Trial Outcomes & Findings for Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus (NCT NCT02446899)

Last Updated: 2023-01-10

Results Overview

Composite endpoint BICLA was defined by meeting all of the following criteria: * Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of \>0 points in SLEDAI-2K * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

373 participants

Primary outcome timeframe

Baseline; Week 52

Results posted on

2023-01-10

Participant Flow

Participants took part in the trial at 119 sites in 15 countries worldwide.

8 participants were assigned study drug, but due to non-compliance were analyzed separately (not included in the participant flow). 3 additional participants were assigned study drug \& included in the participant flow, but did not receive study drug due to an adverse event (1 Anifrolumab 300mg) \& failure to meet randomization criteria (2 Placebo).

Participant milestones

Participant milestones
Measure	Anifrolumab 300 mg Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Study STARTED	181	184
Overall Study Received Study Drug	180	182
Overall Study COMPLETED	156	136
Overall Study NOT COMPLETED	25	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Anifrolumab 300 mg Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Study Adverse Event	4	7
Overall Study Condition Under Investigation Worsened	1	4
Overall Study Study Specific Withdrawal Criteria	1	0
Overall Study Lack of Efficacy	2	8
Overall Study Lost to Follow-up	1	3
Overall Study Severe Non-Compliance to Protocol	0	1
Overall Study Withdrawal by Subject	11	19
Overall Study Miscellaneous	5	4
Overall Study Failure to Meet Randomization Criteria	0	2

Baseline Characteristics

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Total n=362 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	175 Participants n=5 Participants	181 Participants n=7 Participants	356 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	43.1 Years STANDARD_DEVIATION 11.95 • n=5 Participants	41.1 Years STANDARD_DEVIATION 11.47 • n=7 Participants	42.1 Years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	168 Participants n=5 Participants	170 Participants n=7 Participants	338 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants	120 Participants n=7 Participants	238 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White	110 Participants n=5 Participants	107 Participants n=7 Participants	217 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=5 Participants	25 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Asian	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Missing	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Geographic region Asia Pacific	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Geographic region Europe	51 Participants n=5 Participants	46 Participants n=7 Participants	97 Participants n=5 Participants
Geographic region Latin America	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Geographic region United States/Canada	64 Participants n=5 Participants	68 Participants n=7 Participants	132 Participants n=5 Participants
Geographic region Rest of World (South Africa)	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52	86 Participants	57 Participants

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug, with a high interferon (IFN) test result at baseline.

Defined by meeting all of the following criteria: * Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline to \>0 points in SLEDAI-2K * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=150 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=151 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group	72 Participants	46 Participants

SECONDARY outcome

Timeframe: Week 40; Week 52

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug, who had a baseline OCS dose of ≥10 mg/day.

Maintained OCS reduction was defined by meeting all of the following criteria: * Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 * Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=87 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=83 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day	45 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had a CLASI activity score of ≥10 at baseline.

50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria: * Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=49 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=40 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10	24 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had ≥6 swollen and ≥6 tender joints at baseline.

50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria: * Achieve ≥50% reduction from baseline in the number of swollen and tender joints, separately * No discontinuation of investigational product * No use of restricted medications beyond the protocol allowed threshold before assessment

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=71 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=90 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline	30 Participants	34 Participants

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Annualised Flare Rate Through 52 Weeks	0.43 Annualized flare rate ratio Interval 0.31 to 0.59	0.64 Annualized flare rate ratio Interval 0.47 to 0.86

SECONDARY outcome

Timeframe: Baseline to end of study (Maximum of 60 weeks)

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With One or More Adverse Events (AEs)	162 Participants	154 Participants

SECONDARY outcome

Timeframe: Baseline to end of study (Maximum of 60 weeks)

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus \[SLE\]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction \[MI\], or cardiovascular death). AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With One or More Adverse Events of Special Interest (AESIs)	29 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to end of study (Maximum of 60 weeks)

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements	45 Participants	45 Participants

SECONDARY outcome

Timeframe: Baseline to end of study (Maximum of 60 weeks)

Population: Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Outcome measures

Outcome measures
Measure	Anifrolumab 300 mg n=180 Participants Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 Participants Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests	72 Participants	87 Participants

Adverse Events

Anifrolumab 300 mg

Serious events: 16 serious events

Other events: 125 other events

Deaths: 1 deaths

Placebo

Serious events: 34 serious events

Other events: 99 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Anifrolumab 300 mg n=180 participants at risk Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).	Placebo n=182 participants at risk Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Gastrointestinal disorders Nausea	3.9% 7/180 • Number of events 7 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	5.5% 10/182 • Number of events 11 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Bronchitis	12.8% 23/180 • Number of events 31 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	4.4% 8/182 • Number of events 8 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Herpes zoster	6.7% 12/180 • Number of events 12 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	1.6% 3/182 • Number of events 3 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Nasopharyngitis	15.6% 28/180 • Number of events 42 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	12.6% 23/182 • Number of events 31 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Sinusitis	7.2% 13/180 • Number of events 21 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	4.9% 9/182 • Number of events 10 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	23.3% 42/180 • Number of events 57 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	10.4% 19/182 • Number of events 24 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Infections and infestations Urinary tract infection	11.7% 21/180 • Number of events 27 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	14.3% 26/182 • Number of events 40 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	13.9% 25/180 • Number of events 42 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	7.7% 14/182 • Number of events 27 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 10/180 • Number of events 11 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	3.3% 6/182 • Number of events 6 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	6.1% 11/180 • Number of events 12 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	1.6% 3/182 • Number of events 3 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Nervous system disorders Headache	6.1% 11/180 • Number of events 13 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	9.9% 18/182 • Number of events 23 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 10/180 • Number of events 11 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.	3.8% 7/182 • Number of events 7 • Day 1 to end of study (Maximum of 60 weeks) AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. Full analysis set: All participants who had received at least one dose of study drug.

Additional Information

Global Clinical Lead

AstraZeneca AB

Phone: +46317761000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place