Long-Term Outcomes and Predictive Factors of Hospitalized Patients with Severe Ulcerative Colitis Treated with Intravenous Corticosteroids

Background and Aims: Treatment with intravenous corticosteroids (IVCS) is a mainstay in the management of acute severe ulcerative colitis (UC). Although most patients respond to IVCS, little is known about the long-term outcomes. In this study, we assessed the long-term outcomes of IVCS in a real-life cohort. Methods: Disease activity, clinical relapse (partial Mayo score >4), the need for steroids or other maintenance therapies and the rates of colectomy and re-hospitalization were evaluated in consecutive patients admitted to the Tor Vergata University hospital between 2010 and 2020 for acute severe UC who responded to IVCS. Results: Eighty-eight patients were followed up with for a median period of 46 (range 6–133) months. Of these, 56 (64%) patients were treated with 5-aminosalycilic acid and 32 (36%) with immunomodulators or biologics after discharge. A total of 60 out of 88 patients (68%) relapsed, 28 (32%) were re-hospitalized, and 15 (17%) underwent a colectomy with no difference between the two maintenance therapy groups. The multivariate analysis showed that patients in clinical remission 6 months after discharge had a lower risk of relapse during the follow-up. Conclusions: Nearly two-thirds of patients with acute UC responding to IVCS experienced relapse after a median follow-up of 4 years, and this was not influenced by the maintenance therapy.

Download Full-text

P476 Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.599 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S465-S466

Author(s):

M Chaparro ◽

A Garre ◽

M Iborra ◽

M Sierra ◽

M Barreiro-de Acosta ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Practice ◽

Elevated Serum ◽

Real Life ◽

Development Program ◽

Lower Probability ◽

Clinical Activity ◽

Mayo Score

Abstract 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.

Download Full-text

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld-3992 ◽

2021 ◽

Author(s):

Antonio Tursi ◽

Giammarco Mocci ◽

Walter Elisei ◽

Leonardo Allegretta ◽

Raffaele Colucci ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Clinical Remission ◽

Real Life ◽

Mucosal Healing ◽

Term Treatment ◽

Short Term Treatment ◽

Mayo Score

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

Download Full-text

Sustained Clinical Efficacy and Mucosal Healing of Thiopurine Maintenance Treatment in Ulcerative Colitis: A Real-Life Study

Gastroenterology Research and Practice ◽

10.1155/2018/4195968 ◽

2018 ◽

Vol 2018 ◽

pp. 1-7 ◽

Cited By ~ 4

Author(s):

Daniela Pugliese ◽

Annalisa Aratari ◽

Stefano Festa ◽

Pietro Manuel Ferraro ◽

Rita Monterubbianesi ◽

...

Keyword(s):

Ulcerative Colitis ◽

Maintenance Therapy ◽

Clinical Remission ◽

Real Life ◽

Mucosal Healing ◽

Cumulative Probability ◽

Term Outcome ◽

Long Term Outcome

Background and Aims. Thiopurines are commonly used for treating ulcerative colitis (UC), despite the fact that controlled evidence supporting their efficacy is limited. The aim of this study was to evaluate the long-term outcome of thiopurines as maintenance therapy in a large cohort of UC patients. Methods. All UC patients receiving thiopurine monotherapy at three tertiary IBD centers from 1995 to 2015 were identified. The primary endpoint was steroid-free clinical remission. Secondary endpoints were mucosal healing (MH), defined as Mayo endoscopic subscore 0, long-term safety, and predictors of sustained clinical remission. Results. We identified 192 patients, contributing a total of 747 person-years of follow-up (median follow-up 36 months, range 1–210 months). Steroid dependency was the most common indication for thiopurine treatment (58%). Steroid-free remission occurred in 45.3% of patients; 36.3% stopped thiopurines because of treatment failure and 18.2% for adverse events or intolerance. The cumulative probability of maintaining steroid-free remission while on thiopurine treatment was 87%, 76%, 67.6%, and 53.4% at 12, 24, 36, and 60 months, respectively. MH occurred in 57.9% of patients after a median of 18 months (range 5–96). No independent predictors of sustained clinical remission could be identified. Conclusions. Thiopurines represent an effective and safe long-term maintenance therapy for UC patients.

