UK launch of non-steroid psoriasis treatment brings hope for thousands

Author: Frankl Pharma

Date: Nov 2017

The UK launch of a non-steroid treatment for plaque psoriasis could bring hope for thousands of sufferers for whom traditional treatments have failed, according to one of the country’s most respected dermatologists.

Efficacy trials in London of Soratinex, which has been on sale on the Continent for more than a decade, were completed this month and produced improvements in symptoms of between 51 and 100 per cent in 60 per cent of participants.

In eight earlier trials involving more than 2,000 patients in Europe, that level of success was achieved in 85 per cent of cases.

Professor Anthony Chu, former senior consultant at Imperial Healthcare Trust, and Hammersmith and Ealing hospitals in London, said: ‘I have been hugely impressed by the results - in some cases the improvements were quite miraculous.

‘Nearly all the patients in our trial experienced some benefit, but 60 per cent of them experienced significant improvements of between than 50 and 100 per cent.

‘In terms of well-being, almost half said their quality of life had improved by between 76 and 100 per cent, and we recorded no negative side-effects.

‘So to have a topical treatment that works in patients for whom other topicals have failed is absolutely fantastic. In some cases, patients who had been suffering from psoriasis for years, symptoms went away almost completely.

‘This is something that has not been there before, and for patients who have not had positive experiences with the usual drugs it offers new hope.’

Professor Chu has no financial interest in Soratinex.

Psoriasis is an immune condition that speeds up the skin replacement process, meaning cells that normally take 21 to 28 days to replace are actually produced in a few days. This build-up of cells results in raised ‘plaques’ which can become inflamed, flaky and painful . It can occur on all parts of the body. Almost 2 million people in the UK suffer from the condition.

Most sufferers are treated with topical creams containing steroids. Over time, these can damage the skin and in some cases are absorbed into the body, causing side effects such as changes in blood pressure and decreased growth in children.

Soratinex is a three-step steroid-free treatment for plaque psoriasis involving a gel that removes flaky deposits, a cream that reduces inflammation and an oil that moisturises and creates a protective layer. It was developed in Australia (where it has been safely used for many years, marketed as ‘Dr Michaels’) and contains natural oils, herbal ingredients and minerals, which make it safe even for young children.

Dr Benedetta Brazzini, who conducted the trial with Professor Chu, described the results as ‘amazing’.

She added: ‘To begin with I was a bit sceptical and thought Soratinex was something that would either not work, or at best would simply have the effect of being a good moisturiser.

‘We were pleasantly surprised, especially when you consider that in this and previous trials there has been no record of any significant side effects. The patients were very grateful and very happy with the results.’

Soratinex, distributed in Europe by the Czech-based company FRANKL Pharma, is available in Australia, New Zealand, Germany, the Czech Republic, Slovakia, Poland and Hungary, is being introduced to the UK to co-incide with Psoriasis Awareness Week.

The treatment is designated a ‘Medical Device’ under EU legislation and can be bought online at https://www.franklpharma.co.uk without a prescription. Sets, expected to last patients with mild to moderate symptoms between one and three months, retail at £76.50 for small and £121.05 for large.

According to Professor Chu, this compares favourably with traditional hospital-based treatments for severe psoriasis such as such as Ciclosporine, which can cost around £2,000 a year, Methotrexate from £2-300 a year and biologics (cellular treatments grown in the lab) for the most severe cases, which can cost up to £14,000 a year. These treatment require regular hospital visits and blood tests.

The results of the UK trial, which was conducted over a year with a cohort of 20 patients, echo eight studies with larger cohorts conducted by senior dermatologists across Europe. In these, involving 2,050 patients, 85 per cent experienced an improvement in their symptoms of between 51 and 100 per cent.

BEFORE

AFTER

Professor Torello Lotti, Professor and Chair of Dermatology at the University of Rome G.Marconi, has collaborated in studies of Soratinex with clinicians and academics from Italy, Austria, Hungary, the Czech Republic, Romania, Russia and other countries for more than 15 years.

He said: ‘I am pleased that the UK clinical trial conducted by Professor Chu and Dr Brazzini have concluded with results very similar to these previous studies. We have repeatedly found that Soratinex performs at least as well as the established and more powerul systemic treatments, yet because it contains no corticosteroids there is no risk of side effects, which means it can also be used to treat children and pregnant women.

‘The effects of psoriasis can be very debilitating. Those affected think that they have the choice of either using powerful and potent medication every day that can act as a poison over time, or of not using them and suffering.

‘I think now we have something that can work for them but without the side-effects.’

