Stakeholder Insight: Inflammatory Bowel Disease - Debate over early aggressive treatment continues

Published by: Datamonitor

Published: Dec. 19, 2007 - 297 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Immunology and Inflammation pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the inflammatory bowel disease market

Contributing experts

Previous and related reports

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

Epidemiology and patient segmentation

Diagnosis

Treatment options and guidelines

Treatment trends

Key prescribing influences

Brand assessment

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction to treatment trees

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Disease definition

Classification of inflammatory bowel disease

Crohn's disease

Ulcerative colitis

Montreal classification of Crohn's disease and ulcerative colitis

Etiology

Genes associated with inflammatory bowel disease influence phenotype

Smoking

Appendectomy

Oral contraceptives

Infection with a pathogenic organism

Abnormal immune response to gut flora

Pathogenesis

Crohn's disease and ulcerative colitis are mediated by Th1 and Th2 lymphocytes, respectively

Disease incidence and prevalence

Crohn's disease

Ulcerative colitis

US

Europe

France

Germany

Italy

Spain

UK

Japan

Patient segmentation according to disease severity

Severity is measured using different disease activity scales

Majority of Crohn's disease and ulcerative colitis patients suffer mild to moderate disease

CHAPTER 5 DIAGNOSIS OF INFLAMMATORY BOWEL DISEASE

Diagnosis

Diagnosis of inflammatory bowel disease combines many avenues of investigation

Initial investigation begins with laboratory tests

Endoscopy is the most direct way of diagnosing inflammatory bowel disease

Radiology is a crucial adjunct to endoscopy

Serological markers are not yet used for clinical diagnosis

A high diagnosis rate is observed in inflammatory bowel disease

Just over 70% of Crohn's disease patients are diagnosed

Physicians report a higher diagnosis rate for ulcerative colitis than Crohn's disease

Complications arising in Crohn's disease and ulcerative colitis

Abscesses, strictures and fistulae are the most commonly physician-reported complications in Crohn's disease patients

Over 25% of Crohn's disease patients suffer from nutritional deficiencies

Bleeding is reported by almost all gastroenterologists in patients with ulcerative colitis

Almost half of ulcerative colitis patients experience bleeding complications

Association of IBD with immune disorders and co-morbidities

Anemia and anxiety and depression are the most commonly associated co-morbidities in inflammatory bowel disease

Patients with inflammatory bowel disease also suffer from irritable bowel disease

Immune-mediated diseases occur at greater frequency among patients with inflammatory bowel disease

CHAPTER 6 TREATMENT OPTIONS AND GUIDELINES

Treatment options

Non-pharmacological treatment of inflammatory bowel disease

Diet

Probiotics

Pharmacological treatment

Antibiotics

Anti-diarrheals and anti-spasmodics

Topical and oral aminosalicylates

Corticosteroids

Traditional immunosuppressants

Targeted biologics

Pharmacological versus non-pharmacological

Majority of patients with inflammatory bowel disease are treated pharmacologically

There are some patients who do not receive any therapy for inflammatory bowel disease

Treatment guidelines

Several treatment guidelines exist for the treatment of inflammatory bowel disease

Guidelines published by the British Society of Gastroenterology

NICE guidelines on the use of infliximab for Crohn's disease

NICE is appraising the use of infliximab for ulcerative colitis

American College of Gastroenterology guidelines for Crohn's disease

American College of Gastroenterology guidelines for ulcerative colitis

The European Crohn's and Colitis Organisation has published consensus guidelines for Crohn's disease

CHAPTER 7 TREATMENT TRENDS

Changes in therapy

Disease severity influences treatment

Despite lack of evidence to support efficacy, Crohn's disease and ulcerative colitis patients receive antibiotics at all levels of severity

Anti-spasmodics and anti-diarrheals are used as accompanying therapies for all severities of Crohn's disease and ulcerative colitis

Up to 60% of Crohn's disease and ulcerative colitis patients receive oral aminosalicylates

Topical aminosalicylates are used more for ulcerative colitis than Crohn's disease

Use of corticosteroids increases with disease severity

Gradual increase in use of immunosuppressants according to Crohn's disease severity

Immunosuppressants are largely reserved for moderate and severe ulcerative colitis patients

Use of biologics in Crohn's disease occurs in moderate-to-severe disease, but to a limited extent in mild patients

Use of biologic increases significantly with severity of ulcerative colitis

Monotherapy versus combination therapy

Increasing disease severity promotes use of combination therapy

First-line therapy

Oral 5-ASAs are used first-line for Crohn's disease

Corticosteroids are being prescribed at first-line for Crohn's disease

A combination of oral and topical 5-ASAs is the preferred first-line treatment regimen for ulcerative colitis

Almost 45% of Crohn's disease patients move to a second-line therapy

About a third of ulcerative colitis patients progress to treatment with second-line therapy

Second-line therapy

Immunosuppressants are the most commonly prescribed drug class by gastroenterologists at second-line for Crohn's disease

