Up to

61%

of patients had reduced disease activity (SRI-4) at Week 521-3*

of patients had reduced disease activity (SRI-4) at Week 521-3*

SEE SRI-4 DATA

Steroid-sparing efficacy1-3

Steroid-sparing efficacy1-3

SEE STEROID DATA

Up to

49%

reduction in risk of severe flares1-3†

(For BLISS-SC, HR=0.51; 95% CI: 0.35, 0.74)

SEE FLARE DATA

* SRI-4 response rate at Week 52 (primary endpoint).

* SRI-4 response rate at Week 52 (primary endpoint).

† In the BENLYSTA + ST group, the percentage of
patients having ≥1 severe flare over 52 weeks was
11%, 14%, and 18% for
BLISS-SC (n=554), BLISS-52
(n=290), BLISS-76 (n=273), respectively.

CI = confidence interval; HR = hazard ratio; SRI = SLE
Responder Index; ST = standard therapy.

A lupus patient

Which patients are appropriate for BENLYSTA?

FIND OUT MORE

Hypothetical patient profile. May not be representative
of all patients.

BENLYSTA: PROVEN TO REDUCE DISEASE ACTIVITY

SRI-4 response rate at
Week 52 (primary endpoint)1-3*

In patients on placebo + ST, the SRI-4 response rate at Week 52 was 48%, 44%, and 34% for
BLISS-SC (n=279), BLISS-52 (n=287), and BLISS-76 (n=275), respectively.

* In BLISS-76, the difference in SRI-4 response rates was not significantly different at Week 76 (secondary endpoint).

SRI = SLE Responder Index; ST = standard therapy.

MORE PATIENTS
REDUCED DISEASE
ACTIVITY
VS ST ALONE
BY WEEK 84

SRI-4 response by visit*

Graph: Reduced disease activity (SRI-4) by visit

38%

of patients had
reduced disease
activity vs ST as
early as Week 8

Graph: Reduced disease activity (SRI-4) by visit

In a post hoc, pooled analysis involving 5 SLE studies.*†‡ Results are descriptive.
See individual study design.

* The same patient may not have responded
at each visit.

† Five randomized, controlled efficacy and
safety studies included: BLISS-52, BLISS-76,
NE Asia, BLISS-SC, EMBRACE.
The primary
endpoint (SRI-4 at Week 52) was not met in
EMBRACE.

‡ Individual studies were not designed to
establish onset of effect, and not all studies
showed improvement at Week 8.

NE = Northeast; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

REDUCED DISEASE ACTIVITY OVER 7 YEARS5

In the US open-label long-term extension trial of patients receiving
BENLYSTA + ST

SRI-4 responders over 7 years

Graph: Reduced disease activity (SRI-4) over 7 years

76%

of patients achieved SRI-4 at Year 7

Graph: Reduced disease activity (SRI-4) over 7 years

Used with permission from Furie RA, et al. Arthritis Rheumatol. 2018;70(6):868-877.
© 2018 John Wiley and Sons.

79%
of patients did not have
a severe flare during the
7-year follow-up
(n/N=212/267)
40%
of patients reduced
their prednisone dose to
≤7.5 mg/day at Year 7*
(n/N=15/38)

 

Results are descriptive. Other efficacy endpoints. Exploratory results should be interpreted with
additional care. See study design for data limitations.

* Among those receiving a steroid dose of
>7.5 mg/day at baseline (n=86, 32.1% of patients).

SRI = SLE Responder Index; ST = standard therapy.

IMPROVEMENT IN
ORGAN DOMAINS4*†

In a post hoc, pooled analysis
involving 5 SLE studies

Icon: Skin

59%

of patients on BENLYSTA + ST had improvements in skin

(n=1585)

vs 49% of patients on
ST alone (n=1039)

Icon: Joints

60%

of patients on BENLYSTA + ST had improvements in joints

(n=1180)

vs 50% of patients on
ST alone (n=780)

Icon: Kidneys

53%

of patients on BENLYSTA + ST had improvements in kidneys

(n=319)

vs 40% of patients on
ST alone (n=223)

* Results are descriptive. See individual study design.

† Improvement in organ domain, as defined by
SELENA-SLEDAI, at Week 52 among patients with
organ involvement at baseline.
Studies were designed
to evaluate efficacy in overall disease activity and
were not powered to evaluate efficacy in specific
organ
domains.

‡ Five randomized, controlled efficacy and safety
studies included: BLISS-52, BLISS-76, NE Asia,
BLISS-SC, and EMBRACE. The
primary endpoint
(SRI-4 at Week 52) was not met in EMBRACE.

NE = Northeast; SELENA-SLEDAI = Safety of
Estrogens in Lupus Erythematosus: National
Assessment version of the Systemic Lupus
Erythematosus Disease Activity Index; SLE = systemic
lupus erythematosus; SRI = SLE Responder Index; ST =
standard therapy.

POWERFUL PROTECTION AGAINST FLARES

BENLYSTA reduced the risk of severe flare1-3*†

* As measured by the SFI, modified to exclude the single criterion of increased SELENA-SLEDAI score to >12.

* As measured by the SFI, modified to exclude
the single criterion of increased SELENA-
SLEDAI score to >12.

† The incidence of severe flare over 52 weeks
was a secondary endpoint.

‡ Reduction of severe flare was not significant
in BLISS-76.

CI = confidence interval; HR = hazard ratio;
SELENA-SLEDAI = Safety of Estrogens in
Lupus Erythematosus: National
Assessment
version of the Systemic Lupus Erythematosus
Disease Activity Index; SFI = SELENA-SLEDAI
Flare Index; ST =
standard therapy.

BENLYSTA: STEROID-SPARING EFFICACY

Patients with ≥25% reduction in steroid dose to ≤7.5 mg/day at Week 521-3*†

There were no statistically significant differences between treatment groups in any trial.

* In patients who were receiving >7.5 mg/day
at baseline. Overall, 60%, 69%, and 46% of
patients were receiving
doses >7.5 mg/day at
baseline in BLISS-SC, BLISS-52, and
BLISS-76, respectively.

† In BLISS-SC, BLISS-52, and BLISS-76, this
was a secondary endpoint evaluating steroid
dose reduction during Weeks 40-52.

ST = standard therapy.

THE MOST COMPREHENSIVE CLINICAL TRIAL
PROGRAM IN LUPUS TO DATE

Expand all       Collapse all

Choose BENLYSTA now for your
patients
with lupus

Patient crossing her arms #2