scholarly journals P120 Prevalence of endoscopic improvement and endoscopic remission according to patient reported outcomes in ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S196-S196
Author(s):  
P Dulai ◽  
S Singh ◽  
V Jairath ◽  
C Ma ◽  
N Narula ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rectal Bleeding ◽  
Patient Reported Outcomes ◽  
Stool Frequency ◽  
Post Induction ◽  
Mayo Score ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Prevalence Estimates ◽  
Individual Participant

Abstract Background We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib. Methods Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring. Results Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p < 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p < 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0. Conclusion Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.

scholarly journals OP09 Patient reported outcomes reflect histologic disease activity in patients with Ulcerative Colitis: Interim analysis of the APOLLO study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S008-S009
Author(s):  
B Verstockt ◽  
C Jorissen ◽  
E Hoefkens ◽  
N Lembrechts ◽  
L Pouillon ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Remission Rate ◽  
Stool Frequency ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Histological Remission ◽  
General Wellbeing

Abstract Background Treating beyond endoscopic remission, aiming for histological remission, has shown to reduce relapse and hospitalization rates in patients with ulcerative colitis (UC). However, very little is known on how histological remission associates with patient reported outcomes (PROMs). Methods PROMs (Simple clinical colitis activity index [SCCAI], IBD disk and Visual Analogue Scales [VAS]) were prospectively collected through a digital questionnaire in all patients with UC undergoing colonoscopy between July 21st 2020-Jan 21st 2021. Mayo endoscopic sub score and UCEIS were determined, as well as the Nancy histologic index (NHI) of the most affected area. Endoscopic remission was defined as Mayo endoscopic sub score 0 and UCEIS 0; histologic remission as NHI 0, absence of active inflammation as NHI ≤ 1. PRO2 remission was defined as stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1–2 stools more than usual) and rectal bleeding score of 0. Results Fifty-six paired assessments were collected in 48 unique patients (Table 1), with a histologic, endoscopic and PRO-2 remission rate of 23.2%, 28.6% and 38.2% respectively. Patients with histologic remission or absence of histologic inflammation had a significantly lower overall IBD disability (p=0.007, p=0.003) and disease activity score (p=0.003, p<0.001), as compared to patients without. In line, NHI correlated with the overall IBD disk (r=0.40, p=0.002) and SCCAI score (r=0.50, p<0.001). Many individual components of both scores (abdominal pain, arthralgia, impact on education and work/interpersonal interactions/sexual function, regulation of defecation, blood loss, general wellbeing, joint pain, numbers of stools during night/day, urgency) differed significantly between patients with and without histologic remission. VAS scores assessing general wellbeing (r=0.33, p=0.01), impact on daily activities (r=0.41, p=0.002), UC-related symptoms (r=0.42, p=0.001) and worries (r=0.40, p=0.002) correlated with histology. Quartile analysis of the overall IBD disk and SCCAI scores confirmed the highest likelihood for histologic remission in patients with the lowest scores (Q1-Q2 vs Q3-Q4 39.3% vs 7.1%, p=0.01; 40.0% vs 9.7%, p=0.01) (Figure 1). Nevertheless, the overall accuracy of the IBD disk (0.75) or SCCAI score (0.76) for histologic remission is lower (p<0.05) than the accuracy of the Mayo endoscopic (0.90) or UCEIS (0.90) score. Table 1: Baseline features Abstract OP09 – Figure 1: Quartile analysis Conclusion In patients with UC, PROMs for disability and clinical disease activity reflect histologic disease activity and should therefore be further explored in (trial) endpoint discussions. However, they cannot fully replace endoscopic and histologic findings, and should be considered complementary.

scholarly journals P422 Tofacitinib induces clinical and endoscopic remission in biologic refractory ulcerative colitis patients: a real-world Belgian cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S384-S386 ◽  
Author(s):  
A Cremer ◽  
T Lobaton ◽  
S Vieujan ◽  
P Bossuyt ◽  
J F Rahier ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Rectal Bleeding ◽  
Real World ◽  
Stool Frequency ◽  
Janus Kinase ◽  
Short Term ◽  
Mayo Score ◽  
Endoscopic Remission

