Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study

• Published in: Arthritis & rheumatology (Hoboken, N.J.) Vol. 69; no. 5; pp. 1016 - 1027
• Main Authors: Stohl, William, Schwarting, Andreas, Okada, Masato, Scheinberg, Morton, Doria, Andrea, Hammer, Anne E., Kleoudis, Christi, Groark, James, Bass, Damon, Fox, Norma Lynn, Roth, David, Gordon, David
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.05.2017; John Wiley and Sons Inc
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adult; Antibodies, Monoclonal, Humanized - therapeutic use; Autoimmune diseases; Chronic conditions; Confidence intervals; Corticosteroids; Disease Progression; Dosage; Double-Blind Method; Double-blind studies; Estrogens; FDA approval; Female; Flares; Humans; Immunoglobulin G; Immunoglobulin G - immunology; Immunologic Deficiency Syndromes - chemically induced; Immunologic Deficiency Syndromes - immunology; Immunosuppressive agents; Immunosuppressive Agents - therapeutic use; Incidence; Infusions, Subcutaneous; Lupus; Lupus Erythematosus, Systemic - drug therapy; Male; Middle Aged; Monoclonal antibodies; Odds Ratio; Patients; Proportional Hazards Models; Randomization; Safety; Severity of Illness Index; Systemic Lupus Erythematosus; Therapeutics; Therapy; Treatment Outcome

Objective To assess the efficacy and safety of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Methods Patients with moderate‐to‐severe SLE (score of ≥8 on the Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] version of the SLE Disease Activity...