Skip to main content

Table 3 Study designs for long-term (≥12 weeks) pimecrolimus trials in pediatric patients (<12 years) with AD

From: Systematic review of published trials: long-term safety of topical corticosteroids and topical calcineurin inhibitors in pediatric patients with atopic dermatitis

Trial

Duration (wk)a

Baseline AD severity

Age, mean (range)

TCS Use

N

Treatmentb

Controlled studies

 Ruer-Mulard 2009 [60]

22

mild to severe (mean EASI = ~10)

7 yr (2–17)

NRc

134

pimecrolimus 1 % BID (OL) for ≤6 wk until clearance, then pimecrolimus BID (DB) for flares

134

pimecrolimus 1 % BID (OL) for ≤6 wk until clearance, then pimecrolimus QD + vehicle QD (DB) for flares

 Siegfried 2006 [44]

24

mild to severe (mean IGA = 3)

59 mo (3–140)

40 % of pts

183

pimecrolimus 1 % BID (DB) for flares

62 mo (3–143)

55 % of pts

92

vehicle BID (DB) for flares

 Zuberbier 2007 [47]

 Zuberbier 2008 [48]

24

severe (R&L = 8.3)

~8 yr (2–17)

29 % of days

195

prednicarbate cream 0.25 % OL for 7–21 d, then pimecrolimus 1 % BID (DB) until clearance (≥7 d) and pimecrolimus BID for flares

35 % of days

89

prednicarbate cream 0.25 % OL for 7–21 d, then vehicle BID (DB) until clearance (≥7 d) and vehicle BID for flares

 Sigurgeirsson 2008 [45]

26

mild to moderate (IGA ≤1)

7 yr (1–17)

41 % of pts

256

pimecrolimus 1 % BID (DB) for flares

72 % of pts

265

vehicle BID (DB) for flares

 Kapp 2002 [41]

52

mild to severe (mean EASI = ~12)

12 mo (3–23)

36 % of pts

204

pimecrolimus 1 % BID (DB) for flares

65 % of pts

46

vehicle BID (DB) for flares

 Wahn 2002 [46]

52

mild to severe (mean EASI = ~13)

8 yr (1–17)

43 % of pts

474

pimecrolimus 1 % BID (DB) for flares

68 % of pts

237

vehicle BID (DB) for flares

 Sigurgeirsson 2015 [61]

260

mild to moderate (IGA = 2–3)

7 mo (3–12)

64 % of pts

1205

pimecrolimus 1 % (OL) until clearance, and then pimecrolimus as needed for flaresd

-

1213

hydrocortisone 1 % or hydrocortisone butyrate 0.1 % (OL) until clearance and then hydrocortisone as needed for flaresd

Uncontrolled studies

 Kaufmann 2004 [62]

 Staab 2005 [63]

20

mild to severe (mean EASI = ~17)

(3–23 mo)

NRe

188

pimecrolimus 1 % or vehicle BID (DB) for 2–4 wk until clearance, then pimecrolimus 1 % BID (OL) for flares for 12 wks and 4 wks with no treatment

 Lübbe 2006 [64]

24

mild to severe

15 yr (<1–81)

53 % of pts

947

pimecrolimus 1 % BID (OL) for flares

 Simon 2006 [65]

24

mild to severe

21 yr (<1–70)

NRc

109

pimecrolimus 1 % BID (OL) until clearance, then pimecrolimus BID for flares

 Whalley 2002 [66]

 Langley 2008 [67]

26

mild to moderate (IGA = 2–3)

~7 yr (<2–17)

None

233

pimecrolimus 1 % BID (DB) for 6 wks, then pimecrolimus BID (OL)

102

vehicle BID (DB) for 6wks, then pimecrolimus BID (OL)

 Papp 2005 [68]

 Papp 2005 [69]

52 (≤104 wk exposure)

mild to severe (mean EASI = 5.8)

28 mo (18–41)

28 % of pts

91

pimecrolimus 1 % BID (OL) for flares for 1 yr (following 1 yr of pimecrolimus 1 % BID [DB] or vehicle BID in lead-in study [Kapp et al. 2002 [41]]

  1. N safety population
  2. BID indicates twice daily, d days, DB double-blind, EASI eczema area and severity index, IGA investigator’s global assessment, mo months, NR not reported, OL open label, pts patients, QD once daily, R&L Rajka and Langeland, TCS topical corticosteroids, wk week(s), yr year(s)
  3. aFor trials of <12 months: duration in weeks = 4 X total months of study. For trials ≥1 year: duration in weeks = 52 X total years of study
  4. bTo differentiate the long-term study treatments from any short-term lead-in treatments, the long-term treatments are indicated in bold
  5. cTCS use was permitted to treat flares not controlled by study medication; information on the incidence and duration of TCS use was not reported (NR)
  6. dPimecrolimus and TCS dosing during acute and maintenance phases was per the study country’s label
  7. eIt was not stated whether TCS use was permitted
Back to article page

BMC Pediatrics

ISSN: 1471-2431

Contact us