Compared with placebo, anifrolumab was found to demonstrate robust efficacy in patients with moderate to severe systemic lupus erythematosus (SLE)) according to research presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) annual meeting. Anifrolumab is a monoclonal antibody designed for the treatment of systemic lupus erythematosus. It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon- Systemic lupus erythematosus (SLE) is an autoimmune disease. In this disease, the immune system of the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs.
Objective of the Study
To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase 3, randomized, double-blind, placebo-controlled study of adults with moderate-to-severe systemic lupus erythematosus (SLE). An international team of researchers conducted the clinical trials,
Patients were eligible for the study if they met ACR SLE criteria and had an SLE Disease Activity Index (SLEDAI)-2K score ≥6 and a British Isles Lupus Assessment Group (BILAG) index A score ≥1 or B score ≥2. The primary end point was achievement of BILAG-Based Composite Lupus Assessment . Standard of care was stable, with the exception of tapering of oral corticosteroids to a prednisone equivalent ≤7.5 mg/d in patients receiving ≥10 mg/d at baseline. A total of 362 patients received either ≥1 dose of anifrolumab 300 mg intravenously (n=180) or placebo (n=182) every 4 weeks for 48 weeks. Baseline demographics and disease characteristics were similar between the 2 groups; 85.5% of patients in the anifrolumab group completed treatment compared with 71.4% of those in the placebo group.
Anifrolumab was found to be superior to placebo both in BICLA response (47.8% vs 31.5%, respectively; P=.001) and in meeting key secondary end points, including oral corticosteroid reduction and the Cutaneous Lupus Erythematosus Disease Area and Severity Index response. Annualized flare rates were lower in patients who received anifrolumab compared with those who received placebo (0.64 vs 0.43, respectively; rate ratio, 0.67; 95% CI, 0.48-0.94; P=.081).Anifrolumab also demonstrated efficacy in multiple secondary end points, including SLE responder index (SRI)4, higher thresholds of SRI(5-8), time to onset of BICLA response sustained to week 52, and time to first flare.
There was no significant difference in the safety profile of anifrolumab as compared with that of previous trials. Herpes zoster was more common in patients who received anifrolumab compared with those who received placebo (7.2% vs 1.1%, respectively). However, serious adverse events and those leading to treatment discontinuation occurred less frequently in the anifrolumab vs placebo group (8.3% vs 17.0% and 2.8% vs 7.1%, respectively). Few patients (0.6%) developed antidrug antibodies, and 1 death occurred as a result of pneumonia in a patient receiving anifrolumab.
The TULIP-2 study demonstrated that among patients with SLE, anifrolumab was superior to placebo for multiple end points including disease activity, skin disease, and oral corticosteroid tapering, with no new safety signals identified. By targeting the type I interferon receptor, anifrolumab reduces overall disease activity, reduces corticosteroid use and improves skin manifestations. There has only been one new medicine approved for systemic lupus erythematosus in the last 60 years do doctors are very happy to see positive TULIP 2 results.
Cincinnati Rheumatic Disease Study Group are Running Specific Trials for Systemic Lupus Erythematosus (SLE) now… Click Here to Learn More
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About Cincinnati Rheumatic Disease Study Group
The Cincinnati Rheumatic Disease Study Group (CRDSG) is an organization of practicing rheumatologists dedicated to improving the care of patients with arthritis and other rheumatic diseases. It strives to do this by performing rigorous and ethical clinical research with the goal of developing better treatments for all patients with these conditions.
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