Safety and efficacy of Pimecrolimus in atopic dermatitis among Chinese infants: a sub-group analysis of a five-year open-label study

Figures & data

Figure 1. Patient disposition (TCS: Topical corticosteroid; ITT: Intent-to-treat; PIM: Pimecrolimus 1%).

Table 1. Baseline demographics of the Chinese sub-group population (TCS: Topical corticosteroid; PIM: Pimecrolimus 1%).

		PIM (N = 60)	TCS (N = 59)
Age (months)	Mean (std)	5.9 (2.2)	6.0 (2.3)
Sex (N (%))	Male	42 (70.0)	43 (72.9)
	Female	18 (30.0)	16 (27.1)
TBSA affected	Mean (std)	27.5 (18.0)	26.7 (17.6)
IGA (N(%))	0, Clear	0	0
	1, Almost clear	0	0
	2, Mild disease	21 (35.0)	30 (50.8)
	3, Moderate disease	39 (65.0)	29 (49.2)
	4, Severe disease	0	0
	5, Very severe disease	0	0
Facial IGA (N (%))	0, Clear	0	1 (1.7%)
	1, Almost clear	0	1 (1.7%)
	2, Mild disease	20 (33.3)	23 (39.0)
	3, Moderate disease	40 (66.7)	33 (55.9)
	4, Severe disease		1 (1.7)
	5, Very severe disease	0	0
	Not stated	0	0

Figure 2. TCS sparing effect of PIM. Graph shows number of patients in PIM group who used TCS as rescue medication.

Table 2. Number of patients (%) with adverse events (≥ 30%) by preferred term and treatment group during the treatment period—Chinese sub-group population.

Preferred term	PIM N = 60	%	TCS N = 59	%	Total n = 119	%
Diarrhea	19	31.7	26	44.1	45	37.8
Pyrexia	23	38.3	34	57.6	57	47.9
Nasopharyngitis	45	75.0	48	81.4	93	78.2
Upper respiratory tract infection	18	30.0	21	35.6	39	32.8
Cough	21	35.0	28	47.5	49	41.2

Figure 3. Long-term efficacy of PIM compared with TCSs: A, overall; B, facial IGA treatment success (IGA ≤1); C, TBSA affected.

Data availability statement

Raw data were generated at Viatris. Derived data supporting the findings of this study are available from the corresponding author X.D. on request.