Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis (NCT NCT04169373)

Last Updated: 2025-03-17

Results Overview

ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

734 participants

Primary outcome timeframe

Baseline and Week 14

Results posted on

2025-03-17

Participant Flow

This master protocol consists of 2 independent studies with a common screening platform for adults with active axial spondyloarthritis (axSpA). Study 1 enrolled adults with ankylosing spondylitis (AS) who had an inadequate response (IR) to biologic disease-modifying antirheumatic drug (bDMARD) therapy. Study 2 enrolled adults with non-radiographic axSpA (nr-axSpA). Each study includes a double-blind treatment period and an ongoing open-label extension period. Results are reported up to Week 52.

In each study participants were randomized equally to one of two treatment groups. In Study 1 randomization was stratified by high-sensitivity C-reactive protein (hsCRP) at Screening, class of the prior bDMARD use, and geographic region. In Study 2 randomization was stratified by magnetic resonance imaging (MRI) and Screening hsCRP status, and exposure to bDMARDs. For both studies Japan and China each had a separate randomization schedule stratified by Screening hsCRP and MRI (Study 2 only).

Participant milestones

Participant milestones
Measure	Study 1: Placebo / Upadacitinib 15 mg Participants with bDMARD-inadequate response ankylosing spondylitis (bDMARD-IR AS) received placebo tablets orally once a day for 14 weeks. At Week 14 participants switched to receive 15 mg upadacitinib once a day in the open-label extension period.	Study 1: Upadacitinib 15 mg / Upadacitinib 15 mg Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks. At Week 14 participants continued to receive 15 mg upadacitinib once a day in the open-label extension period.	Study 2: Placebo Participants with nr-axSpA received placebo orally once a day for 52 weeks.	Study 2: Upadacitinib 15 mg Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Week 1 to Week 14 STARTED	209	211	158	156
Week 1 to Week 14 Received Study Drug	209	211	157	156
Week 1 to Week 14 COMPLETED	204	206	149	142
Week 1 to Week 14 NOT COMPLETED	5	5	9	14
Week 14 to Week 52 STARTED	204	206	149	142
Week 14 to Week 52 COMPLETED	192	194	138	133
Week 14 to Week 52 NOT COMPLETED	12	12	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Study 1: Placebo / Upadacitinib 15 mg Participants with bDMARD-inadequate response ankylosing spondylitis (bDMARD-IR AS) received placebo tablets orally once a day for 14 weeks. At Week 14 participants switched to receive 15 mg upadacitinib once a day in the open-label extension period.	Study 1: Upadacitinib 15 mg / Upadacitinib 15 mg Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks. At Week 14 participants continued to receive 15 mg upadacitinib once a day in the open-label extension period.	Study 2: Placebo Participants with nr-axSpA received placebo orally once a day for 52 weeks.	Study 2: Upadacitinib 15 mg Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Week 1 to Week 14 Adverse Event	1	0	1	2
Week 1 to Week 14 Withdrawal by Subject	2	0	5	6
Week 1 to Week 14 Lost to Follow-up	1	1	0	1
Week 1 to Week 14 Coronavirus Disease of 2019 (COVID-19) Logistical Restrictions	0	1	0	0
Week 1 to Week 14 Other	1	3	3	5
Week 14 to Week 52 Adverse Event	1	0	0	1
Week 14 to Week 52 Withdrawal by Subject	4	5	7	2
Week 14 to Week 52 Lost to Follow-up	2	1	0	1
Week 14 to Week 52 COVID-19 Logistical Restrictions	1	0	0	0
Week 14 to Week 52 Other	4	5	4	5
Week 14 to Week 52 Ongoing	0	1	0	0

