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. 2025 Mar 3;87(5):2880-2888.
doi: 10.1097/MS9.0000000000003047. eCollection 2025 May.

Efficacy and safety of calcineurin inhibitors in cutaneous lupus: a systematic review and brief meta-analysis of recommended concentration, type, and outcomes

Almaha H Alshathri  1 , Rim Adel Abdellatif  2 , Aljohara H Alshathri  1 , Lamees Fahad Alharbi  3 , Roaa Abdulrahman Allehyani  4 , Mayadah Assaf Alawaji  3 , Abdullah Alajaji  5
Affiliations

Efficacy and safety of calcineurin inhibitors in cutaneous lupus: a systematic review and brief meta-analysis of recommended concentration, type, and outcomes

Almaha H Alshathri et al. Ann Med Surg (Lond). .

Abstract

Background: Establishing effective treatment for cutaneous lupus erythematosus (CLE) is of major importance given lack of approved medications for this autoimmune condition. Topical calcineurin inhibitors have been used to treat all types of CLE, yet there is currently no robust study that evaluated the efficacy of calcineurin inhibitors in this patient population. Our aim is to study the efficacy of topical calcineurin inhibitors for treating patients with CLE and assess the side effects associated with the use of this class of medications.

Materials and methods: A systematic review was conducted following the AMSTAR guidelines. A systematic search for articles published between 2003 and 2024 in PubMed, MEDLINE, the Cochrane library (Cochrane Databases of Systematic Reviews), and the Cochrane Register of Controlled Trials for relevant studies that assessed the efficacy of calcineurin inhibitors in patients with CLE.

Results: Twenty-five studies met the criteria, and we reviewed and collectively included. Based on the Quality assessment, some concerns are raised in the quality assessment of RCTs studies. However, Observational studies have high methodological quality.

Conclusion: In conclusion, our systematic review analyzed 25 studies to evaluate the efficacy and safety of topical calcineurin inhibitors in treating CLE. Our systematic review findings support the effectiveness of these inhibitors, namely pimecrolimus cream and tacrolimus ointment in improving clinical manifestations and disease activity in various forms of CLE, such as discoid lupus and subacute CLE. However, the result from RCTs metanalysis showed no significant difference between calcineurin inhibitors and other treatments. While calcineurin inhibitors are generally safe, the most common side effect was skin burning sensation at application site in the first few days of treatment. Further research is needed to prove the effectiveness of these drugs, explore the comparative effectiveness between different calcineurin inhibitors and comparing their types and their concentration.

Keywords: calcineurin inhibitors; cutaneous lupus erythematosus; discoid lupus; pimecrolimus; subacute LE; tacrolimus.

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Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. The authors declare they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Flowchart of included studies.
Figure 2.
Figure 2.
Comparison of clinical severity scores between calcineurin inhibitors and other treatments.
Figure 3.
Figure 3.
Analysis of erythema score changes in discoid lupus patients across treatment groups.
Figure 4.
Figure 4.
Overview of adverse effects associated with calcineurin inhibitors versus other treatments in discoid lupus patients.
Figure 5.
Figure 5.
Examination of recurrence outcomes among patients treated with calcineurin inhibitors compared to alternative therapies.
Figure 6.
Figure 6.
Quality assessment for RCTs studies (ROB II tool).
See this image and copyright information in PMC

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References

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