Table 4.
Summary of Recommendations of the Korean Clinical Practice Guidelines on Biologics for Moderate to Severe CD
| No. | Recommendations | Strength of recommendation | Quality of evidence |
|---|---|---|---|
| 1 | We recommend infliximab, adalimumab, vedolizumab, or ustekinumab for induction of remission in patients with moderate-to-severe CD who are refractory or intolerant to conventional therapy. | Strong | Moderate |
| 2 | In patients with moderate-to-severe CD who achieve a clinical response or remission with infliximab, adalimumab, vedolizumab, or ustekinumab, we recommend maintenance therapy using the same biologic agents. | Strong | Moderate |
| 3 | a. We recommend infliximab in combination with thiopurines over infliximab monotherapy for induction of remission in patients with moderate-to-severe CD. | Strong | Moderate |
| b. We suggest adalimumab in combination with thiopurines over adalimumab monotherapy for induction of remission in patients with moderate-to-severe CD. | Conditional | Very low | |
| 4 | We recommend the use of adalimumab in patients with moderate-to-severe CD who lose their response to infliximab maintenance therapy. | Strong | Moderate |
| 5 | We suggest the use of TNF-α receptor antagonists to prevent postoperative recurrence in high-risk patients with CD | Weak | Low |
| 6 | We suggest therapeutic drug monitoring (TDM) to optimize treatment in patients with CD who lose their response to TNF-α receptor antagonists. | Conditional | Low |
| 7 | a. We recommend the use of infliximab for induction and maintenance of fistula remission in CD patients with active perianal fistulas. | Strong | Moderate |
| b. We suggest the use of adalimumab for induction and maintenance of fistula remission in CD patients with active perianal fistulas. | Conditional | Low | |
| 8 | We recommend that currently approved anti-TNF biosimilars can be used for induction and maintenance of remission in patients with moderate-to-severe CD. | Strong | Moderate |
| 9 | We recommend patients with CD receiving anti-TNF agents can be switched to biosimilars if they are stable. | Strong | Moderate |
| 10 | We recommend vedolizumab for induction and maintenance of remission in patients with moderate-to- severe CD who have an inadequate response to TNF-α receptor antagonists. | Strong | Low |
| 11 | We recommend ustekinumab for induction and maintenance of remission in patients with CD who have an inadequate response to TNF-α receptor antagonists. | Strong | Moderate |
| 12 | We suggest that discontinuation of TNF-α receptor antagonists is not mandatory prior to surgery in patients with CD. | Conditional | Low |
CD, Crohn’s disease; TNF, tumor necrosis factor.