Elidel^® (Pimecrolimus)

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CLINICAL EXPERIENCE

• Extensive clinical experience exists with the use of Elidel cream in over 5 million patients with atopic dermatitis (including over 19,000 patients in clinical trials)
• Of the 19,000 patients in clinical trials, 14% were infants (3 to 23 months), 38% were children (2-17 years) and 48% were adults.
• Data indicate that the average patient treats for an average of 45 days over the course of a year and uses 72 g/ year
• Published trials have looked at the short term and intermittent long term use (up to 2 years) of Elidel in atopic dermatitis

Clinical trials

• Most clinical trials with Elidel have been done in patients with mild to moderate atopic dermatitis.
• Many trials with Elidel have a similar design. Elidel or placebo cream is applied BID at first signs/symptoms of atopic dermatitis (itch/redness) to prevent progression to flares.In the event of flares, a moderately potent corticosteroid is permitted as rescue medication. The percentage of patients without flares (e.g. without the need to use corticosteroids as a rescue) in patients treated with Elidel versus placebo cream is compared.
• This design of clinical trials is reflecting the practical use of the drug in the clinic.

Adults with AD

• The use of Elidel at first signs/symptoms of AD substantially reduces the number of flares and consequently reduces or eliminates”) the need for corticosteroid treatment in adults.

Meurer M et al. Dermatology. 2004;208(4):365-372: 130 adults treated for 24 weeks. No flares in 59.7% of Elidel patients compared to 22.1% in the placebo group. 74% reduction of % of days on steroid in adults; almost 4 times fewer days on steroid treatment vs vehicle.
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15178928&query_hl=1

Meurer M et al. Dermatology. 2002;205(3):271-277: 192 adults treated for 24 weeks.No flares in 44.8% of Elidel patients compared to 18,8% in the placebo group.
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12399676&query_hl=1

Children with AD

• The use of Elidel at first signs/symptoms of AD substantially reduces the number of flares and consequently reduces or eliminates the need for corticosteroid treatment in children.

REFERENCES:

Wahn U et al. Pediatrics.2002;110 (1):1-8:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve &db=pubmed&dopt=Abstract&list_uids=12093983&query_hl=1
713 patients (2-17 years) treated over a 1 year period.
At 6 months: no flares in 61% of Elidel compared to 34.2% in the placebo group. At 1 year: 50,8% of Elidel compared to 28,3% in the placebo group.

Eichenfield LF et al. J Am Acad Dermatol 2002;46:495-504 :
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11907497&query_hl=3
403 patients (1-17 years) treated over 6 weeks.
At 6 weeks,34,8% of patients receiving Elidel were rated as clear or almost clear compared with 18,4% in the vehicle group.

Infants with AD

• The use of Elidel at first signs/symptoms of AD substantially reduces the number of flares and consequently reduces or eliminates the need for corticosteroid treatment in infants.
• (Note: The use of Elidel in infants (less than 2 years of age) is currently NOT approved by Health Canada)

Ho VC et al. J Ped 2003;142:155-162:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12584537&query_hl=30

Kapp A et al.J All Clin Immunol 2002;110 (2): 277-284:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12170269&query_hl=32

Papp KA et al. J Am Acad Dermatol 2005;52:240-246:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15692468&query_hl=6

Kaufmann R et al. J All Clin Immunol 2004;114(5):1183-1188:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12584537&query_hl=30

Breuer K et al. Dermatology 2004;209:314-320:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15539895&query_hl=36

Onset of action

• Elidel rapidly reduces the pruritus associated with atopic dermatitis. Onset of action on symptoms and signs of AD is fast and sustained with no disease rebound after discontinuation

Kaufmann R et al. J All Clin Immunol. 2004;114(5):1183-1188:
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15536429&query_hl=18

Conclusion

• Elidel cream is a new treatment option for the intermittent long term control of eczema, acting as a flare prevention agent.
• Elidel does not induce skin atrophy.
• Elidel has been shown to be safe according to available clinical data.
• The only significant immediate side effect is a sensation of warmth at site of application, occurring in < 10 % of patients (12 % for the placebo groups).
• Long term safety data are limited to more than 8 years. There is no trend that would suggest toxicity or tachyphylaxis on the long term.

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