Since December 2000, two topical calcineurin inhibitors have been approved for use in patients with atopic dermatitis in the United States and Canada. Since the approval of these agents, several case reports of malignancies (skin and lymphoma) have been reported to the United States Food and Drug Administration, causing a black box warning to be placed in each product's labeling. Several pharmacokinetic analyses, commentaries, and editorials have been published refuting the addition of the black box warning. In light of these findings, this comparative effectiveness review of 2 topical calcineurin inhibitors was commissioned to identify whether additional good-quality studies on safety have been published and to determine whether differences in efficacy and effectiveness exist between the 2 topical agents. The purpose of this review is to compare the effectiveness and harms of topical calcineurin inhibitors in persons with atopic dermatitis or eczema.

Contents

• Purpose and Limitations of Evidence Reports
• Introduction
  • Scope and Key Questions
• Methods
  • Literature Search
  • Study Selection
  • Data Abstraction
  • Validity Assessment
  • Data Synthesis
  • Peer Review and Public Comment
• Results
  • Systematic Reviews
  • Key Question 1
  • Key Question 2
  • Key Question 3
• Summary
• References
• Appendixes
  • Appendix A Search strategy
  • Appendix B Quality assessment of drug class reviews for the Drug Effectiveness Review Project
  • Appendix C Excluded studies
  • Appendix D Glossary
  • Appendix E Results for sensitivity analysis ()
  • Appendix F Assessing the strength of comparative evidence (using the modified GRADE approach)
• Evidence Tables

Prepared for: Drug Effectiveness Review Project, Principal Investigator, Marian McDonagh, PharmD

The funding source, the Center for Evidence-based Policy, is supported by 15 organizations, including 14 state Medicaid programs. These organizations selected the topic and had input into the Key Questions for this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report.

Suggested citation:

Lee NJ, McDonagh MS, Peterson K, Chan B, Thakurta S. Drug class review: Topical calcineurin inhibitors. Original report. http://www.ohsu.edu/drugeffectiveness/reports/final.cfm

The Agency for Healthcare Research and Quality has not yet seen or approved this report.

The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.