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P364 The efficacy of initial treatment with infliximab without previous conventional therapy in patients with moderate-to-severe ulcerative colitis

O. Prymak*

Medical Clinical Investigational Centre of the Medical Centre LLC Health Clinic, Vinnytsia, Ukraine

Background

Anti-tumour necrosis factor alpha (TNFα) antibodies are used in patients with moderate-to-severe ulcerative colitis (UC) who are either refractory to or intolerant to conventional therapy (CT) with aminosalicylates and corticosteroids. The aim of the study was to evaluate the efficacy of infliximab (IFX) for treating patients with moderate-to-severe UC without using previously CT.

Methods

In total, 51 patients from our database with moderate-to-severe UC based on endoscopic and histological findings were included. They were then divided into 2 groups. Group 1 (26 patients) had never received CT for UC. The other 25 patients who had been treated with standard scheme of mesalamine and corticosteroids, were enrolled in group 2. They have not achieved clinical and endoscopy remission or relapsed after CT. All of the patients were naїve to IFX. To evaluate the efficacy, all subjects underwent colonoscopy, routine biochemical evaluation, and filled questionnaires before and after treatment. The disease activity and relapse on treatment of IFX at week 8 were measured. The follow-up period for all subjects was 1 year.

Results

Group 1 received IFX 5 mg/kg at 0, 2, and 6 weeks without previous CT. Before treatment, the mean score of clinical activity index (CAI) was 9.41+/-0.66 points and the mean score of endoscopic index (EI) was 8.05+/-0.52 points. After treatment, 21 patients (80.8%) achieved clinical and endoscopic remission (р < 0.05). The other 5 patients (19.2%) got better clinical and endoscopic indicators, CAI mean score decreased to 5.30+/-0.30 points, and EI mean score became 4.10+/-0.31 points, which met the mild UC activity criteria (р < 0.001). After treatment, the number of patients with abnormal laboratory values (high level of leukocytes, C-reactive protein, ESR, TNFα, and low level of haemoglobin) was decreased (р < 0.05).

Group 2 previously have received CT. After CT, they received IFX 5 mg/kg at 0, 2, and 6 week. Before treatment, CAI mean score was 9.50+/-0.41 points, and EI mean score was 8.90+/-0.41 points. As a result, 20 patients (80.0%) achieved clinical and endoscopic remission (р < 0.05). The other 5 patients (20.0%) got better clinical and endoscopic indicators, CAI mean score decreased to 4.60+/-0.52 points, and EI mean score became 4.30+/-0.41 points, thus meeting the mild UC activity (р < 0.001). Laboratory markers of inflammation were decreased after treatment (р < 0.05).

No significant statistical differences were found between the 2 groups.

Conclusion

The longest period of remission was in patients treated with IFX. The study results allow suggest that is more expediently the initially prescribing anti-TNFα therapy for patients with moderate-to-severe UC without previous prescribing CT.