Download Full-text

Long-term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study

United European Gastroenterology Journal ◽

10.1177/2050640620977405 ◽

2020 ◽

pp. 205064062097740

Author(s):

Stefano Festa ◽

Maria L Scribano ◽

Daniela Pugliese ◽

Cristina Bezzio ◽

Mariabeatrice Principi ◽

...

Keyword(s):

Ulcerative Colitis ◽

Tumour Necrosis ◽

Rescue Therapy ◽

Tumour Necrosis Factor Alpha ◽

Necrosis Factor Alpha ◽

Severe Ulcerative Colitis ◽

Factor Alpha ◽

Necrosis Factor

Background The long-term course of ulcerative colitis after a severe attack is poorly understood. Second-line rescue therapy with cyclosporine or infliximab is effective for reducing short-term colectomy but the impact in the long-term is controversial. Objective The purpose of this study was to evaluate the long-term course of acute severe ulcerative colitis patients who avoid early colectomy either because of response to steroids or rescue therapy. Methods This was a multicentre retrospective cohort study of adult patients with acute severe ulcerative colitis admitted to Italian inflammatory bowel disease referral centres from 2005–2017. All patients received intravenous steroids, and those who did not respond received either rescue therapy or colectomy. For patients who avoided early colectomy (within three months from the index attack), we recorded the date of colectomy, last follow-up visit or death. The primary end-point was long-term colectomy rate in patients avoiding early colectomy. Results From the included 372 patients with acute severe ulcerative colitis, 337 (90.6%) avoided early colectomy. From those, 60.5% were responsive to steroids and 39.5% to the rescue therapy. Median follow-up was 44 months (interquartile range, 21–85). Colectomy-free survival probability was 93.5%, 81.5% and 79.4% at one, three and five years, respectively. Colectomy risk was higher among rescue therapy users than in steroid-responders (log-rank test, p = 0.02). At multivariate analysis response to steroids was independently associated with a lower risk of long-term colectomy (adjusted odds ratio = 0.5; 95% confidence interval, 0.2–0.8), while previous exposure to anti-tumour necrosis factor alpha agents was associated with an increased risk (adjusted odds ratio = 3.0; 95% confidence interval, 1.5–5.7). Approximately 50% of patients required additional therapy or new hospitalization within five years due to a recurrent flare. Death occurred in three patients (0.9%). Conclusions Patients with acute severe ulcerative colitis avoiding early colectomy are at risk of long-term colectomy, especially if previously exposed to anti-tumour necrosis factor alpha agents or if rescue therapy during the acute attack was required because of steroid refractoriness.

Download Full-text

P445 Efficacy and safety of induction therapy with calcineurin inhibitors followed by maintenance therapy with vedolizumab in severe ulcerative colitis: a large patient cohort with long-term follow-up

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.574 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S401-S401

Author(s):

J OLLECH ◽

S Dwadasi ◽

I Normatov ◽

A Israel ◽

V Rai ◽

...

Keyword(s):

