Trial Outcomes & Findings for Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata (NCT NCT03800979)

Results Overview

The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

48 weeks

Results posted on

2022-03-31

Participant Flow

Nineteen participants who met the inclusion criteria were enrolled and received 10 mg/day oral tofacitinib.

Participant milestones

Participant milestones
Measure	Tofacitinib All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib n=19 Participants All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib is the Janus kinase inhibitor, which FDA has approved for Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Age, Continuous	32.68 years STANDARD_DEVIATION 8.75 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	19 participants n=5 Participants
Region of Enrollment Thailand	19 Participants n=5 Participants
Baseline SALT score	95.11 score STANDARD_DEVIATION 14.24 • n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss.

Outcome measures

Outcome measures
Measure	Tofacitinib n=19 Participants All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Number of Responders vs Non-Responders Using SALT Score Responders (SALT score improved >=50%)	9 Participants
Number of Responders vs Non-Responders Using SALT Score Non-responders (SALT score improved < 50%)	10 Participants

SECONDARY outcome

Timeframe: 48 weeks

Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.

Outcome measures

Outcome measures
Measure	Tofacitinib n=19 Participants All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Side Effects From Tofacitinib Dyslipidemia	9 participants
Side Effects From Tofacitinib Upper respiratory tract infection	6 participants
Side Effects From Tofacitinib Tuberculosis	1 participants
Side Effects From Tofacitinib Myalgia	1 participants
Side Effects From Tofacitinib Acne	2 participants
Side Effects From Tofacitinib Weight gain	1 participants
Side Effects From Tofacitinib Constipation	1 participants

Adverse Events

Tofacitinib

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tofacitinib n=19 participants at risk All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Gastrointestinal disorders Intestinal tuberculosis	5.3% 1/19 • Number of events 1 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.

Other adverse events

Other adverse events
Measure	Tofacitinib n=19 participants at risk All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata. Tofacitinib: Tofacitinib is an oral medicine in the Janus kinase inhibitor 3 groups which FDA has approved in treating Rheumatoid Arthritis. It can inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the causes of hair loss.
Metabolism and nutrition disorders Dyslipidemia	47.4% 9/19 • Number of events 9 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Infections and infestations Upper respiratory tract infection	31.6% 6/19 • Number of events 6 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • Number of events 1 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Skin and subcutaneous tissue disorders Acne	10.5% 2/19 • Number of events 2 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Metabolism and nutrition disorders Weight gain	5.3% 1/19 • Number of events 1 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Gastrointestinal disorders Constipation	5.3% 1/19 • Number of events 1 • Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.

Additional Information

Dr. Chinmanat Lekhavat (My old last name is Tangjaturonrusamee.)

Institute of Dermatology

Phone: +660847607474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place