Evidence Table 4

Quality assessment of head-to-head trials of topical calcineurin inhibitors

Author, Year
Country
Randomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contaminationWithdrawal: differential/highIntention-to-treat (ITT) analysisPost- randomization exclusionsQuality RatingFunding
Kempers, 2004
US
Yes, via randomization numbers (by phone system)Yes, through automated phone systemThere were differences in pruritus scores (moderate and severe) between treatment arms. 42% in pimecrolimus arm reported severe pruritus vs. 33% in tacrolimus arm.YesYesNoNoYes
NR
NR
NR
Yes (Pimecrolimus 18.6% vs. Tacrolimus 4.3%)Efficacy- ITT with LOCF (98.6% analyzed)
Safety- ITT (100% reported) without imputation
NoFairNovartis
Paller, 2005Yes, via sequential randomization numbers (by phone system)Yes, through automated phone systemYesYesYesNoNoYes
NR
NR
NR
No/NoEfficacy-evaluable population but end result similar to ITT population (with LOCF)NRFairFujisawa

From: Evidence Tables

Cover of Drug Class Review: Topical Calcineurin Inhibitors
Drug Class Review: Topical Calcineurin Inhibitors: Final Report [Internet].
Lee NJ, McDonagh M, Chan B, et al.
Portland (OR): Oregon Health & Science University; 2008 Oct.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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