scholarly journals Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

2020 ◽  
pp. 205064062097430
Author(s):  
Daniela Pugliese ◽  
Giuseppe Privitera ◽  
Francesca Rogai ◽  
Angela Variola ◽  
Anna Viola ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Cumulative Probability ◽  
Long Term Outcomes ◽  
Necrosis Factor Alpha ◽  
Steroid Dependent ◽  
Factor Alpha ◽  
Few Data

Background Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response. Objective This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy. Results A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range 4–142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio (OR) = 3.02, 95% confidence interval (CI) 1.44–6.29, p = 0.003) and being able to discontinue steroids at week 8 (OR = 3.32, 95% CI 1.34–8.30, p = 0.010) and week 14 (OR = 2.94, 95% CI 1.08–8.02, p = 0.036) were associated with longer persistence on therapy. At week 54, 65/124 (52.4%) post-induction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy ( p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients. Conclusions Biological-naïve status and not requiring steroids at weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.

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

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.

scholarly journals Management of the Complete Clinical Response

2017 ◽  
Vol 30 (05) ◽  
pp. 387-394 ◽  
Author(s):  
Guilherme São Julião ◽  
Bruna Vailati ◽  
Ivana Castro ◽  
Debora Raffaele ◽  
Angelita Habr-Gama
Keyword(s):  
Rectal Cancer ◽  
Clinical Response ◽  
Radical Surgery ◽  
Local Relapse ◽  
Neoadjuvant Chemoradiation ◽  
Complete Clinical Response ◽  
Watch And Wait ◽  
Long Term Outcomes

AbstractOrgan preservation is considered in the management of selected patients with rectal cancer. Complete clinical response observed after neoadjuvant chemoradiation for rectal cancer is one of these cases. Patients who present complete clinical response are candidates to the watch-and-wait approach, when radical surgery is not immediately performed and is offered only to patients in the event of a local relapse. These patients are included in a strict follow-up, and up of 70% of them will never be operated during the follow-up. This strategy is associated with similar oncological outcomes as patients operated on, and the advantage of avoiding the morbidity associated to the radical operation. In this article we will discuss in detail the best candidates for this approach, the protocol itself, and the long-term outcomes.

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

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.

Long-Term Follow-Up of Leukocyte Adsorptive Apheresis (LAA) Treatment in Patients (PTS) with Moderately Active Steroid-Dependent Ulcerative Colitis (UC)

2005 ◽  
Vol 61 (5) ◽  
pp. AB259
Author(s):  
Robert Loefberg ◽  
Axel Dignass ◽  
Norbert Hittel ◽  
Alberto Malesci ◽  
Joachim Moessner ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Steroid Dependent ◽  
Adsorptive Apheresis ◽  
Long Term Follow Up

scholarly journals Dyshidrotic eczema in two patients on secukinumab for plaque psoriasis: A case report

2020 ◽  
Vol 8 ◽  
pp. 2050313X2090456 ◽  
Author(s):  
Reetesh Bose ◽  
Jennifer Beecker
Keyword(s):  
Rare Variants ◽  
Necrosis Factor Alpha ◽  
Post Market Surveillance ◽  
Interleukin 17A ◽  
Potential Association ◽  
Post Market ◽  
Factor Alpha ◽  
Necrosis Factor

Secukinumab was the first fully human anti-interleukin-17a monoclonal antibody and successfully treated moderate-severe psoriasis. These new, targeted, medications are becoming more ubiquitous, but long-term side effects are not fully known. Post-market surveillance is crucial to identify delayed adverse events, analogous to the paradoxical development of pustular psoriasis in a subset of patients treated with the anti-tumor necrosis factor-alpha class drugs. Dyshidrotic eczema and pompholyx are rare variants of dermatitis characterized by vesicles or bullae on the palms, soles and sides of the fingers. The etiology of dyshidrotic eczema is not always known, but medications have been implicated in a minority of patients. Herein, we present two cases of dyshidrotic eczema developing in patients on secukinumab for psoriasis. Extended follow-up and larger numbers of patients are needed to fully understand the potential association between secukinumab and dyshidrotic eczema.

