What is the likelihood of achieving endoscopic remission with Rinvoq (upadacitinib) in the maintenance phase for a patient with moderate to severe ulcerative colitis?

Endoscopic Remission Rates with Upadacitinib Maintenance Therapy in Ulcerative Colitis

In patients with moderate-to-severe ulcerative colitis who respond to upadacitinib induction therapy, approximately 45-49% achieve endoscopic remission during maintenance therapy with upadacitinib 15-30 mg once daily at 52 weeks. 1, 2, 3

Maintenance Phase Endoscopic Outcomes

Primary Efficacy Data

The likelihood of achieving endoscopic remission during maintenance therapy depends on the dose:

• Upadacitinib 15 mg once daily: Approximately 45-49% of patients achieve endoscopic remission at Week 52, compared to 11% with placebo 1, 4
• Upadacitinib 30 mg once daily: Approximately 45-52% of patients achieve endoscopic remission at Week 52, compared to 11% with placebo 1, 4

The absolute treatment difference represents approximately 34-38% greater likelihood of endoscopic remission compared to placebo for both maintenance doses 1, 3

Sustained Long-Term Remission

For patients who enter maintenance therapy already in endoscopic remission, the likelihood of maintaining that remission is substantially higher:

• At Week 48 of long-term extension: 70% maintained endoscopic remission with 15 mg and 76% with 30 mg 4
• At Week 96 of long-term extension: 65% maintained endoscopic remission with 15 mg and 73% with 30 mg 4

These data demonstrate that upadacitinib not only induces endoscopic remission but sustains it over extended treatment periods 4

Comparative Context

Network Meta-Analysis Rankings

Upadacitinib demonstrates superior endoscopic improvement rates compared to other advanced therapies in maintenance phase:

• Results for maintenance of endoscopic improvement were largely similar to clinical remission outcomes, where upadacitinib ranked among the highest efficacy agents 5
• The 2024 AGA evidence synthesis confirms that endoscopic improvement data were broadly consistent with clinical remission comparisons across all treatment phases 5

Biologic-Exposed vs Biologic-Naïve Populations

Endoscopic remission rates remain robust regardless of prior biologic exposure:

• In the overall maintenance population, endoscopic remission rates at Week 52 were 49% (15 mg) and 46% (30 mg) in the as-observed analysis 4
• Among patients with prior biologic failure specifically, endoscopic remission rates were maintained at similar levels during maintenance therapy 1, 2

Clinical and Endoscopic Remission Combined

The likelihood of achieving both clinical AND endoscopic remission simultaneously (the most stringent outcome) is:

• Upadacitinib 15 mg: 16% at Week 52 vs 4% with placebo 1
• Upadacitinib 30 mg: 26% at Week 52 vs 4% with placebo 1

This represents a 22% absolute increase in achieving the combined endpoint with the 30 mg maintenance dose 1

Practical Implementation Considerations

Dose Selection for Maintenance

The choice between 15 mg and 30 mg maintenance dosing should consider:

• Both doses demonstrate similar endoscopic remission rates (45-49%), though the 30 mg dose shows numerically higher rates of combined clinical and endoscopic remission (26% vs 16%) 1, 4
• The 30 mg dose is associated with slightly higher rates of herpes zoster (7.3 vs 6.0 events per 100 patient-years) and creatine phosphokinase elevation (10.1 vs 8.0 events per 100 patient-years) 3
• For patients with cardiovascular risk factors or age ≥65 years, the 15 mg maintenance dose may be preferred given the black box warnings from rheumatoid arthritis data 5, 6

Extended Induction Strategy

For patients without clinical response after 8 weeks of upadacitinib 45 mg induction:

• An additional 8 weeks of 45 mg therapy (16-week extended induction) resulted in 59% subsequently achieving clinical response 7
• These extended induction responders who entered maintenance therapy achieved endoscopic remission rates of 26.5% (15 mg) and 43.6% (30 mg) at Week 52 7

This demonstrates that lack of response at Week 8 does not preclude eventual endoscopic healing with continued therapy 7

Monitoring and Optimization

Endoscopic assessment timing during maintenance:

• The FDA label and clinical trials assessed endoscopic outcomes at Week 52 of maintenance therapy 1, 2
• For patients in clinical remission, biomarker monitoring (fecal calprotectin <150 mg/g) can help identify those likely in endoscopic remission without routine endoscopy 5
• Patients with elevated biomarkers despite clinical improvement warrant endoscopic reassessment to confirm mucosal healing 8

Safety Profile During Maintenance

The most common adverse events during 52-week maintenance therapy include:

• Herpes zoster: 6.0-7.3 events per 100 patient-years (vs 0 with placebo) 3
• Hepatic disorders: 9.2-17.0 events per 100 patient-years (vs 5.9 with placebo) 3
• Creatine phosphokinase elevation: 8.0-10.1 events per 100 patient-years (vs 3.7 with placebo) 3

Serious infections, major adverse cardiovascular events, and venous thromboembolism occurred infrequently, with rates of 1% or less 3