New research shows benefits of Elidel® in eczema patients who require an alternative to conventional steroid treatment

Basel, October 14, 2005 - The importance of ElidelÒ (pimecrolimus) Cream 1% as an alternative to topical corticosteroids has been demonstrated by the results of a new study in which Elidel cleared eczema from the faces of patients allergic to or intolerant of steroids.1 The study found 46.5% of patients treated with Elidel after six weeks were clear or almost clear of facial eczema compared to 16.2% of the group treated with unmedicated placebo "vehicle cream" (p<0.001).

 

"These findings are especially compelling since atopic eczema often occurs on sensitive skin and because disease flare-ups may recur over long periods of time. So, many patients require an alternative to topical steroids," said Dr. Neil Shear of Sunnybrook and Women's College Health Sciences Centre and University of Toronto Medical School, Canada, who presented the results today at the congress of the European Academy of Dermatology and Venereology. "This study demonstrates that Elidel provides a safe and effective option that can be used intermittently to treat sensitive skin when steroids are inappropriate or to provide a break from frequent use of steroids."

 

Topical steroids have been the mainstay of therapy for up to half-a-century, but their long-term use has been associated with a range of harmful side effects. Of the 200 patients enrolled in the study, a total of 45.9% had previously experienced potentially irreversible consequences such as rosacea (redness), atrophy (skin thinning) or telangiectasias (spider veins). Some were allergic to steroids (21.5%) or had eczema in areas where steroid use is inadvisable, such as around the eyes (17.5%) or on the eyelids (10.5%).

 

A special concern was that 82.5% of participants were dependent on steroids to reduce the painful and distressing symptoms of atopic eczema and were using them so frequently that there was an unacceptable risk of side effects (i.e. for an average of 17 days [±7.7] within the previous month). Elidel, one of a class of drugs called topical calcineurin inhibitors, does not contain steroids and acts more selectively to reduce the inflammatory symptoms of atopic eczema.2

 

Patients age 12 and above with a history of mild or moderate atopic eczema were enrolled at 29 centers in five countries. They were randomised into two groups for treatment with either Elidel or vehicle cream during a six-week double-blind phase, followed by six weeks of open label therapy. Efficacy was assessed using standard measures of disease severity such as the Investigator's Global Assessment (IGA).

 

As early as eight days after starting treatment, patients treated with Elidel began to show a significantly greater improvement than those using vehicle cream, with 20.8% of those on Elidel being clear or almost clear of facial eczema compared to 7.1% of those on vehicle (p<0.01). When the double-blind phase ended on day 43, the difference between the groups was even more pronounced (46.5% vs. 16.2% being clear or almost clear). Elidel patients maintained their improvement during the open label phase.

 

Reduction of itching (pruritus), one of the most troubling symptoms of eczema, was significantly greater in Elidel patients, with 69.3% achieving a pruritis score at day 43 of <=1 (where 1 is defined as mild), compared to 34.5% of those on vehicle (p<0.001).

 

In addition, the study showed that Elidel helped to reverse the effects of skin thinning (or atrophy). After six weeks, 46% of Elidel patients who had skin atrophy at the start of the study experienced an improvement (p<0.01), compared to 19% of patients treated with vehicle cream.

 

Elidel was well-tolerated, and safety results were consistent with other studies using the drug.

 

Atopic eczema has traditionally been treated reactively, using topical steroids to manage periodic flare-ups in which the skin becomes abnormally dry, itchy and inflamed, and scratching leads to broken, oozing and bleeding skin. With the availability of calcineurin inhibitors such as Elidel, physicians have been able to progress from reactive treatment to earlier proactive intervention to control the disease.

 

Results from two associated clinical trials also presented at the EADV congress, called the Pimecrolimus in Eczema: Prevention of Progression (PEP) studies, demonstrate that early intervention with Elidel at the first signs or symptoms of disease reduced the number and severity of flare-ups in children and adults.3,4

 

The two 26-week, multi-center, double-blind, vehicle-controlled studies involved 521 children and adolescents (age 2-17 years) and 543 adults (age 18 or above) respectively, with a history of mild to moderate atopic eczema. Flare-ups were defined as a worsening of symptoms despite study treatment, requiring the use of topical steroids.

 

In the paediatric study,3 the mean number of flares-ups was halved in the Elidel group compared to the vehicle group (0.84 vs. 1.68 flare-ups), while the adult study4 showed a 30% reduction (0.97 vs. 1.39). Elidel-treated patients remained flare-free for longer, with a median time to first flare of more than 190 days in both studies, compared to 59 days for children and 67 days for adults treated with vehicle cream (both p<0.0001).

 

Children treated with Elidel at the first signs and symptoms of disease were able to shorten their use of topical steroids by 41% compared to those using vehicle (mean duration of steroid use: 12.9 vs. 21.9 days), while adults achieved a 21% reduction (17.7 vs. 22.5 days). Furthermore, patients using Elidel made at least one-third fewer unscheduled visits to their physician than those using vehicle (87 vs. 246 visits for children, 156 vs. 223 for adults). Elidel was well-tolerated and safety results were consistent with other studies using the drug.

 

Dr Shear commented: "These clinical data demonstrate that Elidel is most effective when used proactively to treat atopic eczema at the very first signs or symptoms of recurrence (e.g. itching and redness), so preventing the majority of patients progressing to a major flare. When used in this manner, early intermittent treatment with Elidel over the long-term provides atopic eczema control, and supports a paradigm shift towards treating the disease proactively with Elidel and reserving topical corticosteroids as rescue therapy for major flares."

 

Elidel has been shown to be an effective treatment for the management of mild to moderate eczema, with a favorable safety profile. It is the only non-steroid prescription cream approved for the short-term and intermittent long-term treatment of mild to moderate eczema in patients as young as two years old, who do not respond well to, or may have side effects from, conventional treatments.

 

Novartis is in product labeling discussions with the FDA and a number of other health authorities, after an FDA Advisory Committee in February 2005 recommended the inclusion of a boxed warning for Elidel and Protopic® (Astellas) relating to a theoretical risk of lymphoma. Novartis and many independent medical experts do not agree that such an action would be justified. Novartis remains confident in the safety and efficacy of Elidel in its approved indications.

 

The foregoing release contains certain forward-looking statements that can be identified by terminology such as "long-term," "supports a paradigm shift," "is in product labeling discussions," "remains confident," or similar expressions, or by express or implied discussions regarding Novartis' product labeling discussions with the FDA and other health authorities,  or any potential revenues from Elidel.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Elidel to be materially different from any future results, performance or achievements expressed or implied by such statements.  There can be no guarantee regarding the outcome of Novartis' product labeling discussions with the FDA and other health authorities, or that Elidel will reach any particular sales levels. In particular, management's expectations regarding commercialization of Elidel could be affected by, among other things, uncertainties relating to clinical trials; new clinical data;  additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally, including the outcome of Novartis' product labeling discussions with the FDA and other health authorities; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; as well as other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission.  Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.  Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Novartis Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

 

 

 

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