Dataset Information

Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn's Disease.

ABSTRACT:

Background and aims

This study evaluated the minimal clinically important short-term improvement in the Modified Multiplier Simple Endoscopic Score for crohn's Disease [MM-SES-CD], a novel modified scoring system of the SES-CD, which reliably predicted 1-year endoscopic remission [ER].

Methods

This post-hoc analysis of two CD clinical trial programmes pooled data of 198 participants with baseline ulcers and SES-CD ≥3, who had baseline, post-induction [8-12 weeks], and 1-year endoscopic assessments. Different cut-off values for endoscopic response were evaluated using receiver operating characteristic [ROC] curves, positive likelihood ratios [PLR], and negative likelihood ratios [NLR]. ER [SES-CD <3] was the binary classifier in all cases. A distribution of cut-offs minimising NLR and maximising PLR was created with 10 000 bootstrapped resamples. An optimal cut-point for low and high probability of 1-year ER was determined based on the maximum Youden Index.

Results

MM-SES-CD ≥40% reduction from baseline was selected as the cut-off maximising PLR and minimising NLR. Among 7.6% [15/198] participants achieving this cut-off post-induction, 1-year ER was 46.7%. One-year ER was 16.9% among those not achieving this cut-off. This threshold predicted 1-year ER with 95.0% (95% confidence interval [CI] 90.4%-97.8%) specificity and a PLR of 3.7 [95% CI 1.4-9.5], which was higher than traditional endoscopic response criteria of SES-CD ≥50% reduction [specificity 62.5%, 95% CI 54.5%-70.0%; PLR 1.9, 95% CI 1.4-2.5]. Lower thresholds of MM-SES-CD reduction also were highly specific for 1-year ER [e.g., MM-SES-CD ≥20% reduction was achieved in 19.7% of patients with 83.1% specificity].

Conclusions

In CD patients, post-induction endoscopic response defined by MM-SES-CD ≥40% reduction from baseline identified patients most likely to achieve 1-year ER.

SUBMITTER: Narula N

PROVIDER: S-EPMC9274823 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn's Disease.

Narula Neeraj N Wong Emily C L ECL Colombel Jean-Frederic JF Sandborn William J WJ Ferrante Marc M Marshall John K JK Reinisch Walter W Dulai Parambir S PS

Journal of Crohn's & colitis 20220501 4

<h4>Background and aims</h4>This study evaluated the minimal clinically important short-term improvement in the Modified Multiplier Simple Endoscopic Score for crohn's Disease [MM-SES-CD], a novel modified scoring system of the SES-CD, which reliably predicted 1-year endoscopic remission [ER].<h4>Methods</h4>This post-hoc analysis of two CD clinical trial programmes pooled data of 198 participants with baseline ulcers and SES-CD ≥3, who had baseline, post-induction [8-12 weeks], and 1-year endos ...[more]

