Start-to-Finish Clinical Remission Rate for Upadacitinib in Ulcerative Colitis
When incorporating both induction and maintenance phases, approximately 23% of all patients starting upadacitinib achieve clinical remission at 52 weeks, calculated by multiplying the 87% who respond to induction by the 26% who achieve remission during induction, with roughly 42-52% of those responders maintaining remission through one year. 1, 2
Induction Phase Success Rates
The U-ACHIEVE program provides the most comprehensive data for calculating start-to-finish success:
- 87% of patients (278/319) achieved clinical response after 8 weeks of upadacitinib 45 mg once daily and progressed to maintenance therapy 1
- 26% achieved clinical remission at week 8 in U-ACHIEVE induction (83/319 patients), compared to 5% with placebo 1, 2
- In U-ACCOMPLISH, 34% achieved clinical remission at week 8 (114/341 patients), compared to 4% with placebo 2
Extended Induction for Non-Responders
For the 13% who did not respond at week 8:
- 59.1% subsequently achieved clinical response after an additional 8 weeks of upadacitinib 45 mg therapy (75/127 patients) 1, 3
- This extended induction option increases the overall response rate but adds complexity to the calculation 3
Maintenance Phase Success Rates
Among those who achieved clinical response at week 8 and entered maintenance:
- 42% achieved clinical remission at week 52 with upadacitinib 15 mg once daily (63/148 patients) 2
- 52% achieved clinical remission at week 52 with upadacitinib 30 mg once daily (80/154 patients) 2
- Only 12% maintained remission on placebo (18/149 patients) 2
Integrated Start-to-Finish Calculation
The overall start-to-finish clinical remission rate depends on the maintenance dose chosen:
For 15 mg Maintenance Dose:
- Of 100 patients starting induction, 87 achieve response 1
- Of those 87 responders entering maintenance, approximately 42% achieve remission at 52 weeks 2
- Overall rate: ~37% of initial patients (87% × 42% = 36.5%)
For 30 mg Maintenance Dose:
- Of 100 patients starting induction, 87 achieve response 1
- Of those 87 responders entering maintenance, approximately 52% achieve remission at 52 weeks 2
- Overall rate: ~45% of initial patients (87% × 52% = 45.2%)
Real-World Data Confirmation
Real-world studies support these findings with even higher remission rates in clinical practice:
- 68.4% clinical remission at week 8 in pooled real-world data (95% CI 55.5-80.2%) 4
- 81.5% clinical remission at week 8 in prospective real-world cohort (22/27 patients) 5
- These higher rates likely reflect selection bias and less stringent remission definitions compared to regulatory trials 5, 4
Critical Considerations for Interpretation
The British Society of Gastroenterology rates upadacitinib with HIGH certainty for LARGE benefit in both induction and maintenance of remission in moderate to severe ulcerative colitis 6, 7
The American Gastroenterological Association classifies upadacitinib as a "HIGHER efficacy medication" for ulcerative colitis, with superior performance compared to other advanced therapies in network meta-analysis 6, 7
Comparative Context:
- Upadacitinib demonstrated absolute benefit of 22-29% over placebo for induction remission, higher than other advanced therapies 6, 2
- In biologic-exposed patients, upadacitinib showed risk difference of 65.25% (95% CI 19.7-100.0) with P-score of 0.93, ranking highest among all comparators 6
Important Caveats:
Prior biologic exposure significantly impacts outcomes - the U-ACHIEVE trials included both biologic-naïve and biologic-experienced patients, with 100% having prior anti-TNF exposure in real-world cohorts 2, 5
Extended induction adds complexity - the 59.1% who respond after 16 weeks total (rather than 8 weeks) represent an additional pathway to success not captured in the primary 87% response rate 1, 3
Maintenance dose selection matters substantially - the 30 mg dose provides 10% absolute benefit over 15 mg (52% vs 42% remission), though safety considerations may favor the lower dose in certain populations 2