AbbVie’s Upadacitinib Meets Primary Endpoint for Systemic Lupus Erythematosus

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The SLEek (NCT03978520) study, which evaluated upadacitinib (Rinvoq; AbbVie), in the 30-mg strength, given alone, or as a combination therapy with elsubrutinib for individuals with moderately-to-severely-active systemic lupus erythematosus (SLE), met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10-mg prednisone, according to the topline results of a phase 2 study.¹

Based on these results, AbbVie is advancing its clinical program of upadacitinib in SLE to a phase 3 trial.¹

“[SLE] 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,” Roopal Thakkar, MD, senior vice president of development and regulatory affairs and chief medical officer at AbbVie, said in a statement.

“With a quarter-century of experience and commitment to the treatment of rheumatic diseases, our focus remains on areas of high unmet need like [SLE], and we look forward to further evaluation of the potential benefits that upadacitinib could bring to patients, he said.”¹

In the phase 2 study, investigators enrolled 341 individuals who were divided into 5 experimental groups according to treatment regimen.¹

The primary outcome measure was achievement of the SRI-4 with a steroid dose less than or equal to 10-m prednisone equivalent once daily at week 24. SRI-4 was defined as a greater or equal to 4-point reduction in the SLE Disease Activity Index 2000 score without the worsening of the overall condition or the development of other disease activity in another organ system.¹

The safety results for the upadacitinib 30-mg dosage were generally consistent with the known safety profile of upadacitinib with no new safety signals. The adverse events (AEs) reported for upadacitinib combined with elsubrutinib were similar to those reported with upadacitinib alone.¹

The full results of the study will be presented at a future medical congress.

The upadacitinib and elsubrutinib combination in SLE is not approved, nor have regulatory authorities evaluated the efficacy and safety.¹

SLE is a multi-organ autoimmune disorder that produces pathogenic autoantibodies and tissue deposition of immune complexes.¹ Symptoms include arthritis; blood cell and immunological abnormalities; fatigue; fever; heart, kidney, and lung issues; oral ulcers; pain or swelling in the joints; psychosis; seizures; skin rashes; and sun sensitivity.²

Anyone can be affected by SLE. However, women of childbearing ages between 15 and 44 years are at greatest risk of developing SLE, according to the CDC.²

Additionally, women of all ages are affected more than men, with an estimated ratio of 4 to 12 women for every 1 man.²

References

1. AbbVie advances upadacitinib (Rinvoq) to phase 3 clinical trials in systemic lupus erythematosus. AbbVie. News release. March 23, 2023. Accessed March 24, 2023. https://news.abbvie.com/news/press-releases/abbvie-advances-upadacitinib-rinvoq-to-phase-3-clinical-trials-in-systemic-lupus-erythematosus.htm

2. Systemic lupus erythematosus (SLE). CDC. Updated July 5, 2022. Accessed March 24, 2023. https://www.cdc.gov/lupus/facts/detailed.html