Baseline Characteristics

Results are reported separately for Study 1 and Study 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study 1: Placebo n=209 Participants Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks. At Week 14 participants switched to receive 15 mg upadacitinib once daily in the open-label extension period.	Study 1: Upadacitinib 15 mg n=211 Participants Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks and continued to receive 15 mg upadacitinib once daily from Week 14 in the open-label extension period.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.	Total n=733 Participants Total of all reporting groups
Age, Continuous Study 1	42.2 years STANDARD_DEVIATION 11.78 • n=209 Participants • Results are reported separately for Study 1 and Study 2	42.6 years STANDARD_DEVIATION 12.39 • n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	42.4 years STANDARD_DEVIATION 12.08 • n=420 Participants • Results are reported separately for Study 1 and Study 2
Age, Continuous Study 2	—	—	42.5 years STANDARD_DEVIATION 12.44 • n=157 Participants • Results are reported separately for Study 1 and Study 2	41.6 years STANDARD_DEVIATION 12.00 • n=156 Participants • Results are reported separately for Study 1 and Study 2	42.1 years STANDARD_DEVIATION 12.21 • n=313 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 1 · < 40 years	92 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	87 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	179 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 1 · 40 - < 65 years	108 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	112 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	220 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 1 · ≥ 65 years	9 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	12 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	21 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 2 · < 40 years	—	—	67 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	72 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	139 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 2 · 40 - < 65 years	—	—	84 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	81 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	165 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Age, Customized Study 2 · ≥ 65 years	—	—	6 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	3 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	9 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Sex: Female, Male Study 1 · Female	51 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	58 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	109 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Sex: Female, Male Study 1 · Male	158 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	153 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	311 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Sex: Female, Male Study 2 · Female	—	—	94 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	89 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	183 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Sex: Female, Male Study 2 · Male	—	—	63 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	67 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	130 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 1 · Hispanic or Latino	20 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	17 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	37 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 1 · Not Hispanic or Latino	189 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	194 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	383 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 1 · Unknown or Not Reported	0 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	0 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 2 · Hispanic or Latino	—	—	15 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	24 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	39 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 2 · Not Hispanic or Latino	—	—	142 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	132 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	274 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Ethnicity (NIH/OMB) Study 2 · Unknown or Not Reported	—	—	0 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · American Indian or Alaska Native	0 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	0 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · Asian	37 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	42 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	79 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	0 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · Black or African American	3 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	1 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	4 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · White	169 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	168 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	337 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · More than one race	0 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	0 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 1 · Unknown or Not Reported	0 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	0 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · American Indian or Alaska Native	—	—	0 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	1 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	1 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · Asian	—	—	28 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	19 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	47 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · Black or African American	—	—	1 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	2 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	3 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · White	—	—	127 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	134 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	261 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · More than one race	—	—	1 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	1 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Race (NIH/OMB) Study 2 · Unknown or Not Reported	—	—	0 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	0 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · North America	25 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	25 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	50 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · South/Central America	14 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	