This excerpt taken from the NVS 6-K filed Nov 2, 2005.
Benefits of early treatment
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 study(4) 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.