Gastroenterology conditions for health professionals

Up-to-date information and tools for gastroenterologists, GPs, pharmacists, nurses and hospitals to optimise the safety and health outcomes of biological and other specialised medicines for inflammatory bowel disease (IBD).

Gastroenterology conditions for health professionals

Key points

  • Crohn disease and ulcerative colitis, known collectively as inflammatory bowel disease (IBD), are increasing in prevalence in Australia and lead to significant morbidity and impaired quality of life.
  • The faecal calprotectin test is highly accurate in distinguishing IBD from non-inflammatory gut disorders such as irritable bowel syndrome (IBS). Patients with elevated faecal calprotectin levels should be promptly referred to a gastroenterologist for further clinical assessment.
  • Rectal therapy might be unappealing for some people with ulcerative colitis but treatment with both oral and rectal 5-ASA compounds, rather than oral therapy alone, increases the likelihood of remission. Ask your patients about their adherence to rectal 5-ASA treatment and counsel appropriately.
  • Immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) are useful for maintaining disease remission in IBD, rather than inducing remission, due to their slow onset of action. Address adherence with patients by explaining that it may take at least 8–12 weeks to achieve an optimal response. Clearly communicate the risks, benefits and role in therapy.
 

MedicineWise News

IBD in primary care and beyond: a round table discussion

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Early intervention and intensive monitoring are essential to achieve tight control of inflammatory bowel disease (IBD). NPS MedicineWise brought together health professionals involved in the diagnosis and management of IBD, who each shared their perspective on some of the common challenges faced when distinguishing IBD from other bowel disorders in primary care and providing optimal care for patients with IBD.

Read the full article

 

Webinars

IBD: Identified uncertainties in optimising biologic and small molecule medicines – the latest evidence

When optimising the use of biologics to manage patients with inflammatory bowel disease (IBD) gastroenterologists may have to deal with areas of uncertainty. This webinar is an opportunity to join an expert panel as they discuss the latest evidence around these uncertainties.

Biologics and biosimilars – a practical guide for pharmacists

The use of biologics and biosimilars is increasing for a number of conditions. Pharmacists have a key role to play in ensuring the good governance of these medications, from an overarching hospital perspective through to the dispensing to individual patients. This webinar will provide practical tips for pharmacists to assist them in managing these medications.

Webinar slides

View the webinar here

Corticosteroids – indication guides optimal use

Join the Pharmaceutical Society of Australia (PSA) and an expert panel as they provide an update on the role of corticosteroids in rheumatology, gastroenterology and dermatology, including practical tips on how to enhance management of patients on corticosteroids to improve outcomes.

Find out more

IBD: diagnosis and management in primary care and beyond

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Join an interdisciplinary panel – comprised of a specialist inflammatory bowel disease (IBD) gastroenterologist, a general gastroenterologist and a GP – as they consider some of the challenges faced in the diagnosis and management of patients with IBD. 

Find out more

 

Gastroenterology conditions for consumers

For consumers, check out : Gastroenterology conditions for consumers

For your patients

Thiopurines for inflammatory bowel disease

Complete this action plan with patients taking thiopurines for Crohn disease and ulcerative colitis, to help explain possible benefits and risks, and plan regular monitoring.

Low-dose methotrexate for Crohn disease

This resource helps people to understand the facts about taking low-dose methotrexate for Crohn disease and plan the best way to take it.

Low-dose methotrexate for Crohn disease

Date published : 21 April 2021

Deciding on the best way to use my ulcerative colitis medicines

Use this tool with your patients to support shared decision making about the use of oral and rectal 5-ASAs for ulcerative colitis.

Crohn’s & Colitis Australia

  • Crohn’s & Colitis Hub
    This website has information, videos and news about living with Crohn disease and ulcerative colitis
 

Supporting safe practices for low-dose methotrexate: Position statement on the use of low-dose methotrexate

This position statement from the Council of Australian Therapeutic Advisory Groups (CATAG) provides guidance to health professionals and medicines governance committees on dispensing and administering low-dose methotrexate (oral and subcutaneous dosage forms). It aims to provide clear information on safety for those dispensing and administering low-dose methotrexate and assists them with providing reassurance to people undergoing treatment with low-dose methotrexate

Read the position statement 

 

Clinical resources

Gastroenterological Society of Australia (GESA)

  • Pregnancy, fertility and IBD
    • Gastroenterologist fact sheet
      This resource provides gastroenterologists with guidance for preconception, monitoring during pregnancy, flare management during pregnancy and medication safety during pregnancy and lactation. 
    • GP and obstetrician fact sheet
      This fact sheet provides GPs and obstetricians with information about medication safety, preconception assessment and monitoring during pregnancy for their patients with IBD.

