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Overview of the medical management of mild to moderate Crohn's disease in adults
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Apr 2012. | This topic last updated: Apr 27, 2011.

INTRODUCTION — Crohn's disease is an inflammatory condition of unknown etiology that can affect any portion of the gastrointestinal tract from the mouth to the perianal area. Its transmural inflammatory nature coupled with the variability of organ distribution gives rise to a spectrum of clinical presentations, each of which has to be considered separately in deciding upon the proper therapeutic approach. (See "Clinical manifestations, diagnosis and prognosis of Crohn's disease in adults".)

Numerous therapies are used for the treatment of Crohn's disease. The choice of therapy will vary depending upon the anatomic location of disease, the severity of disease, and the goal of therapy (ie, induction or maintenance of remission). Medical therapies that are commonly used for Crohn's disease include:

This topic will provide an overview of the use of 5-aminosalicylates, antibiotics, and glucocorticoids for the treatment of Crohn's disease. The approach to patients with severe or refractory Crohn's disease, detailed discussions of individual medications, and other treatments for Crohn's disease are discussed separately:

DEFINITIONS OF SEVERITY — Clinical trials of Crohn's disease often use formal grading systems to describe disease severity. Two commonly used systems are the Crohn's Disease Activity Index (CDAI) (calculator 1) and the Harvey-Bradshaw Index (HBI) (calculator 2) [1], which is a simplified derivative of the CDAI. The HBI has been shown to correlate with the CDAI [2]. A drop in the CDAI of 100 points corresponds to a 3-point drop in the HBI. A CDAI of <150 (clinical remission) corresponds to an HBI of <4.

The following working definitions may be more practical for clinical practice [3]:

  • Asymptomatic remission (CDAI <150) – Patients who are asymptomatic either spontaneously or after medical or surgical intervention. Patients requiring steroids to remain asymptomatic are not considered to be in remission but are referred to as being "steroid-dependent."
  • Mild to moderate Crohn's disease (CDAI 150-220) – Ambulatory patients able to tolerate an oral diet without dehydration, toxicity, abdominal tenderness, mass, obstruction, or >10 percent weight loss.
  • Moderate to severe Crohn's disease (CDAI 220-450) – Patients who have failed treatment for mild to moderate disease or patients with prominent symptoms such as fever, weight loss, abdominal pain and tenderness, intermittent nausea or vomiting, or anemia.
  • Severe-fulminant disease (CDAI >450) – Patients with persisting symptoms despite conventional glucocorticoids or biologic agents (infliximab, adalimumab, certolizumab pegol, or natalizumab) as outpatients, or individuals presenting with high fevers, persistent vomiting, intestinal obstruction, significant peritoneal signs, cachexia, or evidence of an abscess.

STEP-UP VERSUS TOP-DOWN THERAPY — There are two general approaches to the treatment of mild to moderate Crohn's disease: step-up therapy and top-down therapy. Step-up therapy typically starts with medications that are less potent and (often) associated with fewer side effects. If those therapies are ineffective, more potent (and potentially more toxic) medications are used. Top-down therapy starts with more potent therapies, such as biologic therapy or immunomodulator therapy, relatively early in the course of the disease before patients become glucocorticoid dependent, and possibly even before they receive glucocorticoids. (See "Overview of the medical management of severe or refractory Crohn's disease in adults".)

The relative merits of these strategies have not been extensively studied. One of the largest controlled trials included a total of 133 patients with newly diagnosed Crohn's disease who were randomly assigned to combined immunosuppression (with infliximab and azathioprine) or conventional management with glucocorticoids followed by azathioprine and infliximab as needed [4]. Significantly more patients in the initial immunosuppression (top-down) group were in clinical remission at 26 weeks (60 versus 36 percent) and at 52 weeks (62 verus 42 percent). Serious adverse events were seen in a similar proportion of both groups (31 versus 25 percent).

Given the heterogeneity of the disease and multiple options for combining therapy, it is unlikely that sufficient controlled trials will ever become available to guide treatment for every clinical circumstance. In addition, the cost of therapy, patient compliance, and individual susceptibility to drug toxicity are equally relevant factors for making decisions at the bedside.

As a general rule, we favor step-up therapy, beginning treatment with less potent drugs that have relatively long track records and good safety profiles. We then progress to more potent treatments in patients with severe or refractory disease. (See "Overview of the medical management of severe or refractory Crohn's disease in adults".)

