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The Tulip SLE Study: A Clinical Trial of Anifrolumab

An investigational drug that is believed to selectively target interferon-alpha (IFN-α) receptor

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.

About 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.

Eligibility

Patients may qualify for the Tulip SLE Study if they meet the following criteria:

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.

5 MILLION PEOPLE WORLDWIDE HAVE SOME FORM OF LUPUS

About Anifrolumab

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.

Phase II study results

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.2

References: 1. Stohl W. Nat Rev Rheumatol. 2013; 9(12):705-720. 2. Furie R, et al. Arthritis Rheumatol. 2015; 67 (suppl 10).

Refer a Patient for the Tulip SLE Study

Please submit your information below and a Tulip Program representative will contact you to discuss your referral.

Note: Not all patients referred will be enrolled into the study.
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As a symbol of beauty, the tulip is known for its fragile yet colorful petals. Year after year, the flower blooms to display its vibrancy and resilience. In a similar way, the Tulip Program constantly strives for the people living with lupus, so they can open up to life again and showcase their own beautiful lives.

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