Introduction

Welcome back to the consensus process for the Clinical Practice Guidelines on Best Practices for the use of small molecules and anti-IL-23p19 inhibitors in the treatment of ulcerative colitis and Crohn's disease. This crucial initiative, led by the Asia Pacific Association of Gastroenterology (APAGE) Working Group for IBD in collaboration with the Asian Education Network for IBD (AEN-IBD), is nearing its final stages, and your continued expertise is highly valued.

We sincerely appreciate your thoughtful contributions during the previous two rounds of voting. Your feedback has been instrumental in refining the initial statements.

For this third round, we have a focused set of 2 statements remaining: Statement 2a, Statement 2b, Statement 2c, and Statement 3. These statements have been carefully revised based on the collective feedback and voting patterns from the earlier rounds.

Before casting your vote, we strongly encourage you to carefully read the accompanying text and the provided references for each statement. This will ensure that your assessment is well-informed and reflects the available evidence.

The agreement level remains the same:
1 = Reject Completely
2 = Reject with reservation
3 = Accept with major reservation
4 = Accept with some reservation
5 = Accept completely

As before, a statement will be accepted into the final guidelines if more than 80% of the voting panel votes 4 or 5.

Please provide any final comments you may have for each statement in the designated box. Your expert insights at this concluding stage are critical in ensuring the clarity, accuracy, and clinical applicability of these guidelines for the Asia-Pacific region.

We anticipate this final voting round will take approximately 5 minutes.

Rest assured, your voting remains anonymous. Your individual responses will not be linked to your identity, maintaining complete confidentiality.

Thank you once again for your dedication and significant contribution to this vital initiative. Your participation is essential in shaping these important guidelines that will ultimately aim to standardize care and improve outcomes for patients with ulcerative colitis and Crohn's disease across the Asia-Pacific region.

Statement 2 - Text and References

In GALAXY 2&3, Compared to UST, the clinical remission rate at Week 48 was 65% in the group receiving guselkumab 100 mg SC every 8 weeks and 70% in the group receiving guselkumab 200 mg SC every 4 weeks; these rates were not significantly higher than the clinical remission rate of 63% in the UST group. However, the endoscopic remission rate at Week 48 was significantly higher in the guselkumab group (33% and 37% in the groups receiving guselkumab 100 mg SC every 8 weeks and 200 mg SC every 8 weeks, respectively) compared to the UST group (24%).
Panaccione R et al., Gastroenterology, Volume 166, Issue 5, 1057b2, https://doi.org/10.1016/S0016-5085(24)05019-4

In one head-to-head trial comparing risankizumab and ustekinumab in patients with moderate-to-severe Crohn’s disease who had failed anti-TNF therapy, risankizumab was noninferior to ustekinumab in achieving clinical remission at week 24 and showed superior efficacy in inducing endoscopic remission by week 48.
Peyrin-Biroulet L et al. N Engl J Med. 2024 Jul 18;391(3):213-223, https://www.nejm.org/doi/pdf/10.1056/NEJMoa2314585

Statement 3 - Text and References

A real-world study evaluated the effectiveness of risankizumab in both ustekinumab-naive and ustekinumab-experienced patients with Crohn’s disease, finding that prior ustekinumab exposure did not significantly affect the likelihood of achieving steroid-free clinical remission at one year.
Gastroenterol Hepatol. 2024 Jul;20(7 Suppl 5):16–17, https://pmc.ncbi.nlm.nih.gov/articles/PMC11345971/

Similarly, a prospective study involving 134 patients—52% of whom had prior exposure to ustekinumab—reported that clinical remission rates in ustekinumab-experienced individuals were not significantly lower than those in ustekinumab-naive patients. These findings suggest that risankizumab remains effective regardless of previous ustekinumab treatment.
Clin Gastroenterol Hepatol. 2024 Oct 24:S1542-3565(24)00968-6, https://doi.org/10.1016/j.cgh.2024.09.027

D’Haens G. et al., Effectiveness and Safety of Mirikizumab after switching from Ustekinumab in patients with moderate to severe Crohn's disease: results from a long-term extension study, Journal of Crohn's and Colitis, Volume 19, Issue Supplement_1, January 2025, Pages i170–i172, https://doi.org/10.1093/ecco-jcc/jjae190.0085