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Original Research

Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD)

ORCID Icon, , ORCID Icon, , , , , , & ORCID Icon show all
Pages 791-800 | Received 29 Sep 2022, Accepted 05 Apr 2023, Published online: 16 Apr 2023

Figures & data

Figure 1. Patient disposition. aSafety analysis set defined as all patients who received ≥1 dose of study drug during the study observation period. bMost common reasons for discontinuation (≥2% in any group). cFull analysis set defined as all patients who received ≥1 dose of study drug during the study observation period and had ≥1 post-dose assessment of any of the effectiveness endpoints.

Note: Abbreviations: AE = adverse event; AESI = adverse events of special interest; CD = Crohn’s disease; IFX-RP = infliximab reference product (Remicade); n = number of patients; N = total number of patients; PI = principal investigator; SAE = serious adverse event; UC = ulcerative colitis.
Figure 1. Patient disposition. aSafety analysis set defined as all patients who received ≥1 dose of study drug during the study observation period. bMost common reasons for discontinuation (≥2% in any group). cFull analysis set defined as all patients who received ≥1 dose of study drug during the study observation period and had ≥1 post-dose assessment of any of the effectiveness endpoints.

Table 1. Population characteristics and drug utilization patterns (safety analysis set).

Table 2. Summary of TEAEs (safety analysis set).

Table 3. Summary of all-causality TEAEs (SOC and PT ≥ 2% of patients in either cohort) (safety analysis set).a

Figure 2. Rates of clinical remissiona over time following treatment with CT-P13 and IFX-RP for patients with IBD overall, (a) and (b), respectively, and by disease type (CD and UC), (c) and (d) respectively (full analysis set). aBased on physician assessment.

Note: Abbreviations: CD = Crohn’s disease; IBD = inflammatory bowel disease; IFX-RP = infliximab reference product (Remicade); UC = ulcerative colitis.
Figure 2. Rates of clinical remissiona over time following treatment with CT-P13 and IFX-RP for patients with IBD overall, (a) and (b), respectively, and by disease type (CD and UC), (c) and (d) respectively (full analysis set). aBased on physician assessment.

Figure 3. Change in disease status over time for patients with IBD overall (CD and UC) treated with (a) CTP13 and (b) IFX-RP (full analysis set). aChange from baseline to analysis timepoint = (mild disease to mild disease) + (mild disease to moderate disease) + (mild disease to severe disease) + (moderate disease to moderate disease) + (moderate disease to severe disease) + (severe disease to severe disease). bChange from baseline to analysis timepoint = (clinical remission to mild disease) + (clinical remission to moderate disease) + (clinical remission to severe disease).

Note: Abbreviations: IBD = inflammatory bowel disease; IFX-RP = infliximab reference product (Remicade); N’ = number of patients in clinical remission or active disease (mild, moderate, and severe disease) at baseline and had assessment at that analysis timepoint.
Figure 3. Change in disease status over time for patients with IBD overall (CD and UC) treated with (a) CTP13 and (b) IFX-RP (full analysis set). aChange from baseline to analysis timepoint = (mild disease to mild disease) + (mild disease to moderate disease) + (mild disease to severe disease) + (moderate disease to moderate disease) + (moderate disease to severe disease) + (severe disease to severe disease). bChange from baseline to analysis timepoint = (clinical remission to mild disease) + (clinical remission to moderate disease) + (clinical remission to severe disease).
Supplemental material

EOBT-2023-ST-0020_Supplemental_Material.docx

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