Baricitinib/alemin treatment for alopecia areata for 6 months does not increase the risk of VTE

Patients with alopecia areata treated with baricitinib do not have an increased risk of venous thromboembolism (VTE), according to recent study results. This is based on post-marketing data in patients with rheumatoid arthritis treated with tofacitinib. However, they emphasized that JAKi enzymes have different selectivities and therefore have different effects on patients.

This study aimed to: (1) investigate VTE risk factors in a cohort of patients with alopecia areata (AA) eligible for baricitinib treatment, and (2) assess any changes in laboratory VTE markers 6 weeks after several months of baricitinib treatment.

Baricitinib Trial Design and Results

The survey team's prospective observational study was conductedfrom July 2023 to July 2024. They involved patients aged ≥18 years with moderate to severe alopecia areata. These subjects were also considered eligible to receive baricitinib 4 mg and were continuously present at the team's department. The researchers highlighted major risk factors for VTE, which include reporting a previous VTE episode. They also highlighted secondary risk factors, including active malignancy, smoking history, history of thrombophlebitis, recent trauma or fracture, family history of VTE, use of estrogen-progestin contraceptives, recent major surgery, prolonged immobility, recurrent miscarriage, and smoking history.

Laboratory testing in these individuals at baseline included antiphospholipid antibodies, antithrombinIII, protein S, protein C, homocysteine, and factor VIII. These markers were later reassessed at 6 months of age. Researchers also assessed participants' genetic susceptibility to VTE (prothrombin G20210A and factor V Leiden mutations) at baseline. It was also noted that those with 1 major or at least 2 minor risk factors were not eligible to receive baricitinib.

The drug screening involved a total of 47 patients with moderate to severe alopecia areata, who were included in the study. No contraindications based on VTE are excluded. No thrombotic events were reported during baricitinib treatment. However, the team did highlight that 4.2% of these subjects sustained a fracture, a known risk factor for VTE. After 6 months of continued treatment, the team conducted follow-up laboratory tests on 37 of the 47 participants.

No significant changes were observed in most of the studied parameters, although they did highlight a statistically significant decrease in patients' mean factor VIII levels. This reduction decreased from 119.1% at baseline to 101.8% at 6 months (P=0.019). Overall, the team concluded that no participants developed VTE or showed increased susceptibility to VTE during treatment.

These findings are considered consistent with previous evidence from large observational cohorts. In fact, the researchers noted that use of baricitinib was associated with a significant decrease in patients' factor VIII levels, rather than an increase in risk markers. This is noteworthy because elevated factor VIII is considered a prothrombotic marker and is associated with the increased risk of VTE observed in patients with rheumatoid arthritis. This observation is consistent with results from the baricitinib alopecia areata clinical trial program, in which a low VTE incidence rate (0.10 cases per 100 patient-years) was concluded.

The main limitations of the study pointed to the relatively small sample size of this analysis and the limited follow-up time. Despite these limitations, the team highlights its major strength as it is the first detailed assessment of VTE susceptibility in patients with alopecia areata treated with baricitinib.

In summary, the study results indicate that patients eligible for baricitinib treatment can be reassured of the risk of adverse eventsVTE. In clinical practice, comprehensive thrombosis screening is generally not required before initiating JAKi therapy unless the patient has specific clinical risk factors, such as a personal or family history of thrombotic events or recurrent miscarriage.

References:https://www.hcplive.com/view/no-risk-increase-vte-6-months-baricitinib-therapy-alopecia-areata