ABSTRACT
Background and aim: Dual Targeted Therapy (DTT) is a novel therapeutic strategy proposed for the management of patients with complex inflammatory bowel disease (IBD). Our aim was to evaluate the safety and effectiveness of this approach in a real-life setting Materials and methods: In this single centre retrospective cohort study, we collected data on IBD patients receiving DTT from 2017 to 2022. Baseline characteristics, clinical activity of intestinal and extraintestinal disease, C-reactive protein (CRP) levels, endoscopic assessment and adverse events (AEs) were recorded. Clinical remission, CRP normalization, endoscopic remission and occurrence of AEs were investigated at baseline and during follow up Results: Sixteen patients were identified;indications for DTT were: uncontrolled IBD (11 patients), uncontrolled extraintestinal manifestations (EIMs) (6 patients: 4 spondyloarthritis, 2 psoriatic disease). Patients received vedolizumab (VDZ, 14, 87.5%), ustekinumab (UST, 8, 50%), anti-TNFα (7, 43.8%), sekukinumab (2, 12.5%), tofacitinib (1, 6.3%). The most common combinations were: VDZ+UST (6 patients, 37.5%) and adalimumab+VDZ (3, 18.8%). At baseline, 15/16 (93.8%) and 4/6 (66.6%) patients had active intestinal and EI symptoms, respectively;14 (87.5%) patients had positive CRP and 5 (31.3%) were receiving oral steroids. Median follow-up duration on DTT was 15 months (IQR 11-22). Clinical intestinal remission was reported by 6/16 (37.5%) and 3/11 (27.3%) patients at 6 and 12 months, respectively. Clinical remission of EIMs was reported by 3/7 (42.9%) at 6 and 5/7 (71.4%) patients at 12 months, respectively. CRP normalization was observed in 3/16 (18.8%) and 6/11 (54.5%) patients at 6 and 12 months, respectively. 80% of patients on steroid therapy at baseline discontinued them within 6 months. Endoscopic assessments were available for 8 patients, with endoscopic remission in 2, endoscopic improvement in 3 and no improvement in 3. Four patients (25%) experienced an AE (1 COVID-19 and reactivation of perianal disease;1 mild pneumonitis and reactivation of perianal disease;1 drug-induced pneumonitis;1 arthralgia and COVID-19). Finally, 1 patient underwent colectomy due to uncontrolled disease. Three patients discontinued DTT: 2 because of treatment failure, 1 because of an AE (drug-induced pneumonitis) Conclusions: DTT can be considered a reasonably safe and effective treatment in complex IBD patients, either with uncontrolled intestinal inflammation or with concomitant EIMs, when other therapeutic options have failed