Trial Outcomes & Findings for Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) (NCT NCT03502616)

NCT ID: NCT03502616

Last Updated: 2021-09-17

Results Overview

ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 \[not active\] to 10 \[very active\], high score=more disease activity), total back pain (scale of 0 \[no pain\] to 10 \[most severe pain\], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]; participant's level of ability on scale of 0 \[easy\] to 10 \[impossible\], low score= better functional health) and Inflammation (morning stiffness, Mean of Question \[Q\]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] defined as 6-item questionnaire measure disease activity on a scale of 0 \[none\] to 10 \[severe\], high score=more disease activity). ASAS20 response: greater than or equal to (\>=) 20 percent (%) improvement from baseline in disease activity and absolute change of \>=1 unit in \>=3 domains and no worsening of \>=20% and an absolute change of \>=1 unit in remaining domain.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 270 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2021-09-17

Participant Flow

Safety data was planned to be collected and reported for both: Week 0 to Week 16 and from Week 0 to Week 48.

Participant milestones

Measure	Tofacitinib Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Up to Week 16 STARTED	134	136
Up to Week 16 Treated	133	136
Up to Week 16 COMPLETED	132	133
Up to Week 16 NOT COMPLETED	2	3
Week 16 to Week 48 STARTED	132	133
Week 16 to Week 48 Treated	132	133
Week 16 to Week 48 COMPLETED	125	127
Week 16 to Week 48 NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Tofacitinib Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Up to Week 16 Withdrawal by Subject	1	2
Up to Week 16 Lost to Follow-up	0	1
Up to Week 16 Randomized, but not treated	1	0
Week 16 to Week 48 Withdrawal by Subject	6	6
Week 16 to Week 48 Lost to Follow-up	1	0

Baseline Characteristics

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Baseline characteristics by cohort

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).	Total n=269 Participants Total of all reporting groups
Age, Continuous	42.2 Years STANDARD_DEVIATION 11.85 • n=5 Participants	40.0 Years STANDARD_DEVIATION 11.06 • n=7 Participants	41.1 Years STANDARD_DEVIATION 11.49 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	28 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	108 Participants n=7 Participants	224 Participants n=5 Participants
Race/Ethnicity, Customized White	107 Participants n=5 Participants	106 Participants n=7 Participants	213 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index [BASFI]; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Question [Q]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: greater than or equal to (>=) 20 percent (%) improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16	56.39 Percentage of participants	29.41 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16	40.60 Percentage of participants	12.50 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 16 and Baseline up to Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

An AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent were events between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Treatment Emergent Adverse Events (AEs) Up to Week 16	73 Participants	70 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) Up to Week 48	103 Participants	93 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16 and Baseline up to Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

AE: any untoward medical occurrence in subject who receive study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 48 weeks that were absent before treatment or that worsened relative to pretreatment state. The severity grades (mild, moderate and severe) were defined as - mild: did not interfere with participant's usual function, moderate: Interfered to some extent with participant's usual function and severe: Interfered significantly with participant's usual function.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 48: Severe	6 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 16: Mild	53 Participants	52 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 16: Moderate	18 Participants	18 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 16: Severe	2 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 48: Mild	57 Participants	57 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity Up to Week 48: Moderate	40 Participants	36 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16 and Baseline up to Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Hematology (Hemoglobin, Hematocrit, Erythrocyte, Lymphocyte/Leukocyte, Neutrophil/Leukocyte <0.8*Lower limit of normal (LLN), Reticulocyte >1.5*Upper limit of normal (ULN), Erythrocyte Mean Corpuscular Volume, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular HGB Concentration <0.9*LLN, >1.1*ULN, Reticulocyte/Erythrocyte, Leukocyte >1.5*ULN, Lymphocyte, Neutrophil <0.8*LLN and >1.2*ULN, Basophil, Basophil/Leukocyte, Eosinophil, Eosinophil/Leukocyte, Monocyte, Monocyte/Leukocyte >1.2*ULN); Clinical Chemistry (Bilirubin, Glucose >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase >3.0*ULN, Urea, Creatinine, Triglyceride, Cholesterol >1.3*ULN, LDL Cholesterol>1.2*ULN, Potassium, C Reactive Protein >1.1*ULN, Bicarbonate <0.9*LLN, Creatine Kinase >2.0*ULN, HDL Cholesterol <0.8*LLN), Urinalysis (Specific Gravity >1.035, pH >8, Glucose, Ketones, Protein, Hemoglobin >=1, Erythrocyte, Leukocyte >=20, Granular Cast, Hyaline Cast>1.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) Up to Week 16	106 Participants	129 Participants
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) Up to Week 48	126 Participants	131 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16 and Baseline up to Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Criteria for abnormalities in vital signs: Pulse rate <40 beats per minute (bpm) to >120 bpm, Sitting Diastolic blood pressure < 50 millimeter of mercury (mmHg), increase and decrease in change from baseline of >= 20mmHg, sitting systolic blood pressure < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Vital Signs Abnormalities Up to Week 16, Pulse rate: <40 bpm	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Pulse rate: >120 bpm	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting diastolic blood pressure: <50 mmHg	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting diastolic blood pressure: Change >= 20mmHg increase	2 Participants	4 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting diastolic blood pressure: Change >= 20mmHg decrease	6 Participants	4 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting systolic blood pressure: <90mmHg	1 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting systolic blood pressure: Change >= 30mmHg increase	2 Participants	4 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 16, Sitting systolic blood pressure: Change >= 30mmHg decrease	2 Participants	5 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Pulse rate: <40 bpm	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Pulse rate: >120 bpm	0 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting diastolic blood pressure: <50 mmHg	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting diastolic blood pressure: Change >= 20mmHg increase	5 Participants	8 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting diastolic blood pressure: Change >= 20mmHg decrease	11 Participants	8 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting systolic blood pressure: <90mmHg	1 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting systolic blood pressure: Change >= 30mmHg increase	5 Participants	5 Participants
Number of Participants With Vital Signs Abnormalities Up to Week 48, Sitting systolic blood pressure: Change >= 30mmHg decrease	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Screening, Week 16, and Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