Abstract Background Tofacitinib, an oral small molecule Janus kinase inhibitor, has been approved in 2018 for the treatment of moderate to severe ulcerative colitis (UC) in Europe. We report on real-world short-term efficacy and safety data from a multicenter Belgium refractory cohort of UC patients with prior exposure to both anti-TNFα and vedolizumab. Methods This is an observational, national, retrospective multicentre study including all UC active patients started on tofacitinib (10 mg BID) from 25 centres in Belgium between November 2018 and August 2019. Prospectively collected data were retrospectively analysed according to intention to treat. Primary endpoints were clinical and endoscopic response and remission rates at weeks 8 and 16. Clinical response and remission were defined as a reduction in the Modified Clinical Mayo score (rectal bleeding, stool frequency) of ≥2 and ≤1, respectively. Endoscopic response and remission were defined as a reduction in Endoscopic Mayo score of ≥1 and ≤1, respectively. Complete endoscopic remission was defined as an Endoscopic Mayo score of 0. Descriptive statistics and Wilcoxon signed-rank test were calculated using Medcal 19.1. Results Demographic and baseline data of the 70 included patients are presented in Table 1. Of note is that nearly all patients were refractory to at least one anti-TNF and vedolizumab. Median follow-up was 16 weeks (IQR 13–26). Fifty-four per cent (38/70) of patients required prolonged induction at 10mg BID. Clinical evaluation was available in all patients at week 8 and 49 patients at week 16, while endoscopic data were available in 52 patients and 42 at weeks 8 and 16, respectively. Clinical response and remission, and endoscopic response and remission at weeks 8 and 16 are presented in Figures 1 and 2. Fifty per cent (21/42) of the patients under steroids at baseline could have stopped steroids at 16 weeks. Median baseline Modified Mayo score (rectal bleeding, stool frequency and endoscopy) decreased from 7 (IQR 5–8) to 4 (IQR 2–7) after 8 weeks (n = 49) (p < 0.0001), and down to 2 (IQR 1–5) at week 16 (n = 40) (p < 0.0001). Median CRP significantly decreased from baseline (5.3 mg/l, IQR [1.9–16.8]) to 1 mg/l at week 8 (IQR 0.5–6.2) (n = 49) (p = 0.003). Tofacitinib was well tolerated with only 1 reported case of single dermatome herpes zoster and no case of venous thromboembolism. Conclusion Tofacitinib very effectively induced short-term clinical and endoscopic response and remission even in a refractory cohort of patients with UC in a real-world clinical setting. During this short-term follow-up, tofacitinib was well tolerated with respect to adverse events.

scholarly journals P689 Patient-reported outcomes (PRO-2) and intestinal ultrasound in ulcerative colitis patients: subanalysis of the TRUST&UC study cohort

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S560-S561
Author(s):  
C Maaser ◽  
U Helwig ◽  
I Fischer ◽  
S Rath ◽  
S Kolterer ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Wall Thickness ◽  
Rectal Bleeding ◽  
Patient Reported Outcomes ◽  
Bowel Wall ◽  
Stool Frequency ◽  
Invasive Technique ◽  
Moderate Correlation ◽  
Bowel Wall Thickness ◽  
Patient Reported

