B. Moderate to severe disease

No. of studies (# subjects)Risk of bias: (study design/quality)ConsistencyDirectnessPrecisionCommentsOverall strength of evidence
Outcome: Achieving treatment success
Tacrolimus 0.03% ointment compared with pimecrolimus 1% cream
No studiesH2H/Fair--------------------Insufficient
4 (457)RCT/Fair+1−2−1Pooled RR, 0.89 (95% CI, 0.38–2.07)Low
Tacrolimus 0.1% ointment compared with Pimecrolimus 1% cream
1 (224)H2H/FairUnable to determine (1 study)−1+1RR, 1.83 (95% CI, 1.13–2.96)Moderate
4 (456)RCT/Fair+1−2−1Pooled RR, 1.12 (95% CI, 0.48–2.57)Low
Outcome: Reduction in pruritus
Tacrolimus 0.03% ointment compared with pimecrolimus 1% cream
No studiesH2H/Fair--------------------Insufficient
4 (457)RCT/Fair+1−2−1Pooled WMD, 0.86 (95% CI, −0.69 to 2.41)Low
Tacrolimus 0.1% ointment compared with Pimecrolimus 1% cream
1 (224)H2H/FairUnable to determine−1+1Change in pruritus score from baseline −3.7 cm compared with −2.0 cm, P ≤ 0.01Moderate-low
4 (456)RCT/Fair+1−2−1Pooled WMD, 0.74 (95% CI, −0.83 to 2.31)Low
Outcome: Patient assessment of overall disease control
Tacrolimus 0.03% ointment compared with pimecrolimus 1% cream
No studiesH2H/Fair--------------------Insufficient
4 (457)RCT/Fair+1−2−1Pooled RR, 0.98 (95% CI, 0.56–1.73)Low
Tacrolimus 0.1% ointment compared with pimecrolimus 1% cream
No studiesH2H/Fair--------------------Insufficient
4 (456)RCT/Fair+1−2−1Pooled RR, 1.07 (95% CI, 0.53–2.13)Low

Abbreviations: H2H, head-to-head trial; RCT, randomized controlled trial; RR, relative risk; WMD, weighted mean difference

From: Appendix F, Assessing the strength of comparative evidence (using the modified GRADE approach)

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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