Data Supports Launch Of Remicade(R) (infliximab) For The Treatment Of Plaque Psoriasis In The UK

Main Category: Eczema / Psoriasis
Article Date: 11 Oct 2005 - 3:00 PST

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Remicade(R) (infliximab) is launched today in the UK for the treatment of moderate to severe plaque psoriasis. This new indication, supported by the strongest efficacy data in clinical trials of biologics to date, , covers the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or psoralen plus ultraviolet A light (PUVA).

Data from two recent studies revealed that Remicade achieves high levels of treatment efficacy in plaque psoriasis patients1,2 and this has resulted in recent EMEA approval of Remicade for the treatment of moderate to severe plaque psoriasis.

Results from the EXPRESS trial, (European Infliximab for Psoriasis (Remicade(R)) Efficacy and Safety Study), show that the majority of patients maintained significant improvement in psoriasis with continued Remicade treatment for up to 50 weeks1.

The primary endpoint was the percentage of patients who achieved >75 percent improvement in the Psoriasis Area and Severity Index (PASI) - the current gold standard for assessing extensive psoriasis - from baseline at week 10. The data showed:

-- 80.4% of patients achieved a PASI-75 response and 57.1% achieved PASI-90 compared to 2.6% and 1.3% of placebo respectively at week 101.

-- 82.2% of patients reached PASI-75 and 58.3% achieved a PASI-90 response compared with 3.9% and 1.3% of placebo respectively at week 241.

The data from the EXPRESS trial support findings from the SPIRIT clinical trial published in 2004 (Study of Psoriasis with Infliximab (REMICADE) Induction Therapy). SPIRIT found that patients treated with Remicade experienced significantly more improvement in their condition compared to patients given placebo, as measured by PASI2. SPIRIT trial data showed:

-- PASI score improvement of at least 75% after ten weeks was achieved by 88% of patients in the 5mg/kg group compared to 6% receiving placebo2.

-- Response was seen after the first dose of Remicade, with improvement evident in both Remicade-treated groups at as early as two weeks2.

-- After three doses, the response rates observed with Remicade were substantially greater than those of the other available biologic agents2.

"There is a significant number of patients with difficult to treat, high-need psoriasis for whom Remicade represents a significant therapeutic advance" said Jonathan Barker, Professor of Clinical Dermatology, Kings College Medical School. "This research highlights the real improvements that can be made to the quality of life of patients with moderate to severe plaque psoriasis so I am delighted that Remicade has been given approval for use in such patients."

Plaque psoriasis is the most common form of the condition. It is a chronic, immune-mediated disease resulting from overproduction and accumulation of skin cells that causes red, raised, scaly areas on the skin that may itch, burn or bleed . Psoriasis can result in severe pain and cause significant changes to physical appearance, negatively impacting quality of life for people with the condition . It is estimated that psoriasis affects approximately two percent of the UK population5. Patients report a similar detrimental impact on quality of life to patients with cancer, heart disease and diabetes .

Remicade is also currently licensed for the treatment of Crohn's Disease, Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis. More than 575,000 people worldwide have been treated with Remicade to date .

1 - PASI

The Psoriasis Area and Severity Index (PASI) is the current gold standard tool used to assess psoriasis disease severity in clinical trials3. It is a composite score from 0 to 72 that includes assessments of the extent of skin involvement, erythema, plaque thickness and the degree of scaling3.

2 - Recent Remicade Data

The two trials referred to in the press release are:

EXPRESS

EXPRESS (European Infliximab for Psoriasis (Remicade(R)) Efficacy and Safety Study) was a multi-centre, randomised, double-blind study with 378 patients who were candidates for phototherapy or systemic therapy. Patients were randomly allocated to receive intravenous infusions of infliximab 5mg/kg or placebo at weeks 0, 2 and 6 followed by maintenance treatment every 8 weeks. At week 24, placebo-treated patients were crossed over to receive infliximab through to week 46.

SPIRIT

SPIRIT was a multi-centre, randomised, double-blind study assessing the efficacy of Remicade in moderate to severe plaque psoriasis patients2. SPIRIT comprised 249 patients assigned to three groups and administered either placebo (n=51), Remicade at a dose of 3mg/kg (n=99) or Remicade at a dose of 5mg/kg (n=99)2.

3 - About Remicade (infliximab) (anti-TNF therapy)

A biologic agent marketed by Schering Plough as Remicade, infliximab is given by intravenous infusion at 0, 2 and 6 weeks then every 8 weeks thereafter. In the UK, Remicade is currently licensed for: Plaque Psoriasis, Crohn's Disease; Rheumatoid Arthritis; (in combination with methotrexate); Ankylosing Spondylitis; and Psoriatic Arthritis, (in combination with methotrexate). Remicade is now approved for the treatment of adult patients with moderate to severe plaque psoriasis, have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate, or PUVA.

4 - 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 more than 30,000 people around the world.

References

1 Reich K et al. Infliximab produces a sustained and significant improvement in psoriasis over 50 weeks of continuous therapy. Br J Dermatol 2005; 153 (Suppl 1): O-10
2 Gottlieb AB, Evans R, Shu Li, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: A randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42.
3 Feldman S R and Krueger GG. Psoriasis assessment tools in clinical trials. Ann. Rheum. Dis, Mar 2005; 64: ii65 - ii68.
4 eMedicine health, http://www.emedicinehealth.com/articles/30934-3.asp (accessed 22nd September 2005).
5 The Psoriasis Association: What is psoriasis? Available at: http://www.psoriasis-association.org.uk/what-is.html (accessed 22 September 2005). 6 Choi J, Koo J.Y.M. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003;29(2):S57-61.
7 Data on file (PSUR 10, pages 23-25, 2004), Centocor

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