Trial Outcomes & Findings for Long-Term PF-06651600 for the Treatment of Alopecia Areata (NCT NCT04006457)

NCT ID: NCT04006457

Last Updated: 2025-08-14

Results Overview

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

1052 participants

Primary outcome timeframe

From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Results posted on

2025-08-14

Participant Flow

This study consisted of Main study and vaccine sub-study. A total of 1052 participants were enrolled in the Main study and a total of 17 participants who received at least 6 months of study treatment in the main study were enrolled in the vaccine sub-study. Results are reported at primary completion date (PCD).

Participant milestones

Participant milestones
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) Participants with a clinical diagnosis of alopecia areata (AA) received ritlecitinib (PF-06651600) 200 milligrams (mg) once daily (QD) for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine Participants who received at least 6 months of treatment with ritlecitinib 50 mg QD in the Main study continued to receive the study treatment in the main study while participating in vaccine sub-study. Participants were administered a single dose of Tetanus and Diphtheria Toxoids and Acellular Pertussis (Tdap) vaccine with or without a single dose of meningococcal ACWY vaccine intramuscularly on Day 1 of the sub-study.
Main Study: Treatment Period 1 STARTED	449	603	0
Main Study: Treatment Period 1 Treated	447	603	0
Main Study: Treatment Period 1 COMPLETED	289	332	0
Main Study: Treatment Period 1 NOT COMPLETED	160	271	0
Main Study: Treatment Period 2 STARTED	289	332	0
Main Study: Treatment Period 2 COMPLETED	0	0	0
Main Study: Treatment Period 2 NOT COMPLETED	289	332	0
Main Study Observation Period STARTED	29	43	0
Main Study Observation Period COMPLETED	1	1	0
Main Study Observation Period NOT COMPLETED	28	42	0
Vaccine Sub Study STARTED	0	0	17
Vaccine Sub Study Tdap Vaccination With or Without ACWY Vaccination	0	0	17
Vaccine Sub Study ACWY Vaccination With Tdap Vaccination	0	0	13
Vaccine Sub Study COMPLETED	0	0	16
Vaccine Sub Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) Participants with a clinical diagnosis of alopecia areata (AA) received ritlecitinib (PF-06651600) 200 milligrams (mg) once daily (QD) for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine Participants who received at least 6 months of treatment with ritlecitinib 50 mg QD in the Main study continued to receive the study treatment in the main study while participating in vaccine sub-study. Participants were administered a single dose of Tetanus and Diphtheria Toxoids and Acellular Pertussis (Tdap) vaccine with or without a single dose of meningococcal ACWY vaccine intramuscularly on Day 1 of the sub-study.
Main Study: Treatment Period 1 Adverse Event	26	36	0
Main Study: Treatment Period 1 Death	1	1	0
Main Study: Treatment Period 1 Lack of Efficacy	27	79	0
Main Study: Treatment Period 1 Lost to Follow-up	22	17	0
Main Study: Treatment Period 1 Non-Compliance with Study Drug	4	1	0
Main Study: Treatment Period 1 Physician Decision	3	0	0
Main Study: Treatment Period 1 Pregnancy	8	8	0
Main Study: Treatment Period 1 Withdrawal by Subject	41	57	0
Main Study: Treatment Period 1 No Longer Met Eligibility Criteria (for adolescents)	14	29	0
Main Study: Treatment Period 1 No Longer Met Eligibility Criteria (for adults)	4	2	0
Main Study: Treatment Period 1 Other	10	4	0
Main Study: Treatment Period 1 Approved Drug Available For Indication	0	37	0
Main Study: Treatment Period 2 Adverse Event	2	2	0
Main Study: Treatment Period 2 Lack of Efficacy	7	0	0
Main Study: Treatment Period 2 Lost to Follow-up	2	1	0
Main Study: Treatment Period 2 Protocol Violation	3	1	0
Main Study: Treatment Period 2 Withdrawal by Subject	8	7	0
Main Study: Treatment Period 2 Other	2	3	0
Main Study: Treatment Period 2 Approved Drug Available For Indication	179	222	0
Main Study: Treatment Period 2 Ongoing	86	96	0
Main Study Observation Period Adverse Event	1	1	0
Main Study Observation Period Lost to Follow-up	0	1	0
Main Study Observation Period Pregnancy	1	0	0
Main Study Observation Period Withdrawal by Subject	10	14	0
Main Study Observation Period Other	8	16	0
Main Study Observation Period Approved Drug Available For Indication	6	9	0
Main Study Observation Period Ongoing	2	1	0
Vaccine Sub Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=447 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit	401 Participants	515 Participants

PRIMARY outcome

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=447 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit SAEs	30 Participants	42 Participants
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit AEs Leading to Discontinuation	36 Participants	46 Participants

PRIMARY outcome

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Vital signs including blood pressure included systolic blood pressure (SBP) \[Millimeters of mercury, mmHg\]) and diastolic blood pressure (DBP) and pulse rate \[beats per minute (bpm)\] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP\<90mmHg, DBP\<50 mmHg and pulse rate\<40mmHg.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=443 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=600 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Diastolic blood pressure (mmHg): value <50	11 Participants	15 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Diastolic blood pressure (mmHg): change >=20 increase	39 Participants	70 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Diastolic blood pressure (mmHg): change >=20 decrease	45 Participants	51 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Pulse rate (bpm): Value <40	1 Participants	3 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Pulse rate (bpm): Value >120	0 Participants	1 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Systolic blood pressure (mmHg): Value <90	13 Participants	30 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Systolic blood pressure (mmHg): change>=30 increase	18 Participants	42 Participants
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit Systolic blood pressure (mmHg): change>=30 decrease	22 Participants	30 Participants

PRIMARY outcome

Timeframe: From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Population: SAS was defined as all participants who took at least 1 dose of study intervention. Here, the "Overall number of participants analyzed" signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose).

Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\<0.8\*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \<0.8\*LLN or \>1.5\*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\>1.2\*ULN), Prothrombin Time(\>1.1\*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\>3.0\*ULN); Albumin, Urate (\<0.8\*LLN and \>1.2\*ULN; Urea Nitrogen,Creatinine Cholesterol \>1.3\*ULN; Cholesterol \<0.8\*LLN or \>1.2\*LLN, Triglycerides,Potassium,Calcium \< 0.9x LLN \& \> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \>=1; Leukocyte Erythrocytes, Leukocytes \>=20; Epithelial Cells\>=6, Hyaline Cast\>1; Bacteria\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=444 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=602 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit	390 Participants	490 Participants

PRIMARY outcome

Timeframe: Month 1

Population: Safety Analysis Set (SAS) was defined as all participants from this sub-study who received at least 1 vaccine (Tdap or meningococcal ACWY). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Booster response to tetanus toxoid was defined as: \>=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was \<=2.7 International Units per milliliter (IU/mL); OR \>=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was \>2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response	62.5 Percentage of participants Interval 35.4 to 84.8	—

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) until end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) until end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) until end of study

Vital signs including blood pressure (systolic and diastolic blood pressure \[Millimeters of mercury, mmHg\]) and pulse rate (beats per minute \[bpm\]) were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Clinically significant abnormalities will be determined by investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study intervention (Day 1) until end of study

Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: Full Analysis Set (FAS) was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \<= 10 were reported. 95% CI was calculated based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	0.9 Percentage of participants Interval 0.02 to 1.8	27.9 Percentage of participants Interval 24.23 to 31.5
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	16.3 Percentage of participants Interval 12.79 to 19.83	32.6 Percentage of participants Interval 28.77 to 36.4
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	37.7 Percentage of participants Interval 33.07 to 42.35	39.1 Percentage of participants Interval 35.01 to 43.22
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	49.0 Percentage of participants Interval 44.08 to 53.91	44.7 Percentage of participants Interval 40.39 to 49.02
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	55.8 Percentage of participants Interval 50.88 to 60.8	48.2 Percentage of participants Interval 43.72 to 52.7
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	59.5 Percentage of participants Interval 54.5 to 64.53	52.9 Percentage of participants Interval 48.28 to 57.52
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	62.3 Percentage of participants Interval 57.27 to 67.31	53.4 Percentage of participants Interval 48.76 to 58.12
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	62.9 Percentage of participants Interval 57.8 to 68.0	54.9 Percentage of participants Interval 50.18 to 59.59
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	66.4 Percentage of participants Interval 61.32 to 71.42	56.4 Percentage of participants Interval 51.69 to 61.17
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	68.3 Percentage of participants Interval 63.23 to 73.44	59.3 Percentage of participants Interval 54.51 to 64.02
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	69.9 Percentage of participants Interval 64.79 to 75.02	61.0 Percentage of participants Interval 56.16 to 65.76
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	70.9 Percentage of participants Interval 65.77 to 76.12	61.7 Percentage of participants Interval 56.73 to 66.6

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Overall Number Analyzed" signifies number of participants evaluable at specified time points.

SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	1.0 Percentage of participants Interval 0.03 to 2.02	28.5 Percentage of participants Interval 24.68 to 32.35
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	17.7 Percentage of participants Interval 13.88 to 21.57	33.5 Percentage of participants Interval 29.52 to 37.52
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	39.6 Percentage of participants Interval 34.65 to 44.6	39.8 Percentage of participants Interval 35.56 to 44.05
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	50.7 Percentage of participants Interval 45.52 to 55.87	45.3 Percentage of participants Interval 40.9 to 49.78
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	56.8 Percentage of participants Interval 51.56 to 61.98	49.3 Percentage of participants Interval 44.74 to 53.94
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	61.4 Percentage of participants Interval 56.16 to 66.6	53.9 Percentage of participants Interval 49.23 to 58.64
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	65.0 Percentage of participants Interval 59.81 to 70.09	54.1 Percentage of participants Interval 49.38 to 58.86
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	65.2 Percentage of participants Interval 60.05 to 70.41	55.1 Percentage of participants Interval 50.37 to 59.89
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	67.6 Percentage of participants Interval 62.47 to 72.75	57.2 Percentage of participants Interval 52.39 to 61.96
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	69.2 Percentage of participants Interval 64.0 to 74.36	59.6 Percentage of participants Interval 54.76 to 64.35
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	70.3 Percentage of participants Interval 65.16 to 75.5	61.6 Percentage of participants Interval 56.82 to 66.46
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	71.1 Percentage of participants Interval 65.91 to 76.27	62.1 Percentage of participants Interval 57.17 to 67.03

