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* = Presenting author

P600 Safety and efficacy of infliximab biosimilar (Remsima©) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment

M. F. Guerra Veloz*1, F. Argüelles Arias1, R. Perea Amarillo1, L. Castro Laria1, M. B. Maldonado Pérez1, A. Benítez Roldán1, V. Merino2, G. Ramirez2, A. Vilches Arenas3, A. Caunedo Álvarez1

1Unidad de Gestión Clínica de Aparato Digestivo Hospital Universitario Virgen Macarena, Seville, Spain, 2Unidad de Farmacia Hospital Universitario Virgen Macarena, Seville, Spain, 3Universidad de Sevilla, Medicina preventiva y salud pública, Seville, Spain

Background

In 2013, EMA approved the use of the biosimilar of Infliximab for all indications held by the infliximab Remicade©. Nevertheless, no clinical trials have been developed in Inflammatory Bowel Diseases (IBD), thus making more data in this illness necessary. In March, 2015, the biosimilar of IFX (Remsima©) was first used at our hospital.

Methods

It is a single cohort observational study made up of Ulcerative Colitis (UC) patients treated with Remsima©. Both patients switching from Remicade© to Remsima© and naïve to IFX were included. The clinical response after 3 and 6 months of treatment was assessed using the physician’s evaluation and Mayo Partial Score, comparing with the basal score before treatment. Likewise, adverse events thought to be connected to the drug were tested.

Results

In total, 40 patients were included, average age 43 ± 13 years. Main characteristic are described in Table 1.

Table 1 Montreal classification

Further, 31 patients were switched from Remicade© to Remsima©: 23 were in remission when switched was carried out, 8 were not in remission (treated with steroids or with dose escalation), and 9 were naïve to anti-FNT. At 3 months, 34 patients were analysed (27 switch and 7 naïve). Further, 73.7% of patients in remission when treatment was switched, were in remission at 3 months. All naïve patients reached remission at that time. At 6 months, 16 patients were analysed (15 switch and 1 naïve). 70% of patients continue in remission, and 23% of patients without remission when treatment was switched reached remission. No differences were found comparing the group of switched patients that continue in remission to the group that is not in remission. In 2 patients (5%) mild adverse events were noted (headaches)

Conclusion

Treatment with Remsima© is safe. Most of the patients with UC who switched from Remicade© to Remsima© continue in remission after 6 months of treatment. Nevertheless, the follow-up is short and there is no control group to compare with, thus making more studies necessary.