P517 One year effectiveness and safety of ustekinumab in Ulcerative Colitis: a multicentre real-world study from Italy

Abstract Background Efficacy and safety of ustekinumab for the treatment of Ulcerative colitis (UC) has been demonstrated in phase III clinical trials, but real world data are scarce. The aim of this study was to assess effectiveness and safety of ustekinumab in an Italian cohort of UC patients. Methods Data of patients with UC who started using ustekinumab were collected. Primary endpoint was steroid-free clinical remission at 24 and 52 weeks of therapy. Secondary endpoints were: treatment response, endoscopic remission, treatment persistence at 12 months and safety. Results A total of 68 patients (males 63.2 %; mean age (SD) 31 years (14.5)) were included. All patients were biologics experienced. At 24 and 52 weeks, 32 % and 50 % of patients achieved steroid-free clinical remission, 85% and 81% had clinical response, respectively. (Table 1) At the end of follow-up there were a significant reduction of pMS from baseline (p<0.001) and of steroid use (p<0.001) (Figure 1). Of the available endoscopies at 12 months (18/38), 22.2% showed mucosal healing. The probability to persist in therapy with ustekinumab after 12 months of treatment was of 89.7 %. Only one adverse event occurred (diagnosis of an hypophysis adenoma). No patients required colectomy. Conclusion Data from our small real-life cohort of treatment-refractory UC patients suggest satisfactory effectiveness of ustekinumab and an excellent safety. More data assessing mucosal healing after one year of treatment are needed

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P504 Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with real-world ulcerative colitis: A GETAID multicentre cohort study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.626 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S486-S487

Author(s):

M Fumery ◽

J Filippi ◽

V Abitbol ◽

A Biron ◽

D Laharie ◽

...

Keyword(s):

Ulcerative Colitis ◽

Cohort Study ◽

Adverse Events ◽

Real World ◽

Clinical Remission ◽

Real Life ◽

Phase Iii ◽

Phase Iii Trials ◽

One Year

Abstract Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life long-term data is currently available. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined by a partial Mayo Clinic score ≤ 2. The aim of the present study was to assess long-term effectiveness and safety of ustekinumab in UC. Results 103 UC patients (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) were included in 21 centres. History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. At week 54, 44 (43%) patients discontinued ustekinumab, for lack of efficacy (n=41), pregnancy (n=1), persistence of eczematiform lesions (n=1) or personal decision (n=1). Cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7%, and 58.4% after 3, 6, 9, and 12 months, respectively. In multivariate analysis, a CRP>5 mg/L at week 0 (OR=2.91, CI95%[1.15–7.36]; p=0.02) and concomitant steroids at week 0 (OR=3.05, CI95%[1.30–7.14]; p=0.01) were significantly associated with ustekinumab discontinuation within one year. The overall rate of steroid-free clinical remission at week 52 was 32% of whom 71% had null rectal bleeding and stool frequency subscores. Ten patients (9.7%) underwent colectomy within a median of 6.7 [4.3–10.6] months. Adverse events were observed in 15 (16.9%) patients, of whom 4 (4.5%) had severe adverse events including three patients with exacerbation of UC leading to hospitalization, and a 62 years-old men who died from a myocardial infarction four months after ustekinumab initiation. Conclusion In this real-world cohort study that included patients with refractory ulcerative colitis to multiple therapies, more than one-half of patients were still treated by ustekinumab and one-third were in steroid-free clinical remission, after 52 weeks.

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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.

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DOP55 A real-world comparison of the effectiveness and safety of vedolizumab and anti-TNF therapies in early treatment initiation with first-line biologic therapy in ulcerative colitis: Results from EVOLVE

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.094 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S092-S094

Author(s):

