scholarly journals P640 Moderate to severe endoscopic inflammation is frequent after clinical remission in pediatric ulcerative colitis: A cause for disease extension and relapse?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S530-S531
Author(s):  
C Sarbagili Shabat ◽  
D Weiner ◽  
J Wardi ◽  
L Abramas ◽  
M Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Current Therapy ◽  
Sustained Remission ◽  
High Relapse Rate ◽  
Mayo Score ◽  
Remission Rates ◽  
Disease Extension ◽  
Relapse Rates

Abstract Background Pediatric ulcerative colitis (UC) is characterised by low sustained remission rates and frequent extension of disease even if clinical remission is obtained. Current therapy in pediatric UC is driven primarily by clinical response. Extension of disease and high relapse rates may be due to a failure to obtain mucosal healing with treatment despite clinical remission. Our aim was to evaluate this possibility by assessing endoscopic disease activity after remission was obtained. Methods Pediatric UC patients with clinical remission, defined as sustained PUCAI < 10 three months after remission was obtained, were prospectively assessed for mucosal healing by endoscopy. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading. Results 41 children were enrolled after informed consent, 7 were excluded because of a PUCAI score 10–15 at the time of sigmoidoscopy. Thirty-four Sigmoidoscopies were performed 12–20 weeks after reporting clinical remission. Mucosal healing Mayo 0 was present in 15 endoscopies (44%), Mayo 1 was present in 2 endoscopies (6%) and moderate to severe endoscopic scores Mayo 2–3 was present in 17 endoscopies (50%). Conclusion About 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual moderate to severe inflammation. Inadequate endoscopic improvement despite clinical remission may explain disease extension and the high relapse rate in children.

scholarly journals MODERATE TO SEVERE ENDOSCOPIC INFLAMMATION IS FREQUENT AFTER ACHIEVING CLINICAL REMISSION IN PEDIATRIC ULCERATIVE COLITIS

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S13-S13
Author(s):  
Chen Sarbagili-Shabat ◽  
Dror Weiner ◽  
Joram Wardi ◽  
Lee Abramas ◽  
Michal Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Residual Disease ◽  
Activity Index ◽  
Final Analysis ◽  
Mucosal Healing ◽  
Sustained Remission ◽  
High Relapse Rate ◽  
Mayo Score

Abstract Background Pediatric ulcerative colitis (UC) is characterized by low sustained remission rates and frequent extension of disease even if clinical remission is obtained with therapy. Moderate to severe endoscopic activity is a risk factor for relapse while evidence regarding early mucosal healing or persistence of inflammation after remission in children is not available. Our aim was to evaluate if persistence of significant inflammation is common and could explain the high relapse rate in pediatric UC. Methods Pediatric UC patients with clinical remission, defined as pediatric UC activity index (PUCAI) scores < 10, were prospectively assessed for mucosal healing by endoscopy 3–5 months after remission was documented. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading. Symptomatic patients prior to sigmoidoscopy were excluded Sustained remission was assessed retrospectively at 18 months follow-up. Results Forty-six children were enrolled, 28 children in continuous clinical remission at time of sigmoidoscopy were included in the final analysis. Mayo 0 was present in 12/28 (42.86%), Mayo 1 in 2/28 (7.1%) and Mayo 2–3 in 14/28 (50.0%) endoscopies. Among 23/28 patients with follow-up through 18 months, remission was sustained in 2/11 (18.18%) of patients with Mayo 2 and 3 versus 6/12 (50.0%) with Mayo score 0–1. Conclusion Over 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual disease activity, primarily moderate to severe inflammation which was associated with lower sustained remission. Early sigmoidoscopy after clinical remission for assessment of mucosal disease should be considered in pediatric UC.

scholarly journals Effectiveness of treatment of moderate ulcerative colitis with prolonged mesalazine in real clinical practice

2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Topical Therapy ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Prolonged Release ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine ◽  
High Doses