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \<=20 were reported. 95% CI was calculated based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	2.5 Percentage of Participants Interval 1.05 to 3.98	35.6 Percentage of Participants Interval 31.68 to 39.43
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	27.7 Percentage of Participants Interval 23.4 to 31.92	40.2 Percentage of Participants Interval 36.18 to 44.16
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	50.1 Percentage of Participants Interval 45.33 to 54.91	50.4 Percentage of Participants Interval 46.16 to 54.58
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	59.5 Percentage of Participants Interval 54.73 to 64.37	55.9 Percentage of Participants Interval 51.57 to 60.19
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	65.5 Percentage of Participants Interval 60.7 to 70.2	60.0 Percentage of Participants Interval 55.59 to 64.41
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	70.7 Percentage of Participants Interval 66.0 to 75.3	62.3 Percentage of Participants Interval 57.79 to 66.77
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	71.8 Percentage of Participants Interval 67.13 to 76.45	63.5 Percentage of Participants Interval 59.01 to 68.05
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	72.8 Percentage of Participants Interval 68.06 to 77.45	66.3 Percentage of Participants Interval 61.81 to 70.75
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	73.5 Percentage of Participants Interval 68.79 to 78.23	66.7 Percentage of Participants Interval 62.16 to 71.18
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	76.8 Percentage of Participants Interval 72.17 to 81.43	69.0 Percentage of Participants Interval 64.55 to 73.5
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	78.0 Percentage of Participants Interval 73.37 to 82.61	69.5 Percentage of Participants Interval 64.99 to 74.05
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	79.1 Percentage of Participants Interval 74.42 to 83.69	69.7 Percentage of Participants Interval 65.04 to 74.37

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	2.6 Percentage of Participants Interval 0.99 to 4.11	36.6 Percentage of Participants Interval 32.5 to 40.67
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	27.8 Percentage of Participants Interval 23.26 to 32.29	41.2 Percentage of Participants Interval 37.02 to 45.37
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	51.2 Percentage of Participants Interval 46.13 to 56.3	51.0 Percentage of Participants Interval 46.64 to 55.32
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	60.4 Percentage of Participants Interval 55.39 to 65.5	56.5 Percentage of Participants Interval 52.1 to 60.94
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	66.0 Percentage of Participants Interval 61.01 to 70.98	61.2 Percentage of Participants Interval 56.75 to 65.72
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	72.2 Percentage of Participants Interval 67.35 to 76.96	63.4 Percentage of Participants Interval 58.88 to 67.97
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	74.0 Percentage of Participants Interval 69.29 to 78.74	64.5 Percentage of Participants Interval 59.92 to 69.02
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	74.2 Percentage of Participants Interval 69.39 to 78.91	66.6 Percentage of Participants Interval 62.07 to 71.1
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	74.8 Percentage of Participants Interval 70.07 to 79.61	66.9 Percentage of Participants Interval 62.36 to 71.46
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	77.7 Percentage of Participants Interval 73.03 to 82.38	69.2 Percentage of Participants Interval 64.72 to 73.74
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	78.7 Percentage of Participants Interval 74.03 to 83.3	69.3 Percentage of Participants Interval 64.74 to 73.88
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	79.3 Percentage of Participants Interval 74.62 to 83.89	69.9 Percentage of Participants Interval 65.23 to 74.55

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing division of scalp hair into four quadrants (back, top of scalp, right side and left side), with each of four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score is sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	-2.8 Units on a scale Standard Deviation 9.94	-41.8 Units on a scale Standard Deviation 37.34
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	-23.6 Units on a scale Standard Deviation 26.51	-46.0 Units on a scale Standard Deviation 37.32
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	-36.6 Units on a scale Standard Deviation 32.07	-52.0 Units on a scale Standard Deviation 37.26
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	-44.2 Units on a scale Standard Deviation 32.71	-56.8 Units on a scale Standard Deviation 35.89
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	-47.5 Units on a scale Standard Deviation 32.34	-60.1 Units on a scale Standard Deviation 35.17
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	-50.6 Units on a scale Standard Deviation 31.89	-62.8 Units on a scale Standard Deviation 33.88
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	-52.5 Units on a scale Standard Deviation 31.98	-64.2 Units on a scale Standard Deviation 33.64
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	-53.3 Units on a scale Standard Deviation 31.70	-65.8 Units on a scale Standard Deviation 32.43
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	-53.6 Units on a scale Standard Deviation 31.79	-65.5 Units on a scale Standard Deviation 32.67
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	-54.8 Units on a scale Standard Deviation 31.81	-67.2 Units on a scale Standard Deviation 32.49
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	-55.8 Units on a scale Standard Deviation 31.48	-67.8 Units on a scale Standard Deviation 32.42
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	-56.6 Units on a scale Standard Deviation 31.99	-68.1 Units on a scale Standard Deviation 32.17

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into 4 quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss). SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), lower score= less hair loss. Baseline (Roll-over participants: Day 1 from Study B7931005 or B7981015; De novo participants: Day 1 from Study B7981032).