Complete physical examination: included general appearance, skin (presence of rash), heent (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs), lower extremities (presence of peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Abnormalities in physical examination was based on investigator's discretion/clinical judgement.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Abnormalities in Physical Examination Head, eyes, ears, nose, throat: Week 16	4 Participants	7 Participants
Number of Participants With Abnormalities in Physical Examination Abdomen: Screening	2 Participants	1 Participants
Number of Participants With Abnormalities in Physical Examination Abdomen: Week 16	1 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Abdomen: Week 48	1 Participants	1 Participants
Number of Participants With Abnormalities in Physical Examination Extremities: Screening	17 Participants	15 Participants
Number of Participants With Abnormalities in Physical Examination Extremities: Week 16	8 Participants	14 Participants
Number of Participants With Abnormalities in Physical Examination Extremities: Week 48	4 Participants	7 Participants
Number of Participants With Abnormalities in Physical Examination General appearance: Screening	10 Participants	11 Participants
Number of Participants With Abnormalities in Physical Examination General appearance: Week 16	9 Participants	9 Participants
Number of Participants With Abnormalities in Physical Examination General appearance: Week 48	7 Participants	6 Participants
Number of Participants With Abnormalities in Physical Examination Head, eyes, ears, nose, throat: Screening	5 Participants	7 Participants
Number of Participants With Abnormalities in Physical Examination Head, eyes, ears, nose, throat: Week 48	3 Participants	7 Participants
Number of Participants With Abnormalities in Physical Examination Heart: Screening	2 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Heart: Week 16	0 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Heart: Week 48	0 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Lungs: Screening	1 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Lungs: Week 16	0 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Lungs: Week 48	0 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Lymph nodes: Screening	2 Participants	3 Participants
Number of Participants With Abnormalities in Physical Examination Lymph nodes: Week 16	1 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Lymph nodes: Week 48	1 Participants	2 Participants
Number of Participants With Abnormalities in Physical Examination Neurological: Screening	4 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Neurological: Week 16	1 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Neurological: Week 48	2 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examination Skin: Screening	18 Participants	18 Participants
Number of Participants With Abnormalities in Physical Examination Skin: Week 16	14 Participants	13 Participants
Number of Participants With Abnormalities in Physical Examination Skin: Week 48	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16, Baseline up to Week 48

Population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

Twelve-lead electrocardiograms (ECGs) were obtained for all participants. Criteria for ECG abnormality: PR interval >=300 and a percent change from baseline of >=25 or 50%; QRS duration >=140 and a percent change from baseline of >=50%; QT interval >=500; QTCB, QTCF interval <480 or >=450, <500 or >=480, >=500, change from baseline of <60 and >=30, and change from baseline of >=60.

Outcome measures

Measure	Tofacitinib n=131 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=133 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QT interval: >=500	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCB interval: >=450 and <480	10 Participants	10 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCF interval: change >=60	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, PR interval: >=300	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, PR interval: %Change>=25/50%	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QRS duration: >=140	1 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QRS duration: %Change>=50%	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QT interval: >=500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCB interval: >=450 and <480	3 Participants	7 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCB interval: >=480 and <500	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCB interval: >=500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCB interval: change >=30 and <60	9 Participants	7 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCB interval: change >=60	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCF interval: >=450 and <480	3 Participants	4 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCF interval: >=480 and <500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCF interval: >=500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCF interval: change >=30 and <60	5 Participants	3 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 16, QTCF interval: change >=60	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, PR interval: >=300	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, PR interval: %Change>=25/50%	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QRS duration: >=140	3 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QRS duration: %Change>=50%	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCB interval: >=480 and <500	1 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCB interval: >=500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCB interval: change >=30 and <60	14 Participants	11 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCB interval: change >=60	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCF interval: >=450 and <480	5 Participants	5 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCF interval: >=480 and <500	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCF interval: >=500	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Up to Week 48, QTCF interval: change >=30 and <60	9 Participants	7 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASAS20 assess 4 domains: PGA of Disease (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (BASFI; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: >= 20% improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 4	51.13 Percentage of participants	19.85 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 2	28.57 Percentage of participants	10.29 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 8	57.14 Percentage of participants	25.00 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 12	63.91 Percentage of participants	29.41 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 24	63.16 Percentage of participants	59.56 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 32	68.42 Percentage of participants	64.71 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 40	68.42 Percentage of participants	66.91 Percentage of participants
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 48	65.41 Percentage of participants	60.29 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 8	34.59 Percentage of participants	5.88 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 12	42.86 Percentage of participants	11.76 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 24	48.12 Percentage of participants	41.91 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 32	50.38 Percentage of participants	44.12 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 40	50.38 Percentage of participants	42.65 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 48	50.38 Percentage of participants	44.85 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 2	10.53 Percentage of participants	4.41 Percentage of participants
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48 Week 4	27.07 Percentage of participants	3.68 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and calculated by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(high sensitivity [hs] CRP mg/Liter [L] + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-0.88 Units on a scale Standard Error 0.056	-0.17 Units on a scale Standard Error 0.056
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.14 Units on a scale Standard Error 0.065	-0.24 Units on a scale Standard Error 0.065
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-1.30 Units on a scale Standard Error 0.074	-0.24 Units on a scale Standard Error 0.074
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-1.38 Units on a scale Standard Error 0.075	-0.28 Units on a scale Standard Error 0.075
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-1.36 Units on a scale Standard Error 0.073	-0.39 Units on a scale Standard Error 0.073
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-1.51 Units on a scale Standard Error 0.082	-1.32 Units on a scale Standard Error 0.081
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-1.56 Units on a scale Standard Error 0.084	-1.37 Units on a scale Standard Error 0.084
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-1.65 Units on a scale Standard Error 0.086	-1.40 Units on a scale Standard Error 0.086
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 week 48	-1.70 Units on a scale Standard Error 0.087	-1.50 Units on a scale Standard Error 0.086

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Blood samples were collected for analysis of hsCRP using an assay analyzed by central laboratory. hsCRP is an acute phase reactant, which was indicative of inflammation and of its severity.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-1.17 Milligrams per deciliter (mg/dL) Standard Error 0.081	-1.11 Milligrams per deciliter (mg/dL) Standard Error 0.080
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.07 Milligrams per deciliter (mg/dL) Standard Error 0.089	-0.14 Milligrams per deciliter (mg/dL) Standard Error 0.088
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.06 Milligrams per deciliter (mg/dL) Standard Error 0.094	-0.14 Milligrams per deciliter (mg/dL) Standard Error 0.094
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-1.05 Milligrams per deciliter (mg/dL) Standard Error 0.153	-0.03 Milligrams per deciliter (mg/dL) Standard Error 0.152
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-1.11 Milligrams per deciliter (mg/dL) Standard Error 0.089	-0.15 Milligrams per deciliter (mg/dL) Standard Error 0.090
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-1.05 Milligrams per deciliter (mg/dL) Standard Error 0.096	-0.09 Milligrams per deciliter (mg/dL) Standard Error 0.096
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-1.21 Milligrams per deciliter (mg/dL) Standard Error 0.058	-1.16 Milligrams per deciliter (mg/dL) Standard Error 0.058
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-1.16 Milligrams per deciliter (mg/dL) Standard Error 0.076	-1.08 Milligrams per deciliter (mg/dL) Standard Error 0.075
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-1.22 Milligrams per deciliter (mg/dL) Standard Error 0.089	-1.09 Milligrams per deciliter (mg/dL) Standard Error 0.089

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified time point.