G Mantzaris ◽

B Bressler ◽

U Kopylov ◽

M Bassel ◽

N Brett ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Real World ◽

Early Treatment ◽

Clinical Remission ◽

Treatment Initiation ◽

Clinical Effectiveness ◽

Mucosal Healing ◽

First Line

Abstract Background Evidence suggests that early treatment (Tx) with biologic agents in Crohn’s disease improves long-term clinical outcomes. However, there is less evidence in ulcerative colitis (UC), and data comparing early Tx with first-line biologic vedolizumab (VDZ) to anti-tumour necrosis factor (anti-TNF) in real-world settings is needed. This study compared the clinical effectiveness and safety of UC patients who initiated VDZ or an anti-TNF as a first-line biologic within 2 years following diagnosis. Methods This was a real-world, multi-country, retrospective chart review study in Canada, Greece and the United States where biologic-naïve UC patients (≥18 years old) were treated with VDZ or an anti-TNF (adalimumab, infliximab, golimumab) agent within 2 years following diagnosis (initiated Tx May 2014–March 2018). Clinical effectiveness and safety data were collected from Tx initiation to earliest of chart abstraction date, death, or 6 months post-Tx discontinuation (Canada only). Tx persistence was defined as the duration of time from treatment initiation to discontinuation. Analyses of cumulative rates of Tx persistence, clinical response, clinical remission and mucosal healing over 24 months were estimated using Kaplan–Meier analyses. Clinical response, remission and mucosal healing were assessed using pre-defined hierarchical algorithms of standard disease measures reported in the medical records. Analyses of incidence rates (per 100 person-years [PYs]) of disease exacerbations, disease-related surgeries, serious adverse events (SAEs) and serious infections (SIs) were performed. Adjusted analyses used inverse probability weighting to balance cohorts. Results This analysis included 176 UC patients (VDZ: 86; anti-TNF: 90) from 37 sites. Mean (SD) age at index date: VDZ, 41.4 (18.9); anti-TNF, 36.8 (15.6) years (p = 0.20) and the proportion male: VDZ, 58.1%; anti-TNF, 56.7% (p = 0.84). At 12 months, 72.9% and 58.1% continued VDZ and anti-TNF respectively (p = 0.03) (Figure 1A). Though there were no differences in clinical response, clinical remission or mucosal healing between VDZ and anti-TNF groups; VDZ patients were significantly less likely to experience disease exacerbations (HR = 0.47 [95% CI: 0.32–0.69]) and SAEs (HR = 0.37 [95% CI: 0.19–0.72]) (Figure 2). Adjusted outcomes (Figures 1C and D, and 2B) were similar to unadjusted outcomes. Conclusion EVOLVE is one of the first studies that compared early VDZ Tx to early anti-TNF Tx in biologic-naïve UC patients. Results showed VDZ was associated with higher persistence, lower likelihood of experiencing disease exacerbations and a more favourable safety profile. Thus, in early UC, Tx with VDZ may improve long-term clinical outcomes. Sample size limitations warrant further study.

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Tofacitinib in the treatment of ulcerative colitis: efficacy and safety from clinical trials to real-world experience

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284819848631 ◽

2019 ◽

Vol 12 ◽

pp. 175628481984863 ◽

Cited By ~ 11

Author(s):

Ferdinando D’Amico ◽

Tommaso Lorenzo Parigi ◽

Gionata Fiorino ◽

Laurent Peyrin-Biroulet ◽

Silvio Danese

Keyword(s):

Ulcerative Colitis ◽

Clinical Trials ◽

Real Life ◽

Oral Formulation ◽

Phase Iii ◽

Efficacy And Safety ◽

Treatment Algorithms ◽

Phase Iii Clinical Trials ◽

Real Life Data ◽

Three Phase

Tofacitinib is an oral small molecule directed against the JAK/STAT pathway, blocking the inflammatory cascade. Oral formulation of tofacitinib has recently been approved for the treatment of patients with moderate–severe ulcerative colitis. Its efficacy and safety have been demonstrated in three phase III clinical trials and confirmed by promising real-life data. The purpose of this review is to summarize the available evidence on the efficacy and safety of tofacitinib and to define its role and position in the treatment algorithms for patients with ulcerative colitis.