Professor Jana Hercogová, former President of the European Academy of Dermatology, currently Chairwoman of the Dermatovenereology Department of Charles University, Prague, has had experience of Soratinex dating back more than 10 years.

She said: ‘When FRANKL Pharma first asked me to try the treatment, I was sceptical but eventually I tried it on a child with proriasis of the scalp. Everything else had failed, but this cleared it up. Then I tried it on another patient, then another and the results were very encouraging.

‘Between 2005 and 2008, 203 patients in 10 hospitals across the Czech Republic were treated with [Soratinex] and we saw improvements in around 80 per cent of all patients. I would not use it in severe cases where most of the body is covered in lesions because it is a three-part treatment and this makes it impractical.

‘But in cases of plaque psoriasis with symptoms ranging from mild to moderate – which is about 80 per cent of all cases – then I would recommend Soratinex. It is unbelievably effective.’

Greg Pittard, 47, from north west London, one of the volunteers on the UK trial, had psoriasis covering 25 per cent of his body for 18 years. He said: ‘Within a couple of days of using Soratinex my red patches started to clear up and then I began to see other patches below them, which were areas of normal skin.

‘Then it became less inflamed and my skin calmed right down. It is continuing to improve and I’m seeing clear, good skin. There is about a 70 per cent improvement and obviously I’m hoping it goes to 100 per cent.

‘I’m feeling so much happier and confident about myself. I was the last person to be accepted on the trials and I was sceptical when I walked through the door. Now I just can’t believe how lucky I was.’

Sritharan Ratnaswamy, 61, an accountant from West London, also took part in the trials. He said: ‘I first had psoriasis about four or five years ago. It is all over my body to a greater or lesser extent – the severity of it seems to come and go and obviously when it is all over I feel pretty miserable.

‘I’ve been prescribed oral and topical medication and feel like I’d tried everything from methotrexate tablets to Epaderm cream and Balneum bath oil to topical steroids including Dovobet and Dovonet, but nothing seemed to have worked. I also had puva treatment – ultraviolet light therapy – a few years ago.

‘When I was given the Soratinex oil, gel and cream as part of the trial, I’d already thought nothing would work, but this did. I put it on twice a day and soon began to see a difference. Now it has gone and I’m hoping it stays that way.

‘Because it was on my arms and legs, I’d been covering up all the time and wearing a tracksuit outside but now I’ve been able to start wearing shorts and short sleeves again, and I feel so much happier.

‘It might not work for everyone, but it has worked for me and I would recommend other sufferers to give it a try.’

An analysis of eight European studies into the efficacy of Soratinex (2001 to 2016)

TOTAL PATIENTS: 2050

  • 46 non-compliant and discontinued treatment (2%)

Of those who continued treatment

  • Outstanding improvement (76-100%) in 881 patients (43%)
  • Good improvement (51-75%) in 852 patients (42%)
  • Moderate improvement (26-50%) in 184 patients (9%)
  • Ineffective (0-25%) in 59 patients (3%)
  • 28 patients worsened and discontinued (1%)

(Source: Journal of Biological Regulators & Homeostatic Agents, April-June 2016. Analysis: FRANKL Pharma. All studies took place between 2001 and 2016).

https://www.ncbi.nlm.nih.gov/pubmed/27498651 - A multi-centred open trial of “Dr Michaels®” (also branded as Soratinex®) topical product family in psoriasis.

https://www.ncbi.nlm.nih.gov/pubmed/27498668 - Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study.

https://www.ncbi.nlm.nih.gov/pubmed/27498655 - Clinical evaluation of the effectiveness of “Dr Michaels®” (also branded as Soratinex®) products in the topical treatment of patients with plaque psoriasis.

https://www.ncbi.nlm.nih.gov/pubmed/27498669 - Quality of life aspects of patients with psoriasis using a series of herbal products.

https://www.ncbi.nlm.nih.gov/pubmed/27498667 - An innovative, promising topical treatment for psoriasis: a Romanian clinical study.

https://www.ncbi.nlm.nih.gov/pubmed/27498666 - Scalp psoriasis: a promising natural treatment.

https://www.ncbi.nlm.nih.gov/pubmed/27498657 - Dr Michaels® (Soratinex®) product for the topical treatment of psoriasis: a Hungarian/Czech and Slovak study.

https://www.ncbi.nlm.nih.gov/pubmed/27498653 - A clinical examination of the efficacy of preparation of Dr Michaels® (also branded as Soratinex®) products in the treatment of psoriasis.

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Last revised: 7 November 2017

Next review: 7 December 2017