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Review
. 2023 Mar;13(3):729-749.
doi: 10.1007/s13555-023-00892-5. Epub 2023 Feb 15.

A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring

Christeen Samuel  1 , Hannah Cornman  1 , Anusha Kambala  1 , Shawn G Kwatra  2
Affiliations
Review

A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring

Christeen Samuel et al. Dermatol Ther (Heidelb). 2023 Mar.

Abstract

Janus kinase (JAK) inhibitors are disease-modifying agents with efficacy in treating a spectrum of burdensome dermatologic conditions. The US Food and Drug Administration (FDA) recently placed a black box warning on this class of medications due to safety concerns based on data from studies investigating tofacitinib in patients with rheumatoid arthritis. Here we provide an overview of the timeline of FDA approval of JAK inhibitors in dermatology. We also discuss the available safety profiles of approved oral JAK1 inhibitors, namely abrocitinib and upadacitinib, oral baricitinib, a JAK1/2 inhibitor, deucravacitinib, a Tyk2 inhibitor, and the topical JAK1/2 inhibitor ruxolitinib in dermatology patients. Additionally, we offer suggestions for initial screening and laboratory monitoring for patients receiving JAK inhibitors. We found that the rates of venous thromboembolism reported in trials ranged from no events to 0.1-0.5% in dermatology-specific phase 3 clinical trials compared with no events in the placebo. The rates of cardiovascular events ranged from no events to 0.4-1.2% compared with no events to 0.5-1.2% in the placebo. The rates of serious infections were 0.4-4.8% compared with no events to 0.5-1.3% in the placebo. The rates of nonmelanoma skin cancer (NMSC) ranged from no event to 0.6-0.9% compared with no events in the placebo. The rates of non-NMSC ranged from no event to 0.2-0.7% compared with no event to 0.6% in the placebo. Most patients who developed these adverse events had risk factors for the specific event. The most common adverse events of oral JAK inhibitors included upper respiratory infections, nasopharyngitis, nausea, headache, and acne. Dermatologists should consider patients' baseline risk factors for developing serious complications when prescribing oral JAK inhibitors.

Keywords: Alopecia areata; Atopic dermatitis; Chronic pruritus; Eczema; Itch; Janus kinase; Psoriasis; Vitiligo.

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Figures

Fig. 1
Fig. 1
Inhibition of the JAK-STAT pathway and selectivity of various JAK inhibitors. PsoA psoriatic arthritis, RA rheumatoid arthritis, UC ulcerative colitis, AD atopic dermatitis, AA alopecia areata, AS ankylosing spondylitis, PV polycythemia vera, MF myelofibrosis, GvHD graft-versus-host disease. *Topical ruxolitinib is FDA approved for AD and vitiligo only
Fig. 2
Fig. 2
JAK inhibitors targeting common immune pathways
Fig. 3
Fig. 3
a Timeline of FDA approval of JAK inhibitors in dermatology. b Timeline of milestones facilitating the use of JAK Inhibitors in chronic pruritic dermatoses
Fig. 4
Fig. 4
Screening and laboratory monitoring for patients on JAK inhibitors. *Depending on prior laboratory results and patient risk factors
See this image and copyright information in PMC

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