Ulcerative Colitis ◽

Maintenance Therapy ◽

Median Time ◽

Induction Therapy ◽

Calcineurin Inhibitor ◽

Calcineurin Inhibitors ◽

Free Survival ◽

Severe Ulcerative Colitis ◽

Steroid Refractory

Abstract Background The options for the medical management of patients with severe ulcerative colitis failing IV steroids are limited and include the calcineurin inhibitors cyclosporin or tacrolimus, especially in patients who had previously failed anti-TNF agents. Following induction therapy with a calcineurin inhibitor, transitioning to vedolizumab as maintenance therapy could be an option. We report on the largest cohort of patients successfully induced with calcineurin inhibitors who were then transitioned to vedolizumab maintenance therapy. Methods We performed a retrospective observational study of adult ulcerative colitis patients followed at the University of Chicago Inflammatory Bowel Disease Center. Patients with severe steroid-refractory ulcerative colitis were included if they received a calcineurin inhibitor (ciclosporin or tacrolimus) as induction therapy followed by maintenance therapy with vedolizumab between January 2014 and December 2018. Patients who had a follow-up of fewer than three months were excluded. The primary endpoint was colectomy-free survival. Secondary endpoints included survival without vedolizumab discontinuation as well as clinical, steroid-free and biochemical remission at week 14. Results A total of 71 patients (59% male) were treated with vedolizumab after induction therapy with calcineurin inhibitors for severe steroid-refractory colitis. Truelove and Witts criteria for Acute Severe Ulcerative Colitis were fulfilled in 77% of patients, and 97% of patients had moderate to severe endoscopic disease. Patients were followed for a median time of 25 months (IQR 16–36). Colectomy free survival rates from vedolizumab initiation were 67% at one year and 55% at two years (Figure 1, Panel A). At the end of induction with vedolizumab at week 14, 50% of patients were in clinical remission, and 62% of patients had a normal CRP. At one and two years following vedolizumab initiation, 43% and 28% of patients were still on vedolizumab, respectively (Figure 1, Panel B). Vedolizumab was dose escalated to infusions every four weeks in 44% of patients. The median time to dose escalation was 5.6 months (IQR 4.1–8.2). No serious adverse events were recorded in our patient cohort. Conclusion Transitioning to vedolizumab following induction of remission with calcineurin inhibitors is effective and safe. Such a treatment strategy should be considered in patients with severe steroid-refractory ulcerative colitis, especially in cases of previous anti-TNF failure.

Download Full-text

OP26 The first real-life multicentre prospective validation study of the electronic chromoendoscopy score (Paddington International Virtual ChromoendoScopy ScOre) and its outcome in ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.025 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S023-S024 ◽

Cited By ~ 2

Author(s):

M Iacucci ◽

S C Smith ◽

A Bazarova ◽

U N Shivaji ◽

P Bhandari ◽

...

Keyword(s):

Ulcerative Colitis ◽

Validation Study ◽

Real Life ◽

Mucosal Healing ◽

Vascular Changes ◽

Important Goal ◽

Kaplan Meier ◽

Virtual Chromoendoscopy

Abstract Background Mucosal healing is an important goal in the treatment of ulcerative colitis (UC). The newly published PICaSSO score characterises subtle mucosal and vascular changes and defines mucosal healing. We aimed to validate in real-life the PICaSSO score and assess its ability to predict relapse. Methods Patients with UC were prospectively recruited from 11 international centres. Participating endoscopists experienced in IBD received training on PICaSSO before starting the study. The rectum and sigmoid were examined using iScan 1,2 and 3 (Pentax, Japan) and inflammatory activity was assessed using UCEIS and PICaSSO. Biopsies were taken for the histological assessment using Robarts Histological Index (RHI) and Nancy. Follow-up was obtained at 12 months. Results A total of 278 patients were recruited (Table 1). The diagnostic performance in predicting histologic healing is shown in Table 2. When using PICaSSO score of ≤3 for mucosal and vascular architecture the AUROC to predict healing by RHI is 0.79 (95% CI 0.74–0.85) and 0.73 (95% CI 0.68–0.80) respectively and when using the Nancy score the AUROC is 0.78 (95% CI 0.72–0.84) and 0.77 (0.71–0.84). A total PICaSSO score of ≤8 and UCEIS score of ≤1 predicts remission at 12 months with an AUROC of 0.73 (0.65–0.80) and 0.71 (0.64–0.79). A Kaplan–Meier curve shows a favourable survival probability without relapse with a PICASSO score of ≤8 (Figure 1). Conclusion This real-life validation study shows the PICaSSO score can predict accurately histological healing and long-term remission and can be a useful tool in the management of UC.

