HIV infection is associated with a less aggressive phenotype of inflammatory bowel disease. A multicenter study of the ENEIDA registry.

BACKGROUND: The coexistence of human immunodeficiency virus (HIV) infection and inflammatory bowel disease (IBD) is uncommon. Data on the impact of HIV on IBD course and its management is scarce. AIM: To describe the IBD phenotype, therapeutic requirements and prevalence of opportunistic infections (OI) in IBD patients with a coexistent HIV infection. METHODS: Case-control, retrospective study including all HIV positive patients diagnosed with IBD in the ENEIDA registry. Patients with positive HIV serology (HIV-IBD) were compared to controls (HIV seronegative), matched 1:3 by year of IBD diagnosis, age, gender and type of IBD. RESULTS: A total of 364 patients (91 HIV-IBD and 273 IBD controls) were included. In the whole cohort, 58% had ulcerative colitis (UC), 35% had Crohn's disease (CD) and 7% were IBD unclassified. The HIV-IBD group presented a significantly higher proportion of proctitis in UC and colonic location in CD but fewer extraintestinal manifestations than controls. Regarding treatments, non-biological therapies (37.4% vs. 57.9%; P=0.001) and biologicals (26.4% vs. 42.1%; P=0.007), were used less frequently among patients in the HIV-IBD group. Conversely, HIV-IBD patients developed more OI than controls regardless of non-biological therapies use. In the multivariate analysis, HIV infection (OR 4.765, 95%CI 2.48-9.14; P<0.001) and having ≥1 comorbidity (OR 2.445, 95%CI 1.23-4.85; P=0.010) were risk factors for developing OI, while CD was protective (OR 0.372, 95%CI 0.18-0.78;P=0.009). CONCLUSIONS: HIV infection appears to be associated with a less aggressive phenotype of IBD and a lesser use of non-biological therapies and biologicals but entails a greater risk of developing OI.

Trends in Targeted Therapy Usage in Inflammatory Bowel Disease: TRENDY Study of ENEIDA.

Markers that allow for the selection of tailored treatments for individual patients with inflammatory bowel diseases (IBD) are yet to be identified. Our aim was to describe trends in real-life treatment usage. For this purpose, patients from the ENEIDA registry who received their first targeted IBD treatment (biologics or tofacitinib) between 2015 and 2021 were included. A subsequent analysis with Machine Learning models was performed. The study included 10,009 patients [71% with Crohn's disease (CD) and 29% with ulcerative colitis (UC)]. In CD, anti-TNF (predominantly adalimumab) were the main agents in the 1st line of treatment (LoT), although their use declined over time. In UC, anti-TNF (mainly infliximab) use was predominant in 1st LoT, remaining stable over time. Ustekinumab and vedolizumab were the most prescribed drugs in 2nd and 3rd LoT in CD and UC, respectively. Overall, the use of biosimilars increased over time. Machine Learning failed to identify a model capable of predicting treatment patterns. In conclusion, drug positioning is different in CD and UC. Anti-TNF were the most used drugs in IBD 1st LoT, being adalimumab predominant in CD and infliximab in UC. Ustekinumab and vedolizumab have gained importance in CD and UC, respectively. The approval of biosimilars had a significant impact on treatment.

Need for therapeutic escalation in patients with refractory ulcerative proctitis: Results from the PROCU study of the ENEIDA registry.

