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P679 Infliximab biosimilar CT-P13 in inflammatory bowel disease patients that require intensification treatment

Gompertz M., Alfaro I., Ricart E., Lόpez A., Panés J., Gallego M., Barastegui R., Giner A., Vara A., Masamunt M., Ordás I.

Hospital Clinic Barcelona, Department of Gastroenterology, Barcelona, Spain

Background

CT-P13 was the first Infliximab biosimilar approved in Europe. Several studies confirmed the efficacy, safety, and interchangeability of CT-P13 in patients with immune mediated inflammatory disorders, but there are limited reports on clinical outcomes in patients with inflammatory bowel disease (IBD) requiring dose escalation.

Methods

IBD patients that required dose escalation during treatment with Remicade, or were previously under escalated dosing, were switched to biosimilar CT-P13. Escalation was defined as increased dose ≥7.5 mg/kg/8 weeks and/or a shortening of the interval ≤6 weeks.

Disease activity was evaluated with the Crohn's Disease Activity Index (CDAI) for Crohn's Disease (CD) and full Mayo Score (including endoscopy) for Ulcerative Colitis (UC). Clinical and biological variables were analyzed before the first infusion of CT-P13 and after 24 weeks of treatment.

Results

Thirty patients received escalated CT-P13 dose (18 CD and 12 UC), 53% men, median age 42 years (IQR 22–71). 9/30 patients (30%) were previously intensified with Remicade and switched to CT-P13 maintaining the same dose and 21/30 patients (70%) were switched at the time of dose escalation.

Median time with Remicade treatment before switching to CT-P13 was 44 months (IQR 4–110). At 24 weeks of follow-up 80% were in clinical remission: 15/18 (83%) of CD patients had CDAI<150 and 9/12 (75%) of UC patients had Mayo score ≤2 points. No adverse events were observed in this group of patients treated with CT-P13.

26/30 patients (87%) had Infliximab serum levels <3.0 before intensification and 5/30 (17%) after intensification. No patient developed antibodies against Infliximab, during CT-P13 treatment.

No significant changes were observed in clinical and biological parameters after switching to CT-P13 in patients previously intensified with Remicade in whom the dose of Infliximab was maintained stable (see Table 1).

Table 1. Clinical and biological variables in 9 patients previously intensified with Remicade before and after switching to CT-P13

Before switchAfter switchp
CDAI63.60 ±26.037.00 ±30.70.179
Mayo1.25 ±0.90.25 ±0.50.92
PCR (mg/L)5.5 ±5.33.5 ±3.80.70
Hemoglobin (g/dl)13.1 ±1.613.7 ±1.30.101
IFX levels (μg/ml)4.0 ±4.76.6 ±2.50.205

Conclusion

This study provides evidence of the efficacy and safety of CT-P13 in IBD patients that require intensification of anti-TNF treatment, and would incur in the highest cost.