scholarly journals OP21 Predictive value of Milan Ultrasound Criteria in Ulcerative Colitis: A prospective observational cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S020-S021
Author(s):  
M Allocca ◽  
C Dell’Avalle ◽  
F Furfaro ◽  
V Craviotto ◽  
A Zilli ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cumulative Probability ◽  
Non Invasive ◽  
Kaplan Meier ◽  
Endoscopic Remission ◽  
Long Term Follow Up ◽  
Treatment Escalation ◽  
Line P

Abstract Background Endoscopic remission is associated with better outcomes in ulcerative colitis (UC). However, colonoscopy (CS) is invasive and poorly tolerated by patients. Recently, we developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC. We also confirmed that a MUC score &gt; 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore &gt; 2. Aim of this study was to assess the predictive role of MUC on disease course in a prospective cohort of UC patients. Methods UC consecutive patients were followed for at least 12 months after performing baseline bowel US. UC-related outcomes, including need of treatment escalation (defined as the need of corticosteroids or change/optimization of immunosuppressants), hospitalization and surgery, were assessed at 1 year by logistic regression analysis, and were analyzed after long term follow-up (5 years) using Kaplan-Meier survival analysis. Fig. 1A and 1B. Kaplan–Meier curves for the cumulative probability of hospitalization and surgery in patients with Milan ultrasound criteria (MUC) &lt; 6.2 (solid line) or MUC &gt; 6.2 (dotted line). (p= 0.046; p= 0.023; respectively). Fig. 1C and 1D. Kaplan–Meier curves for the cumulative probability of hospitalization and surgery in patients with Mayo endoscopic subscore 0–1 (solid line) or 2–3 (dotted line). (p= 0.035; p= 0.071; respectively). Results 87 UC consecutive patients were included in the study, 31 (36%) were in endoscopic remission (Mayo endoscopic subscore 0–1) and 56 (64%) in endoscopic activity (Mayo endoscopic subscore 2–3). MUC and Mayo endoscopic subscore significantly correlated at baseline (Spearman’s rank correlations [rho]= 0.642; 95% confidence interval (CI) 0.499 to 0.751; p &lt; 0.001). The multivariable analysis identified as independent predictors of need of treatment escalation throughout the 12-month period as being: MUC &gt; 6.2 (OR: 5.95, 95% CI: 1.32–26.76, p &lt; 0.020) and a partial Mayo score (PMS) &gt; 2 (OR: 26.88, 95% CI: 5.01–144.07, p &lt; 0.001). Kaplan-Meier survival analysis of long-term follow up demonstrated a lower cumulative probability of need for surgery and hospitalization in patients with MUC &lt; 6.2 compared to MUC &gt; 6.2 (Fig. 1A and 1B), as well as in patients with a Mayo endoscopic subscore of &lt; 1 compared to Mayo endoscopic subscore of 2–3 (Fig. 1C and 1D). Conclusion MUC is a novel non invasive tool that predicts the course of UC in the short and long term follow-up.

scholarly journals P372 Effectiveness and safety of immunosuppressants for pouch disorders: results from the RESERVO Study of GETECCU

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S388-S390
Author(s):  
F Mesonero Gismero ◽  
Y Zabana ◽  
A Fernández-Clotet ◽  
E Leo ◽  
B Caballol ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Multicentric Study ◽  
Previous Diagnosis

