AbbVie today announced the positive results of its JAK inhibitor upadacitinib (English trade name Rinvoq) in a phase 2 clinical trial as a single drug or combination therapy for the treatment of lupus erythematosus (SLE). Analysis shows that Upatinib achieved the main endpoint of the trial, which was significant remission in patients with moderate to severe SLE at week 24. According to this result, AbbVie will promote the phase III clinical trial of Upatinib in the treatment of SLE.

Lupus is a chronic autoimmune disease in which the patient's immune system attacks their own tissues, leading to various symptoms. Symptoms of SLE include rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, epilepsy, or mental illness. Joint pain or swelling is one of the most common symptoms that affect the quality of life of SLE patients.

Upatinib is a selective reversible JAK inhibitor that has been studied and applied in many severe immune mediated inflammatory diseases. In cell and enzyme activity experiments, compared to JAK2, JAK3, and TYK2, upatinib exhibited a more powerful inhibitory effect on JAK1. This drug has been approved to treat adult patients with moderate to severe Rheumatoid arthritis, psoriatic arthritis, moderate to severe Ulcerative colitis and Ankylosing spondylitis.

In the M19-130 (SLEek) Phase II clinical trial released this time, a total of 341 patients with moderate to severe SLE in the active stage of disease were enrolled and assigned to receive five different treatment schemes (Upatinib combined with placebo; two different doses of Upatinib combined with Bruton's Tyrosine kinase inhibitor elsubritinib; elsubritinib combined with placebo; placebo only).

Analysis showed that the main endpoint of the trial was achieved, which was the SLE remission index (SRI-4) for patients receiving 30 mg of upatinib as a single or combination therapy at week 24, using a daily steroid dose of less than or equal to 10 mg of prednisone. SRI-4 is defined as a decrease of ≥ 4 points in the SLE Disease Activity Index 2000 score, with no overall deterioration or significant disease progression in new organs. No new safety signals were observed during the experiment.

"SLE is a disease that is difficult to predict and can last for a lifetime. It will have different impacts on patients over time. Therefore, it is crucial to develop additional therapies," said Dr. Roopal Thakkar, senior vice president and chief medical officer of development and regulatory affairs of AbbVie, With 25 years of experience and commitment to the treatment of rheumatic diseases, our focus remains on areas with high unmet needs, such as systemic lupus erythematosus, and we look forward to further evaluating the potential benefits that Upatinib may bring to patients

Reference material：[1] AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus. Retrieved March 24, 2023 from 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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