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	-2.9 Units on a scale Standard Deviation 10.32	-42.8 Units on a scale Standard Deviation 37.48
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	-23.8 Units on a scale Standard Deviation 26.88	-47.0 Units on a scale Standard Deviation 37.33
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	-37.3 Units on a scale Standard Deviation 32.12	-52.8 Units on a scale Standard Deviation 37.05
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	-44.8 Units on a scale Standard Deviation 32.73	-57.4 Units on a scale Standard Deviation 35.81
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	-48.5 Units on a scale Standard Deviation 32.20	-61.1 Units on a scale Standard Deviation 34.82
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	-51.6 Units on a scale Standard Deviation 31.43	-63.8 Units on a scale Standard Deviation 33.41
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	-53.5 Units on a scale Standard Deviation 31.39	-65.0 Units on a scale Standard Deviation 33.16
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	-53.8 Units on a scale Standard Deviation 31.57	-66.0 Units on a scale Standard Deviation 32.43
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	-54.1 Units on a scale Standard Deviation 31.93	-65.9 Units on a scale Standard Deviation 32.62
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	-55.2 Units on a scale Standard Deviation 32.01	-67.4 Units on a scale Standard Deviation 32.53
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	-56.0 Units on a scale Standard Deviation 31.69	-67.8 Units on a scale Standard Deviation 32.55
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	-56.5 Units on a scale Standard Deviation 32.04	-68.2 Units on a scale Standard Deviation 32.18

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). An Overall SALT 75 response was a 75% or greater reduction from baseline in SALT score.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	0.9 Percentage of participants Interval 0.02 to 1.8	37.4 Percentage of participants Interval 33.51 to 41.36
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	21.5 Percentage of participants Interval 17.6 to 25.43	42.6 Percentage of participants Interval 38.56 to 46.61
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	44.2 Percentage of participants Interval 39.4 to 48.91	51.3 Percentage of participants Interval 47.08 to 55.5
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	55.5 Percentage of participants Interval 50.65 to 60.41	56.9 Percentage of participants Interval 52.56 to 61.16
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	61.8 Percentage of participants Interval 56.97 to 66.67	61.3 Percentage of participants Interval 56.88 to 65.64
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	67.4 Percentage of participants Interval 62.6 to 72.18	64.7 Percentage of participants Interval 60.31 to 69.16
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	68.4 Percentage of participants Interval 63.62 to 73.25	66.7 Percentage of participants Interval 62.32 to 71.17
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	69.3 Percentage of participants Interval 64.41 to 74.14	67.9 Percentage of participants Interval 63.49 to 72.32
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	69.9 Percentage of participants Interval 65.04 to 74.84	68.1 Percentage of participants Interval 63.64 to 72.55
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	73.4 Percentage of participants Interval 68.5 to 78.21	70.2 Percentage of participants Interval 65.82 to 74.67
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	76.4 Percentage of participants Interval 71.64 to 81.11	70.5 Percentage of participants Interval 66.04 to 75.01
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	76.7 Percentage of participants Interval 71.87 to 81.51	70.8 Percentage of participants Interval 66.16 to 75.39

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score= SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), where lower score=less hair loss. SALT 75 response= 75% or greater reduction from baseline in AA SALT score.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 1	1.0 Percentage of participants Interval 0.03 to 2.02	38.6 Percentage of participants Interval 34.52 to 42.78
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 3	22.8 Percentage of participants Interval 18.53 to 26.98	43.6 Percentage of participants Interval 39.43 to 47.84
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 6	45.6 Percentage of participants Interval 40.48 to 50.62	51.8 Percentage of participants Interval 47.43 to 56.1
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 9	57.1 Percentage of participants Interval 51.98 to 62.22	57.3 Percentage of participants Interval 52.94 to 61.76
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 12	62.8 Percentage of participants Interval 57.74 to 67.91	62.3 Percentage of participants Interval 57.88 to 66.79
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 15	69.2 Percentage of participants Interval 64.21 to 74.11	65.5 Percentage of participants Interval 61.03 to 69.99
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 18	70.7 Percentage of participants Interval 65.79 to 75.6	67.5 Percentage of participants Interval 63.08 to 71.98
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 21	70.8 Percentage of participants Interval 65.82 to 75.71	68.0 Percentage of participants Interval 63.55 to 72.48
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 24	72.0 Percentage of participants Interval 67.08 to 76.95	68.4 Percentage of participants Interval 63.87 to 72.87
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 28	74.8 Percentage of participants Interval 69.88 to 79.63	70.5 Percentage of participants Interval 66.02 to 74.93
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 32	77.3 Percentage of participants Interval 72.6 to 82.07	70.3 Percentage of participants Interval 65.8 to 74.86
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 Month 36	77.2 Percentage of participants Interval 72.42 to 82.01	70.9 Percentage of participants Interval 66.27 to 75.51

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Number of Participants Analyzed" included all participants from FAS without normal EBA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow. Higher scores represent lesser loss of eyebrow hair. 95% CI was based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 1	4.3 Percentage of participants Interval 2.11 to 6.53	38.8 Percentage of participants Interval 34.45 to 43.15
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 3	22.3 Percentage of participants Interval 17.69 to 26.9	43.4 Percentage of participants Interval 38.91 to 47.83
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 6	37.6 Percentage of participants Interval 32.24 to 43.0	50.0 Percentage of participants Interval 45.36 to 54.64
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 12	55.0 Percentage of participants Interval 49.17 to 60.83	60.3 Percentage of participants Interval 55.44 to 65.18
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 18	59.5 Percentage of participants Interval 53.55 to 65.39	64.2 Percentage of participants Interval 59.28 to 69.21
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 24	61.2 Percentage of participants Interval 55.12 to 67.33	67.9 Percentage of participants Interval 62.99 to 72.87
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline Month 36	65.6 Percentage of participants Interval 59.23 to 71.93	69.9 Percentage of participants Interval 64.79 to 75.02