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Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211023386 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110233

Author(s):

Carl Eriksson ◽

Sara Rundquist ◽

Vyron Lykiardopoulos ◽

Ruzan Udumyan ◽

Per Karlén ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Real World ◽

Bowel Disease ◽

Clinical Remission ◽

Real World Data ◽

Inflammatory Bowel

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

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Efficacy and safety of tofacitinib in moderate and severe ulcerative colitis in real clinical practice: three years of observation

Medical Council ◽

10.21518/2079-701x-2021-15-20-29 ◽

2021 ◽

pp. 20-29

Author(s):

O. V. Knyazev ◽

A. V. Kagramanova ◽

A. A. Lishchinskaya ◽

I. A. Li ◽

D. V. Podolskaya ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Practice ◽

Clinical Response ◽

Clinical Remission ◽

Cumulative Effect ◽

Early Response ◽

Mucosal Healing ◽

Efficacy And Safety ◽

One Year ◽

Real Clinical Practice

Introduction. Tofacitinib is the first member of a new class of targeted synthetic anti-inflammatory drugs for the treatment of ulcerative colitis (UC). The article presents a three-year Russian experience of tofacitinib use for the treatment of moderate and severe UC.Aim of the study. To evaluate the efficacy and safety of tofacitinib therapy in real clinical practice in moderate to severe UC patients during three years of follow-up. Methods. The study included 56 patients with UC who had moderate (60.7%) and severe (35.8%) states of disease, the total lesion was diagnosed in 67.8%, and extraintestinal manifestations in 57.1% of patients. Early achievement of clinical response, clinical and endoscopic, corticosteroid-free remission, and safety were evaluated.Results. Early response to tofacitinib therapy was obtained in 47 (83.9%) patients. Clinical remission was achieved in 36 (64.3%) at week 8 of therapy and clinical response was achieved in 13 (23.2%) patients. The majority of patients who achieved clinical remission at weeks 8 and 12 achieved healing of colon mucosa at week 24. Clinical and endoscopic remission rates after 24 weeks – 44 (78.6%) patients, clinical response in 7 (12.5%) patients, 5 (8.9%) did not respond to TFCB therapy. Corticosteroidfree remission was 77.6%. After 2 years of tofacitinib therapy, remission of UC was maintained in 46 (82.1%). After 36 months, remission of UC was maintained in 45 (80.3%) of the 56 patients who had been started on tofacitinib therapy. The cumulative effect of survival in the treatment of tofacitinib in UC was 87.5% after 6 months and persisted for one year, 82.1% after 2 years, and 80.3% after 3 years.Conclusions. The administration of tofacitinib in UC is effective in achieving rapid clinical response, clinical remission, and mucosal healing in patients who do not respond well to biological therapy.

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Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz042 ◽

2019 ◽

Vol 13 (9) ◽

pp. 1111-1120 ◽

Cited By ~ 9

Author(s):

N Plevris ◽

C S Chuah ◽

R M Allen ◽

I D Arnott ◽

P N Brennan ◽

...

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real World ◽

Bowel Disease ◽

Clinical Remission ◽

Mucosal Healing ◽

Inflammatory Bowel

Abstract Background & Aims Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. Methods This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (Harvey–Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. Results Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26–52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. Conclusions Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.

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P465 One year endoscopic and histologic outcomes to tofacitinib therapy in refractory ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.588 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S456-S457

Author(s):

