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National Horizon Scanning Centre


Infliximab (Remicade) for ulcerative colitis July 2005. Available at: www.pcpoh.bham.ac.uk/publichealth/horizon

Summary:


Infliximab may be welcomed by patients with UC who have had an inadequate response to conventional treatment due to the clinical response, and the induction and maintenance of clinical remission demonstrated in recently reported phase III trials. There are, however, significant side effects associated with therapy with TNFα inhibitors.

The number of infusions required for maximum benefit and long-term response is uncertain at present. It is also unclear at present the number of patients that will receive infliximab initially if successfully licensed for UC. It is therefore difficult to estimate the overall cost impact of infliximab for the treatment of UC at this time. Treatment with infliximab may lead to a net saving due to a possible reduction in hospitalisation and surgical procedures. Infliximab is already used in the gastrointestinal setting in the treatment of CD and thus minimal additional training of healthcare professionals will be required.



Scottish Medicines Consortium


Infliximab 100 mg powder for intravenous infusion. March 2007. Available at: www.scottishmedicines.org.uk

Summary:


In the absence of a submission from the holder of the marketing authorisation. Infliximab (Remicade) is not recommended for use within NHSScotland for the treatment of moderately to severely active UC in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result the authors cannot recommend its use within NHSScotland.

NICE Health Technology Appraisal


Infliximab for ulcerative colitis - final scope. March 2007. Available at: www.nice.org.uk

Summary:


This is the final scope of an appraisal of the clinical and cost effectiveness of infliximab for moderately to severely active UC. A first review is scheduled for August 2007 and the date of the second review has not been set.

Use in Adults

Reviews in IBD

Efficacy and safety reviews


Baumgart DC, Sandborn WJ.

Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. Vol. 369(9573)(pp 1641-1657), 2007.


Abstract:


This paper critically reviews the evidence for established (5-aminosalicylic acid [5-ASA] compounds, corticosteroids, immunomodulators, calcineurin inhibitors) and emerging novel therapies-including biological therapies-directed at cytokines (eg, infliximab, adalimumab, certolizumab pegol) and receptors (eg, visilizumab, abatacept) involved in T-cell activation, selective adhesion molecule blockers (eg, natalizumab, MLN-02, alicaforsen), anti-inflammatory cytokines (eg, interleukin 10), modulation of the intestinal flora (eg, antibiotics, prebiotics, probiotics), leucocyte apheresis and many more monoclonal antibodies, small molecules, recombinant growth factors, and MAP kinase inhibitors targeting various inflammatory cells and pathways.
D'Haens G.

Risk and benefits of biologic therapy for inflammatory bowel diseases. Gut. Vol. 56(5)(pp 725-732), 2007.


No abstract available.

Thukral C, Cheifetz A, Peppercorn MA.

Anti-tumour necrosis factor therapy for ulcerative colitis: Evidence to date. Drugs. Vol. 66(16)(pp 2059-2065), 2006.

Abstract:


ACT1 and ACT2 trials were large, randomised and placebo-controlled, and have shown that infliximab is significantly more efficacious than placebo in treating both corticosteroid-responsive and -refractory moderate-to-severe UC. Data from these 2 studies showed that in patients with moderate-to-severe UC, treatment with infliximab (5 and 10 mg/kg), compared with placebo, led to significantly higher rates of clinical response, clinical remission and mucosal healing. However, a significant proportion of patients who were receiving oral corticosteroids at the start of the trials, remained on corticosteroids despite infliximab therapy. Additionally, the safety profile of the drug was found to be similar to what has been reported in clinical studies of infliximab in patients with CD. On the basis of currently available data, the authors use infliximab as a remission-inducing agent in patients who have moderate-to-severe UC and are either refractory to or intolerant of mesalazine products and immunomodulators. Moreover, infliximab seems to be a reasonable therapeutic modality for remission maintenance in those patients with UC in whom mesalazine products and immunomodulators have failed. Although data are limited, infliximab may be considered as a remission-inducing agent in patients with moderate-to-severe UC which is refractory to oral corticosteroids. However, the role of infliximab in the treatment of UC patients who are dependent on oral corticosteroids is still unclear and, therefore, should be considered only in patients who cannot be successfully transitioned to or are intolerant of oral immunomodulators. Furthermore, infliximab may be an alternative to ciclosporin (cyclosporin) in hospitalised patients with severe to moderately severe but not fulminant UC who do not respond to intravenous corticosteroids. At present, there is insufficient evidence to advocate using infliximab as a first-line agent for UC patients with mild or moderate-to-severe disease. Future randomised, controlled trials with clearly defined patient populations should further help to clarify the definitive role of infliximab in the therapeutic scheme for UC.
Scholmerich J.

Treatment of inflammatory bowel disease. Schweizerische Rundschau fur Medizin Praxis. Vol. 96(9)(pp 337-343), 2007.


Abstract:


Standard treatment for IBD with 5-ASA, steroids and immunosuppressants is rather effective and currently optimised using combinations of drugs or application routes. Among the biologics only infliximab has reached the therapeutic arsenal for CD - it is also effective in some patients with UC. Early aggressive treatment thus far is not established. Hormones and growth factors may play a role. Probiotics have a place in the treatment in particular for UC.
Collins P, Rhodes J.

Ulcerative colitis: Diagnosis and management. British Medical Journal. Vol. 333(7563)(pp 340-343), 2006.


No abstract available.

Nakamura K, Honda K, Mizutani T, et al.

Novel strategies for the treatment of inflammatory bowel disease: Selective inhibition of cytokines and adhesion molecules. World Journal of Gastroenterology. Vol. 12(29)(pp 4628-4635), 2006.