13 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	27 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · Western Europe	25 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	16 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	41 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · Eastern Europe	98 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	109 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	207 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · Asia	34 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	41 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	75 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 1 · Other	13 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	7 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	20 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · North America	—	—	19 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	26 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	45 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · South/Central America	—	—	13 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	12 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	25 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · Western Europe	—	—	19 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	24 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	43 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · Eastern Europe	—	—	72 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	68 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	140 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · Asia	—	—	27 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	19 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	46 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Region Study 2 · Other	—	—	7 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	7 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	14 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Time Since AS / nr-axSpA Diagnosis Study 1 - Duration since AS diagnosis	7.5 years STANDARD_DEVIATION 7.51 • n=209 Participants • Results are reported separately for Study 1 and Study 2	7.9 years STANDARD_DEVIATION 7.54 • n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	7.7 years STANDARD_DEVIATION 7.52 • n=420 Participants • Results are reported separately for Study 1 and Study 2
Time Since AS / nr-axSpA Diagnosis Study 2 - Duration since nr-axSpA diagnosis	—	—	4.4 years STANDARD_DEVIATION 5.83 • n=157 Participants • Results are reported separately for Study 1 and Study 2	4.5 years STANDARD_DEVIATION 5.54 • n=156 Participants • Results are reported separately for Study 1 and Study 2	4.4 years STANDARD_DEVIATION 5.68 • n=313 Participants • Results are reported separately for Study 1 and Study 2
Duration of AS / nr-axSpA Symptoms Study 1 -Duration of AS symptoms	12.6 years STANDARD_DEVIATION 9.29 • n=209 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	12.9 years STANDARD_DEVIATION 9.08 • n=211 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	—	—	12.8 years STANDARD_DEVIATION 9.18 • n=420 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
Duration of AS / nr-axSpA Symptoms Study 2 - Duration of nr-axSpA symptoms	—	—	9.2 years STANDARD_DEVIATION 8.12 • n=156 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	9.0 years STANDARD_DEVIATION 7.86 • n=155 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	9.1 years STANDARD_DEVIATION 7.98 • n=311 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
Study 1: Class of Prior bDMARD Use One tumor necrosis factor (TNF) inhibitor	158 Participants n=209 Participants • Class of prior bDMARD use was collected in Study 1 only.	154 Participants n=211 Participants • Class of prior bDMARD use was collected in Study 1 only.	—	—	312 Participants n=420 Participants • Class of prior bDMARD use was collected in Study 1 only.
Study 1: Class of Prior bDMARD Use One interleukin-17 (IL-17) inhibitor	24 Participants n=209 Participants • Class of prior bDMARD use was collected in Study 1 only.	29 Participants n=211 Participants • Class of prior bDMARD use was collected in Study 1 only.	—	—	53 Participants n=420 Participants • Class of prior bDMARD use was collected in Study 1 only.
Study 1: Class of Prior bDMARD Use Prior exposure to 2 bDMARDs	26 Participants n=209 Participants • Class of prior bDMARD use was collected in Study 1 only.	28 Participants n=211 Participants • Class of prior bDMARD use was collected in Study 1 only.	—	—	54 Participants n=420 Participants • Class of prior bDMARD use was collected in Study 1 only.
Study 1: Class of Prior bDMARD Use Missing (no prior bDMARD use)	1 Participants n=209 Participants • Class of prior bDMARD use was collected in Study 1 only.	0 Participants n=211 Participants • Class of prior bDMARD use was collected in Study 1 only.	—	—	1 Participants n=420 Participants • Class of prior bDMARD use was collected in Study 1 only.
Study 2: Prior bDMARD Use Yes	—	—	54 Participants n=157 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.	49 Participants n=156 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.	103 Participants n=313 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.
Study 2: Prior bDMARD Use No	—	—	103 Participants n=157 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.	107 Participants n=156 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.	210 Participants n=313 Participants • Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.
High-sensitivity C-reactive Protein (hsCRP) Level at Screening Study 1 · > upper limit of normal	163 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	165 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	328 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
High-sensitivity C-reactive Protein (hsCRP) Level at Screening Study 1 · ≤ upper limit of normal	46 Participants n=209 Participants • Results are reported separately for Study 1 and Study 2	46 Participants n=211 Participants • Results are reported separately for Study 1 and Study 2	—	—	92 Participants n=420 Participants • Results are reported separately for Study 1 and Study 2
High-sensitivity C-reactive Protein (hsCRP) Level at Screening Study 2 · > upper limit of normal	—	—	126 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	123 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	249 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
High-sensitivity C-reactive Protein (hsCRP) Level at Screening Study 2 · ≤ upper limit of normal	—	—	31 Participants n=157 Participants • Results are reported separately for Study 1 and Study 2	33 Participants n=156 Participants • Results are reported separately for Study 1 and Study 2	64 Participants n=313 Participants • Results are reported separately for Study 1 and Study 2