The ASQoL was an 18-item questionnaire assessed the amount of restriction participant experienced in daily activities, level of pain and fatigue, and the impact on the participant's emotional state. Each item was scored as 0 (no impact) or 1 (yes - impact). A total score was calculated by summing the items. The total score ranged from 0 (no impact) to 18 (yes-impact), with higher values indicated more impaired health-related quality of life.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=131 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48 Week 48	-5.97 Units on scale Standard Error 0.454	-4.70 Units on scale Standard Error 0.451
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48 Week 16	-4.03 Units on scale Standard Error 0.404	-2.01 Units on scale Standard Error 0.405

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

SF-36 v.2 (Acute): 36-item generic health status measure. It measured 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. These domains were aggregated into 2 summary scores - physical component summary (PCS), mental component summary (MCS). Four domains comprised PCS score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised MCS score (vitality, social functioning, role-emotional, mental health). Normalized domain scores, PCS, MCS scores are used in analyses. Component and domain scores were scored by using United States 1998 general population norm. Resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scale and component summary measures had means of 50 and standard deviations of 10. Higher PCS/MCS/domain score represent better health status.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=130 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Physical Component Summary	8.81 Units on a scale Standard Error 0.720	7.39 Units on a scale Standard Error 0.714
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Physical Functioning	5.52 Units on a scale Standard Error 0.665	3.29 Units on a scale Standard Error 0.665
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Role-Physical	6.13 Units on a scale Standard Error 0.744	3.13 Units on a scale Standard Error 0.745
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Bodily Pain	7.93 Units on a scale Standard Error 0.710	3.47 Units on a scale Standard Error 0.713
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: General Health	5.00 Units on a scale Standard Error 0.617	1.76 Units on a scale Standard Error 0.618
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Vitality	5.34 Units on a scale Standard Error 0.864	3.56 Units on a scale Standard Error 0.869
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Social Functioning	5.45 Units on a scale Standard Error 0.835	2.49 Units on a scale Standard Error 0.837
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Role-Emotional	4.13 Units on a scale Standard Error 1.020	2.05 Units on a scale Standard Error 1.017
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Mental Health	3.57 Units on a scale Standard Error 0.886	2.49 Units on a scale Standard Error 0.888
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Physical Component Summary	6.69 Units on a scale Standard Error 0.588	3.14 Units on a scale Standard Error 0.590
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 16: Mental Component Summary	3.45 Units on a scale Standard Error 0.914	2.13 Units on a scale Standard Error 0.915
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Physical Functioning	7.80 Units on a scale Standard Error 0.775	6.94 Units on a scale Standard Error 0.766
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Role-Physical	8.66 Units on a scale Standard Error 0.870	7.29 Units on a scale Standard Error 0.862
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Bodily Pain	11.67 Units on a scale Standard Error 0.920	9.55 Units on a scale Standard Error 0.912
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: General Health	6.31 Units on a scale Standard Error 0.777	5.10 Units on a scale Standard Error 0.770
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Vitality	9.83 Units on a scale Standard Error 0.997	9.28 Units on a scale Standard Error 0.992
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Social Functioning	8.16 Units on a scale Standard Error 0.923	6.77 Units on a scale Standard Error 0.915
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Role-Emotional	7.17 Units on a scale Standard Error 1.004	6.32 Units on a scale Standard Error 0.989
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Mental Health	7.10 Units on a scale Standard Error 0.960	6.45 Units on a scale Standard Error 0.954
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48 Week 48: Mental Component Summary	7.07 Units on a scale Standard Error 0.926	6.35 Units on a scale Standard Error 0.920

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASMI assess axial status and spinal mobility. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component score mapped between 0 and 10, high score=more impairment of axial status, spinal mobility. For cervical rotation angle, participant sit straight on chair with chin level and hands on knees. Blinded assessor place goniometer at top of head in line with nose and ask participant to rotate neck maximally to left, follows with goniometer and record angle between sagittal plane and new plane after rotation. A second reading obtained and both readings recorded. Procedure repeated for right side. Better of two for each side was selected for scoring. Scoring done by calculating mean of left and right measurement and recorded in degrees (range: 0 to 90), higher cervical rotation value=better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	7.25 Degrees Standard Error 1.087	8.23 Degrees Standard Error 1.080
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	2.25 Degrees Standard Error 0.701	0.95 Degrees Standard Error 0.698
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	3.63 Degrees Standard Error 0.797	2.07 Degrees Standard Error 0.792
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	6.26 Degrees Standard Error 0.825	2.44 Degrees Standard Error 0.824
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	6.24 Degrees Standard Error 1.002	2.92 Degrees Standard Error 1.004
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	7.74 Degrees Standard Error 1.009	3.00 Degrees Standard Error 1.008
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	7.68 Degrees Standard Error 1.139	7.49 Degrees Standard Error 1.131
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	7.62 Degrees Standard Error 1.215	8.34 Degrees Standard Error 1.207
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	7.63 Degrees Standard Error 1.201	8.23 Degrees Standard Error 1.188

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of intermalleolar distances, participant should lie supine with the knees straight and feet/toes pointing straight up and asked to separate the legs as far as possible and the distance between the medial malleoli was measured (in Centimeters [cm] to the nearest 0.1 cm). Distance (in cm) was greater than or equal to 0, with no maximum defined range: higher intermalleolar distance value indicates better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	2.29 Centimeters Standard Error 0.733	0.90 Centimeters Standard Error 0.730
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	3.62 Centimeters Standard Error 0.861	0.84 Centimeters Standard Error 0.856
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	4.68 Centimeters Standard Error 0.979	1.36 Centimeters Standard Error 0.976
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	5.33 Centimeters Standard Error 1.106	1.97 Centimeters Standard Error 1.108
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	6.84 Centimeters Standard Error 1.084	2.64 Centimeters Standard Error 1.082
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	7.79 Centimeters Standard Error 1.177	4.39 Centimeters Standard Error 1.174
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	8.98 Centimeters Standard Error 1.221	5.32 Centimeters Standard Error 1.215
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	8.60 Centimeters Standard Error 1.229	4.75 Centimeters Standard Error 1.222
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	7.83 Centimeters Standard Error 1.233	4.34 Centimeters Standard Error 1.222

