Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: a meta-analysis of randomized clinical trials

Abstract

Background

Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disorder. Though corticosteroids are the cornerstone of therapy, the Janus kinase inhibitor abrocitinib has shown promise in recent clinical trials for the treatment of AD.

Objective

To assess the overall efficacy and safety of abrocitinib in moderate to severe AD.

Methods

All randomized controlled trials (RCTs) evaluating the efficacy and safety of abrocitinib in moderate to severe AD were included in the meta-analysis.

Results

The pooled analysis revealed a significant proportion of patients achieving Investigator’s Global Assessment (IGA) response (RR = 3.52, 95% CI; 2.78–4.46, p < .00001), Eczema Area and Severity Index (EASI) response (RR = 3.35, 95% CI; 2.54–4.41, p < .00001), and Peak Pruritus Numerical Rating Score (PP-NRS) response (RR = 2.54,95% CI; 1.95–3.30, p < .00001) in abrocitinib arm compared to the placebo arm. Moreover, the pooled analysis also suggested that treatment-emergent adverse events (TAEs) were relatively higher with abrocitinib than placebo (R.R. = 1.17; 95% CI; 1.06–1.29, p = .002).

Conclusions

This meta-analysis showed that abrocitinib had a significant beneficial effect and tolerable adverse effect profile in patients of AD. Dose regimens of 200 and 100 mg seemed to have similar benefits. However, long-term trials are needed for corroboration.

Key points

• Abrocitinib is emerging as a potential treatment option for moderate to severe atopic dermatitis.

• The pooled analysis from 4 RCTs demonstrated significant effectiveness of abrocitinib in both physician and patient-reported outcomes like IGA, EASI, and PP-NRS. The drug was also well-tolerated across the trials.

• The number needed to treat (NNT) for all efficacy outcomes was low suggesting clinically desirable benefits with the use of abrocitinib.

• Trial registration: Review registration number PROSPERO database: CRD42021255634.

Keywords:

• Atopic dermatitis
• eczema
• JAK inhibitors
• abrocitinib
• systematic review
• meta-analysis
• immune-mediated skin diseases

Acknowledgments

We are thankful to Dr. Rituparna Maiti, Dr. Anand Srinivasan of the Department of Pharmacology, AIIMS, Bhubaneswar, and Dr. Archana Mishra of the Department of Pharmacology, AIIMS, New Delhi, for their constructive suggestions during the conduct of this study.

Disclosure statement

There are no conflicts of interest.

Ethical approval

Exempted from ethics committee review.

Author contributions

The concept was developed by BRM and BMP. BRM and RRM carried out the search, data extraction, and quality assessment. Any disagreement was resolved by BMP. Statistical analysis and inference were done by BRM and BMP. The manuscript was written by BRM, BMP, and RRM. All authors approved the final version for publication.

Data availability statement

All data generated or analyzed during this study are included in this published article and its supplementary information files.