INTERSTELLAR Study Evaluating the Real-World Effectiveness of Anifrolumab for Systemic Lupus Erythematosus A Multi-National Observational Study in Routine Clinical Practice

What this Trial Is About

Researchers are conducting the INTERSTELLAR study to gather important real-world evidence about adding anifrolumab to the usual treatment for systemic lupus erythematosus SLE. This observational study is taking place across multiple countries, including regions like GCC, Mexico, Central America, Colombia, Argentina, Taiwan, and Egypt. It aims to provide data useful for doctors, payers, and patients by using consistent criteria and measures for SLE and skin symptoms related to lupus. Participants will be observed for one year before starting anifrolumab and followed for one year after beginning treatment. The study starts after anifrolumabs commercial launch in each country and includes patients from the time of their first anifrolumab prescription and infusion. Data collection continues even if participants stop taking anifrolumab, unless they withdraw their consent. During the study, clinical assessments and patient-reported outcomes will be collected at baseline and at months 1, 3, 6, and 12. These include disease activity scores PGA, SLEDAI-2K, skin involvement measures CLASI, fatigue assessments FACIT-Fatigue, and quality of life questionnaires LupusQoL, EQ-5D-5L. The study monitors participants until death, loss to follow-up, withdrawal, or study end, aiming to reflect real-world use and outcomes of anifrolumab in routine care.

INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use