AbbVie's Upadacitinib Extended-Release Tablets Receive First-in-China Approval for Giant Cell Arteritis

On June 4, AbbVie announced today that the NMPA has approvedUpadacitinib Sustained-Release Tablets(15 mg, once daily, brand name Rui Fu)Used for treatmentAdult Patients with Giant Cell Arteritis (GCA). This approval came just over a month after its approval in the United States and the European Union, making Upadacitinib Extended-Release TabletsCurrently, the first and only oral JAK inhibitor approved in China for the treatment of adult patients with giant cell arteritis (GCA).。

Source: AbbVie Official WeChat

This approval is based on data from the Phase III SELECT-GCA trial, the results of which were recently published in The New England Journal of Medicine. The trial data showed,Compared with a 52-week glucocorticoid tapering regimen combined with placebo, the 15 mg Upadacitinib extended-release tablet combined with a 26-week glucocorticoid tapering regimen achieved the primary endpoint and key secondary endpoints in this trial.。

The primary endpoint results of the Phase III SELECT-GCA trial showed that patients receiving upadacitinib extended-release tablets 15 mg with a 26-week glucocorticoid tapering regimen,46.4% Achieved Sustained Remission at Week 52, while the proportion was 29.0% among patients receiving placebo combined with a 52-week glucocorticoid tapering regimen.

Key secondary endpoints include:

• Reduced Disease Recurrence: 34.3% of patients receiving RuiFu 15 mg combined with a 26-week glucocorticoid tapering regimen experienced at least one disease recurrence by Week 52, compared to 55.6% of patients receiving placebo combined with a 52-week glucocorticoid tapering regimen (p = 0.001).

• Reduced Cumulative Glucocorticoid Exposure: Over 52 weeks, patients receiving RuiFu 15 mg combined with a 26-week glucocorticoid tapering regimen had significantly lower cumulative glucocorticoid exposure compared to those receiving placebo combined with a 52-week glucocorticoid tapering regimen (median exposure was 1615 mg vs. 2882 mg, respectively; p < 0.001).

• Sustained Complete Remission: 37.1% of patients receiving RuiFu 15 mg combined with a 26-week glucocorticoid tapering regimen achieved sustained complete remission by Week 52, compared to 16.1% of patients receiving placebo combined with a 52-week glucocorticoid tapering regimen (p < 0.001).

During this 52-week placebo-controlled trial,The safety profile of Patinib sustained-release tablets is generally consistent with the results observed in other approved indications.The incidence of serious adverse events was similar in patients receiving upadacitinib extended-release tablets 15 mg combined with a 26-week glucocorticoid tapering regimen and those receiving placebo combined with a 52-week glucocorticoid tapering regimen.

The incidence of serious infections in the Upadacitinib Extended-Release Tablets 15 mg group was 5.7%, compared to 10.7% in the placebo group. Regarding adverse events of special interest, the incidence of malignancies (excluding non-melanoma skin cancer) was similar between the two groups (1.9% in the RINVOQ 15 mg group vs 1.8% in the placebo group), and the incidence of venous thromboembolism was also comparable (3.3% in the RINVOQ 15 mg group vs 3.6% in the placebo group). No adjudicated major adverse cardiovascular events (MACE) were reported in the Upadacitinib Extended-Release Tablets 15 mg group, while two cases were reported in the placebo group. A total of four deaths during the treatment period were reported, with two in the placebo group and two in the Upadacitinib Extended-Release Tablets 15 mg group. Of the two deaths in the Upadacitinib group, one was attributed to COVID-19 infection, and the other had an undetermined cause of death upon adjudication.

Currently, Upadacitinib Sustained-Release Tablets Have Been Approved by the NMPA8 Indications, including ankylosing spondylitis, radiographic-negative axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, adult and adolescent atopic dermatitis, as well as the newly approved adult giant cell arteritis.

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