |
| Mavrilimumab 100 mg | Oxygen Saturation Levels by Pulse Oximetry | Week 132 (n=7) | 97.9 Percent saturation | Standard Error 0.5 |