Sublingual tofacitinib may have a role in the management of alopecia areata with fewer side effects than the oral form of the JAK1/3 inhibitor.
An Australian pilot study of sublingual tofacitinib was conducted in 18 patients with moderate to severe, treatment-resistant alopecia. The 18 patients rolled over to sublingual tofacitinib had been non-responders to either cyclosporine or placebo in a previous trial.
Two responders to either cyclosporine or placebo in the previous trial continued on their treatment allocation.
The study found 37.5% of patients demonstrated some response to tofacitinib; 12.5% achieved a minimum 50% reduction in Severity of Alopecia Tool score (SALT50).
The two participants on cyclosporine did not achieve significant incremental improvement at 24 weeks compared to the initial 12 weeks.
“In this 12-week clinical trial, we found no significant adverse events to sublingual tofacitinib. However, we note that a longer trial may be required to reveal these adverse events.”
The researchers, including senior investigator Professor Rodney Sinclair from Sinclair Dermatology in Melbourne, said optimal dosage of tofacitinib was important given the toxicities associated with higher doses, particularly pulmonary embolism.
“Our pharmacokinetics analysis suggests sublingual tofacitinib may have a substantially longer half-life of 11 hours, compared with a half-life of 3 hours for oral tofacitinib. Sublingual tofacitinib may enable once-daily rather than twice-daily dosing.”
“In conclusion, our study provides the relevant foundation for larger studies to confirm pharmacokinetics data and efficacy.”
“We demonstrate potential efficacy of sublingual tofacitinib to treat moderate-to-severe AA as an alternative to oral administration. Further research is required to elucidate dose-dependent efficacy and safety of sublingual tofacitinib, characterise its drug interactions, and determine differences in AUC compared with oral tofacitinib.”
The study was published in the International Journal of Dermatology.
Disclosures: Professor Sinclair has acted as an investigator for Pfizer and has a patent on sublingual tofacitinib.