Biologics are prescribed at second-line for Crohn's disease

Corticosteroids are prescribed at second-line for ulcerative colitis

Immunosuppressants are also prescribed at second-line for ulcerative colitis

Almost a quarter of Crohn's disease patients progress from second-line to third-line treatment

A fifth of ulcerative colitis patients progress from second-line to third-line treatment

Third-line therapy

Biologics alone, or in combination with immunosuppressants, are the most commonly prescribed therapies for Crohn's disease at third-line

Like Crohn's disease, biologics are prescribed most frequently by gastroenterologists for ulcerative colitis

Surgery

Surgery is more effective for ulcerative colitis than Crohn's disease

Just under a third of Crohn's disease patients will eventually require surgery

Almost half as many patients with ulcerative colitis will eventually require surgery than those with Crohn's disease

Ulcerative colitis patients receive pharmacological therapy for longer than Crohn's disease patients before requiring surgery

"Step-up" versus a "top-down" approach to the treatment of inflammatory bowel disease

Current algorithms promote use of a "step-up" approach, but a "top-down" approach is now being suggested

Is there scope for a "top-down" approach?

Clinical trial data provide evidence showing a "top-down" approach is more effective than "step-up"

A "top-down" approach may change the natural history of Crohn's disease

There are a number of advantages and risks associated with a "top-down" treatment approach

The SONIC study will assess early use of azathioprine, infliximab or both in combination

Only 20% of severe Crohn's disease patients receive a "top-down" treatment approach

The potential for side effects ranks as the leading reason for not using a "top-down" approach in Crohn's disease

Similar percentage of ulcerative colitis and Crohn's disease patients receive a "top-down" treatment approach

The potential for side effects is also the leading reason for not using a "top-down" approach in ulcerative colitis

Gastroenterologists also reported that a lack of evidence and experience prevents use of a "top-down" approach

CHAPTER 8 PRESCRIBING INFLUENCES

Factors influencing physician decision making

Symptomatic improvement and healing of the mucosa are the most important factors influencing physician prescribing

Efficacy

Symptomatic improvement

Efficacy in promoting mucosal healing

Speed of onset of remission

Safety

Side-effect profile

Dosing

Convenient dosing and convenient administration frequency

Cost

Availability (formulary/reimbursement status)

Physician factors

Familiarity with product

Patient factors

Patient compliance

Other

Prevention of colon cancer

CHAPTER 9 BRAND ASSESSMENT

Brand map

How to interpret a brand map

5-ASAs: Lialda may offer advantages in a class where there is little differentiation

Pentasa (mesalazine)

Pentasa is an oral, controlled-release formulation that delivers mesalazine from the duodenum to the rectum

New dose of Pentasa reduces the number of pills taken per day

Gastroenterologists rated Pentasa well on familiarity and availability

Lialda/Mezavant (mesalazine)

Lialda is an oral sustained-release, multimatrix formulation of mesalamine

Lialda is marketed as a once-daily treatment for ulcerative colitis

Lialda has been compared with Asacol in a Phase III clinical trial

Gastroenterologists scored Lialda well on side-effect profile

Lialda is perceived by gastroenterologists to perform well on patient compliance, convenient dose and convenient administration frequency

Asacol (mesalazine)

Asacol is a delayed-release formulation of mesalazine, which is marketed by Proctor & Gamble

Asacol well perceived on familiarity with product and availability

Salofalk (mesalazine)

Salofalk is a Eudragit-L-coated pellet formulation of mesalazine

Salofalk and Pentasa are equally effective in achieving remission in mild to moderate ulcerative colitis patients

Salofalk did not perform well on patient compliance and convenient administration frequency

Claversal (mesalazine)

Like Salofalk, Claversal is a micropellet formulation of mesalazine

Fivasa (mesalazine)

In France, Asacol is marketed as Fivasa by Norgine Pharma

Salazopyrin (sulfasalazine)

Gastroenterologists did not rate Salazopyrin well on side-effect profile

Biologics: brand comparison shows that Remicade remains the leader, but Humira is perceived well by physicians

Remicade (infliximab)

Gastroenterologists rate Remicade well on familiarity with product and symptomatic improvement

Mucosal healing is associated most with Remicade than the other biologics

Remicade is not associated with a convenient dose and convenient administration frequency

More than three-quarters of severe patients with inflammatory bowel disease receive Remicade as their first biologic therapy

40% of patients who receive Remicade as their first biologic will terminate therapy

Most patients terminate Remicade therapy within the first year

An inadequate response is the most common reason for terminating Remicade therapy within the first year

Inadequate response remains the most common reason for terminating Remicade therapy after 1 year

Over a third of patients who fail Remicade therapy will move on to treatment with Humira

Surgery is the next step for many patients who fail Remicade therapy

Almost a quarter of Remicade-refractory patients progress to therapy with corticosteroids

Despite no evidence of efficacy in Crohn's disease, a small percentage of Remicade-refractory patients go on to receive Enbrel (etanercept)

Humira (adalimumab)

Humira is a self-administered, humanized anti-TNF monoclonal antibody

Clinical trials for Humira demonstrate efficacy in biologic-naïve patients and infliximab-refractory patients with Crohn's disease

Abstract

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