BACKGROUND: Ulcerative proctitis (UP) can have a milder, less aggressive course than left-sided colitis or extensive colitis. Therefore, immunosuppressants tend to be used less in patients with this condition. Evidence, however, is scarce because these patients are excluded from randomised controlled clinical trials. Our aim was to describe the characteristics of patients with refractory UP and their disease-related complications, and to identify the need for immunosuppressive therapies. METHODS: We identified patients with UP from the prospective ENEIDA registry sponsored by the GETECCU. We evaluated socio-demographic data and complications associated with immunosuppression. We defined immunosuppression as the use of immunomodulators, biologics and/or small molecules. We used logistic regression to identify factors associated with immunosuppressive therapy. RESULTS: From a total of 34,716 patients with ulcerative colitis, we identified 6281 (18.1%) with UP; mean ± SD age 53 ± 15 years, average disease duration of 12 ± 9 years. Immunosuppression was prescribed in 11% of patients, 4.2% needed one biologic agent and 1% needed two; 2% of patients required hospitalisation, and 0.5% underwent panproctocolectomy or subtotal colectomy. We identified 0.2% colorectal tumours and 5% extracolonic tumours. Patients with polyarthritis (OR 3.56, 95% CI 1.86-6.69; p < 0.001) required immunosuppressants. CONCLUSIONS: Among patients with refractory UP, 11% required immunosuppressant therapy, and 4.2% required at least one biologic agent.

Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU.

BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.

Cribado de cáncer de páncreas en la práctica clínica: es el momento de la prevención

El cribado de cáncer de páncreas en población de alto riesgo puede mejorar la supervivencia. Sin embargo, hay pocas referencias sobre su aplicabilidad y hallazgos en la práctica clínica habitual. Nuestro objetivo es evaluar los hallazgos de las pruebas de cribado de cáncer de páncreas en individuos de alto riesgo en la práctica clínica y describir las variables asociadas a la presencia de lesiones relevantes. Este es un estudio observacional prospectivo en el que se seleccionaron pacientes con alto riesgo de cáncer de páncreas, según los criterios del Consorcio Internacional de Cribado de Cáncer de Páncreas. Se analizaron variables demográficas, presencia de factores de riesgo de cáncer páncreas y los hallazgos de las pruebas. Posteriormente se compararon pacientes que presentan lesiones relevantes con aquellos sin hallazgos. De 70 pacientes de alto riesgo, 25 cumplieron los criterios de cribado. El síndrome hereditario más frecuente fue el cáncer de mama y ovario hereditario (60%). En once individuos (44%) se identificaron hallazgos y en tres (12%) fueron relevantes: dos tumores papilares mucinosos intraductales y un tumor sólido localizado. La mutación en BRCA2 fue la más frecuente en lesiones significativas (66,7% vs 30%, p=0,376) sin encontrar asociación con diabetes ni tabaquismo (0 vs 18 %, p=0,578 y 0 vs 4,5%, p=0,880 respectivamente). En conclusión, las pruebas de cribado permiten detectar lesiones en estadio precoz o resecables en un importante porcentaje de población de alto riesgo seleccionada. Los hallazgos más relevantes fueron en los pacientes pertenecientes al síndrome de cáncer de mama y ovario hereditario.

Pancreatic cancer surveillance can improve outcomes in high-risk individuals. However, little is known about its applicability and findings in routine clinical practice. Our aim was to evaluate findings on screening tests in high-risk individuals in a clinical practice setting and to analyze factors associated with the presence of relevant pancreatic lesions. We developed a prospective observational study of pancreatic cancer high risk patients that meet criteria of surveillance from the International Cancer of the Pancreas Screening Consortium. The demographic variables, other risk factors and imaging findings are collected. Patients with significant findings are compared to those without noteworthy findings. Of 70 high-risk individuals, 25 fitted the criteria for pancreatic cancer surveillance. The most frequent condition was hereditary breast and ovarian cancer syndrome (60%). We identified eleven abnormal imaging findings (44%) and three of them (12%) were relevant: two intraductal papillary mucinous neoplasms and one localized pancreatic neoplasm. BRCA2 mutation was more frequent in patients with significant lesions (66.7% vs 30%, p=0.376) but smoking and diabetes were not associated with relevant findings (0 vs 18 %, p=0.578 and 0 vs 4.5%, p=0.880 respectively). Screening test could detect early-stage or resectable lesions in a significant in a significant percentage of the selected high-risk population. The most relevant findings were in patients belonging to hereditary breast and ovarian cancer syndrome.