TABLE 4.
Predictors of good response to treatment in mild to moderate active ulcerative colitis (UC)
| First author | Year | Number of patients | Study arms | Definition of mild to moderate UC (inclusion criterion) | Predictive factors of response |
|---|---|---|---|---|---|
| Pokrotnieks et al. 18 | 2000 | 111 | Mesalazine foam enema or placebo enema | CAI >4 and EI of ≥4 | ND |
| Farup et al. 19 | 2001 | 227 | Mesalazine 4g daily given as prolonged‐release granules in packets of 1g or prolonged‐release tablets of 0.5 g | UCDAI between 3–5 and 6–8 | ND |
| Vecchi et al. 20 | 2001 | 67 | Mesalazine 4g orally plus placebo enema, or mesalazine 2g orally plus mesalazine 2g enema | CAI from 4 to 12 | ND |
| Raedler et al. 21 | 2004 | 362 | Mesalazine micropellets or tablets | CAI for components 1–4 ≥4 and EI ≥4 | ND |
| Gionchetti et al. 22 | 2005 | 217 | Beclomethasone dipropionate 3 mg enema o.d. or mesalamine enema daily | DAI ≥3 and ≤10 | Moderate disease |
| Hanauer et al. 23 | 2005 | 386 | Mesalamine 2.4 g/day or 4.8 g/day | PGA of 1 or 2 | Previous treatment with steroids |
| Marakhouski et al. 24 | 2005 | 233 | 1.5 g mesalazine pellets or tablets | CAI of 6–12 and EI ≥4 | Mild disease activity |
| No extraintestinal manifestation | |||||
| Marteau et al. 25 | 2005 | 127 | Mesalazine enema or placebo | UCDAI score ⩾3 and ⩽8 | ND |
| D’Haens et al. 26 | 2006 | 38 | MMX mesalazine 1.2 or 2.4 or 4.8 g/day | UCDAI score of 4–10 with a sigmoidoscopy score of ≥1 and a PGA score of ≤2 | ND |
| Miner et al. 27 | 2006 | 159 | Enema of 120 mg alicaforsen or 240 mg alicaforsen or 4g mesalazine | DAI of 4–10 | ND |
| Biancone et al. 28 | 2007 | 92 | Beclomethasone diproprionate enema or foam or mesalazine enema or foam | DAI ranging from 3 to 9, and an endoscopic score ranging from 1 to 2 | ND |
| Eliakim et al. 29 | 2007 | 330 | Low‐volume or high‐volume 5‐aminosalicylic acid foam | CAI >4 and EI ≥4 | Shorter disease duration (<5 years) |
| Hanauer et al. 30 | 2007 | 301 | Oral mesalamine 2.4 g/day or 4.8 g/day | PGA score of 1 or 2 | Moderate disease |
| Previous treatment with steroids | |||||
| Kamm et al. 31 | 2007 | 343 | MMX mesalamine 2.4 g/day or 4.8 g/day, or ASACOL 2.4 g/day or placebo | Modified UCDAI score of 4–10 with a sigmoidoscopy score ≥1 and a PGA score ≤2 | ND |
| Lichtenstein et al. 32 | 2007 | 280 | MMX mesalamine 2.4 g/day given twice daily or 4.8 g/day given once daily or placebo | Modified UCDAI of 4–10, with a sigmoidoscopy score ≥1 and a PGA score ≤2 | ND |
| Cortot et al. 33 | 2008 | 375 | Mesalamine foam or mesalamine enema | CAI for components 1–4 ≥4 | ND |
| Lichtenstein et al. 34 | 2008 | 517 | MMX mesalazine 2.4 g/day or 4.8 g/day or placebo | UCDAI score of 4–10 with a sigmoidoscopy score ≥1 and a PGA score ≤2 | ND |
| Kruis et al. 35 | 2009 | 380 | 3g OD or 1g TID mesalazine granules | CAI >4 and EI ⩾4 | Mild disease |
| Distal disease | |||||
| Sandborn et al. 36 | 2009 | 772 | Mesalamine 4.8 g/day or 2.4 g/day | PGA equal to 2 points, with a score of ≥1 point in both the stool frequency and rectal bleeding clinical assessments and a score of ≥2 points in the sigmoidoscopy assessment with a positive friability assessment | Previous treatment with steroids, oral mesalamine, rectal therapies |
| Scherl et al. 37 | 2009 | 249 | 3.3 g of balsalazide or placebo tablets twice daily | MMDAI score between 6 and 10, inclusive, with an individual subscale score ≥2 for rectal bleeding and mucosal appearance | ND |
