Is the current treatment regimen of risankizumab-rzaa (Skyrizi) and infliximab (Remicade) appropriate for a 30-year-old female patient with Crohn's disease of the small intestine with other complications?

Concurrent Use of Risankizumab and Infliximab is NOT Appropriate

This patient should NOT be receiving both risankizumab (Skyrizi) and infliximab (Remicade) simultaneously, as concurrent use of multiple biologic agents is contraindicated and significantly increases infection risk without evidence of added benefit. 1

Critical Safety Concern: Dual Biologic Therapy

• The medication list shows active prescriptions for BOTH infliximab 100mg IV every 8 weeks AND risankizumab 360mg subcutaneous every 8 weeks, which represents inappropriate concurrent biologic use 1
• Patients should not be using any other biologic drug or targeted synthetic drug concomitantly when receiving risankizumab therapy 1
• One biologic must be discontinued immediately to avoid excessive immunosuppression and infection risk 2

Appropriate Monotherapy Selection

Risankizumab as Preferred Option

• For this 30-year-old female with moderate-to-severe Crohn's disease of the small intestine, risankizumab monotherapy is the appropriate choice given the documented induction regimen already initiated 2, 1
• The European Crohn's and Colitis Organisation (ECCO) provides a strong recommendation for risankizumab as both induction and maintenance therapy in moderate-to-severe Crohn's disease (strong recommendation, high-quality evidence) 1, 3
• The patient has completed the correct induction dosing: 600mg IV at weeks 0,4, and 8, which aligns with FDA-approved dosing for Crohn's disease 1, 4

Why Discontinue Infliximab

• Infliximab should be discontinued because the patient has already completed risankizumab induction therapy and is transitioning to maintenance 1, 5
• There is no evidence supporting dual biologic therapy in Crohn's disease, and guidelines explicitly recommend against concurrent use 1
• The risk of serious infections increases substantially with multiple immunosuppressive biologics without demonstrated efficacy benefit 2

Correct Maintenance Regimen Going Forward

Risankizumab Maintenance Dosing

• The appropriate maintenance dose is risankizumab 360mg subcutaneous every 8 weeks, which demonstrates superior efficacy compared to the 180mg dose 5, 6
• Clinical remission rates at week 52 with risankizumab 360mg were 52% versus 41% with placebo (adjusted difference 15%, 95% CI 5-24%) 5
• Endoscopic response rates at week 52 with risankizumab 360mg were 47% versus 22% with placebo (adjusted difference 28%, 95% CI 19-37%) 5

Evidence Supporting Risankizumab Efficacy

• In the ADVANCE trial, risankizumab 600mg IV induction achieved 45% clinical remission at week 12 versus 25% with placebo (adjusted difference 21%, 95% CI 12-29%) 4
• Endoscopic response at week 12 was 40% with risankizumab 600mg versus 12% with placebo (adjusted difference 28%, 95% CI 21-35%) 4
• Maintenance therapy with risankizumab 360mg sustained clinical and endoscopic outcomes, with 68.6% maintaining clinical remission through week 52 6

Documentation Gaps Requiring Attention

Missing Clinical Information

• No documentation of moderate-to-severe disease activity is present in the chart - this must include either Crohn's Disease Activity Index (CDAI) score, stool frequency/abdominal pain scores, or objective inflammatory markers 1, 3
• Fecal calprotectin or C-reactive protein levels should be documented to confirm active inflammation 1, 3
• Recent endoscopic findings with Simple Endoscopic Score for Crohn's Disease (SES-CD) should be recorded to establish baseline disease severity 4, 6

Required Safety Documentation

• Active serious infection must be ruled out before continuing biologic therapy - the nursing assessment shows no current signs of infection, but this should be explicitly documented by the prescribing physician 1
• Tuberculosis screening is appropriately documented as negative (QuantiFERON-TB Plus negative) 1
• No concurrent live vaccine administration should be confirmed 1

Common Pitfalls to Avoid

• Never continue dual biologic therapy "to see how the patient does" - one agent must be stopped immediately 1
• Do not reduce the risankizumab maintenance dose to 180mg in an attempt to allow dual therapy - this both reduces efficacy and maintains unacceptable infection risk 5
• Avoid automatic substitution or switching between biologics without full agreement and supervision of the prescribing gastroenterologist 2
• Do not delay discontinuation of infliximab while "tapering" - biologics should be stopped completely when switching to an alternative agent 2