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An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch Type Alopecia Areata, Totalis and Universalis

ABSTRACT: An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch Type Alopecia Areata, Totalis and Universalis

PROVIDER: PRJNA435742 | ENA |

REPOSITORIES: ENA

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			Action	DRS
	SRR6768500.fastq.gz	Fastqsanger.gz
	SRR6768510.fastq.gz	Fastqsanger.gz
	SRR6768501.fastq.gz	Fastqsanger.gz
	SRR6768511.fastq.gz	Fastqsanger.gz
	SRR6768502.fastq.gz	Fastqsanger.gz

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An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch Type Alopecia Areata, Totalis and Universalis

Project description:This study was an open-label, clinical trial to investigate tofacitinib 5 mg to 10 mg PO twice daily in the treatment of moderate/severe alopeica areata and to identify if gene expression of the scalp correlates with clinical response. Gene expression profiling was performed on scalp biopsies of alopecia areata patients taken at baseline and up to 24 weeks of treatment of tofacitinib. We applied both naïve and supervised clustering to this dataset in order to assess two features: the overall molecular effect of tofacitinib treatment on patient samples, and the concordant molecular response of the disease. The former was assessed by an unbiased, unsupervised differential expression analysis and the latter was measured by response to previously published gene expression signatures defining AA pathology. To ensure parity of the data, for this analysis we only included patient samples that had matched pre-treatment, Tx-00, and 24 weeks of treatment, Tx-24, samples. Gene expression profiles and Alopecia Areata Disease Activity Index (ALADIN) scores correlated with clinical response.

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An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis.

Project description:Alopecia areata (AA) is a common autoimmune disease with a lifetime risk of ∼2%. In AA, the immune system targets the hair follicle, resulting in clinical hair loss. The prognosis of AA is unpredictable, and currently there is no definitive treatment. Our previous whole genome expression studies identified active immune circuits in AA lesions, including common γ-chain cytokine and IFN pathways. Because these pathways are mediated through JAK kinases, we prioritized clinical exploration of small molecule JAK inhibitors. In preclinical trials in mice, tofacitinib successfully prevented AA development and reversed established disease. In our tofacitinib trial in 12 patients with moderate to severe AA, 11 patients completed a full course of treatment with minimal adverse events. Following limited response to the initial dose (5 mg b.i.d.), the dose was escalated (10 mg b.i.d.) for nonresponding subjects. Eight of 12 patients demonstrated ≥50% hair regrowth, while three patients demonstrated <50% hair regrowth, as measured by Severity in Alopecia Tool scoring. One patient demonstrated no regrowth. Gene expression profiles and Alopecia Areata Disease Activity Index scores correlated with clinical response. Our open-label studies of ruxolitinib and tofacitinib have shown dramatic clinical responses in moderate to severe AA, providing strong rationale for larger clinical trials using JAK inhibitors in AA. ClinicalTrials.gov ID NCT02299297.

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Extensive alopecia areata is reversed by IL-23 cytokine antagonism

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