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

Abstract

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.

Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial

“…The lack of systemic immunosuppression is likely due to the minimal systemic drug exposure in both infants and children. 38 40 The results of the Petite Study show for the first time that as-needed first-line treatment with PIM or TCSs has no safety concerns and no impact on the maturation of the developing immune system. The data suggest that PIM had similar efficacy to TCS and PIM was associated with a substantial corticosteroid-sparing effect.…”

Topical Treatments with Pimecrolimus, Tacrolimus and Medium- to High-Potency Corticosteroids, and Risk of Lymphoma

“…Data from animal studies, case reports in a small number of patients, and immunosuppressive effects and increased cancer risk (including lymphoma) observed in patients who received systemically administered calcineurin inhibitors for suppression of solid-organ transplant rejection prompted the labeling changes [4]. However, data quantifying the risk of lymphoma among users of these drugs in actual practice are scarce [5]. So far, only one observational study assessed the risk of lymphoma in association with pimecrolimus.…”

Discordant Results with Pimecrolimus 1% Cream in the Treatment of Plasma Cell Balanitis

“…Pimecrolimus, a homologue of tacrolimus, is a macrolide with immunosuppressive properties which originated from ascomycin, a lactam substance produced by Streptomyces hygroscopicus [9, 10]. Currently pimecrolimus is approved only for the treatment of slight and moderate atopic dermatitis even if its off-label prescription for the treatment of other inflammatory dermatoses including other genital dermatoses represents a very large field of application [11, 12].…”