Trial
1

Trial
2

120
Q2W

120
Q4W

Placebo

120
Q2W

120
Q4W

Placebo

Enrollment

387

389

388

372

376

376

Efficacy

Primary
Endpoint^a

31.8%

p=0.409

35.2%

p=0.052

29.3%

38.4%

p=0.002

34.8%

p=0.051

27.7%

Corticosteroid
sparing^b

23.4%

p=0.280

17.5%

p=0.747

18.9%

22.5%

p=0.051

17.5%

p=0.342

13.9%

Time
to severe flare^c

HR:
0.94

p=0.724

HR:
0.79

p=0.204

HR:
0.88

p=0.480

HR:
0.98

p=0.910

Worst
fatigue in Last 24 hours^d

LSM:
-1.31

p=0.163

LSM:
-1.38

p=0.081

LSM:
-1.01

LSM:
-0.73

p=0.276

LSM:
-0.66

p=0.556

LSM:
‑0.57

Safety

Safety
Population

386

389

387

371

374

376

Deaths

n=3

Anti-phospholipid
syndrome; pulmonary embolism; disseminated tuberculosis

n=2

Pneumonia;
SLE

n=2

Death^e;

CVA

n=1

Traffic
accident

n=2

Septic
shock; squamous cell carcinoma

n=3

Brain
edema; cardio-pulmonary failure;

cardiac
failure

Serious
Infections^f

5.2%

4.9%

4.4%

4.3%

5.9%

6.6%

Urinary
tract infection

18.9%

13.9%

13.4%

14.6%

16.3%

17.0%

Opportunistic
infections

Herpes
zoster

3.4%

1.0%

2.6%

1.6%

2.7%

1.6%

Disseminated
tuberculosis

0.3%

0%

0%

0%

0%

0%

Pulmonary
tuberculosis

0%

0%

0%

0%

0%

0.3%

Cytomegalovirus

0%

0.3%

0%

0%

0%

0%

Treatment-emergent
anti-drug antibodies

0.5%

0.8%

3.1%

0.8%

1.1%

1.9%

Abbreviations:
120 Q2W = loading dose of tabalumab 240 mg followed
by tabalumab 120 mg every 2 weeks; 120 Q4W =
loading dose of tabalumab 240 mg followed by tabalumab 120 mg every 4 weeks; HR = hazard ratio; LSM =
least squares mean; SELENA-SLEDAI = Safety of Estrogens in Lupus
Erythematosus National Assessment – SLE Disease Activity Index; Trial 1 = ILLUMINATE-1
(H9B-MC-BCDS); Trial 2 = ILLUMINATE-2 (H9B-MC-BCDT).

^aPrimary Endpoint: SLE Responder Index 5 (SRI-5) – a reduction of
≥5 points from baseline in SELENA-SLEDAI score, no new BILAG A or no
more than 1 new BILAG B disease activity scores, and no worsening (defined as
an increase of ≥0.3 points from baseline) in Physician’s Global
Assessment (PGA).

Concomitant
medication rules defining nonresponse:

Trial
1: Unable to taper to baseline dose of corticosteroids; After Week 24,
increase in corticosteroid dose; or initiate or require an increase or
decrease in dose of any allowed concomitant antimalarial or immunosuppressant
at any time. Trial 2: allowed for decrease in concomitant antimalarial or immunosuppressants.

^bCorticosteroid sparing definition – for those patients receiving >
7.5 mg/day of prednisone (or equivalent) at baseline, a patient will have
achieved corticosteroid sparing if they reduce their corticosteroid dose by
at least 25% to ≤ 7.5 mg/day for at least three consecutive months (84
days) during Weeks 24 through 52 without an increase in dose of either antimalarials or immunosuppressants
at any time during the treatment period.

^cTime to severe flare – a severe flare was defined by the
modified SELENA-SLEDAI Flare Index using the SELENA-SLEDAI score, disease
activity scenarios, treatment changes and PGA within 52 week treatment
period.

^dWorst fatigue in 24 hours – worst level of fatigue during the
past 24 hours from baseline to Week 52 from the Brief Fatigue Inventory.

^ePreferred term; verbatim reported by investigator was unknown cause
of death.

^fIdentified by System Organ Class Infections and infestations.