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from FAS without normal ELA score at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash. Higher scores represent lesser loss of eyelash hair.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 12	54.8 Percentage of participants Interval 48.63 to 60.97	56.5 Percentage of participants Interval 51.33 to 61.66
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 1	3.4 Percentage of participants Interval 1.34 to 5.53	37.7 Percentage of participants Interval 33.2 to 42.26
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 3	17.7 Percentage of participants Interval 13.27 to 22.19	42.5 Percentage of participants Interval 37.88 to 47.17
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 6	36.7 Percentage of participants Interval 31.03 to 42.36	47.1 Percentage of participants Interval 42.24 to 51.9
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 18	62.1 Percentage of participants Interval 55.93 to 68.33	61.2 Percentage of participants Interval 55.88 to 66.44
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 24	66.2 Percentage of participants Interval 59.9 to 72.51	68.1 Percentage of participants Interval 62.89 to 73.22
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline Month 36	69.4 Percentage of participants Interval 62.73 to 75.98	70.5 Percentage of participants Interval 65.14 to 75.86

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

PGI-C is a self-administered single item questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. Participants were required to select their response on a 7-point scale ranging from 1 (greatly worsened), 2=moderately worsened, 3=slightly worsened, 4=not changed, 5= slightly improved, 6=moderately improved, 7 (greatly improved). 95% CI was based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 24	82.4 Percentage of participants Interval 78.31 to 86.47	78.6 Percentage of participants Interval 74.65 to 82.5
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 1	16.4 Percentage of participants Interval 12.97 to 19.91	55.2 Percentage of participants Interval 51.17 to 59.22
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 3	57.0 Percentage of participants Interval 52.34 to 61.74	59.3 Percentage of participants Interval 55.31 to 63.31
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 6	68.8 Percentage of participants Interval 64.38 to 73.21	66.4 Percentage of participants Interval 62.44 to 70.4
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 9	76.5 Percentage of participants Interval 72.34 to 80.69	69.5 Percentage of participants Interval 65.55 to 73.55
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 12	78.6 Percentage of participants Interval 74.55 to 82.74	72.6 Percentage of participants Interval 68.56 to 76.59
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 18	81.0 Percentage of participants Interval 76.88 to 85.03	74.8 Percentage of participants Interval 70.69 to 78.85
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 36	83.1 Percentage of participants Interval 78.77 to 87.33	79.0 Percentage of participants Interval 74.9 to 83.17

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 5-8 assessed emotional symptoms with responses scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations with responses scored from 0='not at all' to 4='completely'. AAPPO emotional symptoms sub score was calculated as mean of items 5-8 and ranged from 0 (never) to 4 (always), where higher scores indicated more emotional symptoms. AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 1: Emotional Symptoms	-0.33 Units on a scale Standard Deviation 0.683	-0.84 Units on a scale Standard Deviation 1.036
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 3: Emotional Symptoms	-0.61 Units on a scale Standard Deviation 0.867	-0.86 Units on a scale Standard Deviation 1.055
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 6: Emotional Symptoms	-0.77 Units on a scale Standard Deviation 1.012	-0.95 Units on a scale Standard Deviation 1.087
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 9: Emotional Symptoms	-0.95 Units on a scale Standard Deviation 1.091	-0.95 Units on a scale Standard Deviation 1.123
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 12: Emotional Symptoms	-1.00 Units on a scale Standard Deviation 1.161	-1.04 Units on a scale Standard Deviation 1.128
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 18: Emotional Symptoms	-1.07 Units on a scale Standard Deviation 1.174	-1.11 Units on a scale Standard Deviation 1.129
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 24: Emotional Symptoms	-1.12 Units on a scale Standard Deviation 1.232	-1.07 Units on a scale Standard Deviation 1.172
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 36: Emotional Symptoms	-1.20 Units on a scale Standard Deviation 1.246	-1.11 Units on a scale Standard Deviation 1.204
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 1: Activity Limitations	-0.09 Units on a scale Standard Deviation 0.641	-0.36 Units on a scale Standard Deviation 0.789
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 3: Activity Limitations	-0.21 Units on a scale Standard Deviation 0.667	-0.38 Units on a scale Standard Deviation 0.811
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 6: Activity Limitations	-0.27 Units on a scale Standard Deviation 0.719	-0.44 Units on a scale Standard Deviation 0.829
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 9: Activity Limitations	-0.33 Units on a scale Standard Deviation 0.781	-0.45 Units on a scale Standard Deviation 0.857
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 12: Activity Limitations	-0.36 Units on a scale Standard Deviation 0.793	-0.51 Units on a scale Standard Deviation 0.871
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 18: Activity Limitations	-0.40 Units on a scale Standard Deviation 0.830	-0.51 Units on a scale Standard Deviation 0.869
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 24: Activity Limitations	-0.43 Units on a scale Standard Deviation 0.824	-0.52 Units on a scale Standard Deviation 0.890
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations Month 36: Activity Limitations	-0.43 Units on a scale Standard Deviation 0.858	-0.53 Units on a scale Standard Deviation 0.859

