Product Highlight - Benlysta

Adding BENLYSTA to standard therapy:
• Superior reduction in SLE disease activity^1,2*†‡
• Reduction in corticosteroid dose in patients on >7.5 mg/day at baseline^1,2#
• 39% relative risk reduction of first severe flare^1,2⸹¶
• Significant improvement in fatigue as early as Week 8^{2^}
• Rates of adverse events were similar between BENLYSTA IV and placebo^1-3*

Remarks:
* Defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement.
† Standard therapies permitted, alone or in combination: corticosteroids, immunosuppressants, antimalarials, and NSAIDs.
‡ BLISS-52 and BLISS-76 pooled data.
§ HR (95% CI) = 0.61 (0.44, 0.85); p = 0.004 vs placebo + standard therapy over 52 weeks.
¶ 19.0% of patients on BENLYSTA + standard therapy vs 29.6% of patients on placebo + standard therapy had a severe flare over 52 weeks (p < 0.004).
# Reduction to ≤7.5 mg/day: 24.6% vs 15.0% (p = 0.035).
^ FACIT-Fatigue score improvement at Week 52: 4.07 vs 1.80 (p = 0.004).

References:
1. Benlysta IV Prescribing Information version GDS13.
2. van Vollenhoven RF, Petri MA, Cervera R, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012;71:1343-1349.
3. Navarra SV, Guzman 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.