Azathioprine Effective for Patients with Recalcitrant, Severe Alopecia Areata

Azathioprine is an efficacious systemic treatment for patients living with recalcitrant and severe alopecia areata, according to recent findings.1

These were the results of a recent analysis authored by Susan Farshi and Parvin Mansouri, from the Skin and Stem Cell Research Center at Tehran University of Medical Sciences in Iran. Farshi and Mansouri noted that alopecia areata is a condition whose pathogenesis may be impacted in a significant way by T cells.

Additionally, the investigators highlighted that a plethora of immunosuppressive therapies have been utilized for alopecia areata, adding that such medications have varied in terms of their degrees of success.

“Our recent study demonstrated that [azathioprine] is a safe and effective treatment for [alopecia areata] over a 6-month period,” Farshi and Mansouri wrote.1,2 “In this article, we report the long-term effectiveness and safety profile of [azathioprine] in 63 patients who received the drug for 10 years.”

For the study's recruitment, the investigators drew participants from the dermatology clinic at Imam Hospital and the Skin and Stem Cell Research Center at Tehran University of Medical Sciences. The investigative team's prospective study involved the tracking of individuals living with alopecia areata over a 10-year timeframe.

To be eligible, Farshi and Mansouri required participants to have had a history of alopecia areata lasting more than 6 months (including presentations from patchy hair loss to alopecia universalis or totalis). They would also be required to have reported nonscarring alopecia that impacts 20% of the scalp at minimum and to have not implemented hair-related treatments for at least a single month prior to initiation of the study.

A total of 63 individuals were enrolled in the analysis as subjects after meeting the aforementioned criteria for inclusion, comprising 42.9% females and 57.1% males. Throughout the study, the team did not allow subjects to take any supplements known to impact their hair growth.

Baseline evaluations were performed by the investigators before treatment initiation. Specifically, Farshi and Mansouri performed routine lab tests on participants, looking at erythrocyte sedimentation rates, a complete blood count with differential, blood urea nitrogen, liver enzymes, creatinine, coagulation profiles (prothrombin time, INR, partial thromboplastin time), thyroid function tests, tuberculosis screenings (PPD or IGRA), and hepatitis panels.

Both during the treatment period and each year for 10 years, the investigators looked at scalp hair regrowth levels using the Severity of Alopecia Tool (SALT) scores of participants. Subjects were provided with azathioprine at a daily dose of 2 mg/kg based on their recorded body weight. Their research's primary outcome was determined to be the percent shift in SALT scores throughout the treatment course.

At the point of baseline, the mean duration of the current episode of alopecia areata was found by Farshi and Mansouri to be 34.10 months (±39.16). During the 10-year course of treatment with azathioprine, subjects in the trial were shown to have a mean hair regrowth of 92.69% (±9.08).

Additionally, the investigative team highlighted a decline of subjects' average percentage of hair loss from 74.2% (±27.8) prior to azathioprine use to 5.2% (±8.6) following the treatment period. This shift, the team noted, represented a statistically significant improvement (Paired t-test, 95% CI = 55.9–75.3).

Scores of subjects' mean hair loss severity (on a scale from S0 - S5) were found to have dipped from 5.56 (±1.3) to 0.67 (±0.53), which the investigators suggest also indicated a highly significant change from the point of baseline (Wilcoxon signed-rank test, P < .0001).

“In conclusion, our 10-year follow-up suggests that [azathioprine] is a safe and well-tolerated treatment for [alopecia areata],” they wrote.1 “We hope that future double-blind, controlled clinical trials will further clarify [azathioprine’s] effectiveness compared to other treatments in patients with severe and recalcitrant [alopecia areata].”

References

1. Farshi S and Mansouri P (2025). Efficacy and Safety of Long-Term Azathioprine Therapy for Severe Alopecia Areata: A 10-Year Cohort Study. J Cosmet Dermatol, 24: e70187. https://doi.org/10.1111/jocd.70187.

2. S Farshi, P Mansouri, F Safar, et al. “Could Azathioprine Be Considered as a Therapeutic Alternative in the Treatment of Alopecia Areata? A Pilot Study,” International Journal of Dermatology 49, no. 10 (2010): 1188–1193, https://doi.org/10.1111/j.1365-4632.2010.04576.x.