Abstract Background Patient-reported Outcomes (PRO) are gaining increasing acceptance as new tools to evaluate clinical activity, especially in the context of clinical trials and evaluation of drug efficacy. However, data to support the relevance of these endpoints and their correlation to objective markers of inflammation is still lacking.1 Recently published data demonstrated the feasibility of intestinal ultrasound (IUS) as a routine monitoring technique in clinical practice for Crohn’s disease (CD) and ulcerative colitis (UC) patients.2 Thus, the importance and significance of IUS, as a patient-centric and non-invasive technique has emerged over the last years and will become more relevant in the future.With this sub-analysis of the TRUST&UC study, we aimed to investigate the correlation between improvement in ultrasound parameters and PRO-2 in UC patients. Methods TRUST&UC is a prospective, observational study including 244 patients with an increased bowel wall thickness (BWT) at baseline and active UC (SCCAI ≥ 5). These patients were analysed for the Simple Clinical Colitis Activity Index (SCCAI) subscores stool frequency, urgency and rectal bleeding. These parameters were documented for up to 4 visits (baseline, an optional visit at week 2, week 6 and week 12). Pathological stool frequency was defined as a stool frequency of ≥1 point (≥ 4 stools/day) and pathological rectal bleeding was defined as ≥1 point (traces of blood in stool); the combination of both subscores was defined as PRO-2. Results We found a positive moderate correlation between BWT and the investigated SCCAI-subscores (rectal bleeding and BWT at W12 r = 0.417; stool frequency and BWT at W12, r = 0.483; PRO-2 and BWT at W12, r = 0.518) and even W6, which is in accordance with previously reported correlations of various PROs and endoscopy in UC-patients.3 We demonstrate that patients with normalisation of BWT (sigmoid colon < 4.0 mm) had a significantly higher chance of a non-pathological PRO-2 (pathological PRO-2 yes/no: 4.25 mm and 3.20 mm for week 6 (p < 0.001) and 4.45 mm and 3.00 mm (p < 0.001) for week 12). Conclusion With this sub-analysis of the TRUST&UC study we demonstrated that bowel wall thickness, assessed by intestinal ultrasound, had a moderate correlation with normalisation of patient-reported outcomes as early as week 6 and 12. Furthermore, patients with non-pathological PRO-2 had significantly decreased bowel wall thickness. This again supports the value of intestinal ultrasound in routine medical practice. References

scholarly journals Full, partial and modified permutations of the Mayo Score: Characterizing clinical and patient-reported outcomes in ulcerative colitis patients

2021 ◽  
Author(s):  
April N Naegeli ◽  
Theresa Hunter ◽  
Yan Dong ◽  
Ben Hoskin ◽  
Chloe Middleton-Dalby ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Patient Reported Outcomes ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Assessment Scores ◽  
Mayo Score ◽  
Patient Reported ◽  
Practice Trials ◽  
Highly Correlated

Abstract Background Understanding ulcerative colitis (UC) disease activity assessed via the full, modified or partial Mayo Score may help clinicians apply results from clinical trials to practice and facilitate interpretation of recent and older studies. Methods Mayo Score variables were assessed in a cross-sectional study of 2608 UC patients. Results Permutations of Mayo Scores were highly correlated, and models predicting the omitted variable from each permutation demonstrated significant agreement between predicted and observed values. Conclusions Partial/modified Mayo Scores may be used to predict endoscopic and Physician's Global Assessment scores, and serve as proxies for the full Mayo Score in clinical practice/trials.

scholarly journals Prevalence and risk factors of bowel symptoms in Korean patients with ulcerative colitis in endoscopic remission: a retrospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kwangwoo Nam ◽  
Sang Hyoung Park ◽  
Jun Ho Oh ◽  
Ho-Su Lee ◽  
Soomin Noh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Patient Reported Outcomes ◽  
Significant Risk ◽  
Disease Extent ◽  
Korean Patients ◽  
Female Sex ◽  
Bowel Symptoms ◽  
Patient Reported ◽  
Endoscopic Remission