TREATMENT OF ACTIVE DISEASE — Outpatient therapy with oral medications is appropriate for most patients with mildly to moderately active Crohn's disease. However, hospitalization is required for patients who present with severe symptoms or who appear toxic. (See "Overview of the medical management of severe or refractory Crohn's disease in adults".)

For patients with mild to moderate Crohn's disease, treatment will in part depend upon the site of disease.

Oral lesions — Aphthous ulcerations are the most common oral manifestation of Crohn's disease. A wide variety of additional lesions have been described, including granulomatous masses, cheilitis, and granulomatous sialadenitis. These abnormalities can be severe and may dominate the clinical picture by causing enough pain to impair nutrition. They usually occur with coexistent intestinal disease and respond to treatment directed at the intestinal disease. Topical medications, such as triamcinolone acetonide in Orabase, can provide local symptom relief. (See "Oral lesions", section on 'Treatment'.)

Gastroduodenal Crohn's disease — Fewer than 5 percent of patients with Crohn's disease have gastroduodenal disease, most often in association with concurrent distal intestinal involvement. The distal antrum and duodenum are most commonly affected.

The clinical presentation is often confused with that of peptic ulcer disease and symptoms may include epigastric pain, nausea, and postprandial vomiting. Treatment with a proton pump inhibitor, H2 receptor antagonist, or sucralfate may provide partial or complete relief of symptoms. The slow release form of mesalamine encapsulated in ethylcellulose microgranules (Pentasa®) is partially released in the proximal small bowel and theoretically may be of use in duodenal Crohn's disease. There are, however, no clinical trials to confirm its efficacy in this setting.

Prednisone is necessary and usually effective for most patients with moderate to severe gastroduodenal disease. In one report of 89 patients, 45 of the 49 patients (92 percent) treated medically had a good to excellent response [5]. Thirty-three patients required surgery, usually for gastroduodenal obstruction. The response to therapy is usually seen within two weeks, but the duration of response is variable. We usually suggest azathioprine or 6-mercaptopurine in patients who remain symptomatic despite a course of prednisone or who become steroid-dependent. (See 'Conventional glucocorticoids' below and "Overview of the medical management of severe or refractory Crohn's disease in adults", section on 'Azathioprine and 6-mercaptopurine'.)

Ileitis and colitis — The ileum is the region of the small bowel most commonly involved in Crohn's disease. Patients with active ileitis typically present with diarrhea and abdominal pain; they can also have weight loss (usually related to decreased oral intake), low-grade fever, and anemia. Patients with active ileocolitis or Crohn's disease limited to the colon may present with abdominal pain, bloody or nonbloody diarrhea, fever, and weight loss. (See "Clinical manifestations, diagnosis and prognosis of Crohn's disease in adults".)

For patients with mild to moderate disease, we usually begin therapy with oral 5-aminosalicylates (5-ASA) drugs, though, as noted below, experts disagree about the efficacy of 5-ASA drugs for Crohn's disease. We then progress to treatment with antibiotics, glucocorticoids, and immunosuppressive agents depending upon the response (algorithm 1).

The optimal management of patients who are asymptomatic or minimally symptomatic is unclear. Some data suggest that the use of 5-ASA drugs may decrease the risk of colon cancer. As a result, we typically suggest treatment with a 5-ASA drug for such patients if their Crohn's disease involves the colon. However, whether any treatment alters the natural history of the disease in such patients is unproven. (See "Sulfasalazine and 5-aminosalicylates in the treatment of ulcerative colitis", section on 'Effect in prevention in colon cancer'.)

5-ASA drugs — The use of 5-ASA drugs for Crohn's disease is controversial. Studies evaluating the efficacy of 5-ASA drugs in Crohn's disease have produced mixed results:

  • A 2011 meta-analysis examined the role of 5-ASAs in patients with Crohn's disease for both induction of remission and maintenance of remission [6]. The meta-analysis included 22 randomized trials (6 trials looking at 5-ASAs for the induction of remission, 13 for maintenance of remission, and 3 for both induction and maintenance of remission). The meta-analysis found that:

  • 5-ASAs taken as a group were superior to placebo for the induction of remission. Failure to achieve remission was seen in 68 percent of patients treated with 5-ASAs compared with 75 percent of patients treated with placebo (relative risk [RR] 0.89; 95% CI 0.80-0.99). The study found that in order to achieve remission in one patient with active Crohn's disease, 11 patients would need to be treated.