B Verstockt ◽

K Aden ◽

D Alsoud ◽

A Outtier ◽

J Sabino ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Remission ◽

Kinase Inhibitor ◽

Opportunistic Infections ◽

Real Life ◽

Mucosal Healing ◽

Janus Kinase ◽

Serious Adverse Events ◽

Standard Dosage ◽

Endoscopic Remission

Abstract Background Long-term real-life data on the efficacy of the Janus kinase inhibitor tofacitinib in moderate-to-severe ulcerative colitis (UC) are limited. We here report efficacy of tofacitinib in refractory UC patients with an emphasis on endoscopic and histologic outcome. Methods Fifty-four consecutive UC patients (Mayo endoscopic sub-score ≥2) initiating tofacitinib in 2 tertiary IBD referral centres were prospectively included (Table 1). Almost all were refractory to both anti-TNF (96.4%) and vedolizumab (92.7%) and received tofacitinib in standard dosage. Steroid-free clinical remission was defined as partial Mayo score of ≤2 with no single sub-score >1 and without any steroid exposure at assessment. Biological remission was defined as faecal calprotectin <250mcg/g, endoscopic remission as Mayo endoscopic sub-score of 0, endoscopic improvement as Mayo endoscopic sub-score of ≤1, and histologic remission as Nancy histology index of 0. A combination of endoscopic and histologic remission was referred as mucosal healing. All outcomes were assessed at year 1. Non-responder imputation and last observation carried forward analysis were applied. Results Patients were followed for a median [IQR] of 91.7 [67.2–102.4] weeks, with an exposure to tofacitinib of 23.9 [14.6–51.6] weeks. By year one, 31.5% of patients were in steroid-free clinical remission (Figure 1). Biological remission was observed in 26.9% of patients. Endoscopic improvement, endoscopic remission, histologic remission and mucosal healing, were observed in 31.5%, 24.1%, 22.0% and 18.0% of patients, respectively. Multivariate analysis identified baseline Mayo endoscopic sub score (OR 0.03, p=0.03); endoscopic improvement by week 16 (OR 36.5, p=0.008) and disease extent (OR 0.11, p=0.05) as independent predictors for endoscopic remission at year 1. Patients with left-sided colitis or proctitis experienced higher endoscopic remission rates (33.3% and 25.0%) then patients with extensive colitis (10.5%, p=0.09; p=0.6). Ultimately, 61.1% of all patients discontinued tofacitinib therapy after a median of 15.9 [9.2–24.5] weeks, due to primary non-response (n=25), loss-of-response (n=6) or (serious) adverse events (n=2). Thirteen patients (24.1%) required colectomy. During follow-up, no venous thrombo-embolisms or cancers were observed. One patient had to be admitted at ICU due to several life-threatening opportunistic infections. Conclusion In this highly refractory cohort of UC patients, tofacitinib induced and maintained endoscopic and histologic remission in up to one quarter of patients. UC patients with moderate left-sided colitis and proctitis had a numeric higher likelihood for a sustained effect than patients with extensive colitis.

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VP116 Comparison Between Time To Off Treatment And Italian Medicines Agency Registries Treatment Duration

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317003737 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 203-204

Author(s):

Gabriele Vittoria ◽

Antonio Fascì ◽

Matteo Ferrario ◽

Giovanni Giuliani

Keyword(s):

Clinical Trials ◽

Real World ◽

Treatment Duration ◽

National Level ◽

Real Life ◽

Evidence Base ◽

Phase Iii ◽

Real World Data ◽

The Mean ◽

High Level

INTRODUCTION:The Italian Medicines Agency Registry represents a tool that could be a precious source of information regarding the mean treatment duration of a drug in a real world context. Monitoring registries are applied at the national level after market authorization and are designed not only to apply the Managed Entry Agreements (MEAs) but also to collect Real World Data on drugs safety, effectiveness and real life utilization. The purpose of this analysis was to compare the treatment duration from clinical trials and the mean treatment duration calculated using data from monitoring registries (1).METHODS:For each drug included in the analysis it was collected the treatment duration from Time To Off Treatment curves for the experimental drug (eTTOT) from Phase III clinical trials and the mean treatment duration data calculated by using the number of cycles (converted in months of treatment) of all treated patients extracted from AIFA registries (TTAR). The mean ratios between the Time of Treatment of Italian Medicines Agency and Experimental arm time to off treatment were calculated to identify potential correlations. High level of correlation was expected if Time to Payment By Result /Time To Off Treatment ratio was close to 1 (±.2).RESULTS:Six Roche products or different indications of the same product were identified as candidates for the analysis from 2013 to 2016. The mean TTAR/eTTOT ratio observed in patients treated from 2013 to 2016 was .97 (±.10), meaning that the mean treatment duration calculated from AIFA Registries is strongly comparable with the treatment duration observed in clinical trials. In one case the TTAR is even more major than eTTOT.CONCLUSIONS:A high level of correlation between TTAR and eTTOT was found. Additional analyses considering different cohorts of patients over time could be useful to have a more precise estimate of real world drug utilization. Even though RCTs remain the gold standard for demonstrating clinical efficacy in restricted trial setting, Real World Evidence from AIFA registries can contribute to the evidence base needed for healthcare decisions.

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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.

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