Background: Simponi® (golimumab) is an anti‐tumour necrosis factor alpha (aTNFα) agent authorized for the treatment of moderately to severely active ulcerative colitis (UC). As part of its risk management plan, the sponsor is conducting a postauthorization safety study (PASS) using data from ENEIDA, a large, prospectively maintained registry of patients with inflammatory bowel disease in Spain in the setting of routine clinical practice. Founded in 2006, ENEIDA has not previously been used in a PASS.
Objectives: To describe the ongoing cohort assembly, baseline characteristics of currently enrolled patients with UC, and experience with this new data source. At planned completion in 2023, the study will provide data on the risk of colectomy (due to intractable disease), advanced colonic neoplasia (ACN), and hepatosplenic T cell lymphoma among users of the study medications.
Methods: Qualitative evaluations of the registry data set were performed. On the basis of data accumulated from September 2013 through May 2017, we identified 3 cohorts of adults with UC who were newly prescribed golimumab, other aTNFα agents, or thiopurines. Patients could switch therapies and, if so, were included in all qualifying cohorts.
Results: The total number of patients in the ENEIDA registry with a diagnosis of UC was 21 253; of these, 14 297 were from sites considered to be of research quality. The number of patients in the 3 study cohorts that fulfilled study criteria was 193 for golimumab, 638 for other aTNFα agents, and 610 for thiopurines. As of May 2017, median follow‐up time was 12.9 months for golimumab, 14.4 months for other aTNFα agents, and 17.3 months for thiopurines. Median age at enrolment (ie, first prescription of the corresponding study drug) in the 3 cohorts ranged from 42 to 44 years. Between 51.8% and 55.4% of patients were male. The median duration of UC was longer for the golimumab cohort (6.5 years) than for the other aTNFα agents (4.2 years) or the thiopurines (2.4 years) cohorts. Pancolitis was more common in new users of golimumab and other aTNFα agents than in thiopurines users. As of May 2017, 47 study outcomes have been identified across the 3 cohorts (45 colectomies due to intractable disease and 2 ACNs).
Conclusions: Results indicate that the ENEIDA registry is a useful data source to identify and study patients with UC in Spain who are newly exposed to aTNFα agents and to thiopurines. Results also highlight the need for extended patient follow‐up.