Abstract Background Many patients with ulcerative colitis (UC) in clinical remission frequently complain of bowel symptoms such as increased stool frequency (SF) and rectal bleeding (RB). However, studies on these patient-reported outcomes in patients with inactive UC are limited, especially in Korea. Therefore, we investigated the prevalence and risk factors of bowel symptoms in Korean patients with inactive UC. Methods We investigated the prevalence of bowel symptoms in patients with endoscopically quiescent UC between June 1989 and December 2016 using a well-characterized referral center-based cohort. The Mayo clinic score (MCS) was used to evaluate bowel symptoms at the most recent visit near the date of endoscopy. Clinical characteristics of the patients were compared based on the presence or absence of bowel symptoms. Results Overall, 741 patients with endoscopically quiescent UC were identified, of whom 222 (30%) and 48 (6.5%) had an SF and RB subscore of ≥ 1, respectively. Patients with bowel symptoms (SF + RB ≥ 1; n = 244 [32.9%]) had higher rates of left-sided colitis (E2) or extensive colitis (E3) than patients without bowel symptoms (SF + RB = 0; n = 497 [67.1%]; P = 0.002). Multivariate analysis revealed that female sex (odds ratio [OR]: 1.568; 95% confidence interval [CI]: 1.023–2.402; P = 0.039) and E2 or E3 (OR 1.411; 95% CI 1.020–1.951; P = 0.038) were the significant risk factors for increased SF. Conclusions This study revealed that one-third of patients with endoscopically quiescent UC reported increased SF. Female sex and disease extent may be associated with bowel symptoms.

scholarly journals P687 Early and sustained improvement in stool frequency and rectal bleeding following 52 weeks of mirikizumab treatment

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S559-S560
Author(s):  
G R D’Haens ◽  
T Hibi ◽  
M Ferrante ◽  
B R Bhandari ◽  
E Berliba ◽  
...  
Keyword(s):  
Rectal Bleeding ◽  
Repeated Measures ◽  
Mixed Model ◽  
Randomised Clinical Trial ◽  
Stool Frequency ◽  
Induction Treatment ◽  
Double Blind ◽  
Mayo Score ◽  
Patient Reported ◽  
To Receive

Abstract Background Interleukin (IL)-23 is a key cytokine in inflammatory bowel disease pathogenesis. Mirikizumab (miri), a p19-directed IL-23 antibody, demonstrated efficacy and was well-tolerated in patients with moderate-to-severely active ulcerative colitis (UC) during 52 weeks of a Phase 2 randomised clinical trial (AMAC, NCT02589665). The effects of miri on stool frequency (SF) and rectal bleeding (RB) through Week 52 are reported. Methods Patients (Mayo score 6–12 with endoscopic subscore [ES] ≥2) were randomised 1:1:1:1 to receive intravenous (IV) placebo (n = 63), miri 50 mg (n = 63) or 200 mg (n = 62) with possibility of exposure-based (EB) dose increases, or fixed miri 600 mg (n = 61) every 4 weeks (Q4W). Responders to miri at Week 12 (9-point Mayo score decrease ≥2 points and ≥35% change from baseline, with RB=0 or 1 or decrease ≥1) were re-randomised 1:1 into a double-blind maintenance period to receive miri 200 mg subcutaneously (SC) Q4W (n = 47) or every 12 weeks (Q12W; n = 46), and were treated through Week 52. Patients reported UC symptoms, including SF and RB, via a daily diary. Changes from baseline in average Mayo SF and RB subscores at Weeks 2, 4, and 12 were analysed using a mixed model repeated-measures method to account for missingness and baseline characteristics. Results Significant improvement in SF was observed as early as Week 2 in the miri 600 mg Q4W group and as early as Week 4 in the miri 200 mg Q4W group (Figure). Similarly, significant improvement in RB was observed as early as Week 2 in both the miri 200 mg Q4W and 600 mg Q4W groups. Patients who received miri 200 mg Q4W or 600 mg Q4W had a significantly greater reduction in both SF and RB compared with placebo at Week 12 (all p < 0.001) (Figure). Patients who achieved clinical response at Week 12 and were treated with miri 200 mg SC Q4W or SC Q12W maintained a low average SF and RB score at Week 52. Conclusion Significant improvements in SF and RB occurred as early as Week 2 of induction treatment and continued to improve during maintenance treatment with mirikizumab. These data demonstrate the early efficacy and longer-term effects of an IL-23p19 antibody on these patient-reported outcomes.

scholarly journals Prevalence and risk factors of bowel symptoms in Korean patients with ulcerative colitis in endoscopic remission: a restrospective study

