Abstract Background The use of advanced combination therapies (ACT) in the management of inflammatory bowel diseases (IBD) is an emerging area of interest. Targeted at the management of patients with refractory disease to monotherapy and extraintestinal manifestations, there is limited data on real-world outcomes for this patient group. We aimed to review the rates of clinical, biochemical and endoscopic remission in patients on ACT at 6 months. Secondary outcomes included assessing safety, reasons for discontinuation and the choice of combination therapy. Methods We conducted a retrospective observational study on patients with IBD receiving ACT at a single Australian tertiary centre. Data extracted from electronic medical records included: ACT regimen, disease phenotype, indication and adverse events. Of the patients commenced on ACT, 24 had been on it for at least 6 months at the time of analysis. Further data was collected on these patients regarding clinical, biochemical and endoscopic outcomes. Clinical remission was defined as SCCAI score 2 or CDAI 150 or PDAI 10; endoscopic remission was defined as UCEIS score of ≤ 1 or SES-CD 2; and biochemical remission was defined as faecal calprotectin ≤100. Results A total of 37 patients treated with ACT were included, of whom 27 (73%) with Crohn’s disease and 22 (59%) females, with a median age of 40 years. Eighteen patients (49%) had perianal fistulising disease, and 18 (49%) had at least one extraintestinal manifestation. All initial regimens included Vedolizumab or Ustekinumab (Table 1). The combination regimen was modified in 4 patients and discontinued in 6, primarily for inadequate response. One patient had therapy discontinued due to adverse effects of treatment. Twenty-four patients received ACT for at least 6 months. Baseline faecal calprotectin was elevated in 19 (79%) patients at the time of starting ACT; 11 (46%) had confirmed biochemical remission at 4-9 months. Baseline endoscopy showed evidence of inflammation in 20 (83%) patients. Eleven patients had follow-up endoscopy in a 4–9-month period. Ten (50%) showed a reduction in disease activity, with 4 (17%) achieving endoscopic remission. Clinical remission was observed in 22 (92%) patients. Conclusion Advanced combination therapy appears to be an effective and relatively safe treatment option in patients with complex refractory inflammatory bowel disease. Our findings support the use of combination therapy where monotherapy has failed. However, further longitudinal studies are necessary to fully elucidate the long-term safety and efficacy of this therapeutic approach. Conflict of interest: Malkopoulos, Athanasios: No conflict of interest Kakkadasam Ramaswamy, Pradeep: No conflict of interest Subhaharan, Deloshaan: No conflict of interest James, Rayschelle: No conflict of interest Mohsen, Waled: No conflict of interest
Malkopoulos et al. (Thu,) studied this question.