James D. Lewis
Patients with Crohn’s disease who took anti-tumor necrosis factor drugs had lower mortality rates than those who received treatment with prolonged corticosteroid use, according to a study published in the American Journal of Gastroenterology.
James D. Lewis, MD, MSCE, of the center for clinical epidemiology and biostatistics at the University of Pennsylvania, and colleagues wrote that despite evidence of the effectiveness of anti-tumor necrosis factor (anti-TNF) medication in treating inflammatory bowel disease, many patients choose to go or stay on corticosteroids.
“Corticosteroids have an important role in the management of inflammatory bowel disease, but we need to find alternative strategies to prescribing multiple courses of corticosteroids, particularly for patients with Crohn’s disease,” Lewis told Healio Gastroenterology and Liver Disease. “Patients are often afraid to try anti-TNF drugs, perhaps because the name sounds intimidating, perhaps because of what they have read on the internet, or perhaps because they feel comfortable with corticosteroids.”
However, the data supporting efficacy is stronger for anti-TNF drugs, which sometimes allow for discontinuation of corticosteroids, he and colleagues wrote.
Lewis and colleagues conducted a retrospective cohort study of patients with Crohn’s disease (CD) who were either prolonged corticosteroid users (n = 7,694) or new anti-TNF users (n = 1,879). The participants were Medicaid or Medicare beneficiaries treated between 2001 and 2013.
The primary outcome of the study was all-cause mortality.
“We chose to study death as the primary outcome in this study as it trumps all other adverse events,” Lewis said. “If you are not alive, you cannot experience any of the other outcomes.”
Investigators also analyzed incidence of major adverse cardiovascular events, as well as need for revascularization, such as hip fracture, hospitalization for serious infection and emergency bowel resection.
Researchers found that the risk for death was significantly lower in patients treated with anti-TNF drugs (OR = 0.78; 95% CI, 0.65–0.93). The weighted annual incidence of death per 1,000 treated patients was 21.4 for anti-TNF compared with 30.1 for prolonged corticosteroid use. Patients in the anti-TNF cohort also had lower rates of major adverse cardiovascular events (OR = 0.68; 95% CI, 0.55–0.85) and hip fractures (OR = 0.54; 95% CI, 0.34–0.83).
An analysis of patients with ulcerative colitis showed numerically lower mortality rates for patients on anti-TNF medication compared with corticosteroid users. However, there was not a significant difference (OR = 0.78; 95% CI, 0.63–1.22).
Lewis and colleagues noted that the higher mortality rates are most common in patients with serious comorbid illness and at least partially explained by the higher incidence of major cardiovascular events and hip fractures in patients treated with corticosteroids.
“This population, which is rarely included in clinical trials and for whom some physicians may be reluctant to treat with chronic immunosuppression, may be particularly good candidates for anti-TNF agents as [corticosteroid]-sparing therapy,” they wrote.
“I have argued in the past that a short trial of anti-TNF or other steroid sparing therapies comes with a relatively low risk and allows patients to assess whether they respond to the new therapy,” Lewis said. “Only those who respond would then continue on the drug, and thus, the benefit to potential harm balance is more favorable going forward. I believe that this study supports this theory, showing that patients with Crohn’s disease who tried anti-TNF therapy were less likely to die than those who continued to receive corticosteroids.” – by Alex Young
Disclosures:Lewis reports financial relationships with Celgene, Shire, Janssen, AbbVie, Immune Pharmaceuticals, AstraZeneca, Amgen, MedImmune, Merck, Nestle Health Science, Takeda Pharmaceuticals North America, Pfizer, Lilly, Gilead, Samsung Bioepis, and Johnson and Johnson. Please see the full study for all other authors’ relevant disclosures.
Editor's note: This article was updated on Feb. 16 with additional information from a study author.