Nsw therapeutic Advisory Group Level 5, 376 Victoria Street po box 766




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NSW Therapeutic Advisory Group


Level 5, 376 Victoria Street
PO Box 766
Darlinghurst NSW 2010
Phone: 61 2 8382 2852
Fax: 61 2 8382 3529
Email: nswtag@stvincents.com.au
www.nswtag.org.au

Infliximab in ulcerative colitis



Targeted Literature Review

August 2007

Contents

Infliximab in ulcerative colitis 2

Contents 2

Background 5

Current indications and dosage 5

Current subsidy status 6

Section 100 items 6

Public summary documents 6

Treatment recommendations 6

Disease resistant to conventional therapy 6

Disease that is not steroid refactory 7

Preventing colectomy 7

Safety 7

General 7

Malignancy 8

Infection 9

Use in children 9

Efficacy 9

Safety 10

Use in the elderly 10

Efficacy 10

Safety 10

Cost 10

Introduction 12

Systematic Reviews, Meta-analyses and Guidelines 13

Cochrane 13

Summary: 13

Summary: 15

ACP Journal Club 16

Summary: 16

American Gastroenterological Association Institute 16

Summary: 17

JAMA 17

Summary: 17



National Horizon Scanning Centre 18

Summary: 18

Scottish Medicines Consortium 19

Summary: 19

NICE Health Technology Appraisal 19

Summary: 19



Use in Adults 20

Reviews in IBD 20

Efficacy and safety reviews 20

Abstract: 20

No abstract available. 20

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No abstract available. 23

Safety reviews 23

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Reviews of safety – general and in other therapeutic areas 24

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Efficacy studies 27

RCTs 27

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Non-randomised studies 31

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Safety studies 33

IBD 33

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No abstract available. 39

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Rheumatoid conditions 40

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No abstract available. 52

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Use in Children 57

Reviews in IBD 57

Efficacy and safety reviews 57

Abstract: 57

Safety reviews 57

Reviews of safety – general and in other therapeutic areas 57

Efficacy studies 57

RCTs 57


Non-randomised studies 57

Abstract: 57

Abstract: 58

No abstract available. 59

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Safety studies 61

IBD 61


Abstract: 61

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Predictors of response 63

Abstract: 63



Health economics, resources, risk/benefit 63

Abstract: 63



Acknowledgments 65


Synopsis

This Targeted Literature Review is not a Position Statement and does not represent recommendations from the NSW Therapeutic Advisory Group. The Synopsis has been derived from the main points from the reviews, guidelines and articles identified in a search of the published literature. Summaries or abstracts of these reviews, guidelines and articles have been presented in the main text of this document, either verbatim or edited for conciseness or clarity.



Background


Infliximab is a chimeric humanised murine monoclonal antibody that binds to human tumour necrosis factor alpha (TNFα), a proinflammatory and immunoregulatory cytokine that, when overexpressed, mediates chronic inflammation in diseases such as Crohn's disease (CD) and rheumatoid arthritis (RA). Biological activities attributed to TNFα include: induction of proinflammatory cytokines such as IL-1 and IL-6; enhancement of leucocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leucocytes; activation of neutrophil and eosinophil functional activity; and induction of acute phase and other liver proteins (summarised from MIMS product information.)

Current indications and dosage


The MIMS lisiting for Infliximab (Remicade™) has indications for RA, ankylosing spondylitis, CD, refactory fistulising CD, psoriatic arthritis, psoriasis and ulcerative colitis (UC) (Date of TGA Approval or Manufacturer's Last Amendment 11/01/2007). For UC, the treatment is for moderately severe to severe active UC in patients who have had an inadequate response to conventional therapy.
The dosage of infliximab for UC is 5 mg/kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/kg infusion dose at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If patients have not responded to the initial 3 treatment infusion regimen at weeks 0, 2 and 6 weeks, then careful consideration should be given before persisting with further treatment. Data supporting readministration, other than every 8 weeks, are not available at this time.
A Cochrane review (2006) recommends a dose of 5 mg/kg but it does not recommend an ideal dosing schedule. The American Gastroenterological Association also recommends this dosage (Lichtenstein et al 2006) infused over 2 hours in an induction regimen of 3 doses at weeks 0, 2, and 6 - followed by maintenance therapy every 8 weeks in patients who respond. They add that for patients with CD who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. In the case of nonresponse to 3 infusions, further treatment with infliximab is not recommended. An attempt to withdraw or taper any concomitant corticosteroid therapy is sensible in patients who achieve remission with infliximab.

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