Evaluation of the Burden of Illness in Patients with Mild to Moderate Crohn Disease

Sandra Joshua-Gotlib, MSPH; Karin Coyne, PhD, MPH; Miriam Kimel, PhD; Mervyn Danilewitz, MD; Christine Thompson, Sylviane Forget, MD

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In This Article

Abstract and Introduction

A cross-sectional study of 740 patients with mild to moderate Crohn disease (CD) treated with 5-aminosalicylic acid (5-ASA) derivatives was performed to evaluate clinical parameters and patient-reported outcomes. Patients were assessed with the use of clinical questions, the Treatment Satisfaction Questionnaire–Crohn, the Inflammatory Bowel Disease Questionnaire, and the Crohn Work and Activity Impairment Index. Descriptive analyses were performed, and group comparisons were done using t tests and analysis of variance. Patients reported an average of 3 flares per year, and 73.9% reported 6 or more symptoms during a flare, with diarrhea (88.4%), abdominal cramps and tightening (85.1%), and abdominal pain (85.8%) being the most common. Approximately 54% of patients required more than 1 medication to manage flare symptoms. As the number of flares per year increased, treatment satisfaction, health-related quality of life, and productivity decreased. Patients with mild to moderate CD treated with 5-ASA derivatives have significant morbidity and may require more effective therapy.

Crohn disease (CD) is an inflammatory bowel disease characterized by intermittent flares and is associated with abdominal pain, diarrhea, weight loss, and fever. The gold standard for measuring disease activity is the Crohn's Disease Activity Index (CDAI), which is based on clinical symptoms, systemic manifestations, physical findings, and laboratory parameters.[1] The American College of Gastroenterology has developed guidelines that categorize CD activ ity as remission, mild-moderate, moderate-severe, or severe-fulminant based on the number and severity of symptoms, such as abdominal tenderness or pain, nausea or vomiting, and weight loss.[2] These guidelines can help support clinical decisions about treatment options.

Disease severity can also be categorized according to treatments, which include aminosalicylates for mild disease; topical glucocorticoids for mild to moderate disease; and systemic corticosteroids, immunomodulators, or surgery for severe disease.[3] 5-Aminosalicylic acid (5-ASA) derivatives have been used for the management of mild to moderate ulcerative colitis for more than 50 years and, while not indicated for CD, continue to be used to treat patients with mild to moderate CD.[2] Whether 5-ASA derivatives are effective in maintaining remission in CD is unclear.[4,5,6]

The impact of disease from a patient perspective has been evaluated using patient-reported outcomes (PROs), such as health-related quality of life (HRQOL) and symptom assessments.[7] Therapies for chronic diseases are generally palliative rather than curative. PROs are considered to be appropriate indicators of disease activity and progression in chronic conditions; PROs augment the understanding of clinical status by capturing information that may be missed with traditional measures of effectiveness and safety.[7] Because PROs can be measured in increasingly reliable and valid ways, they are being used more often as efficacy end points in randomized clinical trials and population-based studies.[7]

In CD, most PRO evaluations have involved patients with mod erate to severe disease who are receiving various immunomodulatory ther apies or patients enrolled in clinical trials. Little descriptive research has been conducted to evaluate PROs, such as HRQOL, work productivity, and treatment satisfaction, in patients with mild to moderate CD, particularly among patients being treated with 5-ASA derivatives. Of CD patients treated with medications in 2002, 83% in the United States, 63% in Japan, and 55% in Europe (France, Germany, Spain, and the United Kingdom) were treated with 5-ASA derivatives.[8]

The purpose of this study was to evaluate PROs and burden of illness associated with mild to moderate CD in patients treated with 5-ASA derivatives.

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