Optimization of Golimumab Treatment in Ulcerative Colitis

Optimization of Golimumab Treatment in Ulcerative Colitis

This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.

Inclusion Criteria:

• Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

Exclusion Criteria:

• Patients with Crohn's disease or colitis pending classification
• Patients with ileoanal pouch
• Patients with perianal fistulas related to the disease
• Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
• Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
• Patients with moderate or severe heart failure (NYHA grade III / IV)