ACTIVE SLE

Identifying patients for BENLYSTA in clinical practice

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by

  • Diverse clinical manifestations, which are the result of inflammation in multiple organ systems
  • Waxing and waning disease activity, with signs of active disease often appearing or disappearing despite standard therapy
  • Pathologic production of autoantibodies directed against self-antigens
  • Antinuclear autoantibodies are hallmark of disease
  • Abnormal activation of certain cells, including autoreactive B cells

Several clinical tools have been developed to measure active SLE, including SELENA-SLEDAI, BILAG, and PGA.

SELENA-SLEDAI1
  • Uses 24 weighted disease activity descriptors of SLE; scored as either present or absent in the preceding 10 days
  • Total score ranges from 0 to 105; higher score means a more significant degree of disease activity
BILAG2
  • Assesses changes in specific organ systems over the previous month
  • Includes 86 items within 8 organ systems
  • Each organ is scored on an alphabetic scale from A to E; A represents severe flare
PGA
  • Assesses overall severity of SLE disease activity
  • Employs a 10-cm visual analog scale to score disease activity from 0 to 3; higher score means more severe disease activity
Learn more about identifying appropriate patients for BENLYSTA
Quick SELENA-SLEDAI Overview
Learn about calculating patients' scores
More about recognizing active SLE

Consider evaluating your patients for BENLYSTA if

  • Patient is 18 years of age or older and has been diagnosed with SLE according to the American College of Rheumatology criteria
  • Patient meets at least 1 of the following:
  • Antinuclear antibody (ANA) titer ≥1:80
  • Anti-dsDNA autoantibodies ≥30 IU/mL
  • Patient is currently receiving any of the following types of standard therapy, alone or in combination, for ≥30 days:
  • Antimalarial
  • Immunosuppressive
  • Corticosteroid
  • NSAID
  • Patient has active disease*
  • SELENA-SLEDAI score ≥8 for BLISS-SC
  • SELENA-SLEDAI score ≥6 for BLISS-52 and BLISS-76
    *Can include both clinical and serological manifestations of SLE.
    eg, arthritis, rash, hair loss.
    eg, decreased complement and anti-dsDNA.
  • Patient does not have severe active lupus nephritis
  • Patient does not have severe active CNS lupus
  • Patient is not using other biologics or IV cyclophosphamide
Reductions in disease activity observed were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.

SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index.
BILAG = British Isles Lupus Assessment Group.
PGA = Physician’s Global Assessment.

REFERENCES:

  1. Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992;35(6):630-640.
  2. Hay EM, Bacon PA, Gordon C, et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. QJM. 1993;86(7):447-458.
  3. Data on file, Human Genome Sciences, Inc.
  4. Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two–week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016-1027.
  5. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731.
  6. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63(12):3‍918-3930.

PATIENT PROFILES

Patients like these were represented in BLISS Phase III clinical trials

Olivia has had signs of active disease for the past 6 months

Her active, autoantibody-positive SLE is being treated with an antimalarial and a steroid.

Demographics
  • Female
  • Caucasian
  • Late 30s
  • Diagnosed with SLE 5 years ago
Current medications
  • Hydroxychloroquine:
  • 400 mg/day for 5 years
  • Prednisone:
  • 10 mg/day for 3 months
  • 7.5 mg/day for 9 months prior
  • 5 mg/day for 3.5 years prior
Current disease activity
  • Chronic fatigue
  • Persistent malar rash
  • Persistent polyarthritis
Lab values
  • C3 normal at 90 mg/dL
  • C4 normal at 30 mg/dL
  • Positive ANA (1:160)
  • CBC and urinalysis values are normal
Olivia's SELENA-SLEDAI score
Item Points
Fatigue N/A*
Rash 2
Arthritis 4
Total SELENA-SLEDAI Score 6
 

Ana has had signs of active disease for the past 2 months

Her active, autoantibody-positive SLE is being treated with a steroid.

Demographics
  • Female
  • Hispanic
  • Mid-30s
  • Diagnosed with SLE 5 years ago
Current medications
  • Prednisone:
  • 15 mg/day for 6 weeks; previously 5 mg daily
Current disease activity
  • Fatigue
  • Multiple recurrent oral ulcerations
  • Persistent polyarthritis involving the knee and the 2nd and 3rd interphalangeal joints bilaterally
Lab values
  • C3 normal at 90 mg/dL
  • C4 normal at 30 mg/dL
  • Positive ANA (1:320) homogeneous pattern
Ana's SELENA-SLEDAI score
Item Points
Fatigue N/A*
Mucosal ulcers 2
Arthritis 4
Total SELENA-SLEDAI Score 6
 

Michelle is currently experiencing signs of active disease

Her active, autoantibody-positive SLE is being treated with an antimalarial and a steroid.

Demographics
  • Female
  • Asian
  • Mid-50s
  • Diagnosed with SLE 8 years ago
Current medications
  • Hydroxychloroquine:
  • 400 mg/day for 6 years
  • Prednisone:
  • 12.5 mg/day increased to 25 mg/day for the past 3 months
Current disease activity
  • Malar rash
  • 4 tender and swollen joints
  • Periungual erythema
Lab values
  • C3 low at 40 mg/dL
  • C4 low at 10 mg/dL
  • Positive ANA (1:320)
  • Elevated anti-dsDNA at 160 IU/mL
  • Positive ACA (IgG 40 g/L + >80 GPL U/mL; IgA >20 APL U/mL; IgM >20 MPL U/mL)
Michelle's SELENA-SLEDAI score
Item Points
Rash 2
Arthritis 4
Low complement 2
Increased DNA Binding 2
Total SELENA-SLEDAI Score 10
74% of patients with SLE have been reported to have SLEDAI scores of ≤15 (total possible score = 105).1

*This item is not part of the SELENA-SLEDAI assessment.

REFERENCES:

  1. Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992;35(6):630-640.

831318R0 February 2018

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