Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata

This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Inclusion criteria: Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.

Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.

Study Overview

• Status: Completed
• Conditions: Extensive Alopecia Areata
• Intervention / Treatment: Drug: Oral Tofacitinib citrate

Detailed Description

This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling out contraindications. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.

Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Either gender Age 18 to 60 years Extensive disease (SALT > 24)

Exclusion Criteria:

• Patients taking immunosuppressants or DMARDs Recent live vaccination Active or latent TB, Hepatitis B or C, HIV Malignancy Hypersensitivity to the drug Pregnant or lactating mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients of Extensive alopecia areata; Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT>24)	Drug: Oral Tofacitinib citrate; oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50% reduction in Severity of Alopecia Tool (SALT)	atleast 50% reduction of SALT score from baseline (pre-treatment)	within 24 weeks
50% reduction in Dermatology Life Quality Index (DLQI)	Atleast 50% improvement in quality of life of patients by reduction in DLQI from baseline (pre-treatment)	within 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regrowth rate	(initial SALT score - final SALT score)/(initial SALT score) × 100	within 24 weeks
Response time	time from initiation of treatment to any sign of hair regrowth	within 24 weeks

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan

Publications and helpful links

General Publications

• Xing L, Dai Z, Jabbari A, Cerise JE, Higgins CA, Gong W, de Jong A, Harel S, DeStefano GM, Rothman L, Singh P, Petukhova L, Mackay-Wiggan J, Christiano AM, Clynes R. Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition. Nat Med. 2014 Sep;20(9):1043-9. doi: 10.1038/nm.3645. Epub 2014 Aug 17.
• Jabbari A, Nguyen N, Cerise JE, Ulerio G, de Jong A, Clynes R, Christiano AM, Mackay-Wiggan J. Treatment of an alopecia areata patient with tofacitinib results in regrowth of hair and changes in serum and skin biomarkers. Exp Dermatol. 2016 Aug;25(8):642-3. doi: 10.1111/exd.13060. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2022
• Primary Completion (Actual): February 5, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Estimated): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Tofacitinib; Hair loss; alopecia areata
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: IRB/2022/996/SIMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No