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

Patients had up to

60%

improvement in skin, joints, and kidneys at Week 524†

SEE ORGAN DOMAIN DATA

Real-world data

86%

of patients reduced or discontinued steroids at Week 267‡

of patients reduced or discontinued steroids at Week 267‡

SEE STEROID DATA

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

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

† 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.

‡ Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.

Image: Lindsay Picture B

Which patients are appropriate for BENLYSTA?

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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).

BLISS = Belimumab International SLE Study; 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.

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; 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.

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.

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; 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.

0.79
of patients did not have a severe flare during the 7-year follow-up (n/N=212/267)
of patients did not have a severe flare during the 7-year follow-up (n/N=212/267)

 

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

SRI = SLE Responder Index; ST = standard therapy.

BENLYSTA REDUCES DISEASE ACTIVITY WITH STEROIDS + ANTIMALARIAL6

SRI-4 response by baseline therapy6

SRI-4 response by baseline therapy graph

Did you know?

53%

of patients treated with BENLYSTA in three pivotal trials were not on an immunosuppressant1-3

SRI-4 response by baseline therapy graph

Results are descriptive. Post hoc, pooled analysis of BLISS-52 and BLISS-76. See study design and patient characteristics.

BLISS = Belimumab International SLE Study; SRI = SLE Responder Index.

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.

BLISS = Belimumab International SLE Study; 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

Across 3 pivotal studies:

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.

BLISS = Belimumab International SLE Study; ST = standard therapy.

STEROID-SPARING EFFICACY IN A REAL-WORLD SETTING4,7*

AT WEEK 26

86%

Down arrow icon

OF PATIENTS REDUCED OR DISCONTINUED STEROIDS*

WITH A

MEAN REDUCTION IN DAILY DOSE* BY

Daily dose reduction icon

58%

VS BASELINE

A real-world, observational cohort study. Results are descriptive. See study design for data limitations.

* Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.

† Intent-to-treat (ITT) consisting of all patients enrolled at baseline followed through 24 months using the last observation carried forward (LOCF) method to account for patients who were lost to follow-up and/or discontinued BENLYSTA during follow-up.

THE MOST COMPREHENSIVE CLINICAL TRIAL
PROGRAM IN LUPUS TO DATE

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Choose BENLYSTA now for your
patients
with lupus

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