Table 1.

Baseline study characteristics of included studies

References	Intervention and control	Setting	Participants	Definition of AD	Outcomes of efficacy	Outcomes of safety	Severity of AD	Age of participants
Lawrence F Eichenfield 13	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 weeks DB, Randomized	589	Hanifin and Rajka14	IGA; EASI	—	Mild to very severe	3 months–17 years
Alexander Kapp15	Pimecrolimus 1% b.i.d and Vehicle b.i.d	12 months DB, Randomized	251 Infants	.Seymour et al. 16	Incidence of flares; TCs requirement; IGA; EASI; Pruritus score; Patient’s global assessment of disease control.	Nasopharyngitis, Otitis Media, URTI, Cough, Bronchitis, Rhinitis, Diarrhea, Gastroenteritis, Impetigo, Bacterial Infection, Herpes Simplex, Pyrexia.	Mild to very severe	3–23 months
Roland Kaufmann17	Pimecrolimus 1% b.i.d and Vehicle b.i.d	Four weeks DB, followed by 12 weeks OL	196 Infants	.Seymour et al. 16	Onset of effectiveness; Incidence of flares at EOS; EASI; IGA; Caregiver’s assessment of pruritus severity and sleep loss.	Nasopharyngitis, Cough, Bronchitis, Rhinitis, Diarrhea, Gastroenteritis, Pyrexia.	Mild to very severe	3–23 months
Richard G B Langley13	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 wk DB followed by 20 weeks OL	403 Children and adolescents.	.Williams et al. 18	IGA; EASI and pruritus assessment.	Nasopharyngitis, Otitis Media, URTI, Bacterial Infection, Influenza.	Mild to very severe	2–17 years
D F MURRELL19	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 weeks DB followed by 6 weeks OL	200	Hanifin and Rajka14	IGA; EASI; Pruritus score; Dermatitis score.	Nasopharyngitis, URTI, Herpes simplex, influenza, Headache.	Mild to moderate	12 years or over
D Y M Leung20	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 weeks DB, randomized.	73	Hanifin and Rajka14	IGA; EASI; Pruritus score; Patients AD assessment; TLS	—	Mild to severe	2–49 years
Kristine Breuer21	Pimecrolimus 1% b.i.d and Vehicle b.i.d	4 weeks DB, Randomized followed by 12 weeks OL.	195 Infants	.Seymour et al. 16	IGA, EASI, SCORAD	—	Mild to very severe	3–23 months
Lawrence F Eichenfield5	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 weeks DB, randomized	403 Children and adolescents	.Williams et al.18	IGA; EASI; Pruritus score; Patient’s global assessment of disease control.	Nasopharyngitis, URTI, Application of site burning, Headache	Mild to moderate	1–17 years
Vincent C. HO22	Pimecrolimus 1% b.i.d and Vehicle b.i.d	6 weeks DB, randomized followed by 20 weeks OL	186 Infants	.Williams et al.18	IGA; EASI; Pruritus Score	Nasopharyngitis, URTI, Bronchitis, Rhinitis, Diarrhea, Gastroenteritis, Bacterial Infection, Pyrexia & Influenza.	Mild to moderate	3–23 months
T. LUGER23	Pimecrolimus 1% b.i.d and Vehicle b.i.d	3 weeks DB, randomized.	260 Adults	Hanifen and Rajka14	Adapted EASI; Pruritus score; Patient’s self-assessment of disease control.	—	Moderate to severe	>18 years
B Sigurgeirsson24	Pimecrolimus 1% b.i.d and Vehicle b.i.d	26 weeks, DB, Randomized	521 Children	Williams et al.18.	Number of TCS free days; number of flares.	Nasopharyngitis, Otitis Media, URTI, Cough, Bronchitis, Rhinitis, Gastroenteritis, Impetigo, Pyrexia, Influenza, Application of site burning, Headache.	Mild to moderate	2–17 years
Ulrich Wahn25	Pimecrolimus 1% b.i.d and Vehicle b.i.d	12 month DB	711 Children and adolescents.	.Williams et al. 18	Incidence of flares at 6 and 12 months; TCs requirement; Time to first flare; IGA; EASI.	Impetigo, Bacterial Infection and Herpes Simplex.	Moderate to very severe	2–17 years
Micheal Meurer26	Pimecrolimus 1% b.i.d and Vehicle b.i.d	24 weeks DB, randomized	192 Adults	Rajka and Langland27	Incidence of flares; TCs requirement; IGA; EASI; Pruritus score; Patient’s global assessment of disease control.	Application of Site Burning	Moderate to severe	>18 years

AD, Atopic Dermatitis; B.i.d, Twice daily; DB, Double Bind; EASI, Eczema Area and Severity Index; IGA, Investigators Global Assessment; OL, Open Label; URTI, Upper respiratory tract infection.