Infliximab induces clinical, endoscopic and histological responses in refractory ulcerative colitis

Abstract

Background: infliximab is a monoclonal antiTNF-α antibody that has repeatedly shown to be effective in the management of Crohn's disease. However, data are scarce about its efficacy in ulcerative colitis.Aim: to describe the joint experience of three Spanish hospitals in the use of infliximab in patients with active refractory ulcerative colitis.Patients and methods: we present seven cases of ulcerative colitis (6 with chronic active disease despite immunosuppressive therapy, and one with acute steroid-refractory ulcerative colitis) treated with infliximab 5 mg/kg of body weight. Clinical response was evaluated by means of the Clinical Activity Index at 2, 4 and 8 weeks after initial infusion. Biochemical (erythrocyte sedimentation rate and C-reactive protein), endoscopic, and histological changes were also assessed.Results: mean age of patients was 45.8 ± 17 years (range 23-77); 4 were female. No adverse effects were recorded. Inflammatory activity diminished significantly in 6 of 7 patients (85.7%; CI 95%: 42-99%) both from a clinical (p = 0.01) and biochemical (p <0.05) point of view. Five out of six patients (83.3%; 36-99%) with corticosteroid-dependent disease could be successfully weaned off these drugs. Five patients were endoscopicly controlled both before and after therapy, and a positive endoscopic and histological response could be recorded in all of them.Conclusion: infliximab may be an effective and safe therapy for some patients with ulcerative colitis refractory to other forms of therapy, although controlled studies are needed to assess its role in the general management of this disease.

Infliximab in Steroid-dependent Ulcerative Colitis

“…Only small evidence [6][7][8][9][10][11] and 1 open-label controlled study 12 support the use of IFX in the setting of steroid-dependent UC. These studies are limited in sample size and underpowered to detect predictive variables of response to therapy.…”

“…[6][7][8][9][10][11][12] Moreover, in some of them, the response rates are difficult to infer because of the heterogeneity of the population studied (steroid-dependent and refractory UC patients) and the lack of uniform inclusion criteria. [6][7][8][9][10][11] Current guidelines recommend thiopurines (azathioprine or 6-mercaptopurine) as first-choice therapy to spare steroids 3,17 in steroid-dependent UC. Despite this, evidence supporting the use of thiopurines for the treatment of patients with UC is limited, and in clinical practice, these drugs are considered appropriated for the same indications as Crohn's disease, 18 although this recommendation is not supported by large randomized clinical trials.…”

“…5 Some uncontrolled studies have provided evidence that IFX may be effective in steroid-dependent UC patients, but these studies are all limited concerning sample size, heterogeneity of inclusion criteria, and not enough power to detect predictive variables of response to therapy. [6][7][8][9][10][11][12] Furthermore, in some of these studies, the sample population included also steroid-refractory patients, and the activity of disease ranged from mild to moderate severe. [6][7][8][9][10][11] The aims of our study were to evaluate the effectiveness of IFX for inducing steroid-free clinical and endoscopic remission and to identify predictive clinical variables of response to therapy in a large cohort of steroid-dependent UC patients.…”

Inflammatory bowel disease biopsies: updated British Society of Gastroenterology reporting guidelines

“…Cyclosporine may cause dysplasia-like changes 71. Recent clinical trials have documented histological changes after treatment with specific agents 57 72…”

Pyoderma gangrenosum associated with ulcerative colitis: response to infliximab

“…Su utilidad en el tratamiento de la colitis ulcerosa está siendo objeto de investigación en la actualidad (11)(12)(13). La respuesta a este fármaco de las manifestaciones extraintestinales mucocutáneas tipo PG ha sido recientemente descrita en algunas publicaciones de casos aislados o series cortas (14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24), y abre nuevas perspectivas en su manejo.…”