The management of Crohn's Disease (CD) is based on the location and severity of the disease and its complications.¹ There is no established checklist for determining the severity of CD, but classifications of disease severity as determined by the American College of Gastroenterology may help guide physicians in choosing various medical treatments.¹

American College of Gastroenterology Practice Guidelines¹

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• Crohn's Disease Activity Index
• Harvey-Bradshaw Index
• IBD questionnaire
• Health-related quality-of-life questionnaire
• CDEIS (Crohn's Disease Endoscopic Index Severity)

Crohn's Disease Activity Index

The Crohn's Disease Activity Index (CDAI) is a validated measure of disease activity and response to treatment in clinical trials.² A score is calculated from a variety of factors including:

• The number of bowel movements in a day
• The use of antidiarrheal agents
• Severity of abdominal pain
• State of well-being
• Presence of extraintestinal manifestations
• Severity of anemia
• Amount of weight loss
• Presence or absence of abdominal mass

A calculation based on these parameters generates a number between 0 and 600. The higher the score, the more severe the disease. A score less than 150 indicates remission or inactive disease, and a reduction in score between 70 and 100 points represents a response to treatment in clinical trials.^3,4

Harvey-Bradshaw Index

The Harvey-Bradshaw Index (HBI) was developed to offer a simpler alternative to the CDAI. Rather than relying on a 7-day patient diary (as does the CDAI), the HBI requires only a single day's worth of entries. Furthermore, the HBI does not include all the clinical variables that appear on the CDAI.⁵

IBD questionnaire

The IBD questionnaire (IBDQ) is a health-related quality-of-life (HRQL) measurement specific to inflammatory bowel disease, measuring 4 dimensional scores including bowel function (eg, loose stool, abdominal pain), systemic function (eg, fatigue, altered sleep pattern), social function (eg, work attendance, need to cancel social events), and emotional function (eg, anger, depression, irritability).⁶ Each item is scored on a 7-point scale, with a score of 1 indicating a severe problem and 7 being no problem. Therefore, total IBDQ scores can range from 32 (very poor HRQL) to 224 (very good HRQL).⁶

The IBDQ was developed as an outcome to assess treatment efficacy in clinical trials.⁷ A short-form IBDQ (the SIBDQ) has 10 of the 32 questions of the IBDQ and can discriminate between inactive and active disease.⁷ The SIBDQ may be useful in clinical trials or in clinical practice to identify patients who are coping poorly and who may benefit from adjuvant counseling or more aggressive therapy.⁷

Health-related quality-of-life questionnaire

Quality of life (QoL) can be accurately assessed using the HRQL questionnaire. HRQL encompasses physical function, emotional and social well-being, ability to work productively, and freedom from disease symptoms.⁶ Patients with IBD have a much lower HRQL than other individuals.

An HRQL questionnaire can range from a question asking to rate pain on a 10-point scale, to a survey of 100 questions, and can be either generic or disease-specific. A nonspecific measure of QoL that can be used with patients with CD is the SF (Short Form)-36. A 36-item questionnaire, the SF-36 is useful for estimating disease burden and comparing disease-specific benchmarks with general population norms.⁸

CDEIS (Crohn's Disease Endoscopic Index Severity)

The CDEIS is an endoscopic index used to measure endoscopic activity in Crohn's disease patients. Deep and superficial ulcerations for 5 segments and the presence or absence of ulcerated and non-ulcerated stenosis are weighted to obtain a score of 0-44. A higher score is correlated with worse disease.⁹

Adapted from D'Haens G. Presented at: IBD 2008 3rd Congress of ECCO, Belgium.
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Indication
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

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Indication
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.

*The CIMZIA Co-Pay Savings Card Program is valid for out-of-pocket expenses for CIMZIA for up to 17 uses. The CIMZIA Co-Pay Savings Card Program is not valid for prescriptions that are reimbursed, in whole or part, under Medicare (including Medicare Part D), Medicaid, similar federal or state funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), private insurance in the Commonwealth of Massachusetts, or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA and DoD) for reimbursement. The parties reserve the right to amend or end this program at any time without notice.