Abstract Background Pouchitis and other inflammatory disorders of the pouch (IDP), such as Crohn′s-like disease of the pouch (CDP), are frequent in patients operated for a previous diagnosis of ulcerative colitis. Many different therapies have been used, but the effectiveness of immunosupresants (IMM) has been poorly explored in this setting. Our aim was to evaluate the use, efficacy and safety of IMM in patients with pouchitis or another IDP. Methods Retrospective and multicentric study of a Spanish cohort of pouch-carrying patients with previous diagnosis of ulcerative colitis, and subsequent diagnosis of IDP, following ECCO diagnostic criteria. Patients who used IMM to treat these conditions were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission, and non-response as no improvement or worsening symptoms. Endoscopic response was evaluated when possible using modified pouchitis disease activity index (PDAI) endoscopic subscore. Adverse events were collected. We used descriptive statistics. Results In the overall cohort of 338 patients with IDP, 93 (27%) were treated with IMM. Of those, 57% males, median age 40 (20-71) ys, and 72% non-smokers. Colectomy was performed at a median age of 31 (18-63) ys and IPD was diagnosed 25 (1-235) months after ileostomy closure. IMM used were thiopurines (n=86), methotrexate (n=4), cyclosporine (n=2) and tacrolimus (n=1). IMM were used as monotherapy in 66 (71%) cases and were indicated as treatment of pouchitis (n=60, 65%), CDP (n=32, 34.4%) and cuffitis (n=1, 1%). Effectiveness was evaluated only for thiopurine monotherapy (n=62). After a median follow-up of 23 (1-234) months, clinical remission was achieved in 31%, clinical response in 31% and non-response in 38% (Figure 1). There were no differences in effectiveness between pouchitis and CDP (63.9% vs 57.7%, p= 0.62). Endoscopic response was evaluated in 19 (30.6%) cases. After a median of 9 months of follow-up median PDAI endoscopic subscore dropped from 3 (range 2-4) to 1 (range 0-3), (Figure 2). Adverse events related with treatment appeared in 28 patients (45%). Thiopurines were discontinued in 39 cases (63%) due to failure (17), toxicity (16) and long remission (6 cases). Conclusion In our cohort, thiopurines were used in 27% of patients with IDP, with long-term benefit (remission or response) in around two-thirds of them. This therapy could be one more option to manage these disorders.

scholarly journals Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 4 years: a multicenter study

2020 ◽  
Vol 08 (05) ◽  
pp. E650-E655 ◽  
Author(s):  
Olaya I. Brewer Gutierrez ◽  
Robert A. Moran ◽  
Pietro Familiari ◽  
Mohamad H. Dbouk ◽  
Guido Costamagna ◽  
...  
Keyword(s):  
Clinical Response ◽  
Adverse Event Rate ◽  
Type I ◽  
Safe Procedure ◽  
Long Term Outcomes ◽  
Per Oral Endoscopic Myotomy ◽  
Endoscopic Myotomy ◽  
Per Oral

Abstract Background and study aims Per-oral endoscopic myotomy (POEM) is associated with a short-term clinical response of 82 % to 100 % in treatment of patients with achalasia. Data are limited on the long-term durability of the clinical response in these patients. The aim of this study was to determine the long-term outcomes of patients undergoing POEM for management of achalasia. Methods This was a retrospective multicenter cohort study of consecutive patients who underwent POEM for management of achalasia. Patients had a minimum of 4 years follow-up. Clinical response was defined by an Eckardt score ≤ 3. Results A total of 146 patients were included from 11 academic medical centers. Mean (± SD) age was 49.8 (± 16) years and 79 (54 %) were female. The most common type of achalasia was type II, seen in 70 (47.9 %) patients, followed by type I seen in 41 (28.1 %) patients. Prior treatments included: pneumatic dilation in 29 (19.9 %), botulinum toxin injection in 13 (8.9 %) and Heller myotomy in seven patients (4.8 %). Eight adverse events occurred (6 mucosotomies, 2 pneumothorax) in eight patients (5.5 %). Median follow-up duration was 55 months (IQR 49.9–60.6). Clinical response was observed in 139 (95.2 %) patients at follow-up of ≥ 48 months. Symptomatic reflux after POEM was seen in 45 (32.1 %) patients, while 35.3 % of patients were using daily PPI at 48 months post POEM. Reflux esophagitis was noted in 16.8 % of patients who underwent endoscopy. Conclusion POEM is a durable and safe procedure with an acceptably low adverse event rate and an excellent long-term clinical response.

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