Elidel Eczema Cream: Dr Mark Ballard Answers Our Questions

Dr Mark Ballard, the Medical Director of Respiratory and Dermatology Therapeutic Areas at the Novartis Pharmaceuticals Corporation answers our questions about their eczema cream Elidel.

1. Can you very briefly summarise the results of the recent study on the effect of Elidel on eczema sufferers?  How reliable are these findings?

It was a global study mainly conducted in Europe, Italy and Switzerland. It was a standard controlled study approved by the regulators. The study ran over a six-week period, consisting of a randomized double-blind phase followed by a six-week open-label phase.  It mainly concentrated on Adults with mild to moderate eczema on the head and neck. All patients were either intolerant of, or dependent on topical corticosteroids.

Although there are increasing incidents of eczema in Children, the general feeling is that it will usually regress over time. However, adults with eczema are unlikely to outgrow it and the eczema itself is likely to be harder to control.   Therefore, having the main study group predominantly comprised of adults ensures that the resulting effects upon their eczema are due to the cream’s effectiveness rather than outgrowing the disease.  This aids in assuring the reliability of the results.

The study showed that Elidel is safe, effective and well tolerated in patients with mild to moderate head and neck eczema who are intolerant of, or dependent on topical corticosteroids. The use of Elidel allows physicians the ability to help their patients take control of eczema without having as many flare ups.

Study results showed:
• Almost half (46.5%) of the patients treated with Elidel became clear or almost clear of face and neck eczema after six weeks, in comparison with only 16.2% of patients in the control group
• No or only mild pruritus (itching) was significantly higher in the Elidel group (70%) compared to the control group (34%)
• Eyelid dermatitis clearance was observed in 44.6% of patients using Elidel vs. 19.2% of patients in the control group
• Elidel was also shown to improve the condition of skin (according to dermatoscopic scores) in 46.5% of the patients with skin atrophy (thinning) caused by topical corticosteroid use, more than twice as frequently as the vehicle cream (17.6%)
• Adverse events similar between groups

2. What does the development of this cream mean for eczema sufferers?  Who is it especially useful for?

Elidel is useful for sufferers with mild to moderate eczema who have failed to respond adequately to topical corticosteroids, particularly since it can be used on sensitive areas such as the face and neck.  Topical corticosteroids should not be used as a long term treatment, especially on the face area where the skin is thinner. Doctors can therefore prescribe Elidel as a 2nd line indication, after the short term use of these topical corticosteroids.  Elidel provides those suffering from eczema, who are either intolerant of, or dependent on topical corticosteroids, a treatment option to help obtain control of the condition. It is a great tool in the physician’s armoury for the treatment of eczema in all sufferers aged 2 and over.

3. Is Elidel the only cream of its kind on the market and what makes it a more successful treatment than others?

Elidel is the only topical calcineurin inhibitor in a cream formulation that is ideally suited for use on the face. There are some stronger, more effective topical steroids, but by using these you have various trade offs such as experiencing skin thinning and stretch marks. Therefore, topical steroids are not long term treatment options. With Elidel, Novartis is still conducting long term safety studies, the recent label change is evidence of this. The post marketing studies Novartis are focusing on are studying non-melanoma skin cancer and lymphoma in relation to using the cream, but these studies are finding no causal links. We are actually seeing lower rates of non-melanoma skin cancer and lymphoma than what you would normally expect. Elidel also has low permeability, it is not at the zero level, but it is very low. We will continue to collect safety data for a long period of time to support the long-term safety of using Elidel.

4. Do you have a response to the negative press coverage that Elidel received in the light of possible cancer risks? Have the risks been exaggerated?

FDA’s concerns about the safety of topical calcineurin inhibitors are based on a theoretical risk stemming from the adverse events associated with the systematic use of calcineurin inhibitors in animal studies and transplant patients.  Studies have not established a causal connection between the use of Elidel and development of malignancy, which the new label states. Novartis is confident in the safety and efficacy of Elidel.  It is one of the most thoroughly researched dermatology products in the world and continues to be supported with significant ongoing clinical trials.

With that said, the FDA protects the public and it is important that the public and the Physicians understand possible risks of the treatment, despite the fact that there does appear to be a slightly exaggerated concern of the risks involved.  The FDA does want further safety studies conducted, which we will continue to run, as the well-being of our patients is our primary concern.

5. What does the future hold for Elidel in terms of clinical data, new formulations etc?

Elidel provides a great way for Physicians to achieve control of an exaggerated eczema event. Physicians and patients want to come to a point of control, and this can be achieved by using Elidel to prevent the major flare ups of eczema . We will continue with safety and efficacy studies.