P0930 Adalimumab is equally efficient as infliximab in achieving sustained remission in Ulcerative Colitis but inferior in patients with severe disease
Authors: Gunnarsson J , Mavroudis G , Ågren S , Lasson A , de Lange T , Jonefjäll B 
Published: January 2025

Background

Anti-TNF treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies in patients with ulcerative colitis (UC). No head-to-head studies between the two drugs exist but meta-analysis of RCTs indicate that IFX might be more effective than ADA for the induction of clinical remission1,2. However, observational studies conclude that ADA seems to have similar effect as IFX 3,4. Our aim was to evaluate any difference in effect between IFX and ADA in bio-naive patients with UC in the short and long term in a real world setting during the modern era of therapeutic drug monitoring and dose optimization.

Methods

We performed a retrospective multicentre observational cohort study. Bio-naive patients with active UC, initiating treatment with IFX or ADA at four major out-patient IBD-units 2018-2022, were included. Data was received by a structured review of medical records.

Results

271 patients were included, 105 in the IFX group and 166 in the ADA group. The primary endpoint steroid-free clinical remission (SFCR) at 12 months was reached in 43% (n=37) of patients with IFX and 35% (n=55) with ADA (aOR: 1.41 (0.81-2.45), p=ns).

Regarding secondary endpoints, clinical remission at 3 months was more common with IFX than ADA (68% vs 57%, aOR 1.83 (1.07-3.14), p&lt;0.05) but no difference was observed regarding clinical response at 3 months (74% vs 67%, p=ns), clinical remission at 12 months (49% vs 47%, p=ns) and biochemical remission at 3 months (51% vs 45%, p=ns) and at 12 months (36% vs 40%, p=ns)(Table 1).

In the subpopulations with moderate and mild disease activity, IFX and ADA were equally effective regarding clinical remission at 3 months and SFCR at 12 months. In patients with severe disease activity, IFX had higher remission rates than ADA at 3 months; 70% (n=32) vs 46% (n=26) (p&lt;0.05) and numerically at 12 months; 41% (n=14) vs 25% (n=14) (p=0.11)(Figure 1).

Dose escalation was more frequent with IFX than ADA (44% vs 31%, p&lt;0.05) but did not differ between patients failing to achieve SFCR at 12 months (44% vs 37%, p=ns).

Use of thiopurines during the study period was more common with IFX than ADA (76% vs 50%, p&lt;0,05) and was associated with higher rates of SFCR at 12 months in the ADA group 44% (n=32) vs 27% (n=23) (p&lt;0.05), but not in the IFX group; 44% (n=27) vs 40% (n=10) (p=ns).

Conclusion

Adalimumab seem to have similar effect as infliximab in achieving steroid-free clinical remission after one year in bio-naive patients with ulcerative colitis. However, infliximab was associated with higher remission rate after induction therapy and subgroup analysis indicate that infliximab is superior to adalimumab in patients with severe disease. Differences in dose escalation did not seem to affect the outcomes.

References

1.Bonovas S, Lytras T, Nikolopoulos G, Peyrin-Biroulet L, Danese S. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018 Feb;47(4):454-465.

2.Singh S, Murad MH, Fumery M, Dulai PS, Sandborn WJ. First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2179-2191.

3.Sandborn WJ, Sakuraba A, Wang A et al. Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States. Curr Med Res Opin. 2016 Jul;32(7):1233-41.

4.Pouillon L, Baumann C, Rousseau H et al. Treatment Persistence of Infliximab Versus Adalimumab in Ulcerative Colitis: A 16-Year Single-Center Experience. Inflamm Bowel Dis. 2019 Apr 11;25(5):945-954.