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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