Introduction. Ulcerative colitis (UC) is one of the severe therapeutic diseases. High doses of oral granular mesalazine are required to maintain clinical and endoscopic remission of UC, which may be sufficient and supposedly more acceptable for patients, as some studies showed that adherence to topical therapy is significantly lower than to oral 5-ASA drugs.Objective of the study. To evaluate the efficacy of therapy of patients with moderate left-sided ulcerative colitis (UC) and pancolitis receiving prolonged-release ethylcellulose-coated mesalazine.Materials and methods. The evaluation of the outcomes of treatment of UC patients who received prolonged-release mesalazine was carried out. We examined 87 patients with UC who received granular ethylcellulose-coated mesalazine, of those 38 (43.7%) men and 49 (56.3%) women. The average age of the enrolled patients was 38.3 ± 12.6 years.Results and discussion. After 2 weeks from the beginning of therapy with prolonged-release mesalazine, the majority of patients – 71 (81.6%) responded to the therapy. After 12 weeks, 71 (81.6%) of 87 UC patients, who responded to therapy with prolongedrelease mesalazine, remained in clinical remission. On average, the Mayo score in the group decreased from 7.6 ± 0.99 to 2.6 ± 0.25 points. There was a significant decrease in CRP, ESR, leukocytosis, and fecal calprotectin. After 26 weeks, Mayo score in the group of patients remained on average at the level of 2.2–2.3 points. The number of UC patients with colon mucosal healing was 32 (36.8%) patients. A year after the start of therapy with prolonged-release mesalazine, 69 (79.3%) UC patients who responded to therapy had a clinical remission, of those 32 (36.8%) patients had a clinical and endoscopic remission. During the year of observation, no case of surgical intervention or re-hospitalization due to exacerbation of the disease was recorded in patients with UC who achieved remission.Conclusions. Treatment of moderate active UC should begin with oral mesalazine ≥ 3 g per day in combination with topical mesalazine. The prolonged-release mesalazines are the most preferred

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.

scholarly journals P310 The efficacy of linked colour imaging, a novel endoscopic enhancement system, for diagnosing mucosal redness in ulcerative colitis patients in clinical remission

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S309-S309
Author(s):  
T Takagi ◽  
K Uchiyama ◽  
M Kajiwara ◽  
Y Azuma ◽  
S Takayama ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Colonic Mucosa ◽  
Mucosal Healing ◽  
Time Interval ◽  
Histological Activity ◽  
Index Of Severity ◽  
Long Term Prognosis ◽  
Linked Color Imaging ◽  
Relapse Rates

Abstract Background Endoscopic mucosal healing is considered as an important therapeutic goal in ulcerative colitis (UC) patients, and several endoscopic evaluations for colonic mucosa such as Mayo endoscopic subscore (MES) and Colitis Endoscopic Index of Severity (UCEIS) are used in clinical practice. Though the strict mucosal healing is defined as MES 0, the relapse of UC has been shown in the patients diagnosed as MES 0. In the present study, we aimed to investigate the efficacy of Linked Color Imaging (LCI), a novel endoscopic enhancement system, to predict long-term prognosis in UC patients diagnosed with MES 0. Methods Twenty-six patients with UC in clinical remission and diagnosed with MES 0 were enrolled. Endoscopic colonic images were assessed by LCI and UCEIS, using a LASEREO endoscopic system (FUJIFILM Co., Tokyo, Japan). Endoscopic LCI images were classified into three subgroups by LCI classification as previously reported. Briefly, LCI patterns were classified as A, no redness; B, redness with visible vessels; and C, redness without visible vessels. Forty months was defined as the time interval between endoscopic diagnosis and relapse of UC. Histological activity was scored according to the Geboes’ score (GS) and the active mucosa was defined by GS>2B.1. Results LCI classification can further subdivide the colonic mucosa diagnosed as MES 0. The patients with LCI-A showed no relapse and the non-relapse rates compared with the patients with LCI-B showed significantly higher (p = 0.033), while the relapse rates of the patients with UCEIS 0 showed no difference compared with UCEIS 1 (p = 0.148). There was no statistical difference in the composition of LCI-A and relapse rate between active and inactive mucosa diagnosed by GS score. Conclusion Endoscopic LCI classification can further subdivide samples diagnosed MES 0. LCI can be a novel and surpassing approach to evaluate mucosal healing and predict the outcome in UC patients.

scholarly journals DOP01 Efficacy and safety of the IL-6 trans-signalling inhibitor olamkicept: a phase 2 randomized, placebo-controlled trial in moderately to severely active Ulcerative Colitis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S041-S042
Author(s):  
B Chen ◽  
S Zhang ◽  
B Wang ◽  
H Chen ◽  
Y Li ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Response ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Active Ulcerative Colitis ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Mayo Score

