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Background <p>Atopic dermatitis (AD) is a chronic inflammatory skin disorder. Although non-steroidal agents are available, their use may be limited by variable efficacy, tolerability, and/or suitability for long-term disease control, highlighting the need for therapies with novel mechanisms of action. Tapinarof, a novel topical immune modulator recently approved for plaque psoriasis, has emerged as a viable option in managing AD. We aimed to assess the efficacy, safety, and ideal dosing of Tapinarof for the treatment of AD.</p> Methods <p>A comprehensive literature search was conducted across various databases until February 2025 to identify relevant randomized controlled trials (RCTs). The quality was assessed using the RoB 2 tool and the analysis was performed using RevMan 5 software.</p> Results <p>Five studies (n = 1431 patients) were identified fulfilling our research question. Tapinarof 1% once daily and twice daily regimens had the highest efficacy in achieving IGA success (RR = 2.54, p &lt; 0.001) and (RR = 1.98, p = 0.0003) respectively. In addition, Tapinarof 1% had significantly achieved higher EASI-75 response compared to control (RR = 2.66, p &lt; 0.00001), while Tapinarof 0.5% showed no statistically significant difference. Furthermore, compared to control, the 0.5% group had a similar incidence of adverse events. In contrast, the 1% Tapinarof group had a significantly higher incidence of folliculitis and headache.</p> Conclusions <p>The results suggest that Tapinarof 1% (once or twice daily) improves IGA success and EASI-75 compared with control. Overall tolerability was acceptable; however, treatment was associated with a substantially increased risk of folliculitis (RR 7.40) and headache (RR 4.55), particularly at higher doses. Clinicians may consider initiating therapy with the 1% formulation to maximize efficacy while counseling patients and monitoring for these adverse events, and individualizing dose selection for patients at higher risk or with lower tolerance. The 0.5% formulation may be suitable for patients requiring milder therapy, though its reduced efficacy should be noted.</p>

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Efficacy, safety, and optimal dosing of Tapinarof for atopic dermatitis: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年2月17日

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  • Maab M. Saleh,
  • Sayed Sayem,
  • Mohamed A. Alsaied,
  • Abdelrahman M. Elettreby,
  • Youssef A. Alqahtani,
  • Ayed A. Shati,
  • Ahmed Hamdy Zabady,
  • Ahmed A. Abo Elnaga

摘要

Background

Atopic dermatitis (AD) is a chronic inflammatory skin disorder. Although non-steroidal agents are available, their use may be limited by variable efficacy, tolerability, and/or suitability for long-term disease control, highlighting the need for therapies with novel mechanisms of action. Tapinarof, a novel topical immune modulator recently approved for plaque psoriasis, has emerged as a viable option in managing AD. We aimed to assess the efficacy, safety, and ideal dosing of Tapinarof for the treatment of AD.

Methods

A comprehensive literature search was conducted across various databases until February 2025 to identify relevant randomized controlled trials (RCTs). The quality was assessed using the RoB 2 tool and the analysis was performed using RevMan 5 software.

Results

Five studies (n = 1431 patients) were identified fulfilling our research question. Tapinarof 1% once daily and twice daily regimens had the highest efficacy in achieving IGA success (RR = 2.54, p < 0.001) and (RR = 1.98, p = 0.0003) respectively. In addition, Tapinarof 1% had significantly achieved higher EASI-75 response compared to control (RR = 2.66, p < 0.00001), while Tapinarof 0.5% showed no statistically significant difference. Furthermore, compared to control, the 0.5% group had a similar incidence of adverse events. In contrast, the 1% Tapinarof group had a significantly higher incidence of folliculitis and headache.

Conclusions

The results suggest that Tapinarof 1% (once or twice daily) improves IGA success and EASI-75 compared with control. Overall tolerability was acceptable; however, treatment was associated with a substantially increased risk of folliculitis (RR 7.40) and headache (RR 4.55), particularly at higher doses. Clinicians may consider initiating therapy with the 1% formulation to maximize efficacy while counseling patients and monitoring for these adverse events, and individualizing dose selection for patients at higher risk or with lower tolerance. The 0.5% formulation may be suitable for patients requiring milder therapy, though its reduced efficacy should be noted.