Muñoz Villafranca Carmen, Bravo Rodríguez Maria Teresa, Ortiz de Zárate Jone, Arreba González Paz, García Kamiruaga Iñigo, Heras Martín Juan Ignacio, Cabezudo Gil Pilar, Orive Cura Víctor
Servicio de Digestivo, Hospital Universitario de Basurto, Bilbao, España.
Servicio de Digestivo, Hospital Universitario de Basurto, Bilbao, España.
Gastroenterol Hepatol. 2016 Aug-Sep;39(7):442-8. doi: 10.1016/j.gastrohep.2015.11.011. Epub 2016 Mar 2.
Infliximab (IFX) is effective in treating ulcerative colitis (UC) and in achieving mucosal healing (MH). Little is known about the role of mucosal healing (MH) in the subsequent evolution of the disease and the consequences of discontinuing treatment.
To evaluate the characteristics and evolution of patients with UC treated with IFX who discontinued treatment after disease remission.
Observational, prospective study of patients with moderate to severe UC, corticosteroid-resistant/corticosteroid-dependent, naïve to anti-TNF. IFX administration regimen: 5 mg/kg at 0-2-6 weeks and every 8 weeks thereafter until week 54. In patients achieving MH, IFX was discontinued and the patients were followed-up for at least 20 months. Clinical remission (CR): mayo score <2; Clinical response: decrease in mayo score of 3 points; MH: mayo score 0-1; Deep remission: patient with CR and MH.
Of the 21 patients enrolled, 19 completed the study (colectomy, n = 1; non-responder, n = 1). Mean age: 47.8 years. UC: severe (n = 13) and moderate (n = 6); most patients (n = 11) were steroid-resistant; 57.8% received combined treatment with immunosuppressants, and 31.5% intensified treatment. Week 54: 16 patients (84.2%) showed clinical response, 13 (68.4%) showed CR, and 12 (63.2%) deep remission. Of these, 6 (25%) presented a new episode of UC, and in 3 (25%) IFX was restarted within 12 weeks of discontinuation, with all patients responding. Of the total sample, 91.7% remained IFX-free at week 8, and 75% at week 12, with no remission during follow-up. None of the patients required hospitalization or surgery.
Half of patients with deep remission of UC with IFX therapy presented a new episode after treatment discontinuation, and in 25% IFX therapy was restarted.
英夫利昔单抗（IFX）在治疗溃疡性结肠炎（UC）及实现黏膜愈合（MH）方面有效。关于黏膜愈合（MH）在疾病后续演变中的作用以及停止治疗的后果，人们了解甚少。
评估在疾病缓解后停止使用IFX治疗的UC患者的特征及病情演变。
对中度至重度UC、对皮质类固醇耐药/依赖且未使用过抗TNF药物的患者进行观察性前瞻性研究。IFX给药方案：在第0、2、6周给予5mg/kg，此后每8周给药一次，直至第54周。在实现黏膜愈合的患者中，停止使用IFX，并对患者进行至少20个月的随访。临床缓解（CR）：梅奥评分<2；临床反应：梅奥评分降低3分；黏膜愈合（MH）：梅奥评分0 - 1；深度缓解：达到CR且实现MH的患者。
纳入的21例患者中，19例完成研究（1例行结肠切除术，1例无反应）。平均年龄：47.8岁。UC：重度（13例）和中度（6例）；大多数患者（11例）对类固醇耐药；57.8%接受免疫抑制剂联合治疗，31.5%强化治疗。第54周时：16例患者（84.2%）有临床反应，13例（68.4%）达到CR，12例（63.2%）深度缓解。其中，6例（25%）出现UC新发作，3例（25%）在停药12周内重新开始使用IFX，所有患者均有反应。在整个样本中，8周时91.7%未使用IFX，12周时75%未使用IFX，随访期间无复发。所有患者均未住院或接受手术。
接受IFX治疗达到深度缓解的UC患者中，一半在停药后出现新发作，25%重新开始使用IFX治疗。
