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BENLYSTA is the only SLE treatment that met its primary endpoint in 4 clinical trials1-4
The primary endpoint across trials was SRI-4, measured at 52 weeks.
All 4 studies were randomised, double-blind and placebo-controlled
-
BLISS-SC1,5 Treatment arms
- BENLYSTA SC 200 mg + standard therapy (n=556)
- Control arm: standard therapy + placebo (n=280)
Regions
177 centres throughout North America, South America, Europe, and Asia
-
BLISS-522,5 Treatment arms
- Experimental arm 1: BENLYSTA IV 1 mg/kg* + standard therapy (n=288)
- Experimental arm 2: BENLYSTA IV 10 mg/kg + standard therapy (n=290)
- Control arm: standard therapy + placebo (n=287)
Regions
177 centres throughout North America, South America, Europe, and Asia
-
BLISS-763,5
Treatment arms
- Experimental arm 1: BENLYSTA IV 1 mg/kg* + standard therapy (n=288)
- Experimental arm 2: BENLYSTA IV 10 mg/kg + standard therapy (n=290)
- Control arm: standard therapy + placebo (n=287)
Regions
177 centres throughout North America, South America, Europe, and Asia
-
NE Asia4
Treatment arms
- BENLYSTA SC 200 mg + standard therapy (n=556)
- Control arm: standard therapy + placebo (n=280)
Regions
177 centres throughout North America, South America, Europe, and Asia
Inclusion criteria1-4
In the Phase 3 clinical trials for BENLYSTA, patients:
- Were ≥18 years of age
- Were diagnosed with SLE according to the American College of Rheumatology criteria
- Met ≥1 of the following:
- ANA titre ≥1:80
- Anti-dsDNA autoantibodies ≥30 IU/mL
- Were receiving stable doses of any of the following, alone or in combination, for ≥30 days:
- Antimalarial
- Immunosuppressant
- Corticosteroid
- NSAID
- Had active disease, including clinical (e.g., arthritis, rash, hair loss) or serological (e.g., decreased complement and anti-dsDNA) SLE manifestations:
- SELENA-SLEDAI score ≥8 (BLISS-SC and NE Asia)
- SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)
SLE patients with non-severe, active renal involvement (i.e., proteinuria <6 g/24 hrs) were included in the BLISS trials.5
NSAID = nonsteroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index
Inclusion criteria1-4
In the Phase 3 clinical trials for BENLYSTA, patients:
- Were ≥18 years of age
- Were diagnosed with SLE according to the American College of Rheumatology criteria
- Met ≥1 of the following:
- ANA titre ≥1:80
- Anti-dsDNA autoantibodies ≥30 IU/mL
- Were receiving stable doses of any of the following, alone or in combination, for ≥30 days:
- Antimalarial
- Immunosuppressant
- Corticosteroid
- NSAID
- Had active disease, including clinical (e.g., arthritis, rash, hair loss) or serological (e.g., decreased complement and anti-dsDNA) SLE manifestations:
- SELENA-SLEDAI score ≥8 (BLISS-SC and NE Asia)
- SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)
SLE patients with non-severe, active renal involvement (i.e., proteinuria <6 g/24 hrs) were included in the BLISS trials.5
NSAID = nonsteroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index
Permitted changes to standard therapy in BENLYSTA’s clinical trials2,3
A higher proportion of patients on placebo + standard therapy failed for the following reasons compared with the BENLYSTA groups:
- No new NSAID were permitted after Week 44, unless treatment duration was <1 week
- Patients dropping out early, or requiring non-permitted changes in standard therapy, were considered non-responders
* Prednisone or prednisone equivalent
† At Week 24, daily corticosteroid dose (sum of all corticosteroid doses over 7 consecutive days divided by 7).
‡ Within 8 weeks before Week 52, daily corticosteroid dose could not be increased beyond the dose at Week 44 or at baseline, whichever was higher..
SRI-4: A composite measure designed for lupus
The SRI-4 is a validated, combined clinical endpoint mostly used in lupus clinical trials. It incorporates three assessment measures.6
A higher proportion of patients on placebo + standard therapy failed for the following reasons compared with the BENLYSTA groups:
- Measurement: ≥4-point reduction
- Rationale: Determines global improvement and measures disease activity
SELENA-SLEDAI
- Measurement: ≥4-point reduction
- Rationale: Determines global improvement and measures disease activity
SELENA-SLEDAI
- Measurement: ≥4-point reduction
- Rationale: Determines global improvement and measures disease activity
Paediatric study design
The safety and efficacy of BENLYSTA was evaluated in a randomised, double-blind, placebo-controlled study in paediatric patients (PLUTO).5,7,8
SELENA-SLEDAI
- Measurement: ≥4-point reduction
- Rationale: Determines global improvement and measures disease activity
SELENA-SLEDAI
- Measurement: ≥4-point reduction
- Rationale: Determines global improvement and measures disease activity
New haematuria (≥11-20 RBCs/hpf) or a 2-grade increase in haematuria compared with baseline, associated with >25% dysmorphic RBCs, glomerular in origin, and accompanied by an 800-mg increase in 24-hour urinary protein level or new RBC casts.5
Resources for you and your patients
References
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