Table 4. Anti-Tumor Necrosis Factor α Monoclonal Antibody Treatment.
| 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. |
IFX, infliximab; MTX, methotrexate; ADA, adalimumab; BD, Behçet's disease; ANB, acute neurological BD; CPNB, chronic progressive neurological BD; VBD, vascular BD.