Trial results for upadacitinib (Rinvoq) in participants with Giant Cell Arteritis (GCA) were posted on ClinicalTrials.gov on 2025-03-07. The Phase 3 study (NCT03725202) showed that upadacitinib 15 mg in combination with a 26-week corticosteroid taper achieved 46.4% sustained remission at Week 52, compared to 29.0% for placebo with a 52-week corticosteroid taper. Additionally, both upadacitinib doses significantly reduced cumulative corticosteroid exposure.
Background
The study investigated upadacitinib in participants with Giant Cell Arteritis (GCA), a chronic inflammatory condition affecting large and medium-sized arteries.
Trial design
The study (NCT03725202) was a Phase 3, randomized trial that enrolled 429 participants with Giant Cell Arteritis (GCA). The trial evaluated the efficacy and safety of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen. Comparator arms included upadacitinib 7.5 mg plus a 26-week CS taper, upadacitinib 15 mg plus a 26-week CS taper, and placebo plus a 52-week CS taper. A key objective was to assess the proportion of participants achieving sustained remission at Week 52.
Key results
The trial results showed differences across treatment arms for key efficacy outcomes. For the 'Percentage of Participants Achieving Sustained Remission at Week 52':
- Participants in the placebo + 52-week CS taper group achieved 29.0% sustained remission.
- Participants in the 7.5 mg upadacitinib + 26-week CS taper group achieved 41.1% sustained remission.
- Participants in the 15 mg upadacitinib + 26-week CS taper group achieved 46.4% sustained remission.
An analysis comparing 15 mg upadacitinib to placebo showed an Adjusted Response Rate Difference of 17.1 (95% CI: 6.3 to 27.8) with a p-value of 0.0019. For 7.5 mg upadacitinib versus placebo, the Adjusted Response Rate Difference was 12.1 (95% CI: -0.4 to 24.6) with a p-value of 0.0579.
For 'Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52':
- Placebo + 52-week CS taper group: 16.1%.
- 7.5 mg upadacitinib + 26-week CS taper group: 26.2%.
- 15 mg upadacitinib + 26-week CS taper group: 37.1%.
An analysis comparing 15 mg upadacitinib to placebo showed an Adjusted Response Rate Difference of 20.7 (95% CI: 11.3 to 30.2) with a p-value of 0.0001. For 7.5 mg upadacitinib versus placebo, the Adjusted Response Rate Difference was 9.9 (95% CI: -0.8 to 20.6) with a p-value of 0.0699.
Regarding 'Cumulative Corticosteroid (CS) Exposure Through Week 52':
- The median cumulative CS exposure for the placebo + 52-week CS taper group was 2882.0 mg.
- For the 7.5 mg upadacitinib + 26-week CS taper group, it was 1905.0 mg.
- For the 15 mg upadacitinib + 26-week CS taper group, it was 1615.0 mg.
Both 15 mg upadacitinib and 7.5 mg upadacitinib groups showed a statistically significant reduction in cumulative CS exposure compared to placebo, with a p-value of 0.0001 for both comparisons (van Elteren test).
What this means
The results suggest that upadacitinib, particularly at the 15 mg dose, can significantly improve sustained remission rates in participants with Giant Cell Arteritis while allowing for a shorter corticosteroid taper and reduced overall corticosteroid exposure. The statistically significant improvements in sustained remission and cumulative CS exposure for the 15 mg upadacitinib group compared to placebo indicate a potential benefit for managing GCA with a corticosteroid-sparing effect. The 7.5 mg upadacitinib dose also showed a reduction in CS exposure, though its effect on sustained remission was not statistically significant at the same level as the higher dose.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03725202, titled 'A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis,' were posted on 2025-03-07 on clinicaltrials.gov.