Intest Res > Volume 15(3); 2017 > Article |
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Author (year) | Level of published evidence | No. of patients | Outcome |
---|---|---|---|
Sonta et al. (2000)4 | Case report | 1 | Mesalazine demonstrated clinical efficacy on esophageal ulcers |
Jung et al. (2012)2 | Retrospective (single tertiary academic center) | 143 | • Clinical relapse: 32.2% (relapse rates: 1 yr, 8.1%; 3 yr, 22.6%; 5 yr, 31.2%; 10 yr, 46.7%) |
• Poor response to 5-ASA therapy: younger age <35 yr; CRP >1.5 mg/dL; DAIBD score ≥60 | |||
Hisamatsu et al. (2014)5 | Japanese consensus statements | - | The optimal dose of 5-ASA for adult patients, 2.25-3.00 g/day. Sulfasalazine is also used, the optimal dose is 3-4 g/day. |
Hatemi et al. (2016)3 | Retrospective (multidisciplinary center) | 16 | 10 of 16 patients (62.5%) achieved remission and did not relapse during the 89.3±64.5 mo |
Author (year) | Level of published evidence | No. of patients | Regimen | Outcome |
---|---|---|---|---|
Nakase et al. (2001)6 | Case report | 1 | PSL 40 mg+intravenous dexamethasone 2.5 mg every 2 wk | After 4 wk, the endoscopic findings of cecal ulcer revealed healing |
Toda et al. (2002)7 | Case report | 1 | PSL 40 mg+20 mg of prednisolones injections into the superior and inferior mesenteric arteries | Multiple healing ulcers, but no open ulcers, were observed between the rectum and transverse colon 12 day after intraarterial prednisolone injection. |
Yasuo et al. (2003)8 | Case report | 1 | PSL 0.5 mg/kg | The endoscopic findings of esophageal ulcer revealed healing. |
Park et al. (2010)16 | Retrospective | 54 | The median dosage of corticosteroid, 0.58 mg/kg (0.39-1.20 mg/kg) | |
Hisamatsu et al. (2014)5 | Japanese consensus statements | - | Weight-based approach of 0.5-1.0 mg/kg per day of prednisolone for 1-2 wk followed by a taper of 5 mg weekly until discontinuation. | - |
Saleh and Arayssi (2014)15 | Review | - | 1 g intravenous methylprednisolone infusions daily for 3 day, followed by 1 mg/kg/day prednisolone tapered slowly | - |
Author (year) | Level of published evidence | No. of patients | Regimen | Outcome |
---|---|---|---|---|
Matsumura et al. (2010)25 | Case report | 1 |
• Tacrolimus serum level, 10-15 ng/mL • After 5 mo: 5-10 ng/mL |
• Oral tacrolimus was effective for refractory intestinal BD. • Colonoscopy 33 mo after starting tacrolimus revealed complete disappearance of the ascending colon ulceration. |
Jung et al. (2012)20 | Retrospective | 39 |
• AZA, 2.0-2.5 mg/kg (starting dose, 25 mg or 50 mg/day) • 6-MP, 1.0-1.5 mg/kg (starting dose, 0.5 mg/kg) |
• 39 of the 67 patients (58.2%) constantly received thiopurines for maintaining medically or surgically induced remission. • Relapse rates at 1, 2, 3, and 5 yr after remission were 5.8%, 28.7%, 43.7%, and 51.7%. |
Hisamatsu et al. (2014)5 | Japanese consensus statements | - | AZA, 25-50 mg/day | Japanese consensus statements (the 2nd) recommended thiopurines for refractory intestinal BD such as corticosteroid-dependent or -resistant patients. |
Lee et al. (2015)21 | Retrospective | 77 |
After surgery: Thiopurine (n=27) • AZA, 2.0-2.5 mg/kg 6-MP, 1.0-1.5 mg/kg 5-ASA (n=50) • 5-ASA, 3-4 g/day |
• Postoperative recurrence rate was lower in patients who received postoperative thiopurines (P=0.050). • The hazard ratio for recurrence was 0.636 (95% CI, 0.130-1.016; P=0.053) for postoperative thiopurine use compared with postoperative 5-ASA. |
Park et al. (2015)23 | Retrospective | 83 |
• AZA, 2.0-2.5 mg/kg (6-MP dose was converted to equivalent AZA) • Starting AZA/6-MP dose, 1.0 mg/kg/day |
Leukopenia (WBC count <4,000/µL) during thiopurine maintenance therapy was associated with prolonged remission in patients with IBD and BD during 6 yr. |
Hatemi et al. (2016)3 | Retrospective | 37 | AZA, 2.0-2.5 mg/kg/day | 65% of patients obtained remission and did not relapse during a mean follow-up of 68.6±43.6 mo. |
Author (year) | Level of published evidence | No. of patients | Regimen | Outcome |
---|---|---|---|---|
