VTEs with JAK Inhibitors Similar Between Those with Atopic Dermatitis, General Population

New findings suggest a lack of observed use of Janus Kinase (JAK) inhibitors for atopic dermatitis among venous thromboembolic events (VTEs) cases within half a year prior to VTEs, providing some reassurance for those who prescribe JAK inhibitors.1

These data resulted from an analysis among French patients with atopic dermatitis, with the study being led by Catherine Droitcourt, from the CHU Rennes Department of Dermatology in France. This study was carried out given VTE concerns which had been raised in JAK inhibitors’ initial approvals for rheumatoid arthritis.

“However, most studies focused on [rheumatoid arthritis], an inflammatory disease associated with a greater risk of VTEs in contrast to [atopic dermatitis],” Droitcourt and colleagues wrote.1,2 “Our objective was to assess the JAKi-related risk of VTEs among French DA patients, on a large scale at the French population level.”

The investigative team conducted their research using the French national claims database (SNDS, Système National des Données de Santé). They used a case–control trial design, implementing SNDS data covering 99% of France's population. The study was embedded within a nationwide cohort of adult patients who have diagnoses of severe atopic dermatitis, with the data lasting from 2017 - 2023.

In their determination of participants to involve, the investigators' criteria for inclusion comprised at least a single dispensation of a systemic treatment—methotrexate, cyclosporine, tralokinumab, dupilumab, or a JAK inhibitor such as upadacitinib, baricitinib, or abrocitinib—marking the cohort entry date.

In addition, the team required that subjects have a history of visits to dermatologists, be 18 years or older at the time of study entry, and have received at least 2 dispensations of topical corticosteroids. In their criteria for exclusion, the investigators highlighted previous systemic atopic dermatitis treatment utilization within the year prior to cohort entry and treatments for other indications.

The investigative team defined cases as incident VTE events, encompassing deep vein thrombosis (DVT) and/or pulmonary embolism (PE), taking place in the period between January 2017 - June 2023. The team took note of cases in hospitals, outpatient settings, or emergency departments, identifying them via the validated SNDS EPIGETBAM algorithm.

During the analysis, an exclusive focus was placed on unprovoked VTEs, excluding cases in which there were known strong factors for VTE risk. There were a set of identified provoking factors in the period 3 months prior to the case date, including cesarean section, active cancer, major surgery, hospitalization exceeding 3 days within the previous 4-week timeframe, and initiation of oral estrogen-progestin contraception 3 months prior.

Conditional logistic regression models were applied to estimate 95% confidence intervals (CIs) and odds ratios (ORs) for recent JAK inhibitor exposure versus individuals who were shown never to have implemented JAK inhibitors. The investigators adjusted for general comorbidities.

There were a set of 22,602 subjects included in the overall analysis, with 51.1% being female and the median participant age being 46 years (Q1–Q3: 30–64). Several conclusions were noted by the team, including that the first systemic treatment received at the time of cohort entry had been methotrexate among 38.8% of subjects, dupilumab among 37.3%, cyclosporine among 21%, and tralokinumab among 1.2%.

JAK inhibitors had been provided to 1.6%, and they were distributed as baricitinib (1.2%), abrocitinib (0.05%), and upadacitinib (0.4%). Overall, 225 unprovoked VTE cases were observed by the research team during their evaluation of these data, with the corresponding VTE incidence rate being labeled 1.5 per 1,000 individuals exposed to systemic atopic dermatitis drugs.

There were 48 cases of these cases that the team classified as unprovoked VTEs. Additionally, the investigators found that 68.7% had been managed within an outpatient setting. Notably, in both cases and controls, the team identified no individuals who had been given a JAK inhibitor for atopic dermatitis in the 3 or 6 months before the VTE event.

These findings provide reassurance for prescribers and are supported by several key methodological choices. One would be limiting to those with atopic dermatitis who also do not inherently have a higher VTE risk. Additionally, the team highlighted a greater focus on unprovoked VTEs (excluding strong provoking factors) to improve specificity in the detection of a possible JAKi-VTE relationship despite reduced statistical power.

“However, no conclusion can be drawn about the impact of JAKi in [atopic dermatitis] patients with concomitant risk factors for VTE,” they concluded. “The recommendations of prescription should be maintained.”1

References

1. Droitcourt, C., Kerbrat, S., Staumont-Salle, D., Lescoat, A., Oger, E. and Scailteux, L.-M. (2025), Venous thromboembolic events in patients treated with Janus kinase inhibitors for atopic dermatitis. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.20682.

2. Holmqvist ME, Neovius M, Eriksson J, Mantel Ä, Wållberg-Jonsson S, Jacobsson LTH, et al. Risk of venous thromboembolism in patients with rheumatoid arthritis and association with disease duration and hospitalization. JAMA. 2012; 308(13): 1350.