P519 Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Multicentre study at 12 months results. (16th January 2018)

• Record Type: Journal Article
• Authors: Guerra Veloz, M F; Belvis Jimenez, M; Vázquez Morón, J M; Pallarés Manrique, H; Valdes Delgado, T; Castro Laria, L; Maldonado Pérez, B; Perea Amarillo, R; Merino, V; Caunedo Álvarez, A; Argüelles-Arias, F
• Is Part Of: Journal of Crohn's and colitis. Volume 12:Number 1(2018:Jan.)Supplement 1
• Page Start: S368
• Page End: S369
• Publication Date: 2018-01-16
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx180.646
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Infliximab have changed the natural history of inflammatory bowel diseases (IBD). However, with the advent of biosimilar treatment such as CT-P13 promises to improve availability of biological therapy. Nowadays switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with IBD. Methods: This was a multicentre prospective observational study conducted at the Virgen Macarena Hospital and Juan Ramon Jiménez Hospital (Seville- Huelva, Spain) from March 2015 to February 2016 in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade ® ) to CT-P13 treatment and followed for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score, and C-reactive protein (CRP) for patients with CD and UC, respectively. Results: A total of 167 patients with IBD (116 with CD and 51 with UC) were included. The Baseline demographics according to the Montreal Classification are shown in Figure. Basal remission 87.4% (146 of 167), 12 months post switch 71.7% (109 of 152). Loss of efficacy at 12 months was 15.7%. 9% of patients discontinued CT-P13 during follow-up. CD patient group 88.8% (103 of 116) of patients with CD were in remission at the time of the switch and 69.7% were in remission at 12 months (P > 0.05. In total, 94.0% (109 of 116) of patients with CD completed 12 months of follow-up. The HB score showed significant changes over the 12-month period (median HB score: 1 [0–1] vs. 1 [0–2] ( p = 0.001. No significant changes in median CRP levels were observed at 12 months ( p = 0.49). UC patient group 84.3% (43 of 51) of patients with UC were in remission at the time of the switch and 76.7% were in remission at 12 months ( p > 0.05). In total, 84.3% (43 of 51) of patients with UC completed 12 months of follow-up. No significant changes in the median partial Mayo score ( p = 0.87) were observed at 12 months. Significant changes in the median CRP level were observed over the same period (0.8 [0–4] vs. 0.23 [0–0.58]) ( p = 0.003). Serious adverse events related to medication were reported in 12 of 167 (7.2%). Conclusions: Switching from infliximab RP to CT-P13 is safe and efficacious at 12 months. Loss of efficacy at 12 months was 15.7%.