Trial Outcomes & Findings for Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE) (NCT NCT04931563)

Last Updated: 2026-05-20

Results Overview

Composite endpoint (BICLA),a composite binary endpoint defined by meeting all of the following criteria: * Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B * No worsening from baseline in 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 as an increase of ≥0.30 points on a 3-point PGA visual analogue scale (VAS)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

277 participants

Primary outcome timeframe

Week 52

Results posted on

2026-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Anifrolumab 300mg Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Overall Study STARTED	138	139
Overall Study Started Treatment	138	138
Overall Study COMPLETED	118	113
Overall Study NOT COMPLETED	20	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Anifrolumab 300mg Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	1	9
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	2	7
Overall Study Due to other reasons not listed	9	6
Overall Study Randomised, not treated	0	1

Baseline Characteristics

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 52

Population: Full analysis set. All participants randomized into the study who receive at least 1 dose of investigational product (IP) and is analysed according to randomized treatment (modified Intention-To-Treat \[mITT\])

Outcome measures

Outcome measures
Measure	Anifrolumab 300mg n=138 Participants Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 Participants Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Difference in Proportion of Participants Who Are Responders Between Anifrolumab and Placebo	84 Participants	46 Participants

SECONDARY outcome

Timeframe: Week 52

SRI(4) response defined by meeting all of the following criteria: * Reduction from baseline of ≥ 4 points in the SLEDAI-2K; * No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items compared to baseline; * No worsening from baseline in the participants' lupus disease activity defined by an increase ≥0.30 points on a 3-point PGA VAS;

Outcome measures

Outcome measures
Measure	Anifrolumab 300mg n=138 Participants Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 Participants Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
The Proportion of Participants Who Achieve SRI(4) Response at Week 52	90 Participants	50 Participants

SECONDARY outcome

Timeframe: Week 52

Maintained OCS reduction 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

Outcome measures

Outcome measures
Measure	Anifrolumab 300mg n=93 Participants Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=92 Participants Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
The Proportion of Participants Who Achieve an Oral Corticosteroid (OCS) Dose ≤7.5 mg/Day at Week 40, Which is Maintained Through Week 52 in the Subgroup of Those With Baseline OCS ≥10 mg/Day	65 Participants	43 Participants

SECONDARY outcome

Timeframe: Week 52

Annualised flare rate with flare defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit

Outcome measures

Outcome measures
Measure	Anifrolumab 300mg n=138 Participants Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 Participants Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Annualized Flare Rate Through Week 52	0.22 Flares per person-years	0.51 Flares per person-years

Adverse Events

Anifrolumab 300mg

Serious events: 30 serious events

Other events: 119 other events

Deaths: 0 deaths

Placebo

Serious events: 17 serious events

Other events: 115 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Anifrolumab 300mg n=138 Participants Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 Participants Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Total n=276 Participants Total of all reporting groups
Age, Continuous	36.2 Years STANDARD_DEVIATION 9.7 • n=30 Participants	36.1 Years STANDARD_DEVIATION 9.8 • n=30 Participants	36.1 Years STANDARD_DEVIATION 9.8 • n=60 Participants
Age, Customized Age group · >=18 to <65 years	137 Participants n=30 Participants	137 Participants n=30 Participants	274 Participants n=60 Participants
Age, Customized Age group · >=65 years	1 Participants n=30 Participants	1 Participants n=30 Participants	2 Participants n=60 Participants
Sex: Female, Male Female	128 Participants n=30 Participants	126 Participants n=30 Participants	254 Participants n=60 Participants
Sex: Female, Male Male	10 Participants n=30 Participants	12 Participants n=30 Participants	22 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=30 Participants	138 Participants n=30 Participants	276 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	138 Participants n=30 Participants	138 Participants n=30 Participants	276 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) White	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants

Serious adverse events
Measure	Anifrolumab 300mg n=138 participants at risk Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 participants at risk Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Infections and infestations Gastroenteritis	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Herpes zoster	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Herpes zoster cutaneous disseminated	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Meningitis viral	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Ophthalmic herpes zoster	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Cardiac disorders Lupus endocarditis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Osteomyelitis bacterial	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pneumonia	3.6% 5/138 • Number of events 7 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pneumonia bacterial	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Tonsillitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Typhoid fever	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Urinary tract infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Vestibular neuronitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Injury, poisoning and procedural complications Craniocerebral injury	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Injury, poisoning and procedural complications Multiple fractures	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	2.9% 4/138 • Number of events 4 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Gastrointestinal disorders Gastritis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Gastrointestinal disorders Haemorrhoids	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Gastrointestinal disorders Lupus enteritis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
General disorders Chest pain	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Hepatobiliary disorders Cholecystitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Hepatobiliary disorders Cholecystitis acute	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Immune system disorders Anaphylactic reaction	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Appendicitis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Covid-19	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Escherichia bacteraemia	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Renal and urinary disorders Renal failure	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Reproductive system and breast disorders Cervical dysplasia	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Reproductive system and breast disorders Endometriosis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Reproductive system and breast disorders Pelvic fluid collection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.

Other adverse events
Measure	Anifrolumab 300mg n=138 participants at risk Anifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.	Placebo n=138 participants at risk Placebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Infections and infestations Mycoplasma infection	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Localised infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Helicobacter infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Herpes simplex	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Herpes zoster	6.5% 9/138 • Number of events 9 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Herpes zoster cutaneous disseminated	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Influenza	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Cardiac disorders Cardiac discomfort	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Latent tuberculosis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	2.9% 4/138 • Number of events 4 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Myometritis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Nasal herpes	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Nasopharyngitis	5.1% 7/138 • Number of events 12 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	3.6% 5/138 • Number of events 10 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Onychomycosis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Oral candidiasis	0.72% 1/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Oral herpes	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Oral infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Otitis externa	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Otitis media	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Papilloma viral infection	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pelvic inflammatory disease	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pericoronitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Periodontitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pharyngitis	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Cardiac disorders Mitral valve incompetence	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pneumonia	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pulmonary tuberculosis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pulpitis dental	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pyelonephritis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Pyuria	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 4 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Respiratory tract infection	2.2% 3/138 • Number of events 3 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	3.6% 5/138 • Number of events 6 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Rhinitis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Skin infection	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Soft tissue infection	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Cardiac disorders Myocardial ischaemia	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Suspected covid-19	3.6% 5/138 • Number of events 5 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	2.9% 4/138 • Number of events 4 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Tinea capitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Tinea versicolour	1.4% 2/138 • Number of events 2 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Tonsillitis	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Trichomoniasis	0.00% 0/138 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	0.72% 1/138 • Number of events 1 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.
Infections and infestations Upper respiratory tract infection	46.4% 64/138 • Number of events 120 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.	37.0% 51/138 • Number of events 88 • From date of first dose of investigational product throughout the treatment period up to the final clinical database locks (10JUN2025) and the safety follow-up period (until 84 days following the date of last investigational product dose). Maximum timeframe of 60 weeks.