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Table 1 Characteristics of included studies

From: Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review

Study characteristics

Outcome definitions

First author[year]

Country

Design

Remission criteria(clinical remission or CS-free clinical remission)

Response criteria

Mucosal healing criteria

Singh[2016] [22]

USA

Retrospective case series

Clinical remission: PUCAI < 10 or wPCDAI < 12.5

NR

NR

Conrad[2016] [23]

USA

Prospective case series

Steroid-free remission: Inactive disease by PCDAI (≤ 10) or PUCAI (< 10) and no current corticosteroid therapy

PCDAI decrease ≥ 12.5;PUCAI decrease ≥ 20;

NR

Ledder[2017] [24]

Multi-country

Retrospective case series

Steroid-and exclusive enteral nutrition [EEN]-free remission: wPCDAI < 12.5 or PUCAI < 10 without the need for new medications or surgical intervention;

NR

SES-CD < 3 in CD or UCEIS = 0 in UC/IBD-U

Schneider[2018] [25]

Austria

Retrospective case series

Clinical remission: shPCDAI < 10 points; PUCAI < 10 points

NR

NR

Olbjørn[2020] [26]

Norway

Case series

NR

NR

NR

Jossen[2020] [27]

USA

Retrospective case series

CS-free clinical remission: PCDAI < 12.5, or partial Mayo score < 2 and off corticosteroids

NR

Endoscopic remission and Histologic remission:

Endoscopic remission: Mayo Score = 0;SES-CD score ≤ 2;

Histological remission: Nancy Index score ≤ 1 in UC and a CD histologic activity score ≤ 1 in every segment;

Dolinger[2021] [28]

USA

Prospective case series

CS-free remission: wPCDAI ≤ 12.5 or pMS < 2, and no form of corticosteroids for at least 4 weeks

NR

NR

Fabiszewska[2021] [29]

Poland

Retrospective case series

Clinical remission: PCDAI ≤ 10 or PUCAI ≤ 10 after induction phase (4th dose week) and maintenance phase (10th dose week)

PCDAI decrease ≥ 12.5;PUCAI decrease ≥ 20 after 4th dose week

The level of FCP: a statistically significant decrease in FCP level between baseline and after vedolizumab commencement

Garcia-Romero [2021] [30]

Span

Retrospective case series

Clinical remission: PCDAI < 10 or PUCAI < 10

PCDAI decrease ≥ 15 and final PCDAI < 30;. PUCAI decrease ≥ 20

NR

Hajjat[2021] [31]

USA

Retrospective case series

CS-free clinical remission: PCDAI ≤ 10;PUCAI < 10

NR

NR

  1. Abbreviations: PCDAI pediatric Crohn’s disease activity index, wPCDAI weighted pediatric Crohn’s disease activity index, shPCDAI short pediatric Crohn’s disease activity index, PUCAI pediatric ulcerative disease activity index, pMS partial Mayo score, CS corticosteroids, SES-CD simple endoscopic score for Crohn’s disease, UCEIS ulcerative colitis endoscopic index of severity, CD Crohn’s disease, UC ulcerative disease, IBD-U inflammatory bowel disease unclassified, NR not reported, FCP fecal calprotectin