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASMI assess axial status, spinal mobility, using linear function. It composed of 5 clinical measures. BASMI - Linear Method score-average of 5 component scores mapped between 0 and 10, with high scores =more impairment of axial status, spinal mobility. For assessment of lateral spinal flexion: participant stand upright with head and back rest against wall as close as possible with shoulders level and feet 30 cm apart and feet parallel. At tip of middle finger, place a mark on thigh. This neutral position recorded. Participant bend sideways without bending knees or lifting heels while attempting to keep shoulders in same position (flexion position). Second mark placed, lateral flexion recorded (left or right as appropriate) using cm tape measure. Two tries for left, two tries for right measured. Result of two tries recorded for left and right separately in cm to nearest 0.1 cm. Distance (in cm) should be >=0, with no maximum defined range: high value indicates better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	0.60 Centimeters Standard Error 0.200	-0.21 Centimeters Standard Error 0.199
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	0.96 Centimeters Standard Error 0.235	-0.10 Centimeters Standard Error 0.233
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	1.34 Centimeters Standard Error 0.238	0.15 Centimeters Standard Error 0.237
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	1.42 Centimeters Standard Error 0.214	-0.21 Centimeters Standard Error 0.214
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	1.79 Centimeters Standard Error 0.269	-0.08 Centimeters Standard Error 0.269
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	1.70 Centimeters Standard Error 0.278	0.75 Centimeters Standard Error 0.276
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	1.90 Centimeters Standard Error 0.319	1.31 Centimeters Standard Error 0.316
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	2.15 Centimeters Standard Error 0.332	1.37 Centimeters Standard Error 0.329
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	1.64 Centimeters Standard Error 0.345	1.34 Centimeters Standard Error 0.340

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASMI assessed axial status and spinal mobility. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of lumbar flexion, With the participant standing erect and outer edges of feet 30 cm apart, a mark was placed in the midpoint of a line that joins the posterior superior iliac spines (baseline mark). A second mark (A) was placed 10 cm above the baseline mark and a third mark (B) 5 cm below the baseline mark. Then have the participant maximally bend forward, keeping the knees fully extended. With the participant's spine in full flexion, the distance between marks A and B (in cm to the nearest 0.1 cm) was re-measured. Distance (in cm) was greater than or equal to 0, with no maximum defined range. Higher value indicates better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	0.30 Centimeters Standard Error 0.102	-0.07 Centimeters Standard Error 0.102
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	0.41 Centimeters Standard Error 0.102	-0.11 Centimeters Standard Error 0.102
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	0.32 Centimeters Standard Error 0.116	-0.17 Centimeters Standard Error 0.115
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	0.26 Centimeters Standard Error 0.111	-0.22 Centimeters Standard Error 0.111
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	0.46 Centimeters Standard Error 0.115	-0.06 Centimeters Standard Error 0.115
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	0.51 Centimeters Standard Error 0.149	0.20 Centimeters Standard Error 0.148
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	0.64 Centimeters Standard Error 0.143	0.39 Centimeters Standard Error 0.142
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	0.58 Centimeters Standard Error 0.156	0.50 Centimeters Standard Error 0.155
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	0.45 Centimeters Standard Error 0.146	0.35 Centimeters Standard Error 0.144

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASMI assessed axial status and spinal mobility, using linear function. It composed of 5 clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, cervical rotation. BASMI - Linear Method score was average of 5 individual component scores mapped between 0 and 10, with higher scores indicating more impairment of axial status and spinal mobility. For the assessment of tragus-to-wall distance, participant was placed standing with his/her back against the wall; knees straight; scapulae, buttocks, and heels against wall; and head in as neutral position as possible. The distance between the tragus and wall in cm was measured (to the nearest 0.1 cm) from both the right side and left side at the maximum effort to touch the head against the wall. Distance should be greater than or equal to 0 cm with no defined maximum value, lower tragus-to-wall value indicates better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-0.19 Centimeters Standard Error 0.126	-0.24 Centimeters Standard Error 0.125
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-0.48 Centimeters Standard Error 0.144	-0.07 Centimeters Standard Error 0.143
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-0.51 Centimeters Standard Error 0.177	0.36 Centimeters Standard Error 0.177
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-0.40 Centimeters Standard Error 0.169	0.23 Centimeters Standard Error 0.169
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-0.50 Centimeters Standard Error 0.168	0.09 Centimeters Standard Error 0.168
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-0.66 Centimeters Standard Error 0.202	-0.03 Centimeters Standard Error 0.201
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-0.66 Centimeters Standard Error 0.179	0.00 Centimeters Standard Error 0.178
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-0.60 Centimeters Standard Error 0.200	-0.14 Centimeters Standard Error 0.199
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-0.73 Centimeters Standard Error 0.204	-0.18 Centimeters Standard Error 0.202

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The BASMI was used to assess the axial status and spinal mobility (cervical, dorsal and lumbar spine, hips and pelvic soft tissue) and was analyzed using the linear function method. BASMI score composed of five clinical measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober), maximal intermalleolar distance, and cervical rotation. BASMI - Linear Method score was the average of 5 individual component scores mapped between 0 and 10 and thus the BASMI - Linear Method total score ranged from 0 (very good) to 10 (very poor), wherein higher scores indicated more impairment of axial status and spinal mobility; lower scores indicated better health status.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-0.25 Units on a scale Standard Error 0.044	-0.03 Units on a scale Standard Error 0.043
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-0.39 Units on a scale Standard Error 0.053	-0.06 Units on a scale Standard Error 0.053
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-0.49 Units on a scale Standard Error 0.059	-0.03 Units on a scale Standard Error 0.058
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-0.49 Units on a scale Standard Error 0.058	-0.02 Units on a scale Standard Error 0.058
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-0.63 Units on a scale Standard Error 0.060	-0.11 Units on a scale Standard Error 0.060
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-0.67 Units on a scale Standard Error 0.068	-0.38 Units on a scale Standard Error 0.068
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-0.74 Units on a scale Standard Error 0.069	-0.52 Units on a scale Standard Error 0.068
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-0.74 Units on a scale Standard Error 0.074	-0.55 Units on a scale Standard Error 0.073
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-0.69 Units on a scale Standard Error 0.074	-0.54 Units on a scale Standard Error 0.073