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. Participants reported under "Overall Number of Participants Analyzed" included all participants from FAS who had an AAPPO baseline score \>=2 who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss from the scalp, eyebrows, eyelashes and body using a 5 point scale that ranged from 0 ='no hair loss' and 4='complete hair loss'. In this outcome measure, percentage of participants with AAPPO domain scores of 0 = no hair loss or 1 = a little hair loss, among participants with score \>=2 at baseline are reported.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 1: Current hair loss on Scalp	9.8 Percentage of participants Interval 6.96 to 12.66	37.2 Percentage of participants Interval 33.23 to 41.19
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 3: Current hair loss on Scalp	27.5 Percentage of participants Interval 23.18 to 31.81	38.5 Percentage of participants Interval 34.43 to 42.49
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 6: Current hair loss on Scalp	45.7 Percentage of participants Interval 40.89 to 50.55	46.4 Percentage of participants Interval 42.12 to 50.72
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 9: Current hair loss on Scalp	55.6 Percentage of participants Interval 50.64 to 60.59	49.8 Percentage of participants Interval 45.37 to 54.22
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 12: Current hair loss on Scalp	58.9 Percentage of participants Interval 53.91 to 63.93	52.7 Percentage of participants Interval 48.16 to 57.29
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 18: Current hair loss on Scalp	62.2 Percentage of participants Interval 57.15 to 67.35	57.2 Percentage of participants Interval 52.52 to 61.97
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 24: Current hair loss on Scalp	67.8 Percentage of participants Interval 62.72 to 72.86	60.7 Percentage of participants Interval 55.92 to 65.47
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 36: Current hair loss on Scalp	69.3 Percentage of participants Interval 64.0 to 74.67	58.5 Percentage of participants Interval 53.34 to 63.61
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 1: Current hair loss on Eyebrows	9.9 Percentage of participants Interval 6.33 to 13.38	42.9 Percentage of participants Interval 38.24 to 47.48
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 3: Current hair loss on Eyebrows	32.4 Percentage of participants Interval 26.79 to 37.91	44.1 Percentage of participants Interval 39.43 to 48.79
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 6: Current hair loss on Eyebrows	43.9 Percentage of participants Interval 37.94 to 49.8	49.5 Percentage of participants Interval 44.59 to 54.41
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 9: Current hair loss on Eyebrows	49.0 Percentage of participants Interval 42.75 to 55.22	52.9 Percentage of participants Interval 47.88 to 57.97
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 12: Current hair loss on Eyebrows	55.5 Percentage of participants Interval 49.17 to 61.85	55.0 Percentage of participants Interval 49.81 to 60.28
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 18: Current hair loss on Eyebrows	60.9 Percentage of participants Interval 54.46 to 67.36	60.1 Percentage of participants Interval 54.77 to 65.48
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 24: Current hair loss on Eyebrows	60.7 Percentage of participants Interval 53.94 to 67.45	64.4 Percentage of participants Interval 59.06 to 69.74
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 36: Current hair loss on Eyebrows	63.8 Percentage of participants Interval 56.65 to 70.93	64.7 Percentage of participants Interval 59.08 to 70.37
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 1: Current hair loss on Eyelashes	8.1 Percentage of participants Interval 4.6 to 11.57	40.9 Percentage of participants Interval 36.03 to 45.84
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 3: Current hair loss on Eyelashes	35.8 Percentage of participants Interval 29.61 to 41.94	44.2 Percentage of participants Interval 39.22 to 49.2
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 6: Current hair loss on Eyelashes	45.7 Percentage of participants Interval 39.21 to 52.09	46.6 Percentage of participants Interval 41.35 to 51.8
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 9: Current hair loss on Eyelashes	54.2 Percentage of participants Interval 47.54 to 60.95	54.0 Percentage of participants Interval 48.57 to 59.36
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 12: Current hair loss on Eyelashes	56.2 Percentage of participants Interval 49.36 to 63.08	55.3 Percentage of participants Interval 49.8 to 60.88
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 18: Current hair loss on Eyelashes	61.9 Percentage of participants Interval 54.98 to 68.83	62.3 Percentage of participants Interval 56.61 to 67.94
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 24: Current hair loss on Eyelashes	64.3 Percentage of participants Interval 57.15 to 71.51	65.0 Percentage of participants Interval 59.31 to 70.77
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 36: Current hair loss on Eyelashes	69.8 Percentage of participants Interval 62.43 to 77.17	67.5 Percentage of participants Interval 61.55 to 73.47
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 1: Current hair loss on body	14.7 Percentage of participants Interval 10.54 to 18.85	31.9 Percentage of participants Interval 27.51 to 36.25
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 3: Current hair loss on body	24.3 Percentage of participants Interval 19.22 to 29.33	36.5 Percentage of participants Interval 31.96 to 41.06
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 6: Current hair loss on body	34.6 Percentage of participants Interval 28.91 to 40.21	41.9 Percentage of participants Interval 37.06 to 46.78
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 9: Current hair loss on body	43.7 Percentage of participants Interval 37.53 to 49.77	46.9 Percentage of participants Interval 41.82 to 51.98
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 12: Current hair loss on body	52.3 Percentage of participants Interval 45.98 to 58.54	49.9 Percentage of participants Interval 44.6 to 55.12
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 18: Current hair loss on body	55.9 Percentage of participants Interval 49.49 to 62.41	56.0 Percentage of participants Interval 50.52 to 61.43
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 24: Current hair loss on body	59.1 Percentage of participants Interval 52.45 to 65.82	60.3 Percentage of participants Interval 54.75 to 65.78
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline Month 36: Current hair loss on body	65.2 Percentage of participants Interval 58.25 to 72.13	62.2 Percentage of participants Interval 56.44 to 68.01