    There was no significant benefit in remission rates when only trials using mesalamine were examined. Similarly, when studies using sulfasalazine were examined, the benefit was of borderline statistical significance (RR 0.83; 95% CI 0.69-1.00, p = 0.05). However, higher doses of mesalamine (≥1.5 g/day) were associated with achieving a combined endpoint of remission or symptom improvement (RR 0.96; 95% CI 0.48-.098, number needed to treat [NNT] of 6).
  • Sulfasalazine plus a glucocorticoid was not superior to a glucocorticoid alone for the induction of remission.
  • One trial compared olsalazine with placebo and found olsalazine to be inferior to placebo (RR of failure to improve 1.62; 95% CI 1.18-2.21).
  • There was no benefit with 5-ASA treatment for the maintenance of remission. Patients treated with 5-ASAs had a relapse rate of 56 percent compared with 57 percent for patients who received placebo.

  • Additional findings from a 2010 meta-analysis of 19 randomized trials included:

  • Sulfasalazine was more likely to induce remission than placebo (RR 1.38; 95% CI 1.02-1.87), with the benefit being confined primarily to patients with colitis.
  • Sulfasalazine was inferior to glucocorticoids for inducing remission (RR 0.66, 95% CI 0.53-0.81).
  • Neither low-dose mesalamine (1 to 2 g/day) nor high-dose mesalamine (3 to 4.5 g/day) was superior to placebo for induction of remission.
  • 5-ASAs were inferior to budesonide (RR 0.56; 95% CI 0.40-0.78) in one trial.

  • A 2011 meta-analysis with six trials specifically looked at the use of 5-ASA drugs for the maintenance of remission [6]. In that analysis, there was a trend toward a benefit with sulfasalazine compared with placebo, but there was no definite benefit of mesalamine compared with placebo.
  • In a 2011 study that was not included in the above meta-analyses, mesalamine and budesonide were similarly effective for the induction of remission in patients with mildly to moderately active Crohn's disease [7]. Three hundred nine patients were assigned to receive budesonide 9 mg/day, budesonide 3 mg three times per day, or Eudragit-L-coated mesalamine 4.5 g/day. The remission rates were similar between those who received budesonide and those who received mesalamine (70 versus 62 percent).

The uncertainty about the benefit of 5-ASA drugs is reflected in variable guidelines from gastroenterology societies and recommendations from experts.

  • The Practice Parameters Committee of the American College of Gastroenterology and the British Society of Gastroenterology both recommend 5-ASA drugs for use as first-line therapy in patients with mildly to moderately active Crohn's disease [8,9].
  • The European Crohn's and Colitis Organization Consensus recommends that 5-ASAs not be used for Crohn's disease [10].
  • Some experts recommend that 5-ASA drugs other than sulfasalazine not be used in the treatment of Crohn's disease for either induction or maintenance of remission. However, sulfasalazine (3 to 6 g/day over a course of 16 weeks) may be an option in patients with mild to moderate colonic (left-sided) Crohn's disease [11-13].
  • By contrast, we and others argue that 5-ASAs should be tried in patients with mild Crohn's disease based upon their relative safety compared with glucocorticoids, immunomodulators, and biologic agents, particularly given the potential chemopreventative benefits of 5-ASAs in patients with longstanding Crohn's colitis.

For patients with ileitis and mild symptoms, we often begin treatment with a slow release oral 5-ASA drug (table 1), such as Pentasa® (2 g/day) or Asacol® (2.4 g/day). The dose is then increased to a maximum of 4 g/day for Pentasa® or 4.8 g/day for Asacol®, depending upon the clinical response. By contrast, sulfasalazine is less useful for ileitis because colonic bacteria must cleave the drug to release the active 5-ASA moiety.

For patients with ileocolitis or colitis and mild to moderate symptoms, we initiate therapy with sulfasalazine (2 g/day) or one of the mesalamine drugs (2 to 2.4 g/day, depending upon the drug used) (table 1). Again, the doses of the medications are increased based upon the patient's clinical response.

Side effects of these medications include nausea, headache, fever, rash, pancreatitis, and pneumonitis (table 2) and are more common with sulfasalazine. (See "Sulfasalazine and 5-aminosalicylates in the treatment of ulcerative colitis", section on 'Side effects'.)

Antibiotics — We suggest antibiotics in patients who do not tolerate 5-ASAs or do not improve within three to four weeks of starting a 5-ASA. It is unclear if the efficacy of antimicrobial therapy is due to treatment of an undetected pathogen, bacterial overgrowth, or an unsuspected microperforation. Specific recommendations and supporting data for antibiotics in Crohn's disease are presented separately. (See "Antibiotics for treatment of inflammatory bowel diseases".)