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

FACIT-F is a 13-item questionnaire (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired), with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three type of scores were derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score was calculated by summing the 13 items (range 0 [not at all] to 52 [very much]); higher scores represent less fatigue status. In this outcome measure, change from baseline in FACIT-F total score was reported.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	3.16 Units on a scale Standard Error 0.552	0.32 Units on a scale Standard Error 0.548
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	4.80 Units on a scale Standard Error 0.595	1.19 Units on a scale Standard Error 0.591
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	6.46 Units on a scale Standard Error 0.706	1.03 Units on a scale Standard Error 0.703
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	6.25 Units on a scale Standard Error 0.737	1.24 Units on a scale Standard Error 0.736
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	6.54 Units on a scale Standard Error 0.795	3.12 Units on a scale Standard Error 0.794
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	7.42 Units on a scale Standard Error 0.842	5.84 Units on a scale Standard Error 0.836
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	7.90 Units on a scale Standard Error 0.813	7.24 Units on a scale Standard Error 0.807
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	8.67 Units on a scale Standard Error 0.817	7.15 Units on a scale Standard Error 0.810
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	9.54 Units on a scale Standard Error 0.897	7.35 Units on a scale Standard Error 0.891

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

FACIT-F is a 13-item (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired) questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-F experience domain score was calculated by summing 5 items: I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy. FACIT-F total experience domain score ranged from 0 (not at all) to 20 (very much), with higher scores represented better (less) fatigue impact on daily functioning. In this outcome measure, change from baseline in FACIT-F experience domain score was reported.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	1.35 Units on a scale Standard Error 0.275	0.11 Units on a scale Standard Error 0.274
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	2.30 Units on a scale Standard Error 0.298	0.60 Units on a scale Standard Error 0.296
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	2.72 Units on a scale Standard Error 0.331	0.53 Units on a scale Standard Error 0.330
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	2.78 Units on a scale Standard Error 0.343	0.80 Units on a scale Standard Error 0.344
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	2.85 Units on a scale Standard Error 0.357	1.29 Units on a scale Standard Error 0.357
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	3.58 Units on a scale Standard Error 0.384	2.96 Units on a scale Standard Error 0.382
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	3.65 Units on a scale Standard Error 0.370	3.43 Units on a scale Standard Error 0.367
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	3.98 Units on a scale Standard Error 0.375	3.59 Units on a scale Standard Error 0.371
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	4.22 Units on a scale Standard Error 0.403	3.40 Units on a scale Standard Error 0.400

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

FACIT-F is a 13-item (felt fatigued, felt weak all over, felt listless ["washed out"],felt tired, had energy, had trouble starting things as tired, had trouble finishing things as tired, was able to do usual activities, needed to sleep during day, too tired to eat, needed help doing my usual activities, frustrated by being too tired to do things wanted to do, had to limit my social activity because tired) questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). FACIT-F experience domain score calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless, I feel tired, and I have energy, while FACIT-F impact domain score was calculated by summing the remaining 8 items. FACIT-F impact domain score ranged from 0 (not at all) to 32 (very much), with higher scores represented better (less) fatigue impact on daily functioning. In this outcome measure, change from baseline in FACIT-F impact domain score was reported.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	4.70 Units on a scale Standard Error 0.480	3.57 Units on a scale Standard Error 0.476
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	1.79 Units on a scale Standard Error 0.334	0.17 Units on a scale Standard Error 0.332
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	2.47 Units on a scale Standard Error 0.364	0.55 Units on a scale Standard Error 0.361
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	3.73 Units on a scale Standard Error 0.429	0.46 Units on a scale Standard Error 0.428
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	3.45 Units on a scale Standard Error 0.440	0.41 Units on a scale Standard Error 0.441
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	3.68 Units on a scale Standard Error 0.488	1.81 Units on a scale Standard Error 0.487
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	3.84 Units on a scale Standard Error 0.504	2.86 Units on a scale Standard Error 0.501
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	4.25 Units on a scale Standard Error 0.489	3.80 Units on a scale Standard Error 0.485
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	5.32 Units on a scale Standard Error 0.542	3.95 Units on a scale Standard Error 0.538

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Participants answered the question, "How active was your spondylitis on average during the last week?. Participant's response was recorded using a numerical rating scale ranged from 0 (Not Active) to 10 (Very Active), with higher scores indicated more severe disease.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.21 Units on a scale Standard Error 0.144	-0.32 Units on a scale Standard Error 0.144
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.85 Units on a scale Standard Error 0.168	-0.63 Units on a scale Standard Error 0.167
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.14 Units on a scale Standard Error 0.181	-0.42 Units on a scale Standard Error 0.181
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.37 Units on a scale Standard Error 0.193	-0.65 Units on a scale Standard Error 0.193
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.47 Units on a scale Standard Error 0.204	-0.91 Units on a scale Standard Error 0.204
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.76 Units on a scale Standard Error 0.222	-2.21 Units on a scale Standard Error 0.221
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-3.04 Units on a scale Standard Error 0.228	-2.43 Units on a scale Standard Error 0.226
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.04 Units on a scale Standard Error 0.222	-2.50 Units on a scale Standard Error 0.220
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.47 Units on a scale Standard Error 0.225	-2.94 Units on a scale Standard Error 0.223

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Participants marked their level of total back pain on a numerical rating scale (NRS) ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.28 Units on a scale Standard Error 0.145	-0.38 Units on a scale Standard Error 0.144
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-2.05 Units on a scale Standard Error 0.164	-0.71 Units on a scale Standard Error 0.164
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.51 Units on a scale Standard Error 0.173	-0.53 Units on a scale Standard Error 0.173
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.57 Units on a scale Standard Error 0.192	-0.69 Units on a scale Standard Error 0.192
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.57 Units on a scale Standard Error 0.191	-0.96 Units on a scale Standard Error 0.191
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.99 Units on a scale Standard Error 0.206	-2.47 Units on a scale Standard Error 0.205
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-3.16 Units on a scale Standard Error 0.212	-2.86 Units on a scale Standard Error 0.210
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.11 Units on a scale Standard Error 0.217	-2.62 Units on a scale Standard Error 0.215
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.57 Units on a scale Standard Error 0.220	-2.87 Units on a scale Standard Error 0.218

