Infliximab in ulcerative colitis: real-life analysis of factors predicting treatment discontinuation due to lack of response or colectomy: ECIA (ACAD Colitis and Infliximab Study)

Abstract

Objective. To describe clinical practice with infliximab (IFX) in ulcerative colitis (UC); identification of predictive factors for IFX treatment discontinuation due to insufficient response and for colectomy. Material and methods. Retrospective, multicentric and observational study including every UC IFX-treated patient in 10 Spanish hospitals. Variables analyzed: epidemiological data; variables for poor prognosis; IFX prior treatments; characteristics of the IFX treatment; time from the UC diagnosis to induction with IFX; time from induction to colectomy or until data collection. Predictive and protective factors for IFX discontinuation due to lack of response and for colectomy were analyzed with binary logistic regression and Cox analysis. Results. Follow-up time from induction with IFX to the collection of data or colectomy: 36.7 ± 25.7 months. Prior treatment with immunomodulator medications (IMM): 79%; IFX + immunosuppressant therapy: 77%; discontinuation of IFX: 26%, colectomy 16%. Independent predictive or protective factors for IFX discontinuation: IMM resistance (OR: 2.9, p = 0.022, 95%CI: 1.2–7.2), prior use of leukocytapheresis (OR: 3.3, p = 0.024, 95%CI: 1.1–9.4), IFX + IMM therapy (OR: 0.3, p = 0.022, 95%CI: 0.1–0.9, and HR: 0.4, p = 0.006, 95%CI: 0.2–0.8) and corticosteroid use in induction (HR: 1.9, p = 0.049, 95%CI: 1.0–3.8). Independent predictive or protective factors for colectomy: Use of leukocytapheresis (OR: 3.0, p = 0.036, 95%CI: 1.1–8.4), IFX + IMM therapy (OR: 0.3, p = 0.022, 95%CI: 0.1–0.8, and HR: 0.3, p = 0.011, 95%CI: 0.1–0.8) and severe cortico-resistant flare-up (HR: 2.5, p = 0.032, 95%CI: 1.1–5.9). Conclusions. Prior use of IMM and leukocytapheresis, the use of corticosteroids in induction and a severe cortico-resistant flare predict a worse response to IFX and the need for colectomy. Combination therapy is a protective factor for both.

Key Words:

• colectomy
• infliximab
• predictive factors
• treatment discontinuation
• ulcerative colitis

Acknowledgment

There has been no grant support for the study.

Financial disclosure: MSD supported translation of the manuscript.

Declaration of interest: Dr. Fernández-Salazar reports personal fees and non-finantial support from Abbvie and from MSD, personal fees from Shire, non-financial support from Ferring, outside the submitted work. Dr. Muñoz reports grants from Abbvie, grants from MSD, outside the submitted work. Dr. Barrio has nothing to disclose. Dr. Muñoz reports personal fees from Abbvie, personal fees from MSD, personal fees from Ferring, outside the submitted work. Dr. Pajares reports non-financial support from Abbvie, personal fees from Almirall, personal fees from Shire, outside the submitted work. Dr. Rivero reports non-financial support from Abbvie, non-financial support from Ferring, outside the submitted work. Dr. Prieto reports personal fees and non-financial support from MSD, personal fees and non-financial support from Abbvie, outside the submitted work. Dr. Legido reports personal fees and non-financial support from Abbvie, non-financial support from MSD, non-financial support from Shire, outside the submitted work. Dr. Bohumidi reports personal fees from MSD, personal fees from Abbvie, personal fees from SHIRE, outside the submitted work. Dr. Herranz has nothing to disclose. Dr. Fernández has nothing to disclose. Dr. Sánchez-Ocaña has nothing to disclose. Dr. João has nothing to disclose. Dr. Santos Santamarta has nothing to disclose.