Abstract Background Total inhibition of IL-6 or its receptor represents a potent anti-inflammatory therapy with considerable side effects. Selective targeting IL-6 trans-signalling may have safety advantages that differentiates it from current pan-IL-6 inhibitors. We evaluated the efficacy and safety of olamkicept, a soluble gp130-Fc fusion protein that binds to the IL-6 and soluble IL-6 receptor complex, as induction therapy for active ulcerative colitis (UC). Methods This multi-national, randomized, double-blind, placebo-controlled phase 2 trial (NCT03235752) enrolled patients with active UC (full Mayo score ≥5, rectal bleeding (RB) score ≥1, endoscopy score (ES) ≥2) with an inadequate response to at least conventional therapy, in a 1:1:1 ratio to receive either placebo, olamkicept 300 mg or 600 mg biweekly for 12 weeks. Primary efficacy endpoint was clinical response (decrease in Mayo score from baseline ≥3 and ≥30%, including RB ≤1 or RB decrease ≥1) at week 12. Secondary endpoints were mucosal healing (ES 0 or 1) and clinical remission (Mayo score ≤2, with no subscore >1 and RB=0). The efficacy endpoints were analysed by logistic regression. All p-values were 2-sided without adjustment for multiplicity. Results Of 91 treated patients (30 in placebo, 31 in olamkicept 300 mg group and 30 in 600 mg group), 88 patients (29:30:29) were evaluable for efficacy. Baseline disease and demographic characteristics were similar among the groups (Table 1). Most patients (94.5%) were bio-naïve. The percentage of patients achieving clinical response at week 12 was significantly greater for olamkicept 600 mg than placebo (58.6% vs 34.5%, P=0.032). Clinical remission at week 12 occurred in 0% (placebo), 6.7% (olamkicept 300 mg) and 20.7% (olamkicept 600 mg, P<0.001) of patients. Mucosal healing at week 12 occurred in 3.4%, 10% and 34.5% (P<0.001) of patients, respectively (Figure 1). Incidence of treatment emergent adverse events (TEAEs) was similar across the groups. The most common TEAEs included upper respiratory tract infection, increased AST levels, and increased urine bilirubin levels, which were mild to moderate and mostly transient. Serious adverse events (SAEs) were reported in 6.7%, 3.2% and 3.3% of patients, respectively. There were no deaths, or other severe AEs associated with current IL-6 inhibitors, such as perforations, severe infections, neutropenia or thrombocytopenia. Conclusion Biweekly 600 mg olamkicept induction therapy demonstrated clinical efficacy with respect to achieving clinical response, clinical remission and mucosal healing in patients with active UC. Olamkicept was well tolerated with a favourable safety profile. The positive results of this phase 2 study support further development of olamkicept in IBD.

scholarly journals EFFICACY AND SAFETY OF ADALIMUMAB VERSUS INFLIXIMAB IN PATIENTS SUFFERED FROM MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

2017 ◽  
Vol 10 (3) ◽  
pp. 300 ◽  
Author(s):  
Bahir Razzaq Mshimesh
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Safety Profile ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Chronic Inflammatory Disease ◽  
Efficacy And Safety ◽  
Mild Disease ◽  
Mayo Score ◽  
Hs Crp

ABSTRACTObjective: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine, usually involving the rectum. During the lastdecade, clinical trials have shown adalimumab (ADA) and infliximab (IFX) to be efficacious in inducing and maintaining remission for moderate tosevere UC refractory to the conventional therapies. The purpose of this study was to compare the efficacy and safety of ADA and IFX for inductionremission in Iraqi patients with moderately to severely active UC.Methods: A total of 50 patients with moderate to severe UC, who were refractory to concurrent treatment with oral corticosteroids and/or immunesuppressants, were randomly assigned in 1:1 ratio to receive either ADA (160/80 mg, subcutaneous) or IFX (5 mg/kg, intravenous) during theinduction phase (8 weeks). Primary efficacy endpoint was clinical remission at week 8. Secondary efficacy endpoints were the clinical response,mucosal healing, subscores indicative of mild disease (rectal bleeding subscore [RBS], physician’s global assessment [PGA] subscore, and stoolfrequency subscore [SFS]). Partial Mayo score was also evaluated in addition to the inflammatory bowel disease questionnaire (IBDQ). Additionalsubgroup analysis was based on the Mayo score, extensive colitis, concomitant medications, high sensitivity C-reactive protein (hs-CRP) level, andpatient weight at baseline. The safety profile was assessed in all enrolled patients.Results: At week 8, 24% of patients receiving ADA were in clinical remission, compared with 28% on IFX (p>0.05). Clinical response was achievedin 48% of patients receiving ADA and 52% of patients on IFX (p>0.05). Mucosal healing was achieved in 40% of patients receiving either ADA orIFX (p>0.05). For the subscores indicative of mild disease (≤1), the patients % of RBS and PGA was significantly higher within IFX group (p<0.05)while the patients % of SFS was significantly higher within ADA group (p<0.05). The proportion of patients achieving clinical remission based on thepartial Mayo score, in addition to IBDQ response index, was not differ significantly between the two groups from week 2 and throughout the study(p>0.05). The patients with higher Mayo score (≥10), higher hs-CRP (≥10 mg/L), and higher weight (≥70 kg) at baseline were associated with reducedremission rates. ADA and IFX treatment were generally well-tolerated and the overall safety profile matched.Conclusion: ADA and IFX were comparable in their effectiveness for inducing clinical remission and response in patients with moderate to severe UC.Both of the biologic agents were well tolerated with an approach safety profile.Keywords: Ulcerative colitis, Adalimumab, Infliximab, Clinical remission, Safety profile.

