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Upadacitinib Advances to Phase 3 Clinical Trials in Systemic Lupus Erythematosus


The selective and reversible Janus kinase inhibitor is being studied in several immune-mediated inflammatory diseases.

AbbVie, a biopharmaceutical company, has announced topline results from a Phase 2 study of upadacitinib (RINVOQ®, 30 mg), given alone or as combination therapy with a Bruton's Tyrosine Kinase (BTK) inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE).1

The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose, less than or equal to 10 mg prednisone equivalent, once per day at week 24 in the upadacitinib 30 mg group. AbbVie, will now advance its clinical program of upadacitinib in SLE to Phase 3.


The study enrolled 341 participants, divided into 5 experimental groups according to treatment regimen (upadacitinib in combination with placebo; upadacitinib at two different doses; combined with elsubrutinib; elsubrutinib in combination with placebo; placebo only). Each participant had the clinical diagnosis of SLE at least 24 weeks prior to screening.

The primary outcome measure was achievement of the SRI-4 with a steroid dose ≥ 10 mg prednisone equivalent once daily at week 24. SRI-4 is defined as ≥ 4-point reduction in SLE Disease Activity Index 2000 score without worsening of the overall condition or the development of significant disease activity in new organ systems

There were no new safety signals identified with upadacitinib and types of adverse events reported with upadacitinib combined with elsubrutinib were similar to those reported for patients treated with upadacitinib alone.

"Systemic lupus erythematosus is a very unpredictable life-long condition and the way it affects a patient can change over time. Therefore, there is a critical need for additional treatment options," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer of AbbVie in a company press release.

In January, a phase 3 study found upadacitinib to be safe in the treatment of moderate-to-severe cases of eczema in patients as young as 12 and weighing more than 88.2 pounds. Phase 3 trials in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are currently ongoing.


1. AbbVie Advances Upadacitinib (RINVOQ® to Phase 3 Clinical Trials in Systemic Lupus Erythematosus. AbbVie. Press Release. Published March 23, 2023. Accessed March 23, 2023. https://news.abbvie.com/news/press-releases/abbvie-advances-upadacitinib-rinvoq-to-phase-3-clinical-trials-in-systemic-lupus-erythematosus.htm

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