Background Female sex has been associated with a worse response to anti-TNF drugs and with discontinuation of these drugs in immune-mediated diseases. Data in Inflammatory Bowel Disease (IBD) are unclear. The aims of study are to assess possible differences in long-term treatment persistence and safety of biological drugs between women and men with IBD. Methods Multicenter observational study carried out with data from the ENEIDA registry. Patients diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) who receive or have received biological drugs, and have had a minimum treatment follow-up of 6 months, were included. We evaluated the first biological treatment used in the patient. Statistic analysis; Regression logistic models were used for safety evaluation. Kaplan-Meier curves, Log-Rank test and COX regression were used to treatment persistance. Results A total of 51,595 patients with IBD were evaluated [ 25,947 with CD (13238 men and 12709 women) and 25,648 with UC (13596 men and 12052 women)]. Mean follow up of 13 years. Biologic use: 28.7% of the evaluated patients had been treated with at least one biologic drug. Biologics use in UC was less common in women than in men (15.5% vs. 17.2%, OR (95%CI): 0.88 (0.81-0.94), p= 0.001) and there were no differences between sexes in CD ( 45.7% in men, 44.7% in women). Infliximab (IFX) and adalimumab (ADA) were the most used drugs (in 8914 and 5269 patients, respectively). Safety evaluation. Women suffered more frequently adverse effects to IFX and ADA than men, being the withdrawal of IFX and ADA due to adverse effects also significantly more frequent in women than in men. Biological treatment persistence in patients with IBD was longer in men than in women [median 3.1 years vs. 2.3 years, p < 0.001]. Female sex was a risk factor of biologic discontinuation [adjusted hazard ratio [aHR] (95%CI): 1.20 (1.14-1.25), p<0.001]. Combotherapy with thiopurines and CD were protective factors for discontinuation [ combotherapy; aHR (95%CI): 0.46 ( 0.44-0.48), p<0.001; CD aHR (95%CI): 0.78 (0.74-0.82), p < 0.001]. In the analysis of each specific biological drug, female sex was identified as independent predictor for discontinuation of IFX [aHR (95%CI) 1.21; 1.13-1.30, p<0.001] and ADA [aHR (95%CI) 1.24; 1.14-1.35, p<0.001] in patients with CD and of IFX in patients with UC [aHR (95%CI): 1.16; 1.05-1.28, p=0.004]. Figure 1. Conclusion 1.The use of biologics in ulcerative colitis seems to be higher in men than in women. 2. Female sex is an independent risk factor for the development of adverse effects to IFX and ADA and for the discontinuation of these drugs. 3. The long-term persistence of IFX and ADA (as first biological treatments) is low, being higher in men compared to women.