Download Full-text

Mo1849 – Long-Term Outcomes of Steroid-Responsive and Non-Responsive Patients with Acute Severe Ulcerative Colitis

Gastroenterology ◽

10.1016/s0016-5085(19)39116-4 ◽

2019 ◽

Vol 156 (6) ◽

pp. S-860

Author(s):

Sónia Bernardo ◽

Samuel R. Fernandes ◽

João Estorninho ◽

João Cortez-Pinto ◽

Irina Mocanu ◽

...

Keyword(s):

Ulcerative Colitis ◽

Long Term Outcomes ◽

Severe Ulcerative Colitis

Download Full-text

P156 Long-term outcomes of steroid-responsive and non-responsive patients with acute severe ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjy222.280 ◽

2019 ◽

Vol 13 (Supplement_1) ◽

pp. S167-S167

Author(s):

S Bernardo ◽

S Fernandes ◽

J Estorninho ◽

J Cortez Pinto ◽

I Mocanu ◽

...

Keyword(s):

Ulcerative Colitis ◽

Long Term Outcomes ◽

Severe Ulcerative Colitis

Download Full-text

P663 Efficacy of tofacitinib in patients with ulcerative colitis after previous ineffective biological therapies

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.791 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S545-S546

Author(s):

M Rutka ◽

K Farkas ◽

D Pigniczki ◽

K Szántó ◽

B Anita ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Induction Therapy ◽

Dose Escalation ◽

Real Life ◽

Janus Kinase ◽

Inadequate Response ◽

Mayo Score ◽

Number Of Patients

Abstract Background Tofacitinib (TFC) is an oral, small-molecule Janus kinase inhibitor, which was recently approved for moderate to severe ulcerative colitis (UC). The aim of the current real-life study was to determine efficacy of TFC induction therapy regarding the clinical response and remission in patients with active UC. We evaluated short-term efficacy data in a Hungarian cohort with prior exposure to other biological agents such as anti-TNF drugs and vedolizumab. Methods In this single-centre retrospective study, patients with TFC introduction were included. Since January 2019, a total of 16 patients received an oral TFC induction therapy in a dose of 10 mg twice daily for 8 weeks. Endoscopic activity was evaluated by endoscopic Mayo (eMayo) score before the introduction of TFC and in case of an inadequate therapeutic response to the 5-mg-therapy to confirm therapeutic decision-making. Based on the evaluation of clinical symptoms and laboratory parameters, we either kept the dosage or reduced the dose to 5 mg according to local regulations. We also collected data from the 16. and 24. weeks of the therapy. Primary endpoints were a clinical response (as a reduction in partial Mayo Score [pMayo] by minimum 3 points) or remission (as a Mayo score of the maximum of 2 points and without blood in stool) at week 8. Results Sixteen patients had received the induction therapy (mean age: 36 years, 7 males and 9 females) in our centre. After 8 weeks, 12 (75%) patients responded to the TFC induction therapy and 6 (37.5%) of them were in remission. Four patients were primary non-responders (25%). Corticosteroid therapy (18 ± 7 mg) was required during the induction in 4 responder cases, which could be stepped down by week 8. As a continuous maintenance therapy, 4 patients have already reached the 16th week and 8 have completed the 24th week. By the end of the follow-up, 12 patients responded and 10 was in remission. During the observation period, 3 patients had to remain on 10 mg TFC dose, 6 patients required dose escalation from 5 mg to 10 mg and 5 mg was sufficient in case of only 3 patients after the introduction. Endoscopic activity showed a moderate decrease from 2.5 ± 0.5 eMayo score to 2 ± 1 (n = 7) until week 16. In respect the responder patients, CRP levels decreased from the mean of 7.23 to 5.02. No serious side-effects were observed during the follow-up. Conclusion After the 8-week TFC induction therapy, the response rate was high and only every fourth patients were non-responder. A low number of patients had adequate reactions to the 5 mg-therapy after the introduction, but TFC is effective with dose-escalation in respect of clinical response and remission in patients with UC, who have had an inadequate response to previous biological therapy.

Download Full-text