Although some studies have demonstrated an increased risk of death in patients with inflammatory bowel disease taking corticosteroids, the relationship between death and anti–tumor necrosis factor (anti-TNF) drugs has not been as clear.
Corticosteroids and anti—tumor necrosis factor (anti-TNF) drugs are cornerstones of the treatment for inflammatory bowel diseases (IBD), including Crohn disease (CD) and ulcerative colitis (UC), but randomized trial data comparing the use of corticosteroids versus induction and maintenance with anti-TNFs have been limited.
Serious adverse events (AEs) are associated with both corticosteroids and anti-TNFs; use of both classes of drugs may lead to serious infections and congestive heart failure, and while corticosteroids are linked to osteoporosis, fractures, and pulmonary emboli, anti-TNFs are linked with cancer. Although some previous studies have demonstrated an increased risk of death in patients with IBD taking corticosteroids, the relationship between death and anti-TNF therapies has not been as clear.
A new retrospective cohort study, published in the American Journal of Gastroenterology, was conducted among Medicare and Medicaid beneficiaries who had CS or UC. Among patients with CD, 7694 were prolonged corticosteroid users and 1879 were new anti-TNF users. The follow-up period continued until patient death, discontinued enrollment, age 90 years, or diagnosis with other immune-mediated diseases.
The primary outcome of the study was all-cause mortality. Secondary outcomes included major adverse cardiovascular events (MACE), hip fracture, pulmonary embolus, cancer, hospitalization for serious infection, and emergency bowel resection.
During the follow-up period, there were 1444 patient deaths. The weighted annual incidence of death per 1000 patients was:
The risk of death was statistically significantly lower in patients with CD who were treated with anti-TNF therapy (odds ratio [OR], 0.78; 95% CI, 0.65-0.93) but not significantly different for patients with UC treated with anti-TNF agents (OR, 0.87; 95% CI, 0.63-1.22).
In the corticosteroid cohort, anti-TNF therapy was associated with lower rates of both MACE (OR, 0.68; 95% CI, 0.55-0.85) and hip fracture (OR, 0.54; 95% CI, 0.34-0.83).
The risk of serious infection, pulmonary embolus, and cancer was not significantly different between the corticosteroid and anti-TNF groups in patients with CD, and none of the secondary outcomes were significantly different between the 2 treatment groups in patients with UC.
In patients with UC, emergency surgery was more common in patients treated with anti-TNF agents (OR, 2.18; 95% CI, 1.37-3.46), and IBD-related hospitalizations were slightly more common in the anti-TNF group in both diseases (CD: OR, 1.13, 95% CI, 1.04-1.23; UC: OR, 1.53; 95% CI, 1.29-1.81).
The authors conclude that this study observed a statistically significant reduction in mortality in patients with CD who were treated with anti-TNFs rather than prolonged corticosteroids, although the association was not statistically significant among patients with UC. The authors say that reduced mortality among patients with CD may have been a consequence of excess cardiovascular-related mortality or hip fractures.