Crohn's disease
ICD-10 K50 · ICD-11 DD70

Moderate-to-Severely Active Crohn's Disease When First-Line Advanced Therapy Has Not Achieved Remission

Clinical Scenario

This protocol addresses adult outpatients with moderate-to-severely active Crohn's disease who have previously been exposed to one or more advanced therapies — particularly TNF antagonists — and for whom that prior treatment did not achieve or sustain adequate disease control.

Why the Previous Step Was Not Sufficient

In this population, the preferred first step involves a higher efficacy advanced therapy (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate efficacy advanced therapy (ustekinumab or mirikizumab). The goal of that step is induction and maintenance of clinical remission (CDAI <150). When that remission target is not reached with a preferred first-line approach, this next-line protocol applies.

Next-Line Approach (Partial Overview)

For patients who have not achieved remission with higher or intermediate efficacy advanced therapies, the approach shifts to a lower efficacy advanced therapy. The specific agents, sequencing considerations, and full clinical algorithm are contained in the structured protocol.

Treatment Goal

The primary target remains induction and maintenance of clinical remission, defined as a Crohn's Disease Activity Index (CDAI) below 150.

Instant Access to Structured Evidence-Based Regimens

References

In adult outpatients with moderate-to-severely active CD who have previously been exposed to 1 or more advanced therapies, particularly TNF antagonists, the AGA suggests using a HIGHER efficacy medication (adalimumab, risankizumab, guselkumab, upadacitinib) OR an INTERMEDIATE efficacy medication (ustekinumab, mirikizumab), rather than a LOWER efficacy medication (vedolizumab, certolizumab pegol).

CDAI scores <150 suggest clinical remission, and scores 150–220, 221–450, and >450 denote mild, moderate, and severe disease, respectively.

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