Background The use of ustekinumab (UST) and vedolizumab (VDZ) as first line therapy for inflammatory bowel disease (IBD) is increasing due to safety reasons and contraindications of anti-TNFs. However, there are no studies evaluating their efficacy and safety in clinical practice under these circumstances. Thus, our aims were to describe bionaïve patients’ characteristics starting VDZ or UST and to evaluate treatment persistence of these drugs and their safety profile in this scenario. Methods Descriptive, retrospective and multicenter study based on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). All IBD patients never exposed to biological agents who started VDZ or UST as first-line biological treatment were identified. Results Out of 29,450 IBD patients ever exposed to biological drugs included in the ENEIDA registry, 924 patients met the inclusion criteria. Of these, 366 (40%) started UST and 558 (60%) VDZ as first line biological therapy. UST group: 48% women, 90% Crohn's disease (43% ileal; 13% colic; 43.5% ileocolic; 31% upper gastrointestinal involvement; 25% stricturing behaviour; 12% penetrating, 18% perianal disease), 10% ulcerative colitis (74% extensive, 17% left-sided, 9% proctitis), 27% had extraintestinal manifestations (EIM). Median age at the beginning of UST was 57 years (IQR 57-70), 17% patients had a past history of malignancy and, 34% had associated comorbidities. UST indication was luminal activity except in 2% for perianal disease and 5% for EIM. At the end of follow-up (median 14 months [IQR 6-30]), 12 patients (3.3%) developed adverse effects (AEs) that led to treatment discontinuation in the majority of them (92%). VDZ group: 44% women, 42% Crohn's disease (44% ileal; 18% colic; 38% ileocolic; 25% upper gastrointestinal involvement; 28% stricturing behaviour; 13% penetrating; 7% perianal disease), 58% ulcerative colitis (50% extensive, 42% left-sided, 8% proctitis), 17% had EIM. The median age at the beginning was 61 years (IQR 48-71), 24% had past history of malignancy and, 34% associated comorbidities. The indication was exclusively luminal activity. At the end of follow-up (median 21 months [IQR 8-36]), 36 patients (6.5%) had AEs, that lead to treatment withdrawal in 67% of them (24 patients). Cumulative treatment persistence rates were 78%, 60% and 50% for VDZ and 85%, 75% and 66% for UST at 12, 24 and 36 months, respectively (P<0.001). Conclusion In clinical practice, VDZ and UST are used first-line particularly in elderly patients with comorbidities. Both treatments have a good safety profile and a high persistence of treatment, being superior for ustekinumab.

Background The coexistence of immune-mediated diseases and non-pharmacological immunosuppression states are rare and might determine the natural history of the disease and therapeutic decisions of the physician. IBD guidelines recommend screening for human immunodeficiency virus (HIV) before starting immunosuppressive treatment, but data on the impact of HIV infection on IBD and its management in the era of biological drugs are scarce. Therefore, our aim was to describe IBD phenotype, immunosuppressive requirements, and prevalence of opportunistic infections (OI) in patients with IBD and coexistent HIV infection. Methods Case-control, retrospective, multicenter study including all IBD patients with available HIV serology on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). IBD patients with positive HIV serology were selected (HIV+) and compared to HIV seronegative IBD patients (controls), matched 1:3 by year of IBD diagnosis, age, gender and type of IBD). Demographic, clinical IBD characteristics, therapeutic requirements, OI and IBD complications were registered. Results Eighty-eight HIV+ IBD patients and 264 controls were included. In the whole cohort, 81% were men, 56.8% had ulcerative colitis (UC), 36.4% Crohns’ disease (CD) and 6.8% IBD unclassified. Median age at IBD diagnosis was 38 years (IQR 30-47), median age at HIV infection diagnosis was 36 years (IQR 30-42), 46.3% being were firstly diagnosed of IBD. Among UC patients, HIV+ had a lower proportion of extensive disease (24.5% vs 44.8%; P=0.002), and a higher proportion of proctitis (38.8% vs. 16.6%; P=0.002) than controls, without differences on disease proximal progression (7.7% vs 7.9%). Among CD patients, HIV+ presented a higher proportion of colonic involvement than controls (40.6% vs 12,6%, P=0.002) and lower penetrating behavior (10.7% vs 25%; ns). HIV+ had a lower proportion of extraintestinal manifestations (10.7% vs 25.4%; P=0.005). Although it was not statistically significant, a trend towards a lower proportion of hospitalizations (25.6% vs 35.3%) and IBD complications (6.3% vs. 9.2%) in HIV+ was observed. Regarding IBD therapeutic requirements, immunosuppressant (40.5% vs 58.7%; P=0.003) and biological drugs (28.3% vs 42.8%; P=0.020) were used less frequently among HIV+ than among controls. Conversely, HIV+ had a higher rate of OI (38.3% vs 17.8%; P<0.001) and malignancies (12.5% vs 8.3%, ns) than controls. Conclusion The coexistence of IBD and HIV infection seems to be associated with a less aggressive IBD phenotype and a lower use of immunosuppressants and biologicals but with a remarkable rate of OI.

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