| Andus et al. 38 | 2010 | 354 | Mesalamine 1g suppository at bedtime or one mesalamine 0.5 g suppository thrice daily | DAI between 3 and 11 | Female |
| Mild disease | |||||
| No extraintestinal manifestation | |||||
| D’Haens et al. 39 | 2010 | 36 | Budesonide‐MMX 9 mg tablets or placebo | CAI <14 | ND |
| Hartmann et al. 40 | 2010 | 237 | Budesonide or mesalazine enemas | CAI >4 and EI >2 | ND |
| Ito et al. 41 | 2010 | 225 | Mesalamine 2.4 g/day or 3.6 g/day | UCDAI of 3–8 and a bloody stool score of 1 or greater | Proctitis |
| Moderate disease | |||||
| Gross et al. 42 | 2011 | 343 | 9mg budesonide or 3g mesalazine | CAI ≥6 and EI ≥4 | ND |
| Hiwatashi et al. 43 | 2011 | 123 | 4g/day mesalazine or 2.25 g/day | UCDAI score of 6–8 points | ND |
| Lamet et al. 44 | 2011 | 99 | Mesalamine 1g suppository administered QHS or 500 mg suppository administered BID | DAI between 4 and 11 | ND |
| Sandborn et al. 45 | 2012 | 509 | Budesonide MMX (9 mg or 6 mg) or mesalamine or placebo | UCDAI score of 4–10 points | ND |
| Flourié et al. 46 | 2013 | 206 | Mesalazine (4 g/day) either OD or BD | UCDAI score of 3–8 | ND |
| Watanabe et al. 47 | 2013 | 129 | 1g mesalazine or placebo suppository | UCDAI score between 4 and 8 | ND |
| Probert et al. 48 | 2014 | 127 | Oral mesalazine 4 g/day, plus 1g mesalazine enema or placebo enema | UCDAI score ≥3 and ≤8 | ND |
| Travis et al. 49 | 2014 | 410 | Budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg or placebo | UCDAI score ≥4 and ≤10 | Younger patients (aged ≤43.5 years) |
| Men | |||||
| Eastern European patients | |||||
| Sandborn et al. 50 | 2015 | 546 | Budesonide foam or placebo | MMDAI between 5 and 10, inclusive, with subscale ratings of ≥2 for endoscopic appearance and rectal bleeding | ND |
| Sandborn et al. 51 | 2015 | 672 | Budesonide MMX 9 mg or budesonide MMX 6 mg or placebo | UCDAI score between 4 and 10 | ND |
| Bosworth et al. 52 | 2016 | 546 | Budesonide foam or placebo | MMDAI score ≥5 but ≤10, with subscale ratings ≥2 for rectal bleeding and endoscopic appearance | ND |
| D’Haens et al. 53 | 2017 | 817 | 3.2 g of oral mesalazine, administered as two 1600 mg tablets once, or four 400 mg tablets twice daily | MCS ≥5, a rectal bleeding subscore ≥1, and a MCES score ≥2 | Treatment failure: |
| Younger age | |||||
| Higher endoscopic disease activity | |||||
| Higher histopathologic disease activity | |||||
| Higher leucocyte concentration | |||||
| Rubin et al. 54 | 2017 | 458 | Budesonide multimatrix 9 mg or placebo | UCDAI ≥4 and ≤10, mucosal appearance subscore ≥1, and physician's rating of disease activity score of 1 or 2 | ND |
| Dignass et al. 55 | 2018 | 306 | One 1000 mg mesalazine tablet or two registered 500 mg mesalazine tablets, both taken three times daily | CAI >4 and ≤12 and EI of 4 or greater | ND |
| Kruis et al. 56 | 2019 | 337 | Budesonide suppositories (2 mg BUS) or 4 mg BUS or 1g mesalamine suppositories or the combination of 2 mg BUS and 1 g MES | Modified UCDAI 4–10 with an endoscopic subscore of ≥1 | Mild disease |
Abbreviations: BID, twice a day; CAI, Clinical Activity Index; DAI, Disease Activity Index; EI, Endoscopic Index; MCES, Mayo Clinic Endoscopic Subscale; MCS, Mayo Clinic Score; MES, Mayo endoscopic score; MMDAI, Modified Mayo Disease Activity Index; MMX, multimatrix system; ND, non disponible; PGA, Physician’s Global Assessment; QHS, every bedtime; TID, three times a day; UCDAI, Ulcerative Colitis Disease Activity Index.