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 1	-0.1 Units on a scale Standard Deviation 2.27	-0.6 Units on a scale Standard Deviation 2.87
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 3	-0.4 Units on a scale Standard Deviation 2.47	-0.5 Units on a scale Standard Deviation 2.80
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 6	-0.5 Units on a scale Standard Deviation 2.60	-0.7 Units on a scale Standard Deviation 2.97
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 9	-0.6 Units on a scale Standard Deviation 2.64	-0.9 Units on a scale Standard Deviation 2.94
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 12	-0.6 Units on a scale Standard Deviation 2.66	-0.9 Units on a scale Standard Deviation 3.16
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 18	-0.9 Units on a scale Standard Deviation 2.72	-0.9 Units on a scale Standard Deviation 3.08
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 24	-1.0 Units on a scale Standard Deviation 2.75	-1.1 Units on a scale Standard Deviation 3.11
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 36	-0.8 Units on a scale Standard Deviation 2.92	-1.0 Units on a scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 18	-1.0 Units on a scale Standard Deviation 3.01	-1.1 Units on a scale Standard Deviation 3.45
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 1	-0.6 Units on a scale Standard Deviation 2.57	-0.9 Units on a scale Standard Deviation 3.38
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 3	-0.7 Units on a scale Standard Deviation 2.65	-0.9 Units on a scale Standard Deviation 3.46
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 6	-0.9 Units on a scale Standard Deviation 2.79	-1.2 Units on a scale Standard Deviation 3.33
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 9	-0.9 Units on a scale Standard Deviation 3.02	-1.1 Units on a scale Standard Deviation 3.46
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 12	-0.8 Units on a scale Standard Deviation 3.14	-1.1 Units on a scale Standard Deviation 3.52
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 24	-1.1 Units on a scale Standard Deviation 3.21	-1.2 Units on a scale Standard Deviation 3.48
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 36	-1.0 Units on a scale Standard Deviation 3.35	-1.1 Units on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS included was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from the FAS with a score indicative of depression at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. Improvement on HADS depression score was considered as achieving a "normal" depression subscale score indicative of an absence of depression. Among adults, a HADS-D score of 0-7 was considered "normal"; for adolescents, a HADS-D score of 0-6 was considered "normal". 95% CI was calculated based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=36 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=59 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 1	53.1 Percentage of participants Interval 35.84 to 70.41	56.9 Percentage of participants Interval 44.15 to 69.64
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 3	63.3 Percentage of participants Interval 46.09 to 80.58	52.6 Percentage of participants Interval 39.67 to 65.59
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 6	70.0 Percentage of participants Interval 53.6 to 86.4	70.4 Percentage of participants Interval 58.19 to 82.55
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 9	65.5 Percentage of participants Interval 48.22 to 82.82	69.4 Percentage of participants Interval 56.48 to 82.29
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 12	58.6 Percentage of participants Interval 40.7 to 76.55	72.7 Percentage of participants Interval 59.57 to 85.89
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 18	84.6 Percentage of participants Interval 70.75 to 98.48	63.6 Percentage of participants Interval 49.42 to 77.85
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 24	83.3 Percentage of participants Interval 68.42 to 98.24	62.8 Percentage of participants Interval 48.34 to 77.24
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 36	80.0 Percentage of participants Interval 62.47 to 97.53	75.7 Percentage of participants Interval 61.85 to 89.5

SECONDARY outcome

Timeframe: At Months 1, 3, 6, 9, 12, 18, 24 and 36

Population: FAS was defined as all participants regardless of whether they received study intervention. All participants reported under "Overall Number of Participants Analyzed" included all participants from the FAS with a score indicative of anxiety at baseline who contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. Improvement on HADS anxiety score was considered as achieving a "normal" anxiety subscale score indicative of an absence of anxiety. Among adults, a HADS-A score of 0-7 was considered "normal"; for adolescents, a HADS-A score of 0-8 was considered "normal". 95% CI was calculated based on normal approximation.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=95 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=122 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 1	51.1 Percentage of participants Interval 40.69 to 61.58	54.2 Percentage of participants Interval 45.25 to 63.23
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 3	46.5 Percentage of participants Interval 35.97 to 57.05	59.6 Percentage of participants Interval 50.64 to 68.65
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 6	53.6 Percentage of participants Interval 42.91 to 64.24	62.5 Percentage of participants Interval 53.53 to 71.47
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 9	50.0 Percentage of participants Interval 38.9 to 61.1	57.8 Percentage of participants Interval 48.53 to 67.07
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 12	54.4 Percentage of participants Interval 43.45 to 65.41	64.4 Percentage of participants Interval 55.22 to 73.62
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 18	69.9 Percentage of participants Interval 59.34 to 80.39	62.9 Percentage of participants Interval 53.27 to 72.5
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 24	73.1 Percentage of participants Interval 62.52 to 83.75	61.1 Percentage of participants Interval 51.25 to 70.86
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36 Month 36	62.1 Percentage of participants Interval 49.58 to 74.56	63.9 Percentage of participants Interval 53.52 to 74.19

SECONDARY outcome

Timeframe: Month 1

Population: FAS-Tdap was defined as all participants who received the Tdap vaccine (with or without the meningococcal ACWY vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage of participants with anti-tetanus antibody level \>=1.0 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=1.0 International Units Per Milliliter (IU/mL) at Month 1-Tdap Vaccination	100 Percentage of participants Interval 79.4 to 100.0	—

SECONDARY outcome

Timeframe: Month 1

Percentage of participants with anti-tetanus antibody level \>=0.1 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=0.1 IU/mL at Month 1-Tdap Vaccination	100 Percentage of participants Interval 79.4 to 100.0	—

SECONDARY outcome

Timeframe: Month 1

Percentage of participants with \>=4 times increase in anti-tetanus antibody level from baseline were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With >=4 Times Increase in Anti-tetanus Antibody Level From Baseline at Month 1-Tdap Vaccination	50 Percentage of participants Interval 24.7 to 75.3	—