Hassard et al. (2001)34 | Case report | 1 | IFX, 4 doses during a 6-mo period |
• CDAI decreased from 270 to 13 points by wk 2 and steroid-free remission was sustained. • Endoscopic finding at 10 wk after the first infusion was markedly improved. |
Travis et al. (2001)29 | Case report | 2 |
• IFX, 3 mg/kg (wk 0, 8) • 5 mg/kg (wk 0, 12, 24) |
• Within 10 day the ulcers healed and extraintestinal manifestations were improved. • IFX was used as induction therapy. |
Kram et al. (2003)35 | Case report | 1 | IFX, 5 mg/kg (wk 0, 2, 6) according to the regimen of induction therapy for CD | After 2 IFX infusion, ESR and CRP normalized. Colon ulcers revealed healing. |
Lee et al. (2007)36 | Case report | 1 | IFX, 5 mg/kg (wk 0, 4) | After 2 IFX infusion, symptoms and laboratory tests, colon ulcers revealed decreased. |
Byeon et al. (2007)41 | Case report | 1 | IFX, 5 mg/kg (rescue therapy after a distal ileocecectomy) | IFX was an effective rescue therapy of an unhealed anastomosis site and early recurrent ulcers after surgery. |
Ugras et al. (2008)37 | Case report | 1 | IFX 5 mg/kg (wk 0, 2, 6) | After 2 IFX infusion, clinical symptoms improved. |
Naganuma et al. (2008)39 | Case report | 6 | IFX induction therapy (5 mg/kg at wk 0, 2, 6), followed by maintenance therapy every 8 wk | 4 of 6 patients achieved and maintained remission. |
Maruyama et al. (2012)40 | Case report | 1 | IFX induction therapy (5 mg/kg at 0, 2, and 6 wk), followed by maintenance therapy every 8 wk | Successfully maintained in clinical and endoscopic remission by every 8-wk infusion of IFX for 6 yr. |
Iwata et al. (2011)24 | Retrospective | 10 | MTX+IFX, 3-5 mg/kg (wk 0, 2, 6 and followed by every 8 until 24 wk) |
• Gastrointestinal symptoms and disease-associated complications were improved within 4 wk in all patients. • Ileocecal ulcers were disappeared in 50% patients at 6 mo and 90% patients at 12 mo. |
Lee et al. (2013)42 | Retrospective | 28 | IFX, 5 mg/kg (wk 0, 2, 4, 30, 54) |
• The clinical response rates at 2, 4, 30, and 54 wk were 75%, 64.3%, 50%, and 39.1%, respectively, with clinical remission rates of 32.1%, 28.6%, 46.2%, and 391. %, respectively. • Older age at diagnosis (≥40 yr), female sex, a longer disease duration (≥5 yr), concomitant immunomodulator use, and achievement of remission at 4 wk found to be predictive factors of sustained response. |
Kinoshita et al. (2013)43 | Retrospective | 15 | IFX induction therapy (5 mg/kg at 0, 2, and 6 wk), followed by maintenance therapy every 8 wk |
• At wk 10, 12 patients (80%) exhibited a response to IFX, with 8 (53%) in remission with no intestinal symptoms and normal CRP levels. • A response to IFX was maintained in 7 of the 11 patients (64%) available at 12 mo and in 4 of the 8 patients (50%) available at 24 mo. |
Tanida et al. (2015)44 | A multicenter, openlabel, uncontrolled study | 20 | ADA, 160 mg (wk 0), 80 mg (wk 2), 40 mg (wk 4), followed by 40 mg every other week for 52 wk (n=6) and 11 patients followed by 80 mg every other week for 52 wk. |
• The primary efficacy end point was the percentage of patients with scores of 1 or lower for gastrointestinal symptom and endoscopic assessments at wk 24. • 9 patients (45%) had gastrointestinal symptom and endoscopic assessment scores of 1 or lower at wk 24 of treatment. • 12 patients (60%) had these scores by wk 52. • A total of 9 of 13 patients (69%) taking steroids at baseline were able to taper (n=1) or completely discontinue steroids (n=8) during the study. |
Hibi et al. (2016)45 | A multicenter, prospective, openlabel, single-arm phase 3 study | 18 (intestinal BD, 11; ANB, 2; CPNB,1; VBD, 4) |
• IFX, 5 mg/kg (wk 0, 2, and 6 and every 8 wk thereafter until wk 46) • IFX, 10 mg/kg (patients who showed inadequate responses after wk 30) |
• The percentage of complete responders was 61% (11/18) at both wk 14 and 30 and remained the same until wk 54. • Intestinal BD patients showed improvement in clinical symptoms along with decrease in CRP levels after wk 2. • Scarring or healing of the principal ulcers was found in more than 80% of these patients after wk 14. |