AbbVie announced it would move Rinvoq (upadacitinib) into Phase 3 clinical trials to treat systemic lupus erythematosus (SLE). Rinvoq is a Janus kinase (JAK) inhibitor previously approved for rheumatoid arthritis and other indications.
Rinvoq met the primary endpoint in patients with moderate to severe SLE either as monotherapy or combined with elsubrutinib, a Bruton's Tyrosine Kinase inhibitor. The decision to move Rinvoq into Phase 3 trials for SLE was based on positive results from a Phase 2 trial, M19-130 (SLEek), which demonstrated that Rinvoq was associated with significant improvements in disease activity compared to placebo. There is a considerable improvement in SRI-4 response and steroid dose reduction to less than or equal to 10 mg prednisone. The results also showed that Rinvoq was generally well-tolerated by patients.
SLE affects an estimated 5 million people worldwide and can cause various symptoms, including joint pain and swelling, fatigue, rashes, and organ damage. The disease can be challenging to manage, and there is no cure. The success of Rinvoq will help AbbVie to expand its immunology portfolio.
Rinvoq is already approved in the United States for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.