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Participants marked their level of nocturnal spinal pain on a NRS ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.24 Units on a scale Standard Error 0.162	-0.32 Units on a scale Standard Error 0.161
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-2.15 Units on a scale Standard Error 0.169	-0.56 Units on a scale Standard Error 0.167
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.61 Units on a scale Standard Error 0.191	-0.59 Units on a scale Standard Error 0.190
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.60 Units on a scale Standard Error 0.198	-0.60 Units on a scale Standard Error 0.199
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.67 Units on a scale Standard Error 0.204	-0.84 Units on a scale Standard Error 0.204
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-3.07 Units on a scale Standard Error 0.217	-2.59 Units on a scale Standard Error 0.215
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-3.17 Units on a scale Standard Error 0.219	-2.89 Units on a scale Standard Error 0.217
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.20 Units on a scale Standard Error 0.226	-2.73 Units on a scale Standard Error 0.224
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.52 Units on a scale Standard Error 0.229	-3.01 Units on a scale Standard Error 0.227

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. The first 8 questions/items consider activities related to functional anatomy. The final 2 questions/items assess the participants' ability to cope with everyday life. Each item was scored on a scale of 0=easy to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 (easy) to 10 (impossible), where higher scores indicated more severe disease activity.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-0.87 Units on a scale Standard Error 0.125	-0.45 Units on a scale Standard Error 0.124
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.35 Units on a scale Standard Error 0.140	-0.58 Units on a scale Standard Error 0.139
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-1.79 Units on a scale Standard Error 0.158	-0.69 Units on a scale Standard Error 0.157
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.01 Units on a scale Standard Error 0.164	-0.71 Units on a scale Standard Error 0.164
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.05 Units on a scale Standard Error 0.170	-0.82 Units on a scale Standard Error 0.169
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.25 Units on a scale Standard Error 0.191	-1.91 Units on a scale Standard Error 0.190
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-2.42 Units on a scale Standard Error 0.188	-2.16 Units on a scale Standard Error 0.187
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-2.62 Units on a scale Standard Error 0.192	-2.23 Units on a scale Standard Error 0.191
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-2.61 Units on a scale Standard Error 0.196	-2.32 Units on a scale Standard Error 0.195

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of AS: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity. BASDAI inflammation score was derived by taking mean of the responses of question 5 and 6 and ranged from 0 (none) to 10 (very severe), where higher score indicated more inflammation (morning stiffness).

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.33 Units on a scale Standard Error 0.149	-0.49 Units on a scale Standard Error 0.149
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-2.08 Units on a scale Standard Error 0.164	-0.60 Units on a scale Standard Error 0.163
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.52 Units on a scale Standard Error 0.178	-0.91 Units on a scale Standard Error 0.178
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.71 Units on a scale Standard Error 0.185	-0.84 Units on a scale Standard Error 0.186
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.69 Units on a scale Standard Error 0.185	-0.97 Units on a scale Standard Error 0.185
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.99 Units on a scale Standard Error 0.193	-2.48 Units on a scale Standard Error 0.193
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-3.11 Units on a scale Standard Error 0.200	-2.61 Units on a scale Standard Error 0.199
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.28 Units on a scale Standard Error 0.204	-2.64 Units on a scale Standard Error 0.203
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.46 Units on a scale Standard Error 0.214	-2.90 Units on a scale Standard Error 0.213

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASAS 5/6 consists of 6 domains: 4 used in ASAS20 - PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), Spinal Pain (total back pain) (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity), CRP (was measured in mg per liter) and Spinal mobility was measured in centimeter and calculated as mean of right and left measurements of lateral spinal flexion from BASMI. ASAS 5/6: defined as >=20% improvement in at least 5 domains.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	16.54 Percentage of participants	2.94 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	35.34 Percentage of participants	6.62 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	41.35 Percentage of participants	8.09 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	45.86 Percentage of participants	9.56 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	43.61 Percentage of participants	7.35 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	49.62 Percentage of participants	44.12 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	51.13 Percentage of participants	53.68 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	48.87 Percentage of participants	50.74 Percentage of participants
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	43.61 Percentage of participants	44.85 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

Partial remission was defined as a score of 2 or less (on a scale of 0-10, where 0=no disease activity and 10=high disease activity) in each of the 4 domains in ASAS. These 4 domains included: PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity).

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	2.26 Percentage of participants	0 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	4.51 Percentage of participants	0 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	7.52 Percentage of participants	1.47 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	15.04 Percentage of participants	2.94 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	15.04 Percentage of participants	2.94 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	21.80 Percentage of participants	11.76 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	23.31 Percentage of participants	15.44 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	24.06 Percentage of participants	16.91 Percentage of participants
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	23.31 Percentage of participants	17.65 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. The BASDAI score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.25 Units on a scale Standard Error 0.127	-0.52 Units on a scale Standard Error 0.126
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.95 Units on a scale Standard Error 0.146	-0.67 Units on a scale Standard Error 0.145
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.32 Units on a scale Standard Error 0.164	-0.82 Units on a scale Standard Error 0.163
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.49 Units on a scale Standard Error 0.172	-0.81 Units on a scale Standard Error 0.172
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-2.55 Units on a scale Standard Error 0.175	-1.11 Units on a scale Standard Error 0.174
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.81 Units on a scale Standard Error 0.185	-2.41 Units on a scale Standard Error 0.184
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-2.94 Units on a scale Standard Error 0.191	-2.53 Units on a scale Standard Error 0.190
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.09 Units on a scale Standard Error 0.193	-2.63 Units on a scale Standard Error 0.192
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.30 Units on a scale Standard Error 0.199	-2.80 Units on a scale Standard Error 0.197

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

BASDAI was a validated questionnaire that consisted of 6 questions pertaining to the 5 major symptoms of AS: fatigue; spinal pain; peripheral arthritis; enthesitis, intensity of morning stiffness and duration of morning stiffness. Each question was rated using a numerical rating scale from 0 (none) to 10 (very severe), higher score=high disease activity. BASDAI score was calculated by computing mean of questions 5 and 6 and adding it to sum of questions 1 to 4. This score was then divided by 5. The total BASDAI score was ranged from 0= none to 10= very severe, where higher score indicated high disease activity. BASDAI50 response was defined as decrease of >=50% from Baseline in BASDAI score at specified time points. Percentage of participants with BASDAI 50 response at specified weeks are reported.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	12.03 Percentage of participants	3.68 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	29.32 Percentage of participants	6.62 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	39.85 Percentage of participants	11.03 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	42.86 Percentage of participants	11.03 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	42.86 Percentage of participants	17.65 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	47.37 Percentage of participants	36.76 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	51.13 Percentage of participants	41.18 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	52.63 Percentage of participants	39.71 Percentage of participants
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	51.13 Percentage of participants	40.44 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Analysis included only participants with baseline ASDAS(CRP) \>= 1.736 units. Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) clinically important improvement was defined as decrease from Baseline of >=1.1 units in ASDAS(CRP) score.