SECONDARY outcome

Timeframe: From Baseline (pre-vaccination on Day 1) to Month 1

Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Fold change was defined as the ratio of the post-baseline result to the baseline result. The assay results below the LLOQ were set to 0.5 \* LLOQ except when pre-vaccination assay results is \< LLOQ while postvaccination result is \>= LLOQ, in which case the pre-vaccination value will be set to LLOQ.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Geometric Mean Fold Change in Anti-tetanus Levels Above Baseline Values at Month 1-Tdap Vaccination	5.7 Fold change Interval 3.1 to 10.6	—

SECONDARY outcome

Timeframe: Month 1

Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\* LLOQ.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=16 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Geometric Mean Concentrations (GMCs) of Anti-tetanus Antibody Levels at Month 1-Tdap Vaccination	8.4 milli-international units (mIU)/mL Interval 5.8 to 12.1	—

SECONDARY outcome

Timeframe: Month 1

Population: FAS-ACWY was defined as all participants who received the meningococcal ACWY vaccine (with or without the Tdap vaccine). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage of participants with hSBA titer \>=1.8 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=5 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With Human Serum Bactericidal Activity (hSBA) Titer >=1:8 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	20 Percentage of Participants Interval 0.5 to 71.6	—

SECONDARY outcome

Timeframe: Month 1

Percentage of participants with hSBA titer \>=1.4 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=5 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Percentage of Participants With hSBA Titer >=1:4 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	40 Percentage of Participants Interval 5.3 to 85.3	—

SECONDARY outcome

Timeframe: Baseline (pre-vaccination on Day 1) and Month 1

Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5\* LLOQ.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=12 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination Baseline	5.7 Titers Interval 3.6 to 8.8	—
Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination Month 1	14.1 Titers Interval 4.4 to 44.8	—

SECONDARY outcome

Timeframe: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=17 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=13 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Number of Participants With SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=17 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=13 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Number of Participants With AEs	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Population: SAS was defined as all participants from the vaccine sub study who received at least 1 vaccine (Tdap or meningococcal ACWY).

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.

Outcome measures

Outcome measures
Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=17 Participants Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=13 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.
Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation	0 Participants	0 Participants

Adverse Events

Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)

Serious events: 33 serious events

Other events: 309 other events

Deaths: 1 deaths

Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)

Serious events: 43 serious events

Other events: 372 other events

Deaths: 1 deaths

Vaccine Sub-study: Tdap Vaccination

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Vaccine Sub-study: Meningococcal ACWY Vaccination

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer Clinical Trials.gov Call Center

Pfizer Inc.

Phone: 18007181021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) n=449 Participants Participants with a clinical diagnosis of alopecia areata (AA) received ritlecitinib (PF-06651600) 200 milligrams (mg) once daily (QD) for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first.Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) n=603 Participants Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study.	Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine n=17 Participants Participants who received at least 6 months of treatment with ritlecitinib 50 mg QD in the Main study continued to receive the study treatment in the main study while participating in vaccine sub-study. Participants were administered a single dose of Tetanus and Diphtheria Toxoids and Acellular Pertussis (Tdap) vaccine with or without a single dose of meningococcal ACWY vaccine intramuscularly on Day 1 of the sub-study.	Total n=1069 Participants Total of all reporting groups
Age, Customized Main Study · From 12 to <18 Years	76 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	80 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	156 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Main Study · From 18 to <45 Years	271 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	360 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	631 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Main Study · From 45 to <64 Years	96 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	144 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	240 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Main Study · >=65 Years	6 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	19 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	25 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Vaccine Substudy · From 12 to <18 Years	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Vaccine Substudy · From 18 to <45 Years	—	—	10 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	10 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Vaccine Substudy · From 45 to <64 Years	—	—	7 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	7 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Age, Customized Vaccine Substudy · >=65 Years	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Sex: Female, Male Main Study · Female	289 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	375 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	664 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Sex: Female, Male Main Study · Male	160 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	228 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	388 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Sex: Female, Male Vaccine Substudy · Female	—	—	12 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	12 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Sex: Female, Male Vaccine Substudy · Male	—	—	5 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	5 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Main Study · Hispanic or Latino	55 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	76 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	131 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Main Study · Not Hispanic or Latino	383 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	523 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	906 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Main Study · Unknown or Not Reported	11 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	4 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	15 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Vaccine Substudy · Hispanic or Latino	—	—	4 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	4 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Vaccine Substudy · Not Hispanic or Latino	—	—	13 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	13 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Ethnicity (NIH/OMB) Vaccine Substudy · Unknown or Not Reported	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · American Indian or Alaska Native	5 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	3 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	8 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · Asian	96 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	146 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	242 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · Native Hawaiian or Other Pacific Islander	2 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	1 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	3 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · Black or African American	16 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	21 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	37 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · White	310 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	423 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	733 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · More than one race	7 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	6 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	13 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Main Study · Unknown or Not Reported	13 Participants n=449 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	3 Participants n=603 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	—	16 Participants n=1052 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · American Indian or Alaska Native	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · Asian	—	—	3 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	3 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · Black or African American	—	—	1 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	1 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · White	—	—	13 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	13 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · More than one race	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.
Race (NIH/OMB) Vaccine Substudy · Unknown or Not Reported	—	—	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.	0 Participants n=17 Participants • Number Analyzed = number of participants analyzed for reporting arms of specified rows. Participants of main study and vaccine sub-study were not exclusive.