Long-term infliximab therapy for ulcerative colitis in real clinical practice

• Published in: Terapevtic̆eskii arhiv Vol. 88; no. 8; pp. 46 - 52
• Main Authors: Knyazev, O V, Parfenov, A I, Kagramanova, A V, Ruchkina, I N, Shcherbakov, P L, Shakhpazyan, N K, Noskova, K K, Ivkina, T I, Khomeriki, S G
• Format: Journal Article
• Language: Russian
• Published: Russia (Federation) "Consilium Medicum" Publishing house 01.01.2016
• Subjects: Adult; Colitis, Ulcerative - diagnosis; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - epidemiology; cytomegalovirus infection; deep endoscopic remission; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - etiology; Female; Gastrointestinal Agents - administration & dosage; Gastrointestinal Agents - adverse effects; Humans; infliximab; Infliximab - administration & dosage; Infliximab - adverse effects; Long Term Adverse Effects - epidemiology; Long Term Adverse Effects - etiology; Male; Medication Therapy Management - statistics & numerical data; Middle Aged; Outcome and Process Assessment (Health Care); Patient Acuity; Retrospective Studies; Russia - epidemiology; steroid-dependence; steroid-resistance; Symptom Assessment - methods; Symptom Assessment - statistics & numerical data; Treatment Outcome; ulcerative colitis
• ISSN: 0040-3660; 2309-5342
• DOI: 10.17116/terarkh201688846-52

to retrospectively evaluate the efficiency of long-term infliximab (INF) therapy in patients with refractory ulcerative colitis (UC). The investigation enrolled 48 patients with refractory UC who had taken IFL in 2008 to 2014. Steroid-dependent or steroid-refractory UC was established in 40 (83.3%) patients; 8 (16.7%) were noted to be refractory to therapy with azathioprine or 6-mercaptopurine. Cytomegalovirus DNA was identified in the biopsy specimens of the large intestinal mucosa (LIM) from 7 patients. One patient received antiviral therapy. Induction therapy with IFL was in its administration in a dose of 5 mg/kg at 0, 2, and 6 weeks, then maintenance therapy was continued every 8 weeks. After an IFL induction cycle, 3 (6.3%) patients were unresponsive to therapy and were excluded from the investigation. At present, 25 (55.5%) of the 45 patients who have responded to the therapy continue to take IFL 5 mg/kg every 8 weeks and are in clinical remission; 4 (8.8%) patients receive intensified IFL therapy. Initially 23 patients received combined therapy with IFL + an immunosuppressive drug; 22 had IFL monotherapy. Escape from the effect of the performed therapy was observed in 5 (11.1%) patients, which required its intensification. The intensified therapy resulted in sustained remission in 4 (8.8%) patients; colectomy was carried out in one (2.2%) case. Secondary loss of response to IFL, its intolerance, development of severe infectious complications, which did not allow for further maintenance therapy with IFL, were seen in 11 (24.4%) patients; 5 (11.1%) stopped the therapy because they had been excluded from the additional drug subsidy list. Maintenance therapy with IFL proved successful during 64 months in 29 (64.4%) of the 45 patients and during 64 months if its intensity, when the occasion required, was enhanced. The long-term use of IFL in UC confirmed its high efficacy in achieving clinical response, in inducing a clinical remission and its capacity to heal LIM, and in sustaining remission.