European Crohn’s and Colitis Organisation (ECCO)

Crohn’s & Colitis Australia

  • GutSmart
    This online education platform delivers CPD courses to health professionals on the topics of Crohn disease and ulcerative colitis. The current course being offered is Nutrition and IBD for Dietitians.

Key reference

Reference

Summary

Gastroenterological Society of Australia (GESA)

Clinical Update for General Practitioners and Physicians, Inflammatory Bowel Disease (Updated 2018)

Provides a general guide to appropriate  diagnosis and management of IBD.  

Primarily intended  for Australian clinicians, this update complements recent consensus statements published by the European Crohn's and Colitis Organisation (ECCO), the British Society of Gastroenterology and other international organisations. 

 

Use of oral and rectal 5-ASA preparations for ulcerative colitis (UC)

Reference

Summary

Gastroenterological Society of Australia (GESA)

Clinical update for general practitioners and physicians, inflammatory bowel disease (updated 2018)

Section  4.3.1.1 5-ASA Therapy:  Mesalazine  preparations.

5-ASA can be given orally and rectally.  A combination of both  can achieve remission more quickly than oral therapy alone. For the treatment of distal disease, rectal 5-ASA therapy is  at least as effective as rectal steroids. 

Marshall et al, 2010

Rectal 5-aminosalicylic acid for induction of remission in ulcerative colitis

A systematic review including 38 randomised trials, evaluated the efficacy of rectal 5-ASA for treating active distal UC. Rectal 5-ASA was superior to placebo for  inducing:   

  • symptomatic  remission;  pooled odds ratio [OR]: 8.3 (8 trials, 95% confidence interval [CI] 4.28 to 16.12; p < 0.00001), 
  • endoscopic  remission;  OR:5.3 (7 trials, 95% CI 3.15 to 8.92; p < 0.00001), and 
  • histological improvement and remission; OR:6.3 (5 trials, 95% CI 2.74 to 14.40; p < 0.0001).   

Rectal 5-ASA was superior to rectal corticosteroids for symptomatic improvement and remission.   

Authors’ conclusions: rectal 5-ASA should be considered a first-line therapy for patients with mild to moderately active distal UC.   

Marteau et al, 2005

Combined oral and enema treatment with  Pentasa  (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind,  placebo controlled  study

A randomised  double blind  study in 127 patients with extensive mild/moderate active UC.   

Combination of oral and rectal  mesalazine  was more effective in achieving remission  at 8 weeks (64% (95% CI 50% to 76%)) than oral  mesalazine  alone  (43% (95% CI 28% to 58%;  p = 0.03) 

 

Lymphoma risk with the use of thiopurines for IBD

Reference

Summary

Lemaitre et al, 2017

Association Between between use of thiopurines or  tumor  necrosis factor antagonists alone or in combination and risk of lymphoma in patients  with  inflammatory bowel disease

Cohort study of over 189,000 patients with IBD to assess the risk of lymphoma associated with thiopurines and anti-TNF agents.   

Compared with unexposed patients, the risk of lymphoma was higher among those exposed to:

  • thiopurine monotherapy (adjusted hazard ratio [aHR] 2.60; 95% CI 1.96 to 3.44; p < .001),
  • anti-TNF monotherapy (aHR 2.41; 95% CI 1.60 to 3.64; p < .001), or
  • combination therapy (aHR 6.11; 95% CI 3.46 to 10.8; p < .001).   

The risk of lymphoma was higher for patients exposed to combination therapy vs those exposed to thiopurine monotherapy (aHR 2.35; 95% CI 1.31 to 4.22; p < .001) or anti-TNF monotherapy (aHR 2.53; 95% CI 1.35 to 4.77; p < .001).

