Background The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life. Methods Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at week 16. Results A total of 95 patients were included. At week 16, 53% of patients had response (including 35% of patients in remission). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at weeks 24 and 52, respectively. Thirty-six percent of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusions Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.
Background and objectives: plastic biliary stents are often used after an ERCP session without complete common bile duct stones (CBDS) extraction. Sometimes, the volume of biliary drainage with these stents may be insufficient. We present our experience with the use of fully covered self-expanding metal stents (FCSEMS) in the setting of incomplete CBDS extraction.Patients and methods: after an ERCP session with difficult CBDS not completely removed, biliary FCSEMS (Wallflex) were inserted in some patients when it was deemed that biliary sphincterotomy and a single plastic stent would not provide an adequate drainage.Results: a retrospective study was performed. Biliary FCSEMS were inserted in 29 patients, mean age 81 years. CBDS could not be extracted through a biliary sphincterotomy due to its large size (n = 18) or because of the presence of inflammatory distal strictures (n = 11). The greatest biliary drainage with shortest ERCP time was considered mandatory due to clinical instability of patients and/or poor tolerance to conscious sedation administered by the endoscopist. Successful biliary drainage was obtained in all cases. FCSEMS were removed after a median of 199.5 days in 16 patients with a complete CBDS extraction in 15 (93.7%). FCSEMS were not removed in the remaining 13 patients due to their clinical condition, and a wait-and-see strategy was undertaken.Conclusions: in selected cases, utilization of removable FCSEMS can be a good option for a quick and adequate biliary drainage in the setting of difficult CBDS. Because of the higher cost of these stents its use needs to be individualized.Key words: ERCP. Difficult common bile duct stones. Biliary plastic stents. Fully covered self-expanding metal stents. INTRODUCTIONFor nearly 40 years endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy has been the treatment of choice to remove common bile duct stones (CBDS). Since 2003, biliary sphincterotomy balloon dilation or sphincteroplasty is used for difficult cases with very good results (1). Complicated CBDS are usually those with more than 10 mm in diameter, multliple, impacted stones in the bile duct, concretions of hard consistency, peridiverticular situation of the ampulla, tortuosity or narrowing of the distal common bile duct and other conditions arising from the patient, like coagulation disorders (2).Plastic stents are the most used palliative method when after an ERCP session all CBDS cannot be removed. Friction between stones and stents produce the CBDS to fragment and shrink or become mud in a period of time from 3 to 6 months. Afterwards, the vast majority of CBDS can be removed fairly easily after a second ERCP session. For the remaining stones it is necessary to use certain forms of lithotripsy, such as mechanic lithotripsy. However, some CBDS may even continue without being extracted (3).Sometimes, ursodeoxycholic acid is added to plastic stents. As other solutions, such as terpene choleretic, they have the property to make more soluble cholesterol, ca...
We aim to describe the incidence and source of contagion of COVID-19 in patients with IBD, as well as the risk factors for a severe course and long-term sequelae. This is a prospective observational study of IBD and COVID-19 included in the ENEIDA registry (53,682 from 73 centres) between March–July 2020 followed-up for 12 months. Results were compared with data of the general population (National Centre of Epidemiology and Catalonia). A total of 482 patients with COVID-19 were identified. Twenty-eight percent were infected in the work environment, and 48% were infected by intrafamilial transmission, despite having good adherence to lockdown. Thirty-five percent required hospitalization, 7.9% had severe COVID-19 and 3.7% died. Similar data were reported in the general population (hospitalisation 19.5%, ICU 2.1% and mortality 4.6%). Factors related to death and severe COVID-19 were being aged ≥ 60 years (OR 7.1, 95% CI: 1.8–27 and 4.5, 95% CI: 1.3–15.9), while having ≥2 comorbidities increased mortality (OR 3.9, 95% CI: 1.3–11.6). None of the drugs for IBD were related to severe COVID-19. Immunosuppression was definitively stopped in 1% of patients at 12 months. The prognosis of COVID-19 in IBD, even in immunosuppressed patients, is similar to that in the general population. Thus, there is no need for more strict protection measures in IBD.
Background The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims Primary: to evaluate the durability of ustekinumab treatment in UC patients in clinical practice. Secondary: to assess the short-term response (at week 16) and the long-term effectiveness (at maximum follow-up) and to assess the safety of ustekinumab in clinical practice. Methods Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Results 95 patients were included (table 1). At week 16, 53% of patients had clinical response (including 35% of patients in remission) (figure 1). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with clinical remission. Long-term remission is represented in figure 2. 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72 (figure 3); primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusion Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.
(1) Scant information is available concerning the characteristics that may favour the acquisition of COVID-19 in patients with inflammatory bowel disease (IBD). Therefore, the aim of this study was to assess these differences between infected and noninfected patients with IBD. (2) This nationwide case–control study evaluated patients with inflammatory bowel disease with COVID-19 (cases) and without COVID-19 (controls) during the period March–July 2020 included in the ENEIDA of GETECCU. (3) A total of 496 cases and 964 controls from 73 Spanish centres were included. No differences were found in the basal characteristics between cases and controls. Cases had higher comorbidity Charlson scores (24% vs. 19%; p = 0.02) and occupational risk (28% vs. 10.5%; p < 0.0001) more frequently than did controls. Lockdown was the only protective measure against COVID-19 (50% vs. 70%; p < 0.0001). No differences were found in the use of systemic steroids, immunosuppressants or biologics between cases and controls. Cases were more often treated with 5-aminosalicylates (42% vs. 34%; p = 0.003). Having a moderate Charlson score (OR: 2.7; 95%CI: 1.3–5.9), occupational risk (OR: 2.9; 95%CI: 1.8–4.4) and the use of 5-aminosalicylates (OR: 1.7; 95%CI: 1.2–2.5) were factors for COVID-19. The strict lockdown was the only protective factor (OR: 0.1; 95%CI: 0.09–0.2). (4) Comorbidities and occupational exposure are the most relevant factors for COVID-19 in patients with IBD. The risk of COVID-19 seems not to be increased by immunosuppressants or biologics, with a potential effect of 5-aminosalicylates, which should be investigated further and interpreted with caution.
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