Remicade(R) (infliximab) Receives NICE Approval For Severe Psoriasis, UK

Main Category: Eczema / Psoriasis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Jan 2008 - 1:00 PST

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The National Institute for Health and Clinical Excellence (NICE) announced that Remicade(R) (infliximab) is approved for use within its licensed indications for the treatment of adults with very severe plaque psoriasis when specific criteria are met.1 Severe psoriasis can impact on a patient's quality of life to the same extent as more life-threatening disorders such a diabetes, heart disease and cancer2,3 and infliximab can now provide these patients with a much needed treatment option.

Infliximab, a biologic treatment, represents a significant advance in the management of psoriasis in patients with severe disease who require fast onset and a long lasting response. In clinical trials the vast majority of patients achieved a 75% improvement in their psoriasis (PASI* 75) after 10 weeks of treatment with infliximab.4,5 Over half of these patients had a 90% improvement in their psoriasis4, equating to clearance of the disease.

Infliximab, within its licensed indications, is recommended as a treatment option for adults with severe plaque psoriasis only when the following criteria are met:

- The disease is very severe as defined by a total Psoriasis Area Severity Index (PASI) of 20 or more and a Dermatology Life Quality Index of more than 18

- The patient failed to respond to standard treatments or was intolerant or had a contraindication to these treatments

- NICE recommended that treatment with infliximab be continued beyond 10 weeks only in those patients that have shown an adequate response to treatment.

Welcoming today's NICE ruling Gladys Edwards, Chief Executive of the Psoriasis Association, said: "Psoriasis is a long term chronic condition and for many people it can have a profound social and psychological impact on their lives. We welcome the NICE approval of infliximab as it increases the treatment options available to those people who have severe psoriasis for whom previous treatments have been unsuccessful or inappropriate."

"It is important that people with severe psoriasis unresponsive to traditional systemic therapies have further options. Infliximab is a highly effective biologic therapy and offers hope for even the most recalcitrant cases of psoriasis," said Professor Christopher Griffiths, Professor of Dermatology, University of Manchester, Manchester.

About infliximab

Infliximab (Remicade(R)) is a monoclonal antibody that specifically targets TNF-. 5 mg/kg given as an intravenous infusion over a 2 hour period followed by additional 5 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

Infliximab is one of three anti-TNF (tumour necrosis factor) therapies and is shown to be effective in psoriasis. 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 6 months, and up to a year later, with what equates to only six infusions of infliximab per year. The EXPRESS study confirms that infliximab is generally well-tolerated and has a good risk-to-benefit balance.4,5 Compared to placebo, infliximab improves both the signs and symptoms of psoriasis in adult plaque psoriasis and further, improves patient quality of life.1

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.7

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

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

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.

http://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.

References

1. National Institute for Health and Clinical Excellence (NICE). Infliximab for the treatment of adults with psoriasis. January 2008

2. National Institute for Health and Clinical Excellence (NICE).). NICE technology appraisal guidance 103: Etanercept and efalizumab for the treatment of adults with psoriasis. July 2006.

3. Rapp S R et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999

4. 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): 1367-1374

5. 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

6. Remicade Summary of Product Characteristics - available at http://emc.medicines.org.uk. Accessed 17 January 2008.

7. What is Psoriasis? The Psoriasis Association. Downloaded from here. Downloaded 23.08.06

http://www.nice.org.uk

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