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	39.39 Percentage of participants	6.62 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	53.03 Percentage of participants	12.50 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	59.85 Percentage of participants	14.71 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	60.61 Percentage of participants	15.44 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	61.36 Percentage of participants	19.12 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	65.15 Percentage of participants	60.29 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	65.91 Percentage of participants	61.76 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	63.64 Percentage of participants	57.35 Percentage of participants
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	58.33 Percentage of participants	52.94 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Analysis included only participants with baseline ASDAS(CRP) \>= 2.636 units. Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR). Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) major improvement was defined as a response if improvement (decrease) from Baseline in ASDAS(CRP) of >=2.0 units.

Outcome measures

Measure	Tofacitinib n=123 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=129 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	8.94 Percentage of participants	0.00 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	17.89 Percentage of participants	1.55 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	22.76 Percentage of participants	2.33 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	26.02 Percentage of participants	3.10 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	30.08 Percentage of participants	4.65 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	34.15 Percentage of participants	24.81 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	36.59 Percentage of participants	34.11 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	39.02 Percentage of participants	31.78 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	33.33 Percentage of participants	28.68 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Analysis included only participants with baseline ASDAS(CRP) \>= 1.3 units. Here, on-drug data was used and missing response (MR) was considered to be Non-response (NR) (MR=NR).

ASDAS(CRP) was derived using BASDAI (6-item questionnaire measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity) and PGA (measure disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity) and by using the following formula, 0.121 x Back Pain (Q2 of BASDAI) + 0.058 x Duration of Morning Stiffness (Q6 of BASDAI) + 0.110 x PGA + 0.073 x Peripheral Pain/Swelling (Q3 of BASDAI) + 0.579 x Ln(hsCRP mg/L + 1). If hsCRP values were smaller than 2 mg/L, they were set to 2 mg/L in the formula. The range of score was >= 0.636 to no defined upper limit. A negative change from baseline value indicates decrease in disease activity; a positive change from baseline value indicates increase in disease activity. ASDAS(CRP) inactive disease is defined as a response if actual ASDAS(CRP) was <1.3 units.

Outcome measures

Measure	Tofacitinib n=133 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	0.75 Percentage of participants	0.00 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	3.76 Percentage of participants	0.00 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	6.02 Percentage of participants	0.74 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	11.28 Percentage of participants	0.74 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	6.77 Percentage of participants	0.00 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	12.78 Percentage of participants	11.76 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	18.05 Percentage of participants	13.24 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	17.29 Percentage of participants	16.91 Percentage of participants
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	15.04 Percentage of participants	13.24 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Analysis included only participants with baseline MASES \> 0. Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Sites assessed included 1st costochondral joint (left [l]/right [r]), 7th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES score ranging from 0 (no tenderness) to 13 (worst possible score) with higher score indicated more severe tenderness.

Outcome measures

Measure	Tofacitinib n=70 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=79 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.42 Units on a scale Standard Error 0.264	-0.59 Units on a scale Standard Error 0.244
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.02 Units on a scale Standard Error 0.275	-1.28 Units on a scale Standard Error 0.255
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-1.89 Units on a scale Standard Error 0.289	-1.17 Units on a scale Standard Error 0.271
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-1.94 Units on a scale Standard Error 0.288	-1.41 Units on a scale Standard Error 0.272
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.50 Units on a scale Standard Error 0.251	-2.32 Units on a scale Standard Error 0.240
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-2.73 Units on a scale Standard Error 0.204	-2.54 Units on a scale Standard Error 0.200
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-2.73 Units on a scale Standard Error 0.189	-2.75 Units on a scale Standard Error 0.183
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-2.87 Units on a scale Standard Error 0.225	-2.56 Units on a scale Standard Error 0.222

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Analysis included only participants with baseline SJC(44) \> 0. Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Swollen joint count was an assessment on 44 joints (sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, knees, ankles, and metatarsophalangeals). Each joint was assessed for swelling as: Present or Absent. Artificial joints were not assessed

Outcome measures

Measure	Tofacitinib n=33 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=38 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	-1.71 Joint count Standard Error 0.376	-2.09 Joint count Standard Error 0.358
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	-1.90 Joint count Standard Error 0.418	-2.23 Joint count Standard Error 0.398
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	-2.39 Joint count Standard Error 0.456	-2.45 Joint count Standard Error 0.438
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	-2.79 Joint count Standard Error 0.428	-2.45 Joint count Standard Error 0.419
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	-3.35 Joint count Standard Error 0.475	-2.79 Joint count Standard Error 0.465
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	-2.81 Joint count Standard Error 0.346	-3.32 Joint count Standard Error 0.335
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	-2.45 Joint count Standard Error 0.357	-3.21 Joint count Standard Error 0.341
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	-3.04 Joint count Standard Error 0.289	-3.34 Joint count Standard Error 0.274
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	-3.31 Joint count Standard Error 0.176	-3.82 Joint count Standard Error 0.174

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Chest expansion (measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion which was defined to be greater than or equal to 0 cm with no defined maximum/upper limit. Greater chest circumference corresponds to higher score indicated more spinal mobility/better health status (measured as Chest Expansion in cm).

Outcome measures

Measure	Tofacitinib n=132 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=136 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 2	0.22 Centimeter Standard Error 0.084	-0.09 Centimeter Standard Error 0.083
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 4	0.25 Centimeter Standard Error 0.094	-0.07 Centimeter Standard Error 0.094
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 8	0.46 Centimeter Standard Error 0.114	0.22 Centimeter Standard Error 0.114
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 12	0.57 Centimeter Standard Error 0.102	0.25 Centimeter Standard Error 0.102
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 16	0.59 Centimeter Standard Error 0.128	0.38 Centimeter Standard Error 0.127
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 24	0.62 Centimeter Standard Error 0.133	0.63 Centimeter Standard Error 0.132
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 32	0.61 Centimeter Standard Error 0.149	0.71 Centimeter Standard Error 0.148
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 40	0.75 Centimeter Standard Error 0.132	0.68 Centimeter Standard Error 0.131
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 Week 48	0.50 Centimeter Standard Error 0.127	0.47 Centimeter Standard Error 0.125

