Efficacy

Only four RCTs have been published in full in three papers at the time of this summary (two trials in adults, n = 34 and n = 260, and two trials in children combined into one, n = 403).6-8 It is likely that there are many more unpublished and ongoing studies.

In the first study, 34 patients with moderate atopic eczema were randomised within a right-left body comparison study.6 Topical 1% pimecrolimus (syn. with ascomycin) was applied twice daily (n = 16) or once daily (n = 18) and compared with the corresponding vehicle cream for symmetrical lesions on one or other side of the body. The trial was very short (3 weeks) and all participants were adults. At the end of 21 days, those in the twice-daily pimecrolimus group showed a 71-9% decrease in baseline severity scores compared with 10-3% in the placebo group (P<0-001). The magnitude of benefit was less impressive in the once-daily pimecrolimus group, with a 37-7% reduction in the severity index in the active-treatment group, compared with a 6-2% reduction in the vehicle group (P= 0-002). None of the patients in the once-daily group (neither active nor placebo) showed total clearance of their lesions. This compared with 3 out of 15 patients showing total clearance in the twice-daily pimecrolimus group.

The large dose-finding RCT7 enrolled 260 adults who were randomised to 0-05% (n = 42), 0-2% (n = 46), 0-6% (n = 42) or 1% (n = 45) pimecrolimus, matching vehicle cream (n = 43) or betamethasone 17-valerate cream (n = 42) twice daily for 3 weeks.7 The results were

How might topical pimecrolimus be used?

analysed on an ITT basis and 23-5% discontinued from the trial (mainly because of treatment failure in the vehicle and low-strength pimecrolimus groups). Outcomes as assessed by a modified EASI score (a composite scale of the four signs of erythema, papulation/induration, excoriation and lichenification combined with extent, taking into account omission of head and neck) suggested dose-related improvements in all parameters in the 0-2%, 0-6% and 1% pimecrolimus groups but little or no benefit in those using the 0-05% strength. The greatest improvement was seen in the betamethasone group. At 12 weeks, the median percentage changes from baseline were -2-7, -14-8, -17^3, -27-6, -37-9 and -64-1 in the vehicle, 0-05%, 0-2%, 0-6%, 1% pimecrolimus and betamethasone valerate groups, respectively. Pruritus and patient-derived scores were similar, 88^1% of patients in the betamethasone group showed greater than 50% improvement compared with 53-3% in the 1% pimecrolimus group.

The third report8 evaluated twice-daily 1% pimecrolimus cream versus vehicle cream (randomised 2:1 respectively) for 6 weeks in 403 people aged 1-17 years with predominantly moderate atopic eczema affecting at least 5% of body surface area. This report represented combined data from two almost identical industry-sponsored multicentre studies in the US. At the end of the 6-week treatment period, those in the active group demonstrated clear gains in efficacy when compared with the vehicle group. For the primary outcome measure, 35% of those using 1% pimecrolimus, compared with 18% using vehicle were clear or almost clear according to the investigator, using an ITT analysis (P=0-05). Similar differences in favour of pimecrolimus were shown for other outcome measures such as EASI, and patient-reported itch.

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