PMID: 34664635

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Project description:BackgroundDespite advancements in the therapeutic armamentarium for Crohn's disease (CD), biologic and small molecule monotherapies are associated with sub-optimal response and remission rates. Utilizing dual biologic therapy (DBT) holds the potential to increase efficacy in the treatment of refractory or partially responsive CD. Evidence pertaining to this strategy remains limited.MethodsWe retrospectively examined refractory CD patients treated with a combination of ustekinumab and vedolizumab. Outcomes to DBT at week (wk) 52 were compared to monotherapy. The primary outcome constituted corticosteroid-free remission. Secondary outcomes included adverse events, infections, hospitalizations, surgeries, treatment persistence, and disease clearance.ResultsSixteen of 21 active refractory CD patients (76%) on DBT achieved disease remission at wk 52. Mucosal healing was observed in 38% (n = 6), biochemical remission in 25% (n = 4), and both clinical and biochemical remission in 38% (n = 6). Of these patients, 50% (n = 8) achieved corticosteroid-free remission. Three patients (37.5%) with corticosteroid-free remission achieved complete disease clearance. Paired median fecal calprotectin decreased from 508 to 118 µg/g (P < .0001). Paired C-reactive protein median decreased from 1.04 to 0.50 mg/dL (P < .0001). Median Harvey Bradshaw Index score reduced from 7 to 2 (P = .003). Endoscopic healing was achieved with a paired simple endoscopic score for CD decrease from 6 to 3 (P = .013). Corticosteroid dependency reduced from 17 to 8 patients discontinuing altogether. Patients still requiring corticosteroids experienced a decrease in average daily dose from 9 to 6 mg (P = .045). At wk 52, 5 patients (24%) did not meet the criteria for remission with 4 requiring CD-related surgical intervention. Mean CD-related hospitalizations reduced from 2.95 ± 2.33 to 0.52 ± 1.12 (P < .001) and surgeries from 1.76 ± 1.3 to 0.14 ± 0.4 (P < .001). Three infections with 1 requiring hospitalization and 1 report of headache were noted. Two patients discontinued DBT.ConclusionsDual biologic therapy with ustekinumab and vedolizumab is a safe and effective strategy to induce disease remission in refractory CD. Large-scale studies are necessary to validate findings in a prospective setting.

Project description:BackgroundCrohn's disease (CD) is a chronic inflammatory disease of the digestive tract with unknown etiology. It follows a relapse-remission pattern, making disease activity assessment crucial for treatment. Our study aims to evaluate the diagnostic accuracy of various imaging modalities and to validate and compare the International Bowel Ultrasound Segmental Activity Score (IBUS-SAS), the multidetector computed tomography enterography score (MDCTEs), and the simplified endoscopic activity score for Crohn's disease (SES-CD).MethodsWe assessed diagnostic performance using the CD Activity Index (CDAI). We first categorized patients into remission and active groups. For those in the active stage, we further categorized them into mild/moderate and severe activity groups. We used Spearman rank correlation to evaluate the relationships among IBUS-SAS, bowel wall thickness (BWT), Color Doppler imaging signal (CDS), inflammatory fat (i-fat), bowel wall stratification (BWS), and clinical inflammatory indicators.ResultsA total of 103 CD patients were evaluated. The IBUS-SAS cut-off for remission and activity was 23.8, with an AUC of 0.923, sensitivity of 91.4%, and specificity of 84.8%. The SES-CD had an AUC of 0.801, sensitivity of 62.9%, and specificity of 84.4% at a cut-off of 4.5. The MDCTEs showed an AUC of 0.855, sensitivity of 77.1%, and specificity of 75.8% for a cut-off of 6.5. The Delong test revealed significant differences in diagnostic efficacy when comparing IBUS-SAS to SES-CD and IBUS-SAS to MDCTEs. In the group of mild or moderate-to-severe active, the IBUS-SAS had an AUC of 0.925, sensitivity of 83.7%, and specificity of 88.9% at a cut-off of 40. The SES-CD exhibited an AUC of 0.850, sensitivity of 90.7%, and specificity of 70.4% at a cut-off of 8.5. MDCTEs showed an AUC of 0.909, sensitivity of 83.7%, and specificity of 85.2% at a cut-off of 8.5. During Delong test, the IBUS-SAS, MDCTEs, and SES-CD showed no significant differences in assessing moderate-to-severe activity. Both IBUS-SAS and ultrasound parameters correlated with certain serum indicators (p < 0.05), although only weakly to moderately (all r < 0.5).ConclusionThe IBUS-SAS, MDCTEs and SES-CD can evaluate disease remission/active and mild/moderate-to-severe active in CD, and IBUS-SAS offers the potential to precisely define CD activity.

Dataset Information

Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn's Disease.

Background and aims

Methods

Results

Conclusions

Publications

Early Reduction in MM-SES-CD Score After Initiation of Biologic Therapy is Highly Specific for 1-year Endoscopic Remission in Moderate to Severe Crohn's Disease.

Similar Datasets

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