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=131 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 16: Mobility	-0.23 Units on a scale Standard Error 0.044	-0.06 Units on a scale Standard Error 0.044
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 16: Self-Care	-0.21 Units on a scale Standard Error 0.043	-0.20 Units on a scale Standard Error 0.043
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 16: Usual Activities	-0.18 Units on a scale Standard Error 0.046	-0.09 Units on a scale Standard Error 0.046
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 16: Pain/Discomfort	-0.30 Units on a scale Standard Error 0.036	-0.12 Units on a scale Standard Error 0.036
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 16: Anxiety/Depression	-0.11 Units on a scale Standard Error 0.048	-0.10 Units on a scale Standard Error 0.048
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 48: Mobility	-0.32 Units on a scale Standard Error 0.051	-0.26 Units on a scale Standard Error 0.050
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 48: Self-Care	-0.33 Units on a scale Standard Error 0.048	-0.33 Units on a scale Standard Error 0.047
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 48: Usual Activities	-0.32 Units on a scale Standard Error 0.053	-0.34 Units on a scale Standard Error 0.053
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 48: Pain/Discomfort	-0.37 Units on a scale Standard Error 0.047	-0.36 Units on a scale Standard Error 0.047
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48 Week 48: Anxiety/Depression	-0.17 Units on a scale Standard Error 0.054	-0.21 Units on a scale Standard Error 0.053

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Its second part included EQ-VAS. EQ-VAS recorded the participant's self-rated health on a VAS ranging from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state), with higher scores indicating better health state.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=130 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48 Week 48	20.64 Millimeter (mm) Standard Error 1.879	18.00 Millimeter (mm) Standard Error 1.862
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48 Week 16	13.00 Millimeter (mm) Standard Error 1.840	2.89 Millimeter (mm) Standard Error 1.840

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified time point.

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent work time missed due to health problem was a subscale and calculated as: Q2/(Q2+Q4) for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity.

Outcome measures

Measure	Tofacitinib n=77 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=85 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48 Week 16	-3.65 Units on a scale Standard Error 2.659	0.88 Units on a scale Standard Error 2.622
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48 Week 48	-8.10 Units on a scale Standard Error 2.136	-5.79 Units on a scale Standard Error 2.047

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified time point.

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent Impairment while Working due to Health Problem was a subscale and calculated as: Q5/10 for those who were currently employed and actually worked in the past 7 days. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment and less productivity.

Outcome measures

Measure	Tofacitinib n=75 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=82 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48 Week 16	-19.83 Units on a scale Standard Error 2.274	-6.94 Units on a scale Standard Error 2.303
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48 Week 48	-25.35 Units on a scale Standard Error 2.769	-23.00 Units on a scale Standard Error 2.656

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Here, "number analyzed" signifies participants evaluable for this outcome measure for specified time point.

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to health problem was a subscale and calculated as: Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)] for those who were currently employed. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Outcome measures

Measure	Tofacitinib n=75 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=82 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48 Week 16	-21.49 Units on a scale Standard Error 2.508	-7.64 Units on a scale Standard Error 2.559
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48 Week 48	-27.63 Units on a scale Standard Error 3.005	-23.22 Units on a scale Standard Error 2.890

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 48

Population: FAS: included all participants who were randomized to the study and received at least one dose of the randomized investigational product (i.e., tofacitinib or placebo). Here, on-drug data was used and missing response was not imputed. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which Ankylosing Spondylitis affected work productivity and regular activities over the past 7 days. The questions are as follows: Q1 = currently employed; Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to health problem was a subscale and calculated as: Q6/10 for all respondents. Subscale score was expressed as an impairment percentage (range: 0-100%) where higher numbers indicate greater impairment.

Outcome measures

Measure	Tofacitinib n=129 Participants Participants received Tofacitinib tablets 5 milligram (mg), twice daily for 48 weeks.	Placebo Then Tofacitinib n=131 Participants Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48 Week 16	-19.03 Units on a scale Standard Error 1.969	-5.63 Units on a scale Standard Error 1.968
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48 Week 48	-27.37 Units on a scale Standard Error 2.339	-19.77 Units on a scale Standard Error 2.310

Adverse Events

Tofacitinib: Up to Week 16

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo: Up to Week 16

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Tofacitinib: Day 1 to Week 48

Serious events: 7 serious events

Other events: 51 other events

Deaths: 0 deaths

Placebo Then Tofacitinib: Day 1 to Week 48

Serious events: 2 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tofacitinib: Up to Week 16 n=133 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 16 weeks.	Placebo: Up to Week 16 n=136 participants at risk Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks.	Tofacitinib: Day 1 to Week 48 n=133 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 48 weeks.	Placebo Then Tofacitinib: Day 1 to Week 48 n=136 participants at risk Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Ear and labyrinth disorders Hypoacusis	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Gastrointestinal disorders Abdominal adhesions	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Infections and infestations Meningitis aseptic	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Nervous system disorders Migraine	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Renal and urinary disorders Ureterolithiasis	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
General disorders Condition aggravated	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Hepatobiliary disorders Hyperplastic cholecystopathy	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.74% 1/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

Other adverse events

Measure	Tofacitinib: Up to Week 16 n=133 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 16 weeks.	Placebo: Up to Week 16 n=136 participants at risk Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks.	Tofacitinib: Day 1 to Week 48 n=133 participants at risk Participants received tofacitinib 5 mg tablets twice daily for 48 weeks.	Placebo Then Tofacitinib: Day 1 to Week 48 n=136 participants at risk Participants received tofacitinib matching placebo tablets, twice daily for 16 weeks followed by tofacitinib tablets 5 mg, twice daily for next 32 weeks (i.e. up to Week 48).
Infections and infestations Upper respiratory tract infection	10.5% 14/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	7.4% 10/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	15.8% 21/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	13.2% 18/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Infections and infestations Nasopharyngitis	6.8% 9/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	7.4% 10/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	8.3% 11/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	12.5% 17/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Musculoskeletal and connective tissue disorders Arthralgia	0.75% 1/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 8/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 2/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	6.6% 9/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Gastrointestinal disorders Diarrhoea	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	7.5% 10/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.9% 8/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Alanine aminotransferase increased	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	6.0% 8/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 2/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Nervous system disorders Headache	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	3.8% 5/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.1% 7/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	1.5% 2/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	5.1% 7/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).
Investigations Protein urine present	0.00% 0/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	0.00% 0/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	6.0% 8/133 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).	2.9% 4/136 • For the first 2 arms: (tofacitinib and Placebo [up to Week 16]): Baseline to Week 16 and for the next 2 arms (tofacitinib and placebo then tofacitinib [Day 1 to Week 48]): Baseline to Week 48 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least one dose of the investigational product (i.e., tofacitinib or placebo).

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