2020 ◽  
Author(s):  
Kwangwoo Nam ◽  
Sang Hyoung Park ◽  
Jun Ho Oh ◽  
Ho-Su Lee ◽  
Soomin Noh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Patient Reported Outcomes ◽  
Significant Risk ◽  
Disease Extent ◽  
Korean Patients ◽  
Female Sex ◽  
Bowel Symptoms ◽  
Patient Reported ◽  
Endoscopic Remission

Abstract Background Many patients with ulcerative colitis (UC) in clinical remission frequently complain of bowel symptoms such as increased stool frequency (SF) and rectal bleeding (RB). However, studies on these patient-reported outcomes in patients with inactive UC are limited, especially in Korea. We investigated the prevalence and risk factors of bowel symptoms in Korean patients with inactive UC. Methods We investigated the prevalence of bowel symptoms in patients with endoscopically quiescent UC between June 1989 and December 2016 using a well-characterized referral center-based cohort. The Mayo clinic score (MCS) was used to evaluate bowel symptoms at the most recent visit near the date of endoscopy. Clinical characteristics of the patients were compared based on the presence or absence of bowel symptoms. Results Overall, 741 patients with endoscopically quiescent UC were identified, of whom 222 (30%) and 48 (6.5%) had an SF and RB subscore of ≥ 1, respectively. Patients with bowel symptoms (SF + RB ≥ 1; n = 244 [32.9%]) had higher rates of left-sided colitis (E2) or extensive colitis (E3) than patients without bowel symptoms (SF + RB = 0; n = 497 [67.1%]; P = 0.002). Multivariate analysis revealed that female sex (odds ratio [OR]: 1.568; 95% confidence interval [CI]: 1.023–2.402; P = 0.039) and E2 or E3 (OR 1.411; 95% CI 1.020–1.951; P = 0.038) were the significant risk factors for increased SF. Conclusions This study revealed that one-third of patients with endoscopically quiescent UC reported increased SF. Female sex and disease extent may be associated with bowel symptoms.

scholarly journals End of Induction Patient Reported Outcomes Predict Clinical Remission but not Endoscopic Remission in Crohn’s Disease

2020 ◽  
Author(s):  
Emily C L Wong ◽  
Elisa Buffone ◽  
So Jeong Lee ◽  
Parambir S Dulai ◽  
John K Marshall ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Patient Reported Outcomes ◽  
Post Induction ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
One Year ◽  
The Relationship

Abstract Background and Aims It is unclear however whether early symptom improvement in Crohn’s disease (CD) provides any prognostic information for patients long-term. This paper aims to investigate the relationship between early patient reported outcomes (PROs) after completion of induction of infliximab and their relationship with long-term clinical remission (CR) and endoscopic remission (ER). Methods This post-hoc analysis (Clinicaltrials.gov: NCT02096861) used data from 220 CD patients to evaluate the relationship of week 6 and 14 PRO variables and week 54 clinical remission (CR) (CDAI < 150), PRO2 remission (mean score abdominal pain (AP) ≤ 1 and stool frequency (SF) ≤ 1.5), and endoscopic remission (SES-CD < 3). Multivariable logistic regression models adjusted for confounders were used to assess the relationships between post-induction PROs and outcomes of interest. Results Patients with moderate or severe AP after induction had reduced odds of achieving one-year CR and PRO2 remission compared to those with mild AP (aOR for CR 0.31, 95% CI 0.17-0.57, p=0.0002). Similarly, patients with moderate to severely elevated SF after induction had reduced odds of one-year CR and PRO2 remission compared to patients with less SF (aOR for CR 0.31, 95% CI 0.16-0.58, p=0.0003). No significant differences were found when comparing higher week 6 or 14 PRO scores of AP and/or SF to lower PRO scores in the odds of achieving one-year ER. Conclusions Post-induction PROs of AP and SF strongly predict likelihood of one-year CR but are not associated with one-year ER. Clinical symptoms alone should not be relied upon when assessing response to therapies for CD.

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