Icon: Disease activity

SYMPTOMS

Up to

61%

of patients had reduced lupus symptoms (SRI-4) at Week 521-3*

of patients had reduced lupus symptoms (SRI-4) at Week 521-3*

SEE SRI-4 DATA

Icon: Steroids

STEROIDS

Real-world data

86%

of patients reduced or discontinued steroids at Week 264,5†

of patients reduced or discontinued steroids at Week 264,5†

SEE STEROID DATA

Icon: Kidneys

KIDNEYS

53%

of patients on BENLYSTA had improvements in kidneys4‡

of patients on BENLYSTA had improvements in kidneys4‡

SEE KIDNEY DATA

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

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

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

‡ 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.

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 LUPUS SYMPTOMS

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

Bar graph: SRI-4 response rate at Week 52 (primary endpoint)¹¯³*
Bar graph: 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

Kidney preservation data

53%

of patients on BENLYSTA + ST had improvements in kidneys

(n=319)

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

Results are descriptive; use caution when interpreting data. See individual study design and limitations.

* 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
HAD REDUCED LUPUS SYMPTOMS
VS ST ALONE
BY WEEK 84

SRI-4 response by visit*

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

38%

of patients had
reduced lupus symptoms
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; use caution when interpreting data.
See individual study design and limitations.

* 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.

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

‡ 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 LUPUS SYMPTOMS OVER 7 YEARS6

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 76

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-up6 (n/N=212/267)
of patients did not have a severe flare during the 7-year follow-up6 (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 LUPUS SYMPTOMS WITH STEROIDS + ANTIMALARIAL7

SRI-4 response by baseline therapy7

Line graph of SRI-4 response by baseline therapy

Did you know?

53%

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

Line graph of SRI-4 response by baseline therapy

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.

HOW DOES FATIGUE IMPACT YOUR PATIENTS?

Mean change in baseline FACIT-Fatigue score by visit4*

Line graph of mean change in baseline FACIT-Fatigue score by visit
Line graph of mean change in baseline FACIT-Fatigue score by visit

Results are descriptive; use caution when interpreting data. See individual study design and limitations.

* Pooled data from adult clinical trials of BENLYSTA (BLISS-52, BLISS-76, BLISS-SC, and EMBRACE). The individual EMBRACE and BLISS studies in SLE were not powered to detect significant differences in the FACIT-Fatigue score with BENLYSTA treatment plus standard therapy versus standard therapy alone. BLISS-52, BLISS-SC, and EMBRACE did not have scheduled FACIT-Fatigue assessments at Weeks 20, 32, 40, or 48, while BLISS-76 did not have assessments at Week 36.

† MCID has not been definitively established in SLE.

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; FACIT = Functional Assessment of Chronic Illness Therapy; SLE = systemic lupus erythematosus.

POWERFUL PROTECTION AGAINST SEVERE 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 RESULTS IN A REAL-WORLD SETTING4,5*

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.

‡ Total percentage may not add up to 100% due to rounding.

STEROID-SPARING EFFICACY RESULTS IN AFRICAN-AMERICAN PATIENTS IN A REAL-WORLD SETTING9*

Mean steroid dose over 24 months in patients still receiving BENLYSTA at 24 months (n=69)

SRI-4 response by baseline therapy graph

61%

reduction

in steroid dose within 6 months

SRI-4 response by baseline therapy graph

Post hoc analysis. 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. Care should be taken when interpreting the present findings due to patient attrition, small sample size, and the lack of a control group.

* Analysis of African-American patients in the OBSErve US study.

† In the OBSErve US study, 501 patients with SLE were enrolled; 123 (24.6%) were African-American. Of that, 69 (56.1%) continued to receive BENLYSTA at Month 24, 26 (21.1%) were lost to follow-up, and 28 (22.8%) discontinued BENLYSTA.

SD = standard deviation.

STEROID-SPARING EFFICACY RESULTS IN HISPANIC PATIENTS IN A REAL-WORLD SETTING9*

Mean steroid dose over 24 months in patients still receiving BENLYSTA at 23 months (n=43)†

SRI-4 response by baseline therapy graph

66%

reduction

in steroid dose within 6 months

SRI-4 response by baseline therapy graph

Post hoc analysis. 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. Care should be taken when interpreting the present findings due to patient attrition, small sample size, and the lack of a control group.

* Analysis of Hispanic patients in the OBSErve US study.

† In the OBSErve US study, 501 patients with SLE were enrolled; 88 (17.6%) were Hispanic. Of that, 43 (48.9%) continued to receive BENLYSTA at Month 24, 23 (26.1%) were lost to follow-up, and 22 (25.0%) discontinued BENLYSTA.

SD = standard deviation.

THE MOST COMPREHENSIVE CLINICAL TRIAL
PROGRAM IN LUPUS TO DATE

Choose BENLYSTA now for your
patients
with lupus

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