P973 Real-world data on the effectiveness on IBD of anti-IL23 drugs prescribed for psoriasis indication

Abstract

Abstract Background There is a significant association between psoriasis and IBD, which share the pathogenic role of IL-23. In the dermatological field, drugs targeting the p19 subunit of IL-23, such as risankizumab, guselkumab, and tildrakizumab, have been approved for the treatment of moderate to severe psoriasis. However, there are still no real-life data on the efficacy and safety profile of IL-23 inhibitors in patients with IBD. Methods A prospective, single center observational study was conducted on patients with IBD and psoriasis from April 2021 to March 2023 at the gastroenterological-dermatological outpatient clinic at “Città della Salute e della Scienza of Turin”, Italy. Patients received a dermatological indication to start drug therapy with IL-23 inhibitors according to the dermatological dosing schedule. They were treated either with guselkumab subcutaneously at a dose of 100 mg every 8 weeks, or with risankizumab subcutaneously at a dose of 150 mg every 12 weeks, or with tildrakizumab 100 mg every 12 weeks subcutaneously. Objectives of this study included evaluating the achievement of clinical remission at 3, 6, and 12 months, defined as disease activity with Harvey-Bradshaw Index (HBI) < of 5 in CD and pMAYO < of 2 in UC. Results At 3 months after the start of drug treatment, clinical remission was achieved by 73.3% of patients (p=0.006). This number also remained almost constant at 6 (62.4%, p=0.008) and 12 months (60.3%, p=0.04). In addition, there was a statistically superior steroid-free clinical remission compared to T0 at 3 (15.3% vs 73.3%, p=0.006) and 6 months (7.1% vs 54.1%, p=0.04). No major side effects were reported. Two cases of arthralgias (11.8%) and one case of fever with chills (5.9%) were reported. IL-23 inhibitors appear to be effective in maintaining the steroid-free clinical remission. In addition, there was a reduction in fecal calprotectin values to a median value at 6 months of 81.0 (95%IC= 28.2-249.8; p=0.03) from a median value at T0 of 343.1 (95%IC= 44.8-869.7). The maintenance rate of IL-23 inhibitors therapy at the end of follow-up was 75.8%. Conclusion In this study risankizumab, guselkumab, and tildrakizumab appear to be effective in inducing clinical remission and steroid-free clinical remission in patients with IBD. In addition, they appear to be effective in maintaining steroid-free clinical remission. IL-23 inhibitors demonstrated a good safety profile in patients with IBD. Despite the limitations of the study with the need to publish further real-world data on a larger scale and with higher dosing of IL-23 inhibitors, the results obtained are promising as they, for the first time, provide real-life support for the clinical potential of these drugs as treatment for IBD in addition to psoriasis.