Percentage of Rinvoq Patients on High-Dose Steroids in Ulcerative Colitis
The available evidence does not provide specific percentages of patients taking Rinvoq (upadacitinib) who are concurrently on high-dose corticosteroids in ulcerative colitis.
What the Evidence Shows
Clinical Trial Data
- In the phase 2b trial of upadacitinib for UC, baseline corticosteroid use was documented, but the study did not report specific percentages of patients on high-dose steroids at the time of upadacitinib initiation 1
- The 16-week extended induction study similarly tracked steroid-free remission as an outcome but did not specify baseline high-dose steroid use rates 2
Real-World Evidence Context
- A systematic review and meta-analysis of 1,388 real-world UC patients treated with upadacitinib found that steroid-free remission was achieved in 39% of patients at week 8, suggesting that a substantial proportion were on steroids at baseline, though specific dosing was not quantified 3
- In acute severe UC (ASUC) case reports, patients receiving upadacitinib were typically steroid-dependent or steroid-refractory, but exact percentages on high-dose therapy were not reported 4, 5
Clinical Context for Steroid Use with JAK Inhibitors
When Upadacitinib is Used in Practice
- The 2025 British Society of Gastroenterology guidelines indicate that JAK inhibitors like upadacitinib should be restricted to corticosteroid-refractory patients in ASUC where conventional rescue therapy has failed 6
- In hospitalized ASUC patients, upadacitinib is being used as sequential rescue therapy following failure of intravenous corticosteroids and dose-intensified infliximab 5
Steroid Dosing Considerations
- High-dose corticosteroids in UC are typically defined as ≥20 mg prednisolone daily for oral therapy or 60 mg methylprednisolone IV/400 mg hydrocortisone IV daily for hospitalized patients 6, 7, 8
- Use of ≥15 mg oral corticosteroid within 30 days of surgery or ≥20 mg in the setting of proctocolectomy is associated with increased risk of complications 6
Important Clinical Caveats
Steroid Tapering with Upadacitinib
- The goal of upadacitinib therapy is to achieve steroid-free remission, with guidelines recommending that corticosteroids be tapered and discontinued rather than maintained long-term 7, 8
- Approximately 50% of patients experience short-term corticosteroid-related adverse events including acne, edema, sleep disturbance, mood changes, glucose intolerance, and dyspepsia 6, 7
Safety Considerations
- Concurrent high-dose corticosteroids and JAK inhibitors may increase infection risk, though subgroup analyses comparing prednisolone doses >20 mg versus ≤20 mg did not show significant differences in infection rates in tofacitinib studies 6
- The FDA black box warning for JAK inhibitors includes thrombosis risk, which is compounded in ASUC itself as an additional risk factor 6
The lack of specific data on concurrent high-dose steroid use with upadacitinib represents a knowledge gap, though clinical practice patterns suggest many patients initiating upadacitinib are either steroid-dependent or recently exposed to high-dose steroids, particularly in the ASUC setting 6, 3, 5.