Anti-TNF Drugs versus Long-Term Steroid Use for Patients with Inflammatory Bowel Diseases

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What was the research about?

Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases that cause long-term diarrhea and stomach pain. CD and UC affect more than 1.5 million Americans. These illnesses can reduce quality of life and even lead to death.

CD and UC are usually treated with either steroids or anti-TNF drugs. Anti-TNF drugs block a specific part of the immune system. Both steroids and anti-TNF drugs have side effects. Little information exists about which treatment carries lower risks of death or serious side effects for patients with CD and UC.

The research team compared insurance claims from patients with CD and UC who took anti-TNF drugs or long-term steroids. The team wanted to learn about the risks and benefits of these treatments. The team then made a computer model to predict the impact of these treatments on quality of life for patients with CD.

What were the results?

For patients with CD, the risk of death was lower for those taking anti-TNF drugs than for those taking long-term steroids. Patients taking anti-TNF drugs also had fewer major heart problems and broken hips. But they had slightly more hospital visits for health problems related to CD. The computer model predicted that patients taking anti-TNF drugs would have a better quality of life than patients taking long-term steroids would.

For patients with UC, the study didn’t find a difference between the two treatments in the risk of death, heart problems, or broken hips. Patients taking anti-TNF drugs had more emergency surgeries and hospital visits for health problems related to UC than patients taking long-term steroids did.

What did the research team do?

The research team looked at Medicare and Medicaid billing claims from 13,256 patients with CD and UC who were taking long-term steroids or anti-TNF drugs. The team looked at how likely it was for patients to die or have serious side effects.

The team also surveyed 812 patients with CD about their disease symptoms, length of time on treatment, and risk of side effects. The research team used patients’ answers to predict patients’ quality of life for each treatment.

What were the limits of the study?

The research team couldn’t be sure the anti-TNF drugs caused the hospital visits and surgeries. For example, patients taking anti-TNF drugs may be sicker than patients taking long-term steroids. Also, doctors may have prescribed anti-TNF drugs as a last attempt to treat very sick patients with medicine before trying surgery.

The review of patients’ medical claims and the survey included two different groups of patients. If the patients in these two groups were different, such as in their age or how sick they were, then it could affect the quality-of-life results.

Future research could keep looking at quality-of-life concerns for patients with UC and CD.

How can people use the results?

Patients with inflammatory bowel diseases and their doctors may use the results to discuss the benefits and risks of using anti-TNF drugs or long-term steroids. Anti-TNF drugs may be safer than long-term steroids, particularly for patients with CD. For patients with UC, anti-TNF drugs didn’t show the same benefits as they did for patients with CD.

Objective

To compare mortality, major adverse events, and quality of life in patients with inflammatory bowel diseases (IBD) taking prolonged corticosteroids versus those taking anti-tumor necrosis factor (TNF) therapy

Study Design

Researchers conducted a retrospective cohort study of patients with IBD who took anti-TNF therapy or prolonged corticosteroids. Prolonged corticosteroids use was defined as a total dose of greater than 3,000 mg of prednisone or 600 mg of budesonide administered as multiple courses in a 12-month period. Researchers reviewed Medicare and Medicaid claims for 13,256 patients ages 18–90 with Crohn’s disease (CD) or ulcerative colitis (UC). Among CD patients, 7,694 were taking prolonged corticosteroids, and 1,879 were taking anti-TNF therapy; among UC patients, 3,224 were taking prolonged corticosteroids, and 459 were taking anti-TNF therapy. In this study, 63% of patients with CD and 55% of patients with UC were female. There were no clinically significant differences in baseline characteristics between patients taking the two therapies.

Separately, researchers surveyed 812 patients with CD about treatment attributes they would be willing to trade off for disease remission. These attributes included duration of CD symptoms of varying severity, duration of corticosteroid therapy, and adverse event risks. Researchers used survey responses to develop a measure called the remission time equivalent and used this measure to predict the effects of the two treatments on quality of life for patients with CD.

Results

Patients with CD

• All-cause mortality. The risk of death was significantly lower with anti-TNF therapy than with prolonged corticosteroids; the annual incidences of death per 1,000 treated patients were 21.4 and 30.1, respectively (odds ratio [OR]=0.78; 95% confidence interval [CI] 0.65, 0.93).
• Adverse events. Compared with patients taking prolonged corticosteroids, patients taking anti-TNF therapy had fewer 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). The risks did not differ significantly between the two treatments for serious infection, pulmonary embolus, emergency bowel resection, and cancer. IBD-related hospitalizations were slightly more common in the anti-TNF-treated group than in the prolonged corticosteroids group (OR=1.13; 95% CI 1.04, 1.23).
• Quality of life. The research team estimated that anti-TNF therapy had higher remission time equivalents than prolonged corticosteroids at 6 months (mean difference 0.5; 95% CI 0.4, 0.6), 12 months (mean difference 0.8; 95% CI 0.5, 1.1), and 24 months (mean difference 1.4; 95% CI 0.9, 2.0).

Patients with UC

• All-cause mortality. The risk of death did not differ significantly between anti-TNF therapy and prolonged corticosteroids; the annual incidences of death per 1,000 treated patients were 23.0 and 30.9, respectively (OR=0.87; 95% CI 0.63, 1.22).
• Adverse events. The risks did not differ significantly between the two treatments for major adverse cardiovascular events, hip fractures, serious infection, pulmonary embolus, and cancer. Emergency surgery (OR=2.18; 95% CI 1.37, 3.46) and hospitalizations (OR=1.53; 95% CI 1.29, 1.81) for IBD-related issues were more common in patients taking anti-TNF therapy than in patients taking prolonged corticosteroids.

Limitations

Patients on anti-TNF therapy may have had high rates of hospitalizations and emergency surgeries because their disease was more severe or did not respond to therapy. Differences between patients who participated in the survey and patients who participated in the cohort study could have affected the results of the quality-of-life analyses.

Conclusions and Relevance

Prolonged corticosteroid use is common among patients with CD and UC. For patients with CD, compared with prolonged corticosteroids, anti-TNF therapy was associated with reduced mortality and improved quality of life. Prolonged corticosteroid use may have higher mortality risk than anti-TNF therapy because of its associated side effects (cardiovascular events, hip fractures). For patients with UC, the risk of death was similar for both treatments.

Future Research Needs

Future studies could look at treatments and quality-of-life concerns for patients with IBD.