Herpes simplex infections in atopic eczema.

David, T J; Longson, Maurice

doi:10.1136/adc.60.4.338

Cited by 82 publications

(42 citation statements)

References 14 publications

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“…Intermittent long-term treatment of infants with pimecrolimus for up to 2 years did not alter the frequency of skin infections over time, as the incidence of skin infections was comparable in the first and second years of treatment. Compared with control treatments [36, 37], the incidence of all bacterial and viral infections with pimecrolimus in infants treated for more than 1 year was low [31]. With regard to the specific types of infection, a meta-analysis of paediatric patients has demonstrated that the incidence of bacterial skin infections was slightly lower in the pimecrolimus group, compared with the vehicle group (table 2) (unpublished data).…”

Section: Skin Infectionsmentioning

confidence: 99%

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

et al. 2007

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Atopic eczema is predominantly a disease of children and infants, and is often a significant burden for both the sufferer and the family. Pimecrolimus cream 1% (Elidel®) is a topical calcineurin inhibitor that has been developed for the treatment of inflammatory skin diseases. When applied twice daily, pimecrolimus has been shown to be effective and well tolerated in paediatric patients with mild to moderate atopic eczema, and appears to be particularly suitable for use on the face, the neck and skin folds. Reduction of pruritus or erythema can be seen within 48 hours of initiating treatment, and when used at the first signs or symptoms of recurrence, pimecrolimus can significantly reduce the incidence of flares and the amount of topical corticosteroid used. Long-term pimecrolimus therapy shows that the initial reduction of disease severity (Eczema Area and Severity Index) is sustained and that most patients have minimal residual disease at 2 years. The most common application-site reaction is a mild to moderate, transient, warm/burning sensation occurring in approximately 10% of patients. Blood concentrations of pimecrolimus following topical administration remain low in all patients. Currently there is no evidence for systemic adverse events, immune suppression or alterations in the vaccine response, after short-term or prolonged treatment. In conclusion, pimecrolimus is an effective treatment option for the short-term treatment and long-term control of atopic eczema in paediatric patients.

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Section: Skin Infectionsmentioning

confidence: 99%

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

et al. 2007

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“…Eczema herpeticum is a form of herpes simplex virus infection with extensive skin involvement, occurring predominantly among patients with AD. 47,49 The actual incidence of eczema herpeticum among infants with AD is unknown. In total, 10 infants treated with 1% pimecrolimus cream in the 6 clinical studies experienced clinically diagnosed eczema herpeticum.…”

Section: Most Frequently Reported Adverse Eventsmentioning

confidence: 99%

“…It has been reported that patients with AD are at higher risk of herpes simplex infections, compared with the general population. [47][48][49] The ID rate of herpes simplex virus skin episodes, including eczema herpeticum and severe initial infections, among children with AD has been estimated to be 4.7 cases per 1000 patient-months of follow-up monitoring (95% CI: 2.6 -7.7) (unpublished report on file at Novartis Pharma AG). The ID rates of herpes simplex virus infections, not including eczema herpeticum, observed during the DB phases of the studies were 0.8 cases per 1000 patient-months in the pimecrolimus group and 1.7 cases per 1000 patientmonths in the vehicle group (relative risk: 0.462; 95% CI: 0.04 -9.93; P ϭ .528).…”

Section: Most Frequently Reported Adverse Eventsmentioning

confidence: 99%

“…Among infants treated with 1% pimecrolimus cream for up to 2 years (study 0315/0315-E1), 39 skin infections were not more frequent during the second year of treatment than during the first year, and the incidence of all bacterial and viral skin infections was low, compared with the incidence of these infections reported in studies in which pediatric patients with AD who were receiving conventional treatment were monitored for Ͼ12 months. 47,50 To evaluate more completely the systemic immunosuppressive potential of 1% pimecrolimus cream, its effect on the immune response to vaccinations was assessed among 91 infants and young children who completed the 1-year DB study 0315 and then were monitored for an additional 1 year (study 0315-E1). 40 At inclusion in the DB study, the majority of patients (58 of 91 patients, 63.7%) had moderate AD, and the mean percentage of TBSA affected by AD lesions at baseline was 27.6%.…”

Section: Most Frequently Reported Adverse Eventsmentioning

confidence: 99%

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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Pimecrolimus is a calcineurin inhibitor developed for the topical treatment of atopic dermatitis. During the clinical development of 1% pimecrolimus cream, 1133 patients 3 to 23 months of age with mild to severe atopic dermatitis were treated for up to 2 years. The objective of this review is to discuss the safety and tolerability of 1% pimecrolimus cream among infants, on the basis of the combined results from all studies (4 pharmacokinetic studies and 6 clinical trials) conducted among these patients. Pimecrolimus blood concentrations measured for 35 patients were consistently low (Յ1 ng/mL in Ͼ80% of samples), irrespective of the disease severity and extent, and remained low during intermittent treatment for up to 1 year. The level of systemic exposure to pimecrolimus among infants was comparable to that observed for older pediatric patients enrolled in the same studies and treated in the same way with 1% pimecrolimus cream, which indicated that young pediatric patients are not at higher risk of significant percutaneous absorption of topically applied pimecrolimus, despite their large skin surface area/body mass ratio. The 6 clinical trials included a total of 1098 infants, who were treated for periods ranging from 4 weeks to 2 years. Most of these patients (60%) had moderate to severe disease at baseline. The most frequently reported adverse events were common childhood disorders such as nasopharyngitis, pyrexia, upper respiratory tract infections, ear infections, and bronchitis. During the double-blind (DB) studies or DB phases of studies, the incidence rates for the most frequently reported adverse events were similar for patients who received 1% pimecrolimus cream and patients who received the vehicle, except for the incidence of teething, which was higher among the pimecrolimus-treated infants (relative risk: 2.02; 95% confidence interval: 1.32-3.27). Treatment with 1% pimecrolimus cream was not associated with an increase in the overall incidence of nonskin infections, compared with the vehicle (relative risk: 1.015; 95% confidence interval: 0.88 -1.18). The incidence density (ID) rates for total bacterial, fungal, parasitic, and viral skin infections during the DB studies or DB phases of www.pediatrics.org/cgi

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“…Other specific types of skin infections reported in patients treated with pimecrolimus cream 1% in clinical trials, such as impetigo, folliculitis, furuncle, skin papillomas (viral warts) and mollusca contagiosa (tables 3 and 4) are infections known to occur more frequently in patients with AD than in normal individuals [47,48,49,50]. None of these infections occurred significantly more frequently in patients treated with pimecrolimus cream 1% than in patients who received the vehicle (tables 3 and 4).…”

Section: Adverse Events In Clinical Trialsmentioning

confidence: 99%

An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance

et al. 2007

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In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel®) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has afavourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2–5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.

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Herpes simplex infections in atopic eczema.

Cited by 82 publications

References 14 publications

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

Clinical Management of Atopic Eczema with Pimecrolimus Cream 1% (Elidel®) in Paediatric Patients

Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance

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