Elidel
Long-term control of atopic dermatitis with pimecrolimus cream 1% in infants and young children: a two-year study.

Papp KA, Werfel T, Folster-Holst R, Ortonne JP, Potter PC, de Prost Y, Davidson MJ, Barbier N, Goertz HP, Paul C.

Probity Medical Research, Hannover Medical University, Waterloo, Ontario, Canada. kapapp probitymedical.com

OBJECTIVE AND METHODS: The safety and efficacy of treatment with pimecrolimus cream 1% was evaluated for up to 2 years in infants and young children with atopic dermatitis. Ninety-one patients participated in a 1-year, open-label extension to a 1-year double-blind study. Of these, 76 received pimecrolimus for 2 years. Pimecrolimus was applied twice daily at the first signs or symptoms of the disease until clearance. Outcome measures included the incidence of adverse events and the Eczema Area and Severity Index (EASI). RESULTS: No patient discontinued because of adverse events. The incidence of systemic and skin infections did not increase over time. Over the 2-year period, 2 patients experienced an episode of clinically diagnosed eczema herpeticum. In patients receiving pimecrolimus for 2 years, the mean decrease in EASI score from baseline was 68.7% at 3 months and 70.8% at 24 months. CONCLUSION: Treatment with pimecrolimus cream 1% for up to 2 years was well tolerated and resulted in a marked and sustained improvement of atopic dermatitis.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15692468&dopt=Abstract pimecrolimus Elidel



Elidel
Long-term treatment of atopic dermatitis with pimecrolimus cream 1% in infants does not interfere with the development of protective antibodies after vaccination.

Papp KA, Breuer K, Meurer M, Ortonne JP, Potter PC, de Prost Y, Davidson MJ, Barbier N, Goertz HP, Paul C.

Probity Medical Research, Waterloo, Ontario, Canada. kapapp probitymedical.com

OBJECTIVE: We investigated whether treatment of atopic dermatitis with pimecrolimus cream 1% in infants affects the development of a normal antibody response to vaccinations. METHODS: In all, 91 patients participated in a 1-year, open-label extension to a 1-year double-blind study: 76 used pimecrolimus twice daily at the first signs or symptoms of the disease until clearance for 2 years and 15 only in the second year. Serum concentrations of antibodies against tetanus, diphtheria, measles, and rubella were measured at months 18 and 24. RESULTS: The seropositivity rates of 93.6% for tetanus, 88.6% for diphtheria, 88.5% for measles, and 84.4% for rubella were comparable with those reported in literature. Seropositivity was not significantly affected by the use of pimecrolimus at the time of vaccinations (+/- 28 days). CONCLUSIONS: Treatment of atopic dermatitis with pimecrolimus cream 1% in early childhood does not appear to interfere with the development of a normal immune response to vaccinations.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15692469&dopt=Abstract pimecrolimus Elidel



Elidel
Pimecrolimus cream 1% can be an effective treatment for seborrheic dermatitis of the face and trunk.

Rallis E, Nasiopoulou A, Kouskoukis C, Koumantaki E.

Department of Dermatology, NIMTS Hospital of Athens, Athens, Greece. efrall otenet.gr

The ascomycin macrolactam derivative pimecrolimus is a novel, nonsteroidal, cell-selective inhibitor of inflammatory cytokines specifically developed for the treatment of inflammatory skin diseases. Our objective was to assess the efficacy, tolerability and safety of pimecrolimus cream 1% in the treatment of seborrheic dermatitis. Adults with seborrheic dermatitis of the face and upper trunk who were seen from October 2003 to April 2004 at the Dermatologic Outpatient Clinic of the University of Thrace were enrolled in this 9-week open-label uncontrolled study. Pimecrolimus cream 1% was applied as monotherapy twice daily for 7 days and for an additional period of 7 days thereafter, if needed, until complete clearance was achieved. In cases of recurrence a 5-day course was additionally applied. After screening and an appropriate washout period, subjects were evaluated at baseline (day 0) and at follow-up visits at weeks 1, 3, 6 and 9. The clinical severity of seborrheic dermatitis was estimated as mild (total score 1-3), moderate (total score 4-6) and severe (total score 7-9) in terms of erythema, scaling and lesional extent using a scale from 0 to 3 for each. Patients also assessed their symptoms on a scale from 0 to 5 in terms of the efficacy, safety and tolerability of topical application. Nineteen patients (12 males, seven females) were enrolled in this study. At the end of weeks 1, 3, 6 and 9 the percentages of complete clearance were 63%, 100%, 47% and 52%, respectively. At the end of the study, subjects' average assessment score was 9.73. Apart from topical burning and irritation of the skin in four patients, no other adverse event was mentioned. This pilot study indicates that pimecrolimus applied twice daily can be a safe and efficacious alternative in the treatment of seborrheic dermatitis. Further studies are needed to determine the initial and maintenance therapy.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15700745&dopt=Abstract pimecrolimus Elidel



Elidel
Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials.

Ashcroft DM, Dimmock P, Garside R, Stein K, Williams HC.

School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester M13 9PL. darren.ashcroft manchester.ac.uk

OBJECTIVE: To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic searches of the Cochrane Library, Medline, and Embase. STUDY SELECTION: Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability. DATA EXTRACTION: Efficacy: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections. DATA SYNTHESIS: 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ. CONCLUSIONS: Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15731121&dopt=Abstract pimecrolimus Elidel



Elidel
Topical 0.05% clobetasol propionate versus 1% pimecrolimus ointment in vitiligo.

Coskun B, Saral Y, Turgut D.

Firat University Faculty of Medicine, Department of Dermatology, Elazig-Turkey.

Vitiligo is a common skin condition resulting from loss of normal melanin pigments in the skin which produces white patches. Topical corticosteroids are indicated for the treatment of limited areas of vitiligo. Pimecrolimus, which inhibits calcineurin, has recently been shown to be effective for the treatment of vitiligo. We performed a prospective study to evaluate the efficacy of the 0.05% clobetasol propionate and 1% pimecrolimus in the treatment of vitiligo. Ten patients with virtually bilateral symmetrical lesions of vitiligo were included. 0.05% clobetasol propionate was applied twice daily over the lesion on right side of the body, and topical 1% pimecrolimus was applied twice daily over the lesion on left side of the body. It was determined that both treatment modalities resulted in a comparable rate of repigmentation. Response to treatment was varied according to the anatomical location of the lesions where better results were seen on the trunk and extremities. Results from this pilot study indicate that topical 1% pimecrolimus is as effective as clobetasol propionate in restoring skin disfiguring due to vitiligo. For a better conclusive statement further studies involving larger groups of patients should be performed.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15757818&dopt=Abstract pimecrolimus Elidel