Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease

Table 1 Variables collected at baseline and during follow-up visits

Variable	Baseline	Follow-up
Demographic data
Date of birth	X	-
Gender	X	-
Smoking habit	X	-
Disease data
Date of diagnosis	X	-
IBD type (Crohn’s disease, ulcerative colitis)	X	-
Montreal classification	X	-
Type of fistula (perianal, entero-enteral, enterovesical, enterovaginal, enterocutaneous, other)	X	-
Intra-intestinal complications (yes or no)	X	-
Extraintestinal complications (dermatological, osseous, optical, hepatic)	X	-
Harvey-Bradshaw index	X	X
Crohn’s disease activity index	X	X
Partial Mayo Score	X	X
Truelove-Witts severity index	X	X
Laboratory analysis
C-reactive protein	X	X
Erythrocyte sedimentation rate	X	X
Hemoglobin	X	X
Calprotectin	X	X
CT-P13 trough levels and antibodiesx	-	X
Imaging tests
Disease severity and lesion location according to endoscopy result (mild, moderate, severe)	X	X
Disease severity and lesion location according to magnetic resonance enterography result (mild, moderate, severe, fibrotic stenosis)	X	X
Treatment data
Current treatments (mesalazine, cortisone, AZA/6-MP, MTX)	X	X
Previous treatments (mesalazine, corticosteroids, AZA/6-MP, MTX, infliximab, adalimumab)	X	-
Reasons to start treatment with CT-P13 (corticosteroid dependence, corticosteroid resistance, failure of AZA/6-MP, perianal disease/fistula, start of severe illness)	X	-
Clinical situation
Active clinical disease	X	X
Clinical remission	X	X
Clinical response	-	X

IBD: Inflammatory bowel disease; AZA: Azathioprine; 6-MP: 6-Mercaptopurine; MTX: Methotrexate.