Most Read Articles
5 days ago
New drug applications approved by US FDA as of 01 - 15 January 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Product Highlight - Benlysta

20 Dec 2019
Adding BENLYSTA to standard therapy:
• Superior reduction in SLE disease activity1*†‡
• Reduction in corticosteroid dose in patients on >7.5 mg/day at baseline1#
• Severe flare risk reduction by 50%1
• Significant improvement in fatigue as early as Week 82^
• Rates of adverse events were similar between BENLYSTA and placebo1-3*

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. # 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 SC Prescribing Information version GDS15.
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.


Related MIMS Drugs

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Pharmacy - Hong Kong digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
5 days ago
New drug applications approved by US FDA as of 01 - 15 January 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.