 

Use of methotrexate for IBD

Reference

Summary

Nielsen et al, 2020

Efficacy and safety of methotrexate in the management of inflammatory bowel disease: A systematic review and meta-analysis of randomized, controlled trials

Systematic review and  meta-analysis  of 10 randomised control trials (n = 767) of methotrexate (MTX) for induction and maintenance of remission in IBD.  Authors concluded that:

  • Parenteral MTX is efficacious for maintenance of remission in Crohn disease.
  • MTX monotherapy is not effective for induction of remission in Crohn disease.
  • In ulcerative colitis, MTX is not shown to be effective for induction or maintenance of remission.
 

Use of faecal calprotectin to assist in diagnosis and monitoring of IBD

Reference

Summary

Gastroenterological Society of Australia (GESA)

Clinical update for general practitioners and physicians, inflammatory bowel disease (updated 2018)

Section 5.1.3 Faecal Calprotectin in Established IBD

Faecal calprotectin is a non-invasive biomarker of disease activity in IBD. Data support its utility in monitoring for sub-clinical disease activity and relapse.

 

Thiopurine metabolite testing

Reference

Summary

Gastroenterological Society of Australia (GESA)

Clinical update for general practitioners and physicians, inflammatory bowel disease (updated 2018)

Section  4.9.1 Thiopurine Metabolite Testing 

Thiopurine metabolite testing can be used to optimise thiopurine dosing and identify ‘shunters’ who might benefit from the addition of allopurinol in combination with a reduced dose of thiopurine. This testing can also be used to identify non-adherence and to minimise the risk of hepatotoxicity. 

 

Anti-TNF drug level and antibody testing

Reference

Summary

Mitrev et al, 2017

Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases

Evidence-based consensus statements from a committee of 25 Australian and international experts.

For anti-TNF agents, therapeutic drug monitoring (TDM) should be performed:

  • upon treatment failure,
  • following successful induction,
  • when contemplating a drug holiday and
  • periodically in clinical remission only when results would change management.   

Further data are required prior to recommending TDM for non-anti-TNF biological agents. 

 

Biosimilars

Reference

Summary

Jorgensen et al, 2017

Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

Non-inferiority, double-blind trial including 482 patients on stable treatment with infliximab originator. Patients were randomised in a 1:1 ratio to continue infliximab originator or switch to biosimilar infliximab treatment, with unchanged dosing regimen. Patients were being treated for a range of conditions – 55 (32%) had Crohn disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

  • Over 52 weeks, disease worsening occurred in 53 (26%) patients in the infliximab originator group and 61 (30%) patients in the biosimilar infliximab group.
  • The frequency of adverse events was similar between groups (for serious adverse events, 24 (10%) for infliximab originator vs 21(9%) for biosimilar infliximab; for overall adverse events, 168 (70%) vs 164 (68%); and for adverse events leading to discontinuation, 9 (4%) vs 8 (3%), respectively.

Haifer et al, 2021

Switching Australian patients with moderate to severe inflammatory bowel disease from originator to biosimilar infliximab: a multicentre, parallel cohort study

Prospective, open label, multicentre, parallel cohort, non-inferiority study in 7 Australian hospitals  over 48 weeks. Examining  non-medical switching of originator and biosimilar infliximab in 345 patients with IBD (232 with CD)

  • Deterioration of clinical condition was experienced by similar numbers of patients in the originator (7%) and biosimilar (8%) groups.
  • Switching clinically stable patients with IBD from originator to biosimilar infliximab was safe and clinically non-inferior to continuing treatment with originator infliximab.
  • Serious adverse events leading to infliximab discontinuation were infrequent in both the switch (6, 3%) and control (6, 4%) groups.  Infliximab treatment persistence over 48 weeks was similar for the 2 groups.
 

Corticosteroids for IBD

Reference

Summary

Gastroenterological Society of Australia (GESA)

Clinical update for general practitioners and physicians, inflammatory bowel disease (updated 2018)

Section  4.3.1.2 Corticosteroids

Corticosteroids are used for moderate-to-severe active IBD. They suppress  inflammation and  provide  rapid relief of symptoms. However, significant side-effects should exclude recurrent or long-term use. Corticosteroids are not effective for maintenance therapy.