Established Efficacy in Patients with SLE
BENLYSTA IS THE FIRST BIOLOGIC APPROVED TO TREAT CLINICAL MANIFESTATIONS OF SLE WHEN ADDED TO STANDARD THERAPY
Superior disease activity reduction (SRI-4) vs standard therapy (ST) alone at Week 521-3
Primary endpoint
SRI-4 achieved significant improvement
These reductions were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.
SRI = SLE Responder Index; SC = subcutaneous.
* In BLISS-76, the difference in SRI-4 response rates was not significantly different at Week 76 (secondary endpoint).
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SLE RESPONDER INDEX (SRI-4):
DESIGNED TO MEASURE RESPONSE TO LUPUS TREATMENT
The SRI-4 is a combined clinical endpoint used in lupus trials
The SRI-4 incorporates three assessment measures – to be considered a responder, patients must meet all 3 components.
The primary endpoint, SRI-4, was defined as ≥4-point reduction in SELENA-SLEDAI score, and no new BILAG A or 2 new BILAG B organ domain scores, and <0.30-point increase in PGA score at Week 52.4
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.
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BLISS-SC, BLISS-52, and BLISS-76 study designs
Phase III trials in adults were randomized, double-blind, and placebo-controlled, and assessed intravenous and subcutaneous methods of administration1-3
KEY INCLUSION CRITERIA1-3
- Patients were ≥18 years of age
- Patients were diagnosed with SLE according to the ACR criteria
- Patients met ≥1 of the following:
- ANA titer ≥1:80
- Anti-dsDNA autoantibodies ≥30 IU/mL
- Patients were receiving stable doses of any of the following, alone or in combination, for ≥30 days:
- Antimalarial
- Immunosuppressant
- Corticosteroid
- NSAID
- Patients had active disease¶¶
- SELENA-SLEDAI score ≥8 (BLISS-SC)
- SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)
KEY EXCLUSION CRITERIA10
- Severe active lupus nephritis
- Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio
- Serum creatinine >2.5 mg/dL
- Required hemodialysis within 90 days of study entry
- Required high-dose prednisone (>100 mg/day) within 90 days of study entry
- Severe active CNS lupus
- Patient required therapeutic intervention for any of the following within 60 days of study entry:
- Seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis
- Patient required therapeutic intervention for any of the following within 60 days of study entry:
- Use of other biologics or IV cyclophosphamide was not permitted
ACR = American College of Rheumatology; ANA = antinuclear antibody; NSAID = non-steroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; CVA = cerebrovascular accident; CNS = central nervous system.
¶¶ Can include both clinical (eg, arthritis, rash, hair loss) and serological (eg, decreased complement and anti-dsDNA) manifestations of SLE.
