P335 Long-term follow-up of switching from original infliximab to infliximab biosimilar: real-world data
M. Guerra Veloz*1, M. Belvis Jimenez1, T. Valdes Delgado1, L. Castro Laria1, B. Maldonado Pérez1, A. Benítez Roldán1, R. Perea Amarillo1, V. Merino Bohorquez2, M. A. Calleja Hernandez2, A. Caunedo Álvarez1, A. Vilches Arenas3, F. Argüelles-Arias1
1Virgen Macarena Hospital, Gastroenterology, Seville, Spain, 2Virgen Macarena Hospital, Pharmacy Unit, Seville, Spain, 3Virgen Macarena Hospital, Preventive Medicine and Public Health, Seville, Spain
Infliximab original has changed the natural history of inﬂammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently, switching drugs data in IBD are limited. Our aim was to assess the long-term data of effectiveness, loss of response, safety and immunogenicity of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease.
This was a prospective single-centre observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade®) to CT-P13 treatment and followed up to 24 months. The efficacy endpoint was the change in clinical response according to the Harvey–Bradshaw (HB) score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) and IFX-drug level were also measured. Adverse events and ADAs were monitored and recorded throughout the study.
A total of 100 patients with inflammatory bowel disease (64 CD/36 UC) were included. Seventy-two per cent of them remained on CTP-13 and 28% patients discontinued the therapy due to loss of response (15%), adverse events (4%) or remission/mucosa healing (8%). Baseline demographics and phenotypic characteristics of patients with CD and UC according to the Montreal Classification are shown in Table 1.
Baseline demographics and phenotypic characteristics according to the Montreal Classification.
Global Remision: 75.8% (75/99), 69.6% (64/92), 69.9% (65/93), and 68.5% (63/92) of patients were in remission at 6, 12, 18 and 24 months, respectively. Twenty-two per cent of patients increased the dose, reaching remission in 60%.
CD and UC remission.
HB score, partial Mayo Score, CRP and IFX-drug levels did not show clinical significant changes.
Scores UC and CD.Serious adverse events related to medication were reported in 14 (14%) patients, two patients developed low levels of ADAs during the follow-up.
Most of the patients switching from infliximab original maintained CT-P13 at 2 years of follow-up with a good profile of effectiveness and safety.