scholarly journals P494 The efficacy and safety of adalimumab for patients with moderately to severely active ulcerative colitis and predictors of response in Korea

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S432-S432
Author(s):  
S Shin Shin ◽  
S J Park ◽  
Y Kim ◽  
J P Im ◽  
H J Kim ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Drug Level ◽  
Mucosal Healing ◽  
Efficacy And Safety ◽  
Faecal Calprotectin ◽  
Mayo Score ◽  
Predictors Of Response ◽  
Tnf Α

Abstract Background The aim of this study to assess the efficacy and safety of adalimumab (ADA), a monoclonal antibody against tumour necrosis factor α (TNF-α), and to explore predictors of response in Korean patients with ulcerative colitis (UC). Methods We conducted a prospective observational multicenter study over 56 weeks in adult patients with moderately to severely active UC. Clinical response and remission were assessed by Mayo score. Mucosal healing was defined as Mayo subscore 0 or 1. Faecal calprotectin (FC) were assessed at baseline, week 8 and 56. Adalimumab drug levels were checked at week 8 and at loss of response. Missing or incomplete data were handled using the nonresponder imputation method. Results A total of 146 patients were enrolled and included in the analysis. Clinical response rates were 52.1% (76/146) and 37.7% (55/146) at week 8 and 56, respectively. Clinical remission was achieved in 24.0% (35/146) and 21.9% (32/146) of patients at week 8 and 56. Steroid-free remission rates were 21.2% (31/146) at week 56. Mucosal healing rates were 39.0% (57/146) and 30.1% (44/146) at week 8 and 56. Prior use of anti-TNF-α did not affect the clinical and endoscopic responses. Treatment persistence was achieved in 57.5% (84/146) of patients at week 56. Adalimumab drug level was significantly higher in patients with clinical response (10.8 vs. 8.0, p = 0.004), clinical remission (11.7 vs. 8.8, p = 0.007) and mucosal healing (11.0 vs. 8.5, p = 0.010) at week 8. Adalimumab dose was escalated to 40 mg weekly in 25 (17.1%) patients, and clinical response and remission were achieved in 40% and 20% of patients at week 56, respectively. Mean faecal calprotectin levels were significantly more decreased in clinical responders compared with non-responders at week 8 (336.3 mg/kg vs. 628.8 mg/kg, p &lt; 0.001). The Fecal calprotectin levels are well correlated with endoscopic severity, and the best cut-off value to predict mucosal healing was 274 mg/kg. The lower endoscopic severity, higher body mass index and higher serum albumin level at baseline were associated with a clinical response at week 8. The lower Mayo score, lower C-reactive protein level, clinical response (74.5% vs. 38.5%, p &lt; 0.001) and mucosal healing (52.7% vs. 30.8%, p = 0.008) at week 8 were associated with clinical response at week 56. Serious adverse drug reactions were identified in 2.7% (4/146) of patients including 1 case of pulmonary tuberculosis. Conclusion Adalimumab is safe and effective for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF therapy. Adalimumab drug level is associated with the efficacy of induction therapy. A better response to induction therapy can predict a better long-term response.

scholarly journals ADALIMUMAB FOR ULCERATIVE COLITIS: RESULTS OF A BRAZILIAN MULTICENTER OBSERVATIONAL STUDY

2017 ◽  
Vol 54 (4) ◽  
pp. 321-327 ◽  
Author(s):  
Patrícia ZACHARIAS ◽  
Aderson Omar Mourão Cintra DAMIÃO ◽  
Antonio Carlos MORAES ◽  
Fábio Vieira TEIXEIRA ◽  
Juliano Coelho LUDVIG ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Latin American ◽  
Clinical Remission ◽  
Demographic Data ◽  
Case Series ◽  
Severe Ulcerative Colitis ◽  
Mayo Score ◽  
Adalimumab Therapy ◽  
Remission Rates

