Efficacy and Safety of Second-Line Advanced Therapy After Vedolizumab in Ulcerative Colitis: A Multicenter Cohort Study From the GETAID
Louis Calméjane et al for GETAID
ABSTRACT
Background and Aims
Vedolizumab has become the preferred first-line advanced therapy in ulcerative colitis (UC). However, the optimal second-line treatment following vedolizumab failure remains unclear. We aimed to evaluate the effectiveness and safety of second-line therapies after first-line vedolizumab.
Methods
We conducted a multicenter retrospective study including UC patients from 31 centers who received infliximab (IFX), subcutaneous (SC) anti-TNFs, or ustekinumab after vedolizumab failure. The primary endpoint was steroid-free clinical remission (SFCR) at week 14. Predictors of remission were identified using multivariate logistic regression.
Results
Among 196 patients, 99 received IFX, 27 anti-TNF SC, and 70 ustekinumab. At week 14, SFCR was achieved in 78 patients (39.8%): 38 (38.4%) with IFX, 8 (29.6%) with anti-TNF SC, and 32 (45.7%) with ustekinumab, with no significant difference between groups (p = 0.32). Median treatment persistence ranged from 8 to 9.2 months. Baseline corticosteroid use was associated with lower odds of SFCR (OR = 0.37, 95% CI [0.18–0.73]). Adverse events occurred in 15.8% of patients, including 12.2% serious events. Overall adverse events were less frequent with ustekinumab than with IFX (10.0% vs. 24.2%, p = 0.02), while serious events were comparable (5.7% vs. 16.1%, p = 0.08). Discontinuation due to adverse events was more frequent with IFX (12.1%) and anti-TNF SC (14.8%) than with ustekinumab (2.9%, p = 0.045 and 0.049).
Conclusion
In UC patients failing vedolizumab, second-line IFX, anti-TNF SC, and ustekinumab showed similar effectiveness and persistence. Infliximab remains a robust option for rapid control in high inflammatory burden, whereas ustekinumab may be preferred for its superior safety profile in high-risk patients.
Key Summary
- Summarise the established knowledge on this subject
- Vedolizumab is commonly used as a first-line advanced therapy in ulcerative colitis.
- Data on the effectiveness and safety of second-line advanced therapies after vedolizumab are limited.
- What are the significant and/or new findings of this study?
- No statistically significant difference was observed in the effectiveness of second-line advanced therapies including infliximab, antiTNF SC and ustekinumab, following vedolizumab at week 14.
- Infliximab, anti-TNF SC and ustekinumab showed similar treatment persistence, remission and response rates at 52 weeks.
- Baseline use of corticosteroids was associated with poorer outcomes at week 14.
- The overall adverse event rate was lower with ustekinumab than with infliximab. Treatment discontinuation due to adverse events was more frequent with infliximab and anti-TNF SC compared with ustekinumab.
- Ustekinumab offers a safety advantage in high-risk patients, while infliximab remains a robust option in the setting of high baseline inflammation.
LEGGI TUTTO https://onlinelibrary.wiley.com/doi/10.1002/ueg2.70203#:~:text=https%3A//doi.org,Object%20Identifier%20(DOI)
