Trial Outcomes & Findings for Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus (NCT NCT05188521)

Last Updated: 2024-06-11

Results Overview

Measured by Physician Global Assessment (PGA) of skin by grade. The assessment ranges from Grade 0 (completely clear with no evidence of disease; 100% improvement) to Grade 6 (worse than at baseline evaluation by ≥25%; more progressive disease).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Week 16

Results posted on

2024-06-11

Participant Flow

Of the 11 participants that concluded the initial 16 weeks of treatment, six were eligible to enroll in the dose escalation extension for an additional 12 weeks of treatment. Five of the six elected to continue with the study.

Participant milestones

Participant milestones
Measure	Cutaneous LP Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks	Dose Escalation Extension Group Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks
Baricitinib 2mg Initial Study STARTED	12	0
Baricitinib 2mg Initial Study COMPLETED	11	0
Baricitinib 2mg Initial Study NOT COMPLETED	1	0
Baricitinib 4mg Extension Study STARTED	0	5
Baricitinib 4mg Extension Study COMPLETED	0	5
Baricitinib 4mg Extension Study NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cutaneous LP Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks	Dose Escalation Extension Group Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks
Baricitinib 2mg Initial Study Travel issues	1	0

Baseline Characteristics

Data collected from each group are being reported separately to avoid multi-counted participants.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Cutaneous LP n=11 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Physician Global Assessment (PGA) of Skin Overall Response Grade 0	5 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 1	5 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 2	0 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 3	0 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 4	1 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 5	0 Participants
Physician Global Assessment (PGA) of Skin Overall Response Grade 6	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Measured by Modified CAILS-Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS). The area of the lesion is measured with digital planimetry. Lesion size by square centimeter is graded on a scale of 0 to 18, where 0 is no measurable area and 18 is greater than 300 centimeters. The higher the score the larger the lesion.

Outcome measures

Outcome measures
Measure	Cutaneous LP n=12 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Modified CAILS Score of the Cutaneous Index Treatment	-10.6 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Week 16, Week 28

Outcome measures

Outcome measures
Measure	Cutaneous LP n=5 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Modified CAILS Score of the Cutaneous Index Treatment	-1.1 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline, Week 16

Change in the number of subject's skin lesions from baseline to Week 16.

Outcome measures

Outcome measures
Measure	Cutaneous LP n=12 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Skin Lesion Count	-134.8 number of skin lesions Standard Deviation 157.0

SECONDARY outcome

Timeframe: Week 16, Week 28

Change in the number of subject's skin lesions from Week 16 to Week 28.

Outcome measures

Outcome measures
Measure	Cutaneous LP n=5 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Skin Lesion Count	-12.6 number of skin lesions Standard Deviation 17.6

SECONDARY outcome

Timeframe: Baseline, Week 16

The Pruritus NRS is self-reported single question that asks "how severe itching has been over the last 24 hours". The response uses a scale of 0 (no itching) to 10 (severe itching). The higher the score, the worse the itching.

Outcome measures

Outcome measures
Measure	Cutaneous LP n=11 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Pruritus Numerical Rating Scale (NRS)	-5.3 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Week 16, Week 28

Outcome measures

Outcome measures
Measure	Cutaneous LP n=5 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Pruritus Numerical Rating Scale (NRS)	-1.0 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Week 16

This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.

Outcome measures

Outcome measures
Measure	Cutaneous LP n=12 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Overall Skindex-16 Assessment	-37.3 score on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Week 16, Week 28

Outcome measures

Outcome measures
Measure	Cutaneous LP n=5 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks
Change in Overall Skindex-16 Assessment	4.0 score on a scale Standard Deviation 12.3

Adverse Events

Cutaneous LP

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Dose Escalation Extension Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cutaneous LP n=12 participants at risk Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks	Dose Escalation Extension Group n=5 participants at risk Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks
General disorders Hospitalization due to fall	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.

Other adverse events

Additional Information

Dr. Aaron R. Mangold, Principal Investigator

Mayo Clinic

Phone: 480-301-9196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cutaneous LP n=12 Participants Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks	Dose Escalation Extension Group n=5 Participants Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks	Total n=17 Participants Total of all reporting groups
Age, Categorical Baricitinib 2mg Initial Study · <=18 years	0 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Age, Categorical Baricitinib 2mg Initial Study · Between 18 and 65 years	5 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	—	5 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Age, Categorical Baricitinib 2mg Initial Study · >=65 years	7 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	—	7 Participants n=12 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Age, Categorical Baricitinib 4mg Extension Study · <=18 years	—	0 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Age, Categorical Baricitinib 4mg Extension Study · Between 18 and 65 years	—	3 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	3 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Age, Categorical Baricitinib 4mg Extension Study · >=65 years	—	2 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.	2 Participants n=5 Participants • Data collected from each group are being reported separately to avoid multi-counted participants.
Sex: Female, Male Baricitinib 2mg Initial Study · Female	11 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	11 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Baricitinib 2mg Initial Study · Male	1 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	1 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Baricitinib 4mg Extension Study · Female	—	5 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	5 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Sex: Female, Male Baricitinib 4mg Extension Study · Male	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 2mg Initial Study · Hispanic or Latino	2 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	2 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 2mg Initial Study · Not Hispanic or Latino	10 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	10 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 2mg Initial Study · Unknown or Not Reported	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 4mg Extension Study · Hispanic or Latino	—	1 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	1 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 4mg Extension Study · Not Hispanic or Latino	—	4 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	4 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Ethnicity (NIH/OMB) Baricitinib 4mg Extension Study · Unknown or Not Reported	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · American Indian or Alaska Native	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · Asian	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · Black or African American	1 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	1 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · White	9 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	9 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · More than one race	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	0 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 2mg Initial Study · Unknown or Not Reported	2 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	—	2 Participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · American Indian or Alaska Native	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · Asian	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · Native Hawaiian or Other Pacific Islander	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · Black or African American	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · White	—	4 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	4 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · More than one race	—	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	0 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Race (NIH/OMB) Baricitinib 4mg Extension Study · Unknown or Not Reported	—	1 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	1 Participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
Region of Enrollment United States	12 participants n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	5 participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.	5 participants n=5 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.

Measure	Cutaneous LP n=12 participants at risk Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Baricitinib (LY3009104) 2 mg: 2 mg orally administered once daily for 16 weeks	Dose Escalation Extension Group n=5 participants at risk Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Baricitinib (LY3009104) 4 mg: 4 mg orally administered once daily for 12 weeks
General disorders Foot/leg pain/cramps	16.7% 2/12 • Number of events 2 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Headache	16.7% 2/12 • Number of events 2 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Constipation	0.00% 0/12 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 2 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Night Sweats	0.00% 0/12 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Cold symptoms	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders COVID-19	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Subconjunctival hemorrhage in left eye	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Chest pain/tenderness	8.3% 1/12 • Number of events 2 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Hives	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Ankle swelling	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Rash on chest/back	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Side pain	0.00% 0/12 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Visual field changes	0.00% 0/12 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	20.0% 1/5 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Lichen planus flare	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Low neutrophil count	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.
General disorders Elevated creatine kinase	8.3% 1/12 • Number of events 1 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.	0.00% 0/5 • Adverse events were collected for each participant from baseline to 30 days following the last administration of the study product. The Baricitinib 2mg group was followed for a total of approximately 5 months. The participants who continued in the Baricitinib 4mg extension group were followed for a total of approximately 9 months.