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. 2020 Apr 27;7(2):189–205. doi: 10.17294/2330-0698.1722

Table 1.

Sample and Study Characteristics of Reviewed Articles

Author Risk of Biasa Sample Target Treatment Control Treatment Duration Primary Efficacy Endpoint Efficacy on Primary Endpoint? (Hedges’ g) IBDQ Outcomes
Bloom (2004)26 Low 106 pts with mild-to-moderate active UC at hospital outpatient clinics in Europe & Canada Tinzaparin 175 anti-Xa IU/kg/day for 14 days followed by tinzaparin 4500 anti-XA IU/day for 28 days (n=48) Placebo (n=52) 6 weeks Ad hoc CAI (bowel frequency, rectal bleeding, histology, sigmoidoscopy) No (−0.04)

  • Domains
Boye (2011)27 Moderate 58 pts with mostly mild- to-moderate active UC at university clinics in Norway & Germany Stress management EW (n=35) TAU (n=23) 18 months RCAI (modified) Yes (0.59)

  • Total
Cross (2012)28 Low 47 pts with mild-to-moderate UC at a university hospital or veterans clinic in the U.S. Home telemanagement (n=25) BAC (n=22) 12 months Seo index Yes (1.69)

  • Total
Elsenbruch (2005)29 High 30 pts with mild active UC recruited via public advertisements in Germany Mind-body therapy EW (n=15) Wait-list control (n=15) 10 weeks RCAI No (−0.12)

  • Total

  • Domains
Feagan (2005)30 Low 181 pts with mild-to-moderate active UC at university medical centers globally VDZ 2 mg/kg (n=60) Placebo (n=63) 6 weeks TMS Yes (0.70)

  • Total
Feagan (2007)31 Low ACT 1: 364 pts with moderate-to-severe active UC at medical sites globally IFX 5 mg/kg (n=121) Placebo (n=121) 8 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) Yes (0.74)

  • Total

  • Domains
ACT 2: 364 pts with moderate-to-severe active UC at medical sites globally IFX 5 mg/kg (n=121) Placebo (n=123) 8 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) Yes (0.81)

  • Total

  • Domains
Feagan (2013)32 Low 895 pts with moderate-to-severe active UC at medical centers in 34 countries VDZ 300 mg (n=225) Placebo (n=149) 6 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) Yes (0.53)

  • Total
Leiper (2011)33 Low 24 pts with moderate- to-severe active UC at a university hospital in U.K. RTX 1 g (n=16) Placebo (n=8) 12 weeks Remission: (TMS < 3) No (0.26)

  • Total
Panaccione (2014)34 Low 181 pts with moderate-to- severe active UC at medical centers in Belgium AZA+IFX (n=63) AZA-only (n=53) + IFX-only (n=65) 16 weeks Remission: (TMS < 3) & (all MS items < 2) & (No CS use) Yes (0.43)

  • Total
Panes (2015)35 Low 194 pts with moderate-to-severe active UC at medical centers globally Tofacitinib 10 mg BID (n=33) Placebo (n=48) 8 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) No (0.42)

  • Total

  • Domains
Panes (2018)36* Low OCTAVE Induction 1: 614 pts with moderate-to-severe active UC at medical sites globallyy Tofacitinib 10 mg BID (n=476) Placebo (n=122) 8 weeks Remission: (TMS < 3) & (all MS items < 2) & (RB = 0) Yes (0.51)

  • Total

  • Domains
OCTAVE Induction 2: 547 pts with moderate-to-severe active UC at medical sites globall Tofacitinib 10 mg BID (n=429) Placebo (n=112) 8 weeks Remission: (TMS < 3) & (all MS items < 2) & (RB = 0) Yes (0.93)

  • Total

  • Domains
Probert (2003)37 Low 43 pts with moderately active, glucocorticoid-resistant UC at medical centers in U.K. & Germany IFX 5 mg/kg (n=23) Placebo (n=20) 6 weeks Remission: (TMS < 3) or (Baron score = 0) No (0.22)

  • Total
Rutgeerts (2015)38 Low 291 pts with moderate-to-severe active UC at medical centers globally GLM 4 mg/kg (n=77) Placebo (n=77) 6 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) No (0.27)

  • Total
Sandborn (2003)39 Low 88 pts with mild-to-moderate UC at medical centers in U.S. Repifermin 50 μg/kg (n=14) Placebo (n=28) 4 weeks Remission: (TMS EA = 0) & (RB = 0) & (SF < 2) & (PGA < 2) No (−0.75)

  • Total
Sandborn (2014)40 Low Phase II: 164 pts with moderate-to-severe active UC at medical centers globally GLM 200/100 mg (n=41) Placebo (n=40) 6 weeks TMS No (0.28)

  • Total
Phase III: 761 pts with moderate-to-severe active UC at medical centers globally GLM 200/100 mg (n=252) Placebo (n=252) 6 weeks Response: (TMS decrease ≥ 3 pts/30%) & (RB decrease ≥ 1 pt or RB < 2) Yes (0.48)

  • Total
a

Based on number of domains with high risk of bias: 0 = low risk; 1–2 = moderate risk; 3 or more = high risk. High risk of bias studies were excluded from the primary analysis.

*

Data in the meta-analysis were based on those reported in a published erratum to this article.53

5-ASA, 5-aminosalicylic acid; AZA, azathioprine; BAC, best available care; BID, twice daily; CAI, Colitis Activity Index; CS, corticosteroids; DAI, disease activity index; EA, endoscopic appearance; EW, every week; GLM, golimumab; IBDQ, Inflammatory Bowel Disease Questionnaire; IFN, interferon-β-1a; IFX, infliximab; IU, international kg, kilogram; MS, Mayo score; PGA, Physician’s Global Assessment; pts, patients; RB, rectal bleeding; RCAI: Rachmilewitz clinical activity index; RTX, rituximab; SF, stool frequency; TAU, treatment as usual; TMS, total Mayo score; UC, ulcerative colitis; VDZ, vedolizumab.