Conventional glucocorticoids — Oral glucocorticoids continue to be a mainstay of treatment for patients with mild to moderate disease who are unresponsive to the above measures, or for those presenting with more severe initial symptoms (but who are not so ill that they require hospitalization and intravenous glucocorticoids) [11,14,15]. A 2011 meta-analysis failed to show a statistically significant benefit with glucocorticoids compared with placebo for the induction of remission due to heterogeneity between the included studies (RR of failure to achieve remission 0.46, 95% CI 0.17-1.28). However, the individual studies included in the analysis both showed a benefit [11,14].

The initial dose of prednisone is 40 to 60 mg/day. Sixty to 80 percent of patients will respond to this dose, usually within 10 to 14 days. At that point, a gradual tapering by 5 mg/week should be considered with the definite goal of discontinuing the prednisone. Glucocorticoids should not be used long-term due to significant side effects. (See "Major side effects of systemic glucocorticoids".)

5-ASA drugs and antibiotics can be used concomitantly with prednisone. One controlled trial demonstrated that the combination of sulfasalazine and prednisone was better than either alone [14], though not all studies have shown a benefit with combination therapy (see '5-ASA drugs' above). Once remission is achieved and the prednisone tapered and stopped, maintenance therapy with an oral 5-ASA drug at a dose of 3 to 3.6 g/day (depending upon the drug chosen) should be considered (table 1). (See 'Maintenance therapy' below.)

Non-systemic glucocorticoids — Controlled ileal release (CIR) budesonide is a glucocorticoid with a high first-pass hepatic metabolism that may be used as an alternative to prednisone for patients with active ileitis or right-sided Crohn's colitis, particularly in those with prior intolerance or contraindications to systemic glucocorticoids. Systemic side effects are seen to a lesser extent with budesonide than with conventional glucocorticoids. (See "Budesonide in the treatment of Crohn's disease".)

Placebo-controlled trials have demonstrated that CIR budesonide 9 mg/day is effective in patients with mildly to moderately active Crohn's ileitis and/or right colon involvement [16]. While CIR budesonide is somewhat less effective than standard glucocorticoids for inducing remission, it is associated with significantly fewer glucocorticoid-associated side effects [16,17]. CIR budesonide is used at a dose of 9 mg/day for 8 to 16 weeks and then tapered by 3 mg increments over two to four weeks.

Antidiarrheal medications — Symptomatic treatment with antidiarrheal drugs should be considered in patients not responding completely to first-line therapy. We suggest loperamide because of its efficacy and relative safety [18]. Cholestyramine is another consideration for patients with non-stenosing ileitis who have chronic watery diarrhea. It is also indicated for patients with previous ileal resections who have bile salt diarrhea. The initial dose is 4 g/day, which is increased as needed to 12 g/day in three divided doses. For patients intolerant of cholestyramine because of dyspepsia, colestipol, a similar binding resin, is often a suitable alternative. (See "Lipid lowering with drugs other than statins and fibrates".)

Probiotics — Probiotics are viable microorganisms with beneficial physiologic or therapeutic activities. Limited clinical trials suggest that selected probiotic species, alone or in combination, can prevent recurrent intestinal inflammation and possibly treat active inflammatory bowel disease. The best results have been observed in patients with pouchitis, while mixed results have been reported in other settings. (See "Probiotics for gastrointestinal diseases".)

Lactose avoidance — Patients with Crohn's disease, particularly those with ileal disease, have an increased frequency of acquired lactase deficiency and symptomatic lactose intolerance [19,20]. Patients with suggestive symptoms should undergo a trial of lactose avoidance. If the diagnosis is in doubt, a lactose breath hydrogen test can be obtained. If the patient responds to lactose avoidance or if the test is positive, the patient should be instructed to avoid lactose containing foods (table 3). Calcium supplementation should be maintained in patients on a limited lactose intake to minimize the risk of bone loss. (See "Lactose intolerance".)

Other dietary interventions — Dietary interventions in patients with Crohn's disease aim to improve nutrition and eliminate food triggers. This topic is discussed in detail elsewhere. (See "Nutrition and dietary interventions in adults with inflammatory bowel disease".)

Perianal disease — Perianal abscesses and fistulae occur in up to one-third of patients with Crohn's disease. The management of such patients is discussed in detail elsewhere. (See "Perianal complications of Crohn's disease".)