ABSTRACT BACKGROUND: Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE: To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS: Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score) at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF) and Non responder imputation (NRI) analysis were used. RESULTS: Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION: Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up.

scholarly journals Ulcerative Colitis Patients Continue to Improve Over the First Six Months of Vedolizumab Treatment: 12-Month Clinical and Mucosal Healing Effectiveness

2018 ◽  
Vol 3 (2) ◽  
pp. 74-82
Author(s):  
Petros Zezos ◽  
Boyko Kabakchiev ◽  
Adam V Weizman ◽  
Geoffrey C Nguyen ◽  
Neeraj Narula ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Healing Rate ◽  
Mucosal Healing ◽  
Common Side Effect ◽  
Induction Phase ◽  
Mayo Score ◽  
And Migration ◽  
One Year ◽  
Vascular Adhesion

Abstract Background Vedolizumab (VDZ) is a humanized monoclonal IgG1 antibody which inhibits leukocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade. Aims We retrospectively assessed the 12-month, real-world efficacy and safety of VDZ as induction and maintenance therapy in adult patients with ulcerative colitis (UC). Methods The rates of clinical remission (CR, partial Mayo score &lt; 2), steroid-free clinical remission (SFCR), and mucosal healing were assessed with nonresponder imputation analysis. Baseline independent predictors of clinical remission were investigated, and adverse events were recorded. Results We analyzed outcomes in 74 patients; 32% were anti-TNF naïve, 68% had pancolitis, and 46% were on systemic steroids at baseline. At week six, week 14, six months and one year, the CR rates were 26%, 34%, 39% and 39% respectively, and the SFCR rates were 24%, 31%, 38% and 39%, respectively. Among patients not in CR after induction, the probability of remission at six months was 20%. Sustained SFCR between weeks 14 and 52 and between weeks 22 and 52 was found in 69% and 86% of the patients, respectively. Steroid-free clinical remission at 12 months was significantly associated with remission after the induction phase (OR = 30.4; 95% CI, 6 to 150; P &lt; 0.001). Mucosal healing rate at one year was 39%. The most common side effect was headache (7%). Conclusions Increasing remission rates were observed over the first six months of VDZ treatment. One-fifth of patients not in remission post-induction achieved remission by six months of continued therapy. Mucosal healing was associated with higher rates of one-year steroid-free remission and VDZ treatment continuation.

scholarly journals Effect of disease duration on the association between serum albumin and mucosal healing in patients with ulcerative colitis

2021 ◽  
Vol 8 (1) ◽  
pp. e000662
Author(s):  
Sen Yagi ◽  
Shinya Furukawa ◽  
Kana Shiraishi ◽  
Yu Hashimoto ◽  
Kazuhiro Tange ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Serum Albumin ◽  
Clinical Outcomes ◽  
Clinical Remission ◽  
Acute Inflammation ◽  
Japanese Patients ◽  
Cross Sectional Study ◽  
Mucosal Healing ◽  
High Serum ◽  
Cross Sectional

ObjectiveSerum albumin is used as a marker of acute inflammation. Several studies have addressed the association between serum albumin and clinical outcome in patients with ulcerative colitis (UC). While mucosal healing (MH) has been indicated as the therapeutic goal for UC, the association between serum albumin and MH remains unclear. We evaluated this issue in patients with UC overall and explored whether duration of UC affected this association.DesignThis cross-sectional study recruited consecutive patients with UC. Study subjects consisted of 273 Japanese patients with UC. Serum albumin was divided into tertiles based on its distribution in all study subjects. One endoscopy specialist was responsible for measuring partial MH and MH, which were defined as a Mayo endoscopic subscore of 0–1 and 0, respectively. The association between serum albumin and clinical outcomes was assessed by multivariate logistic regression.ResultsRates of clinical remission, partial MH and MH were 57.9%, 63% and 26%, respectively. Only high serum albumin (>4.4 mg/dL) was significantly positively associated with MH (OR 2.29 (95% CI: 1.03 to 5.29), p for trend=0.043). In patients with short UC duration (<7 years) only, high serum albumin was significantly positively associated with MH and clinical remission. In patients with long UC duration (≥7 years), in contrast, no association between serum albumin and clinical outcomes was found.ConclusionIn Japanese patients with UC, serum albumin was significantly positively associated with MH. In patients with short UC duration, serum albumin might be a useful complementary marker for MH.

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