Abstract:


Infliximab has become a standard therapy for CD and it is also likely to be beneficial for UC. Several TNFα inhibitors have been developed but most of them seem to not be as efficacious as infliximab. Adalimumab may be useful for the treatment of patients who lost responsiveness or developed intolerance to infliximab. Antibodies against IL-12 p40 and IL-6 receptor could be alternative new anti-cytokine therapies for IBD. Anti-interferon-gamma and anti-CD25 therapies were developed, but the benefit of these agents has not yet been established. The selective blocking of migration of leukocytes into intestine seems to be a nice approach. Antibodies against a4 integrin and a4beta7 integrin showed benefit for IBD. Antisense oligonucleotide of intercellular adhesion molecule 1 may be efficacious for IBD. Clinical trials of such compounds have been either recently reported or are currently underway. In this article, the authors review the efficacy and safety of such novel biological therapies for IBD.
De La Rue SA, Bickston SJ.

Evidence-based medications for the treatment of the inflammatory bowel diseases. Current Opinion in Gastroenterology. Vol. 22(4)(pp 365-369), 2006.


Abstract:


This review is an update on several significant analyses that have been published recently. It is intended to raise awareness of the data, helping clinicians to evaluate new treatments and to revisit older treatments with a critical eye.
Cottone M, Mocciaro F, Modesto I.

Infliximab and ulcerative colitis. Expert Opinion on Biological Therapy. Vol. 6(4)(pp 401-408), 2006.


Abstract:


Despite the fact that the cytokine profiles associated with UC and CD are classically considered different (a Th2 pattern in UC and a Th1 pattern in CD), there are several evidences in vitro and in vivo that TNFα has an important role in UC. Infliximab has been evaluated in different clinical settings both in adults and in children: in moderate-severe steroid-dependent UC, in severe refractory UC as rescue therapy, in active non-steroid-refractory UC, in resistant pouchitis and in maintenance of moderate-severe UC responsive to infliximab. On the basis of the RCTs, it is possible to draw the following conclusions for adults: infliximab seems active in severe steroid-refractory UC, allowing colectomy to be spared even if further controlled trials are needed with a larger sample of patients adopting strict and well-defined inclusion criteria. The drug seems active in inducing remission after 8 weeks in steroid-refractory patients, in patients taking steroids (even if it is not clear at which dosage of steroid dependence the drug is more active) and also in patients failing aminosalicylates therapy. The long-term response of infliximab in comparison to placebo in these subgroups of patients is not clinically impressive even if it is statistically significant. Further trials are warranted in order to establish the role of infliximab in steroid-dependent UC (defined with clear criteria), in maintaining remission after severe UC, in non-steroid-dependent moderate-severe UC and in refractory pouchitis. For children it is not possible to draw the same conclusions, due to a lack of RCTs, despite the encouraging data coming from open studies, mainly in steroid-refractory UC.
Travassos WJ, Cheifetz AS.

Infliximab: Use in inflammatory bowel disease. Current Treatment Options in Gastroenterology. Vol. 8(3)(pp 187-196), 2005.


Abstract:


Infliximab initially was developed to be used in patients with moderate-to-severe luminal or fistulising CD who are refractory to standard medical therapy. More and more practitioners now are using infliximab as first-line therapy because of its superior efficacy. Infliximab rapidly induces remission in CD, but when given chronically, it can provide long-term maintenance of remission. In addition, there are some data to support its use as a steroid-sparing agent and treatment for various extraintestinal manifestations of IBD and, although used predominantly to treat CD, recent data suggest that infliximab also may have a role in the management of UC. Overall, infliximab represents a clinically useful, cost-effective therapy that works well, even though careful patient monitoring is required to avoid rare but significant toxicities. The hope is that infliximab, together with other biologic agents that currently are in development, will allow us to modify the course of IBD, avoid complications such as strictures and abscesses, and reduce the need for surgery.
Knigge K.

Severe, steroid-refractory ulcerative colitis: Infliximab to the rescue? Evidence-Based Gastroenterology. Vol. 6(4)(pp 110-111), 2005.


No abstract available.




Safety reviews


Blonski W, Lichtenstein GR.

Complications of biological therapy for inflammatory bowel diseases. Current Opinion in Gastroenterology. Vol. 22(1)(pp 30-43), 2006.


Abstract:


This review analyses the complications associated with treatment of IBD with biologic agents. The data concerning biologics' associated toxicity in patients with inflammatory bowel disease are the most robust in the case of infliximab. These data are derived from both prospective, RCTs and from post-marketing experience. In the case of the remaining agents the data concerning safety in inflammatory bowel disease are limited, as these agents were not evaluated in as many trials as infliximab; indeed, some of them included only several patients.
Kamm MA.

Safety issues relating to biological therapies, with special reference to infliximab therapy. Research & Clinical Forums. Vol. 24(1)(pp 79-86), 2002.


Abstract:


The only licensed biological therapy for IBD is infliximab. Acute infusions can be associated with an allergic reaction. Development of human anti-chimeric antibodies is associated with acute infusion reactions, delayed type hypersensitivity reactions, and altered drug pharmacokinetics with a consequent diminuation in clinical efficacy. Ultrasound and MRI studies suggest that the subcutaneous track of subcutaneous fistulae often persist. Mucosal healing can lead to stricture formation. Infliximab increases the risk of infection. The risk of TB has been estimated as approximately 3 per 10,000, and has led to some deaths. CD is associated with an increased cancer risk. Any increased risk from treatment is controversial; long term, large, cohort studies are required. Teratogenicity is not apparent either experimentally or in early clinical data. TNFα inhibitors are dramatically effective in CD, often when other treatments have failed. As with every new treatment, however, its use should be judicious and tempered by data on the long-term benefit, side effects and safety issues.

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