MAINTENANCE THERAPY — Once a patient has achieved remission using a 5-ASA drug, antibiotics, and/or a glucocorticoid, we suggest maintenance therapy with a 5-ASA drug. In patients with ileal disease, mesalamine (Pentasa®, Asacol®) at a dose of 3 to 3.6 g/day should be considered as long-term therapy, with the hope of preventing disease relapse [21-24]. However, it must be acknowledged that there is inconsistent evidence supporting this approach. (See '5-ASA drugs' above and "Sulfasalazine and 5-aminosalicylates in the treatment of ulcerative colitis", section on 'Maintaining remission'.)

Limited data also suggest that antibiotics are effective for the maintenance of remission [25]. (See "Antibiotics for treatment of inflammatory bowel diseases", section on 'Crohn's disease'.)

Budesonide may be effective for the short-term maintenance of remission (three to six months), but studies suggest it is not effective for long-term maintenance [16]. Conventional glucocorticoids are not effective for preventing relapses in patients in remission [3,26,27]. (See "Budesonide in the treatment of Crohn's disease".)

REFRACTORY CROHN'S DISEASE — Patients with Crohn's disease who relapse while on treatment, who fail to respond to the above treatments, or who cannot be successfully tapered off of steroids may require treatment with immunomodulators or biologic therapy. The management of these patients is discussed separately. (See "Overview of the medical management of severe or refractory Crohn's disease in adults".)

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SUMMARY AND RECOMMENDATIONS

  • Outpatient therapy with oral medications is appropriate for most patients with mildly to moderately active Crohn's disease. However, hospitalization is required for patients who present with severe symptoms or who appear toxic. (See 'Treatment of active disease' above and "Overview of the medical management of severe or refractory Crohn's disease in adults", section on 'Severe disease'.)
  • There are two general approaches to the outpatient treatment of Crohn's disease: step-up therapy and top-down therapy. Step-up therapy typically starts with medications that are less potent and (often) associated with fewer side effects. If those therapies are ineffective, more potent (and potentially more toxic) medications are used. Top-down therapy starts with more potent therapies, such as biologic therapy or immunomodulator therapy, relatively early in the course of the disease. In general, we favor step-up therapy. (See 'Step-up versus top-down therapy' above.)
  • We suggest an initial trial of 5-aminosalycilic acid (5-ASA) drugs in patients with mild to moderate Crohn's disease who do not have systemic symptoms rather than treatment with glucocorticoids, immunomodulators, or biologic therapies (Grade 2C). This suggestion is based upon the relative safety of 5-ASAs compared with the other drugs. However, data supporting the use of 5-ASA drugs are variable and some authorities recommend that 5-ASA drugs (with the possible exception of sulfasalazine) not be used in the treatment of Crohn's disease. (See '5-ASA drugs' above.)

    For patients with ileitis and mild symptoms, we often begin treatment with a slow release oral 5-ASA drug (table 1), such as Pentasa® (2 g/day) or Asacol® (2.4 g/day). The dose is then increased to a maximum of 4 g/day for Pentasa® or 4.8 g/day for Asacol®, depending upon the clinical response. By contrast, sulfasalazine is less useful for ileitis because colonic bacteria must cleave the drug to release the active 5-ASA moiety.

    For patients with ileocolitis or colitis and mild to moderate symptoms, we initiate therapy with sulfasalazine (2 g/day) or one of the mesalamine drugs (2 to 2.4 g/day, depending upon the drug used) (table 1).
  • We suggest antibiotics (eg, ciprofloxacin and metronidazole) in patients who do not tolerate 5-ASA drugs or do not improve within three to four weeks (Grade 2B). (See "Antibiotics for treatment of inflammatory bowel diseases".)
  • We suggest prednisone 40 to 60 mg/day for patients with mild to moderate disease who are unresponsive to the above measures, or for those presenting with more severe initial symptoms (but not requiring hospitalization) (Grade 2A). Controlled ileal release (CIR) budesonide is a glucocorticoid with a high first-pass hepatic metabolism that is a reasonable alternative to prednisone for patients with active ileitis or right-sided Crohn's colitis, particularly in those with prior intolerance or contraindications to systemic glucocorticoids. (See 'Conventional glucocorticoids' above and "Overview of the medical management of severe or refractory Crohn's disease in adults", section on 'Severe disease' and 'Non-systemic glucocorticoids' above.)
  • We suggest maintenance therapy with a 5-ASA drug rather than budesonide or no treatment for patients who have achieved remission with a 5-ASA drug, antibiotics, and/or glucocorticoids (Grade 2C). (See 'Maintenance therapy' above.)
  • Patients with refractory disease may require treatment with immunomodulators or biologic therapy. (See "Overview of the medical management of severe or refractory Crohn's disease in adults".)

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