Patients with alopecia see continual hair regrowth up to 68 weeks with deuruxolitinib
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Key takeaways:
- At week 24, 32.6% and 40.3% of patients treated with deuruxolitinib 8 mg and 12 mg, respectively, achieved 20% or less hair loss.
- By week 68, these rates increased to 48.8% and 60.9%, respectively.
SAN DIEGO — Deuruxolitinib showed significant hair regrowth for up to 68 weeks in patients with alopecia areata, according to a late-breaking presentation at the American Academy of Dermatology Annual Meeting.
There are only two presently approved Janus kinase (JAK) inhibitors for the treatment of alopecia. One is baricitinib and the other is ritlecitinib, which was recently approved in June 2023 as the first treatment option for alopecia areata (AA) in adolescents.
A third treatment option that is under investigation, deuruxolitinib — a JAK1 and JAK2 inhibitor — has shown efficacy in the treatment of AA after 24 weeks of treatment, as Healio previously reported.
In the new late-breaking data presented at the AAD Annual Meeting by Brett King, MD, PhD, FAAD, associate professor of dermatology at Yale School of Medicine, deuruxolitinib continued to show efficacy in this indication for up to 68 weeks.
“Alopecia is relatively new to us,” King said during his presentation. “And what makes it different than other inflammatory skin disease patients is that it takes time to treat. So, we might expect to see continued efficacy or continued improvement in efficacy at other time points.”
The data presented were from the extension trial of two phase 3 trials, THRIVE-AA1 and THRIVE-AA2. In these trials, patients were randomly assigned to receive twice-daily deuruxolitinib 8 mg or 12 mg or placebo twice a day for 24 weeks. After 24 weeks, patients who were originally on deuruxolitinib continued their dosages, whereas those taking placebo switched to deuruxolitinib.
The North American cohort included 1,099 patients (mean age, 39 years; 63.9% women; 74.3% white) and the European Union cohort included 407 patients (mean age, 38.2 years; 66.3% women; 77.4% white).
Results showed that the proportion of patients in the 8 mg group that achieved a Severity of Alopecia Tool (SALT) score of 20 or less, or only 20% or less scalp hair loss, increased from 32.6% at week 24 to 48.8% at week 68.
Similar findings were observed in the 12 mg group with the proportion of patients that achieved SALT 20 or lower increasing from 40.3% to 60.9%.
“You can see that there’s a continued rise in the number of patients who are achieving scalp hair regrowth out past 24 weeks,” King said.
“This really challenges the notion that we get from atopic dermatitis, psoriasis and other inflammatory skin diseases that we can change or improve this disease quickly,” he explained, echoing that the treatment of AA takes time.
At week 24, the mean SALT score of patients in the placebo group was 88.3. After switching to deuruxolitinib, the mean SALT score decreased to 28.8 by week 68. The mean SALT score of patients in the deuruxolitinib groups was 48.4 at week 24 and 28.6 at week 68.
According to the presentation, 19.9% of patients discontinued the trial. The most common reason for discontinuation was withdrawn consent (65.2%) followed by experiencing a treatment-emergent or worsening adverse event (12.7%).
Adverse events were experienced by 78.2% of patients, with 3.3% citing serious adverse events, 0.6%of which were related to treatment. The most common adverse events, defined as being experienced by 5% or more patients, were COVID-19, nasopharyngitis, lipid elevation, asymptomatic COVID-19, upper respiratory tract infection, acne and increased blood creatine phosphokinase. One death was reported.
Serious infections, opportunistic infections and malignancy occurred in 0.6%, 0.5% and 0.9% of patients, respectively. There were no major adverse cardiovascular events reported; however, there were six cases of thrombosis.
“These are the adverse events that catch our eyes and give us pause to think in the JAK inhibitor class,” King admitted. However, he goes on to explain that the majority of thrombosis cases occurred in the 12 mg arm with only 1 occurring in the 8 mg arm. Further, the patient on 8 mg that experienced thrombosis had been treated with 12 mg a long time beforehand.
In terms of efficacy, both doses yielded significant hair regrowth up to 68 weeks.
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King BA, et al. S050 late-breaking research: session 2. Presented at: American Academy of Dermatology Annual Meeting; March 8-13, 2024; San Diego.
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