Impact of co-morbidities on loss and lack of response to anti-TNFs in inflammatory bowel disease: VERNE study

Abstract

Background Although anti-TNFα therapy is an effective approach for IBD, a great amount of patients does not respond to induction therapy and a significant proportion loses response over time, making it necessary to search for accurate prognostic markers to guide patient selection. This study aimed to evaluate the impact of the co-morbidities profile on the response to anti-TNFs in IBD patients treated in Spanish hospitals.

Methods This was a retrospective, non-interventional, multi-centre (24 sites), observational study that included consecutive adult patients diagnosed with UC or CD who started treatment with biologics between June 2011 and June 2013. Data about patient characteristics, including comorbidities, were collected. Studied variables were analysed descriptively.

Results Three hundred and ten patients with IBD were analysed, 194 with CD and 116 with ulcerative colitis. Average age was 44.9 years (SD: 13), 53.5% were male and most of them Caucasian (95.8%). CD locations were ileum and colon (44.6%), terminal ileum (37.3%), colon (15.5%) and upper gastrointestinal tract (2.6%); UC locations were extensive colitis (48.2%), left colitis (43.8%) and proctitis (8.0%). Most frequent comorbidities were: Chronic Obstructive Pulmonary Disease (COPD) (3.7%), connective tissue disease (3.0%), diabetes mellitus (2.3%), mild chronic hepatopathy (2.0%), myocardial infarction (1.7%), solid tumours (1.7%), congestive heart failure (1.3%) and cerebrovascular disease (1.3%).

Logistic regression models showed that COPD was an independent factor associated with lack of response (OR 2.67 CI 95%: 1.33–5.35; p = 0.006), and myocardial infarction of loss of response (OR 3.30; CI 95%: 1.48–7.35; p = 0.003) to anti-TNF therapy.

The concomitant use of corticosteroids was an additional independent factor associated with lack of response (OR 2.16; CI 95%: 1.25–3.73; p = 0.006) and loss of response (OR 2.45; CI 95%: 1.35–4.44; p = 0.003), and, in contrast, CD was a negative independent predictor of lack of response (OR 0.59; CI 95%: 0.37–0.93; p = 0.024) and loss of response (OR 0.58; CI 95%: 0.34–0.99; p = 0.044).

Conclusions In this population of IBD patients who received first anti-TNF treatment, the most frequent comorbidities were COPD, connective tissue disease, diabetes and hepatopathies. Those associated with lack and loss of response were COPD and myocardial infarction, respectively. Results suggest that patients characteristics should be considered when selecting the optimal biological treatment for IBD patients.