Remicade® (infliximab) Receives Scottish Medicines Consortium Ruling For Severe Psoriasis

Main Category: Eczema / Psoriasis
Article Date: 10 May 2007 - 12:00 PST

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The Scottish Medicines Consortium (SMC) today announced that Remicade® (infliximab) is approved for restricted use within the NHS Scotland for the treatment of severe plaque psoriasis. Infliximab is indicated for use in adult patients who have not responded to, have a contraindication to, or who are intolerant of systemic therapy, including ciclosporin, methotrexate or psoralen ultraviolet A (PUVA).1

The National Institute for Health and Clinical Excellence (NICE) are currently reviewing guidance for patients in England and Wales, with a decision** expected towards the end of 2007.

Commenting on today's recommendations, Professor Chris Griffiths, Professor of Dermatology at Hope Hospital in Manchester, says of the SMC advice: "The biologic agents such as infliximab are a real advance in the management of psoriasis. Both the symptoms and signs of severe psoriasis can be rapidly and effectively controlled by these agents and in so doing greatly improve patients' lives".

Infliximab is one of three biologic therapies licensed for psoriasis in the UK. The main trial to assess the efficacy of infliximab in psoriasis was the EXPRESS study that enrolled over 350 patients with moderate-to-severe plaque psoriasis. After 10 weeks of treatment with infliximab, more than 80% of patients had at least a 75% improvement in their psoriasis (PASI*** 75). Importantly, this early improvement in psoriasis was maintained for up to a year later, with what equates to between six to eight infusions of infliximab per year. The EXPRESS study confirms that infliximab is generally well-tolerated and has a good risk-to-benefit balance.2,3 Compared to placebo, infliximab improves both the signs and symptoms of psoriasis in adult plaque psoriasis and further, improves patient quality of life.1

Psoriasis is characterised by visible red, scaled plaques, covered with silvery white scales. An estimated that 2% of the UK population has psoriasis and men and women are similarly affected.4 Psoriasis is a chronic disorder causing both physical and psychological trauma to the individual: living with the condition is comparable to that of other major medical diseases, such as rheumatoid arthritis, hypertension, heart disease and depression.5

Commenting on today's SMC advice Gladys Edwards, Chief Executive of the Psoriasis Association, says: "For Scottish patients with psoriasis this is very welcome news of an additional treatment option. Psoriasis is a difficult skin disease that can have a profound social and psychological impact on people's lives. People with psoriasis need a wide range of treatments available and this drug offers real hope to those for whom all other treatments have failed."

About infliximab

Article Type Normal Article Headline Article Article Type Infliximab (Remicade®) is a monoclonal antibody that specifically targets TNF-a. 3 mg/kg given as an intravenous infusion over a 2?hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Remicade must be given concomitantly with methotrexate. Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.6

About psoriasis

Psoriasis is a chronic, relapsing skin condition that appears as red, scaled plaques covered with silvery white scales. It can affect any part of the skin, although the elbows, knees and scalp are the most common sites. 2

For additional information, please refer to the separate Fact Sheet on Psoriasis

***Psoriasis Area Severity Index (PASI) is an objective technique to assess the physical severity of the disease.

About the Scottish Medicines Consortium (SMC)

The remit of the Scottish Medicines Consortium (SMC) is to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licenced from January 2002). This advice will be made available as soon as practical after the launch of the product involved. www.scottishmedicines.org.uk

About the National Institute for Health and Clinical Excellence (NICE)

Part of the NHS, NICE is an independent organisation responsible for providing national guidance on treatments and care for people using the NHS in England and Wales. Their guidance is for healthcare professionals, patients and their carergivers and helps them make decisions about treatment and healthcare.

**A Single Technology Appraisal (STA) is designed for the appraisal of a single medicine product, device or technology with a single indication, where the majority of the relevant evidence lies with one manufacturer or sponsor. www.nice.org.uk

About Schering-Plough

Schering-Plough is a global science-based healthcare company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its workforce of more than 32,000 people around the world. www.schering-plough.com

References

1. Scottish Medicines Consortium: Infliximab 100mg powder for intravenous infusion (Remicade®). Number 318/06. Published 7th May 2007 at: http://www.scottishmedicines.org.uk
2. Reich K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005; 366(9494): 1367-74
3. Reich K, et al. Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe: a randomised controlled trial. Br J Dermatol. 2006, 154 (6): 1161-8
4. What is Psoriasis? The Psoriasis Association. Downloaded from www.psoriasis-association.org.uk/what-is.html. Downloaded 23.08.06<** to match with psoriasis backgrounder **>
5. Sterry W, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. British Journal of Dermatology 2004;151 (Suppl 69): 3-17
6. Remicade® Summary of Product Characteristics - available at www.emc.medicines.org.uk/Accessed 10.11.06

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