Basel, February 21, 2005 - Treatment with Elidel® (pimecrolimus) Cream 1% provided sustained control of the symptoms associated with atopic eczema for up to 18 months in both adult and paediatric patients, according to new study results1 announced during the congress of the American Academy of Dermatology in New Orleans, USA.
"Helping patients control symptoms long-term is a key goal in the overall management of eczema," said Dr Richard Langley, Assistant Professor, Director of Research, Division of Dermatology, Dalhousie University, Canada. "This study provides encouraging news because one of the most unsettling aspects of eczema is the unpredictability of the condition. What this study shows is that using Elidel® to treat a flare-up at the onset of symptoms such as tingling or itching may enable patients to control flares and better manage their condition long-term."
The objective of the multinational study was to evaluate long-term efficacy and safety of Elidel® in paediatric and adult patients with eczema of any severity, who had previously completed a six-month core study demonstrating the effectiveness of Elidel® in controlling the acute signs and symptoms of atopic eczema. The extension study included 368 of these patients, who were treated for up to 18 months.
Patients experienced sustained relief of their eczema symptoms (up to 18 months) when treated with Elidel® in a naturalistic setting, i.e. in a clinical study that closely replicated real life. In the core study, 79.6% of patients who had used Elidel® twice-daily experienced relief from the itching (pruritis) associated with mild to moderate eczema, defined as an improvement in symptoms to absent/mild pruritus. These compelling results were sustained for an additional 18-month period for 75.0% of those completing the extension study. At the end of the core study, improvements in the Investigators' Global Assessment (IGA) score were experienced by 83.8% of patients for the face and 73.7% for the whole body. Again, the results were sustained for an additional 18 months during the extension study (80.3% and 68.9% respectively). In addition, 76.8% of patients rated their disease control as either "complete" or "good" at the end of the extension study.
During the extension phase, Elidel® was incorporated into patients' daily treatment as needed. Elidel® was applied twice-daily to affected areas beginning at the earliest signs or symptoms of a flare (e.g. tingling or itching), continuing for as long as the flare persisted. If signs or symptoms returned, patients resumed twice-daily treatment to prevent progression. Emollients and topical corticosteroids could be added to the treatment regimen if the treating physician felt this was warranted.
There were no unexpected safety findings. The most common adverse events (occurring in 5% of patients or more) were infections (nasopharyngitis, upper respiratory tract infection, influenza), respiratory disorders, application-site conditions and headache. The overall incidence of viral infections was less than 1%. Treatment-related herpes simplex occurred in 4 patients (1.1%). The incidence of adverse events decreased from the end of the core study to the end of the extension study. Application-site burning, pruritus and impetigo all became less frequent in the extension study.
Impact of atopic eczema on patients' lives
For many patients, the burden of eczema extends beyond the outwardly visible symptoms and can have a severe impact on their overall quality of life. This was demonstrated by results from a multinational survey called ISOLATE (International Study Of Life with ATopic Eczema), presented yesterday by Dr Seth Orlow of New York University School of Medicine, USA.2 This showed that among US participants in the survey, most patients and caregivers of children with eczema (51% of patients and 63% of caregivers) always or sometimes worried about their next flare-up. The study also revealed that around 75% of patients and caregivers lack confidence in the ability to effectively manage their disease during a flare-up.
"Patients often report that eczema flares influence multiple aspects of their lives, including the ability to sleep or even attend work or school. The stress of eczema also affects caregivers and other family members of children who suffer from eczema," said Seth J. Orlow, MD, PhD, New York University School of Medicine, New York, USA. "Eczema is not only a physical disease. It can carry a psychological burden and influence the quality of life of patients and caregivers."
The ISOLATE study involved 2,000 participants from eight countries (i.e. France, Germany, Spain, Mexico, Netherlands, Poland, and UK, as well as the US). Data were presented at the meeting from a sub-analysis of approximately 400 patients and caretakers of patients from the US. Participants underwent in-depth interviews using a comprehensive questionnaire developed in collaboration with national patient groups and physicians. The study was supported by an unrestricted educational grant from Novartis.
The benefits of Elidel® for patients' quality of life were demonstrated by a study involving nearly 1,000 participants that was also presented at the meeting3. This showed that treatment with Elidel® was associated with a statistically significant improvement in quality of life at months two and six of treatment compared to baseline, in both adult patients and parents of children with eczema (up to 12 years old). Those parents who had previously reported concerns about corticosteroid use had a significantly greater improvement in quality of life six months after Elidel® treatment than did those without such concerns (p=0.006). Assessments were based on the Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD), a standard measure used for patients aged 12 and under, and the Quality of Life Index for Atopic Dermatitis (QoLIAD) for those above 18 years.
About eczema and Elidel®
Eczema is a broadly-used term to describe patchy, red, dry itchy and scaly skin, which, when severe, can 'weep', bleed and/or crust over. This common and often distressing skin condition tends to run in families and almost always begins in childhood, usually during infancy. The term eczema most often refers to 'atopic dermatitis', a chronic relapsing inflammatory skin condition related to allergic rhinitis ('hay fever') and asthma.
Elidel® has been demonstrated 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 non-immunocompromised patients as young as two years old, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.
Elidel® may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds. The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "key goal," "long-term management," or similar expressions, or by discussions regarding the potential that Elidel® will be approved for marketing, or regarding 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 that Elidel® will be approved for sale in any market. In particular, management's expectations regarding commercialization of Elidel® could be affected by, among other things, uncertainties relating to clinical trials; new clinical data; unexpected regulatory actions or delays or government regulation generally; 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.
