P0601 Is advanced combination therapy effective in patients with refractory Inflammatory Bowel Disease?

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Abstract Background Advanced combination therapy (ACT) involves combining two biological therapies or a biological drug with a small molecule, in order to complement their mechanisms of action inhibiting multiple inflammatory cascades. The primary aim of our study was to evaluate the effectiveness of combination therapies in Inflammatory Bowel Disease (IBD) Methods A prospective, single-centre observational study was conducted, including all patients diagnosed with ulcerative colitis (UC) or Crohn´s disease (CD) starting treatment with ACT from March to August 2024. Clinical and biological response and remission were assessed at week 16 and the last available visit. Clinical response was defined as a decrease ≥3 points from baseline Harvey-Bradshaw Index (HBI) in CD or baseline Partial Mayo Score (pMS) in UC. Clinical remission was considered as a HBI score ≤4 or pMs of 0-1. Biological response was determined as a ≥50% decrease from baseline C-reactive protein (CRP) and faecal calprotectin (FC) and remission as a CRP<5 and FC<250 Results A total of 20 patients were included, 70% (14/20) diagnosed with UC (Figure 1A). The most frequent combination was vedolizumab (VEDO) with upadactitinib (UPA) (Figure 1B) The median baseline HBI was 10.5 [IQR 6-15] decreasing to 6.5 at week 16 [IQR 3-11] and to 5.5 [IQR 2-10] at the last follow-up (p<0.001)(Figure 2A). The median baseline pMS was 7 [IQR 5-8] decreasing to 4 [IQR 2-4] at week 16 and to 2 [IQR 1-3] at the last visit (p<0.005) (Figure 2B) The median baseline FC was 1994 [IQR 805-3238], decreasing to 635 [IQR 183-222] at week 16 and to 387 [IQR 93-1115] at the last follow-up (p=0.047) (Figure 2C). Regarding CRP, the median baseline was 5.3 [IQR 1-31], decreasing to 2.4 [IQR 1-5] at week 16 and to 1.2 [IQR 1-4] at the end of follow-up (p=0.014) (Figure 2D) 65% of patients achieved clinical response and 20% reached clinical remission at week 16. At the end of follow-up, 80% achieved clinical response and 65% clinical remission (Figure 2E) At week 16, 45% and 20% of patients achieved biological response and remission, respectively. At the end of follow-up, 65% were in biological response and 45% in biological remission (Figure 2F) Treatment was discontinued in 3 patients, in 2 of them due to improvement and in the reimaining one due to lack of response. Treatment intensification was required in 7 patients. A total of 8 mild adverse effects were recorded, none of which led to discontinuation of the ACT Conclusion These results demonstrate adequate clinical and biological response in patients treated with ACT. Clinical and biological remission was achieved in 65% and 45% of patients at the end of follow-up, with good safety profile. Nevertheless, to confirm this results futher large prospective studies are needed