Real-world results support tofacitinib in alopecia patients

Hair & nails

By Siobhan Calafiore

19 Jun 2024

Half of patients with alopecia areata achieve a ‘good’ hair regrowth response after being treated with tofacitinib for 12 months, Australian real-world data suggest.

Investigators say their findings add to growing evidence that the JAK inhibitor is a safe and effective option in patients with moderate-to-severe disease, although further randomised controlled trials are required to establish the optimal regimen.

The retrospective study involved 202 patients (mean age at initiation 33, 66% female) with scalp alopecia areata (AA) started on oral (n=25) or sublingual (n=96) tofacitinib or a mix of both (n=81) between November 2016 and May 2019.

Fifty-five patients (27.2%) had a Severity of Alopecia Tool (SALT) score of more than 90 at initiation of tofacitinib, with a score of 100 indicating complete hair loss.

As well as scalp hair loss, 54%, 36%, and 25% of patients had eyebrow, eyelash and nail involvement, respectively, while 58% of the 69 men had beard hair loss.

Patients were started on a mean 4.4 mg daily dose (range 2.5-10 mg), with titration according to response and tolerability to a mean 8.6 mg (maximum 20 mg) daily.

Findings published in the Australasian Journal of Dermatology [link here] showed that the median SALT score improved from 34.5 (IQR 12.0–97.3) at baseline to 3 (IQR 0.0–12.75) after 18 months of treatment.

At this time point, 55.9%, 42.6% and 29.2% of patients had achieved 50%, 75% and 90% reductions in their SALT scores respectively, the researchers noted.

There was no statistically significant correlation between age and change in score, however women achieved more significant regrowth than men, with the difference achieving statistical significance for up to 12 months of therapy (72% vs 50%).

There was no difference in response after 15 months, however.

The investigators also observed that the reduction in SALT score was inversely related to the duration of disease prior to tofacitinib treatment. Patients with extensive AA required prolonged treatment to achieve comparable hair regrowth.

The team also noted 124 patients and 168 patients received concomitant systemic corticosteroids or low-dose oral minoxidil during tofacitinib therapy, respectively.

The median percentage change in SALT score was not significantly different for monotherapy (87.1%) compared with combination systemic therapy (83.7%).

However, neither systemic corticosteroid therapy nor oral minoxidil was associated with greater improvement in SALT score after 18 months of treatment, they added.

While no serious adverse events were reported, six stopped treatment due to upper respiratory tract infection, one due to headache and one due to pancreatitis.

However, the researchers added that it was important to note the potential for serious adverse effects, including viral reactivation (particularly herpes zoster infections), tuberculosis reactivation and gastrointestinal perforation.

They said a study of 5671 patients treated with tofacitinib for rheumatoid arthritis found that the overall rates and types of malignancies were similar to those of patients with untreated moderate-to-severe rheumatoid arthritis.

The researchers noted that tofacitinib, a selective JAK1/3 inhibitor, was initially the most studied for the treatment of AA, however evidence had since emerged showing similar efficacy of various agents with different JAK selectivity including baricitinib, ritlecitinib, deuruxolitinib, brepocitinib and upadacitinib.

“This suggests that JAK selectivity may be relatively insignificant for efficacy and provides compelling evidence that failure of one JAK inhibitor does not predict failure of another,” the authors wrote.

“The relationship between JAKi selectivity and clinical effectiveness remains unclear, but it may be appropriate to consider an alternative JAKi in patients who have not responded adequately within an expected timeframe.”

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