Upadacitinib for Lupus

(SELECT-SLE Trial)

This trial tests the safety and effectiveness of upadacitinib, a medication approved for other inflammatory conditions, in treating systemic lupus erythematosus (SLE), a disease where the immune system attacks various organs. Participants will receive either upadacitinib or a placebo (a non-active substance) to assess its impact on SLE symptoms over time. Those diagnosed with SLE for at least 24 weeks and experiencing moderate to severe symptoms may be eligible. The study requires regular clinic or hospital visits to monitor treatment effects and side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements for SLE.

The trial does not require you to stop your current medications. You must be on a stable dose of your existing lupus treatments for at least 60 days before starting the trial, except for oral corticosteroids, which need to be stable for at least 14 days.

Research has shown that upadacitinib has been safely used in people with conditions like rheumatoid arthritis. This medicine underwent study for other uses before consideration for lupus. Although not yet approved for lupus, studies have found it to be well-tolerated in patients with these other conditions.

Most treatments for lupus, like corticosteroids and immunosuppressants, aim to reduce inflammation and suppress the immune system. However, Upadacitinib works differently by targeting the JAK1 pathway, an important component in the inflammatory process. This selective inhibition could lead to more precise control of lupus symptoms with potentially fewer side effects. Researchers are excited because Upadacitinib offers a novel approach that might improve symptom management and quality of life for lupus patients compared to current therapies.

Studies have shown that upadacitinib can help reduce symptoms in people with systemic lupus erythematosus (SLE). This trial will administer upadacitinib in various doses to evaluate its effectiveness in managing SLE symptoms. Already approved for treating other inflammatory conditions like rheumatoid arthritis, the medication has shown positive results in earlier research, suggesting it might also be effective for SLE, though it is not yet approved for this specific use. Upadacitinib works by targeting certain parts of the immune system to control inflammation.¹²⁴⁵⁶