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Background The use of biosimilar adalimumab (ADA) is effective and safe in inflammatory bowel disease (IBD), although clinical data on switching between ADA biosimilars is still rare. At the end of 2020, a non-medical switch to biosimilar ADA became mandatory in Hungary due to reimbursement policy changes of the National Health Insurance Fund of Hungary (NEAK). The aim of the present study was to evaluate short- and medium term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. Methods 246 consecutive patients on maintenance ADA therapy (n=181 Crohn’s disease [CD] and n=65 ulcerative colitis [UC], male/female: 44%/56%, median disease duration: 10years(y) (IQR: 10–16)) were included from 4 IBD centers between September 2019 and December 2020. Data on clinical efficacy, using Crohn’s Disease Activity Index (CDAI) and partial Mayo Score (pMayo), laboratory parameters (C-reactive protein – CRP) and adverse events were collected at 8–12 weeks prior switch, at baseline, and 8–12 weeks, 20–24 weeks after switch. Drug sustainability following the switch was evaluated after a median of 41 weeks (IQR: 35–42) follow-up time. Results A total of 246 IBD patients (n=153 patients [115CD/38UC, median age: 38y(IQR: 27–45)] and n=93 patients [66CD/27UC, 32y(IQR: 26–40.5)] underwent a non-medical switch from the originator to a biosimilar, and biosimilar to biosimilar. Clinical disease activity based on CDAI and pMayo scores are presented in Figures 1 and 2. No significant difference was found in the proportion of patients in clinical remission at week 8–12 prior switch / switch / week 8–12 and week 20–24 in either patients switched from originator to biosimilar (86.8% / 88.2% / 86.0% / 85.0%; p=0.87 among groups) or biosimilar to biosimilar (72.0% / 77.4% / 84.9% / 77.6%; p=0.21). 89.2% and 83.1% of patients who were in clinical remission at switch/baseline sustained clinical remission up to week 20–24 in the first and second cohorts. Mean CRP levels were also unchanged during follow-up in both cohorts (p=0.71 and p=0.94). Drug survival was similar between originator to biosimilar and biosimilar to biosimilar switch cohorts, with a probability of 90.6% (SE: 2.4) and 85.8% (SE:3.7) to stay on drug after 40 weeks (log-rank: p=0.271). Figure 3. Two cases of skin reactions were registered as adverse events, one leading to treatment discontinuation. Conclusion Clinical remission was sustained following non-medical switch from originator or biosimilar adalimumab to a biosimilar in IBD patients. Medium-term drug sustainability following the switch was high, and comparable between patients with an originator to biosimilar and a biosimilar to biosimilar switch.

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Background Emerging data suggest that a treat-to-target approach and early therapeutic intervention using regular objective disease assessment leads to improved outcomes. Our aim was to evaluate the value of objective disease monitoring during regular follow-up. Methods Patients presenting in our IBD center between January and December in, 2018 were included and followed up for, 1 year. Data from clinical visits, clinical disease activity using Crohn’s Disease Activity Index and partial Mayo Score, biomarkers (CBC, CRP, FCAL), stool culture, colonoscopy/sigmoidoscopy, CT/MRI scans, abdominal US, total number of visits, hospitalization or surgery rates, and change in medical therapy were collected. We compared monitoring strategy according to the clinical disease activity in the given quarter-year period based on the patient’s status of clinical disease activity (remission/ flare / post-flare/ continuous activity). Results N=161 patients were included (CD:118/UC:43; male:, 56%), with predominantly moderate-to-severe disease phenotype (70% on biological therapy). In total, n=644 quarter year periods (n=, 554 with patient visit) were evaluated (remission, 57%; continuous activity, 19%; post-flare, 11%; flare, 13%). CBC and CRP were performed in, 82.9% and, 83.9% of all patients with at least one clinical visit in a quarter-year period, regardless of clinical activity in IBD. Colonoscopy was performed in patients with flare or continuous disease activity in, 21.1% and, 18.9%, but, 10.1% of the patients in clinical remission also underwent colonoscopy in a given quarter-year period. In a sub-analysis of UC patients, 24.1% of the patients presenting with disease flare had colonoscopy in a given period. Stool culture and C.difficile stool tests were performed in, 17.2% of UC patients with flare. CT scans were performed at a low rate of, 2.4% in CD patients with disease flare, while MRI scans were similar in all subgroups of CD patients (7.7–16.7%)., 13.2% of patients with cont. activity and, 24.5% of patients with flare needed initiation or dose optimization of corticosteroids, while biological start or dose optimization was needed in, 31.1% and, 33.8% in a given quarter-year period. Mean number of follow-up visits per quarter-year period was high(1.6) even for patients in remission, and, 2.4 in flare. Conclusion Our study confirmed the use of regular objective biomarker monitoring, independent of clinical activity. We report high utilization of c-scope/sigmoidoscopy as well as MRI (in CD) in the objective evaluation of patients with clinical symptoms or even as part of routine monitoring. CT was reserved for emergency situations, while the use of US was relatively low. Objective monitoring resulted in frequent and early optimization of the therapeutic strategy.

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