Raptiva - A New, Breakthrough In The Treatment Of Psoriasis

Main Category: Eczema / Psoriasis
Article Date: 28 Oct 2004 - 12:00 PDT


A new, breakthrough treatment for moderate to severe chronic psoriasis is launched today in the UK. Raptiva (efalizumab) is the first biologic agent to receive an EU licence in this therapeutic area. Raptiva may offer new hope to those patients who have previously had limited therapy options.

Until now, dermatologists have struggled to manage some patients with moderate to severe chronic psoriasis due to the harsh long-term side effects and contraindications associated with current second line treatments. Raptiva, however, focuses on the disease process as opposed to the symptoms, and works by targeting three key steps responsible for the generation and maintenance of psoriasis plaques. Raptiva inhibits the activation of T-cells, the binding and trafficking of T-cells and the reactivation of T-cells.

Dr Anthony Chu, Consultant Dermatologist at Hammersmith Hospital in London said: "Despite the number of treatment options available to the psoriasis sufferer, many patients find the topical agents unacceptable for long-term use and systemic treatments are potentially toxic and do not always work.

Raptiva represents a major advance in our treatment of this chronic condition. It is well tolerated and effective, leading to a major improvement in the patient's quality of life. Raptiva heralds a new golden age in the treatment of psoriasis allowing consultants to treat psoriasis more effectively and maintain long term control of this disease."

Due to the visible and often painful nature of psoriasis it can have a devastating effect on health and mental well-being. Patients who have experienced feelings of stigmatisation and rejection have been shown to suffer from higher levels of anxiety and depression,1 and up to 10% of sufferers have contemplated suicide as a direct result of their condition. A recent survey of psoriasis patients revealed that over one third of patients were unhappy with their current treatment.

In clinical trials, 59% of patients who received Raptiva demonstrated a 50% improvement in their psoriasis using the Psoriasis Area and Severity Index (PASI), which measures the severity of the psoriasis, after 12 weeks of treatment, whilst 27% achieved at least a 75% improvement in their PASI.

Raptiva has been shown to provide rapid and sustained6 improvement of psoriasis symptoms as measured by PASI from as early as week two.5

The clinical efficacy of Raptiva has been shown to increase with continual treatment over time:

* PASI-75 response improved from 26.6% (placebo: 4.3%, p<0.001) at week 12 to 43.8% at week 24

* PASI-50 response improved from 58.5% (placebo: 13%, p<0.001) at week 12 to 66.6% at week 24.

In a long-term study, efficacy was maintained throughout 30 months of continuous treatment with Raptiva - the longest continuous treatment data for psoriasis patients receiving a biologic. Of those patients remaining in the study, PASI-75 responses were achieved by 71% of patients and PASI-90 responses were achieved by 45% of patients. The mean percentage PASI improvement achieved at week 12, relative to baseline, was maintained through month 30 of the study.

The safety and tolerability of Raptiva has been demonstrated in a database of 3291 patients with psoriasis to date. No evidence of end-organ toxicity7 or cumulative toxicity7 has been observed within 30 months of continuous use and no increase in malignancies versus placebo has been detected.8

Raptiva is licenced for adult patients, over 18 years old, with moderate to severe plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen, + ultra violet A). 8

Serono received EMEA approval at the end of September 2004 and is expecting to launch to other EU countries in early 2005.

For further information or to speak to a dermatologist or individuals about their personal experiences of psoriasis please contact: Kate Burd, Fiona Cheetham or Karine Jegard at Munro & Forster Communications on 0207 815 3900.

Notes to editors

1. Psoriasis is a chronic, relapsing skin condition, which affects 1.2 million people in the UK. It is an autoimmune disease that causes the skin cells to mature at a faster rate causing raised, red patches of skin with silvery scales, which are often painful, itchy and may bleed.

2. Dermatologists diagnose psoriasis clinically based upon the characteristics of the skin lesions/plaques and the areas affected. It is monitored in clinical trials using the Psoriasis Area and Severity Index (PASI). This scale measures the severity in terms of redness, plaque thickness and scaling of the skin on a scale of 0 to 72 - the higher the score the more severe the psoriasis.

3. PUVA therapy is combination of psoralen, a light sensitising drug, and exposure to ultraviolet light. It is used to manage patients with moderate to severe psoriasis. Patients require treatment two to five times a week in a specialist clinic. Phototherapy can be associated with side effects such as nausea, skin burns and the development of cancerous cells. Patients also require eye protection after treatment.

4. The presentation for Raptiva is 100 mg/ml powder and solvent for solution for injection. An initial single dose of 0.7 mg/kg body weight is given, followed by weekly injections of 1.0 mg/kg body weight (maximum single dose should not exceed a total of 200 mg). The duration of therapy is 12 weeks. Therapy may be continued in patients who responded to treatment (PGA [Psoriasis Global Assessment] good or better). The usual cost of treatment for one patient for one year is 8,798.40.

5. The most frequent symptomatic side effects observed during Raptiva therapy were mild to moderate, dose-related, acute flu-like symptoms including headache, fever, chills, nausea and myalgia. After initiation of therapy, these reactions were generally less frequent and occurred at similar rates to that seen in the placebo group from the third and subsequent weekly injections.

References

1. Fried RG et al. Trivial or terrible? The psychosocial impact of psoriasis. Int J Dermatol. 1995 Feb;34(2):101-5

2. Krueger G et al. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey

3. All Party Parliamentary Group on Skin; Report on the enquiry into impact of skin diseases on people's lives, July 2003

4. Gordon K et al. Efalizumab Study Group. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA. 2003 Dec 17;290 (23):3073-80

5. Gordon K et al. Efficacy and safety of efalizumab in a large cohort of patients with moderate to severe plaque psoriasis pooled results from randomised phase III trials. Poster presented at: 62nd Annual Meeting of the American Academy of Dermatology; February 6-11, 2004; Washington DC

6. Menter A et al. Efficacy and safety of 24-week continuous efalizumab therapy in patients with moderate to severe plaque psoriasis. Poster presented at AAD July 25-29, 2003; poster 44

7. Gottlieb AB et al. Efficacy and safety outcomes of extended efalizumab therapy of patients with moderate to severe plaque psoriasis: an update. Poster presented at AAD; July 28-August 1, 2004 New York detail aid

8. Raptiva Summary of Product Characteristics, October 2004

Kate Burd
Senior Account Executive
Munro & Forster
89 Albert Embankment
London, SE1 7TP
0207 815 3963
0207 815 3999

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