If you have patients with moderate-to-severe systemic lupus erythematosus (SLE), you may want to consider referring them to the Tulip SLE Study, a clinical research study evaluating anifrolumab in addition to standard of care.
This information is intended for potential clinical investigators and other healthcare professionals who may want to enroll or refer patients for the Tulip SLE Study.
The Tulip SLE Study is evaluating the effect of anifrolumab on SLE disease activity in addition to standard of care. It is a Phase III, double-blind, placebo-controlled clinical trial in adults with moderate-to-severe SLE, active for at least 6 months.
Secondary study objectives include the proportion of patients with a baseline oral corticosteroid dose ≥10 mg/day who achieve a dose of ≤7.5 mg/day at Week 40 that is maintained until the end of the study.
Patients will be randomized to receive anifrolumab or placebo intravenously every 4 weeks for a total of 13 doses.
Participants will receive close monitoring of their lupus symptoms. Study-related care and the study drug will be provided at no charge for the duration of the study.
Please consider referring patients who may qualify for this clinical research trial. Should you decide to refer patients, please note that they should continue to see you for their regular medical care.
Anifrolumab is believed to selectively target the interferon-alpha (IFN-α) receptor, blocking (or completely inhibiting) IFN binding. Studies have shown that blocking the IFN-α receptor may slow lupus activity.1
Based on Phase II study results, the U.S. Food and Drug Administration has assigned Fast Track Designation for anifrolumab in order to facilitate quicker development and to expedite the review process.
Data from a large Phase IIb (n=305) study were presented at the American College of Rheumatology 2015 Annual Scientific Meeting indicating that anifrolumab significantly reduced disease activity in adults with moderate-to-severe SLE and improved lupus symptoms such as rash and arthritis.
Anifrolumab met the primary endpoint of reduction in global disease activity score (SRI-4) at 6 months, with responders also tapering to <10 mg/day steroids. Greater efficacy was observed in a pre-defined subgroup of patients with elevated interferon gene signature at baseline.2References: 1. Stohl W. Nat Rev Rheumatol. 2013; 9(12):705-720. 2. Furie R, et al. Arthritis Rheumatol. 2015; 67 (suppl 10).
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