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI Spine Score Study 1	8.8 score on a scale STANDARD_DEVIATION 12.52 • n=209 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	10.7 score on a scale STANDARD_DEVIATION 15.43 • n=199 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	—	—	9.7 score on a scale STANDARD_DEVIATION 14.05 • n=408 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI Spine Score Study 2	—	—	1.4 score on a scale STANDARD_DEVIATION 3.72 • n=147 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	2.7 score on a scale STANDARD_DEVIATION 6.88 • n=139 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	2.1 score on a scale STANDARD_DEVIATION 5.52 • n=286 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
SPARCC MRI Sacroiliac Joint Score Study 1	5.6 score on a scale STANDARD_DEVIATION 10.63 • n=202 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	5.0 score on a scale STANDARD_DEVIATION 10.80 • n=199 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	—	—	5.3 score on a scale STANDARD_DEVIATION 10.71 • n=401 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
SPARCC MRI Sacroiliac Joint Score Study 2	—	—	3.5 score on a scale STANDARD_DEVIATION 7.60 • n=148 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	4.4 score on a scale STANDARD_DEVIATION 8.74 • n=142 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.	3.9 score on a scale STANDARD_DEVIATION 8.18 • n=290 Participants • Participants with available data; Results are reported separately for Study 1 and Study 2.
Study 2: Magnetic Resonance Imaging (MRI) Inflammation Status MRI-positive	—	—	66 Participants n=157 Participants • MRI inflammation status was only collected in Study 2.	70 Participants n=156 Participants • MRI inflammation status was only collected in Study 2.	136 Participants n=313 Participants • MRI inflammation status was only collected in Study 2.
Study 2: Magnetic Resonance Imaging (MRI) Inflammation Status MRI-negative	—	—	91 Participants n=157 Participants • MRI inflammation status was only collected in Study 2.	86 Participants n=156 Participants • MRI inflammation status was only collected in Study 2.	177 Participants n=313 Participants • MRI inflammation status was only collected in Study 2.
Study 2: MRI Inflammation and hsCRP Status MRI positive and hsCRP > ULN	—	—	35 Participants n=157 Participants • MRI inflammation status was only collected in Study 2.	38 Participants n=156 Participants • MRI inflammation status was only collected in Study 2.	73 Participants n=313 Participants • MRI inflammation status was only collected in Study 2.
Study 2: MRI Inflammation and hsCRP Status MRI positive and hsCRP ≤ ULN	—	—	31 Participants n=157 Participants • MRI inflammation status was only collected in Study 2.	32 Participants n=156 Participants • MRI inflammation status was only collected in Study 2.	63 Participants n=313 Participants • MRI inflammation status was only collected in Study 2.
Study 2: MRI Inflammation and hsCRP Status MRI negative and hsCRP > ULN	—	—	91 Participants n=157 Participants • MRI inflammation status was only collected in Study 2.	86 Participants n=156 Participants • MRI inflammation status was only collected in Study 2.	177 Participants n=313 Participants • MRI inflammation status was only collected in Study 2.
Patient's Global Assessment of Disease Activity (PtGA) Study 1	7.2 units on a scale STANDARD_DEVIATION 1.40 • n=209 Participants • Results are reported separately for Study 1 and Study 2.	7.4 units on a scale STANDARD_DEVIATION 1.48 • n=211 Participants • Results are reported separately for Study 1 and Study 2.	—	—	7.3 units on a scale STANDARD_DEVIATION 1.44 • n=420 Participants • Results are reported separately for Study 1 and Study 2.
Patient's Global Assessment of Disease Activity (PtGA) Study 2	—	—	7.3 units on a scale STANDARD_DEVIATION 1.38 • n=157 Participants • Results are reported separately for Study 1 and Study 2.	7.0 units on a scale STANDARD_DEVIATION 1.62 • n=156 Participants • Results are reported separately for Study 1 and Study 2.	7.1 units on a scale STANDARD_DEVIATION 1.51 • n=313 Participants • Results are reported separately for Study 1 and Study 2.
Patient's Assessment of Total Back Pain Study 1	7.4 units on a scale STANDARD_DEVIATION 1.43 • n=209 Participants • Results are reported separately for Study 1 and Study 2.	7.5 units on a scale STANDARD_DEVIATION 1.48 • n=211 Participants • Results are reported separately for Study 1 and Study 2.	—	—	7.4 units on a scale STANDARD_DEVIATION 1.46 • n=420 Participants • Results are reported separately for Study 1 and Study 2.
Patient's Assessment of Total Back Pain Study 2	—	—	7.3 units on a scale STANDARD_DEVIATION 1.39 • n=157 Participants • Results are reported separately for Study 1 and Study 2.	7.2 units on a scale STANDARD_DEVIATION 1.55 • n=156 Participants • Results are reported separately for Study 1 and Study 2.	7.3 units on a scale STANDARD_DEVIATION 1.47 • n=313 Participants • Results are reported separately for Study 1 and Study 2.
Bath Ankylosing Spondylitis Functional Index Study 1	6.2 score on a scale STANDARD_DEVIATION 1.87 • n=209 Participants • Results are reported separately for Study 1 and Study 2.	6.3 score on a scale STANDARD_DEVIATION 2.03 • n=211 Participants • Results are reported separately for Study 1 and Study 2.	—	—	6.2 score on a scale STANDARD_DEVIATION 1.95 • n=420 Participants • Results are reported separately for Study 1 and Study 2.
Bath Ankylosing Spondylitis Functional Index Study 2	—	—	6.0 score on a scale STANDARD_DEVIATION 2.14 • n=157 Participants • Results are reported separately for Study 1 and Study 2.	5.9 score on a scale STANDARD_DEVIATION 2.08 • n=156 Participants • Results are reported separately for Study 1 and Study 2.	5.9 score on a scale STANDARD_DEVIATION 2.11 • n=313 Participants • Results are reported separately for Study 1 and Study 2.
Inflammation Study 1	6.8 score on a scale STANDARD_DEVIATION 1.55 • n=209 Participants • Results are reported separately for Study 1 and Study 2.	6.9 score on a scale STANDARD_DEVIATION 1.84 • n=211 Participants • Results are reported separately for Study 1 and Study 2.	—	—	6.8 score on a scale STANDARD_DEVIATION 1.70 • n=420 Participants • Results are reported separately for Study 1 and Study 2.
Inflammation Study 2	—	—	6.7 score on a scale STANDARD_DEVIATION 1.67 • n=157 Participants • Results are reported separately for Study 1 and Study 2.	6.6 score on a scale STANDARD_DEVIATION 1.83 • n=156 Participants • Results are reported separately for Study 1 and Study 2.	6.6 score on a scale STANDARD_DEVIATION 1.75 • n=313 Participants • Results are reported separately for Study 1 and Study 2.

PRIMARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation (MI).

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14	44.5 percentage of participants Interval 37.8 to 51.3	18.2 percentage of participants Interval 13.0 to 23.4

PRIMARY outcome

Timeframe: Baseline and Week 14

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14	44.9 percentage of participants Interval 37.1 to 52.7	22.5 percentage of participants Interval 16.0 to 29.1

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement (MMRM) analysis including all observed data up to Week 14 was used.

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS \< 1.3) and very high disease (ASDAS \> 3.5). A negative change from Baseline score indicates improvement in disease activity.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14	-1.52 score on a scale Interval -1.64 to -1.39	-0.49 score on a scale Interval -0.62 to -0.37

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data

In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice. The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=181 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=186 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14	-3.95 score on a scale Interval -5.06 to -2.83	-0.04 score on a scale Interval -1.14 to 1.06

SECONDARY outcome

Timeframe: Baseline and Week 14

The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14	43.1 percentage of participants Interval 36.4 to 49.8	16.7 percentage of participants Interval 11.7 to 21.8

SECONDARY outcome

Timeframe: Baseline and Week 14

ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units \[on a scale of 0 to 10\]) in the remaining domain: * Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants With an ASAS20 Response at Week 14	65.4 percentage of participants Interval 59.0 to 71.8	38.3 percentage of participants Interval 31.7 to 44.9

SECONDARY outcome

Timeframe: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score \< 1.3.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14	12.8 percentage of participants Interval 8.3 to 17.3	1.9 percentage of participants Interval 0.1 to 3.8

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14	-3.00 score on a scale Interval -3.3 to -2.7	-1.47 score on a scale Interval -1.77 to -1.16

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=208 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14	-3.21 score on a scale Interval -3.52 to -2.89	-1.52 score on a scale Interval -1.84 to -1.2

SECONDARY outcome

Timeframe: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score \< 2.1.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14	44.1 percentage of participants Interval 37.4 to 50.8	10.1 percentage of participants Interval 6.0 to 14.2

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14	-2.26 score on a scale Interval -2.53 to -2.0	-1.09 score on a scale Interval -1.35 to -0.83

SECONDARY outcome

Timeframe: Week 14

ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=209 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14	17.5 percentage of participants Interval 12.4 to 22.7	4.3 percentage of participants Interval 1.6 to 7.1

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0). Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=210 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=208 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14	-5.10 score on a scale Interval -5.69 to -4.52	-2.03 score on a scale Interval -2.62 to -1.44

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

The ASAS health index (HI) measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=211 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=208 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in ASAS Health Index at Week 14	-2.93 score on a scale Interval -3.36 to -2.5	-1.07 score on a scale Interval -1.51 to -0.64

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data

The BASMI is a composite score based on 5 direct measurements of spinal mobility: 1. cervical rotation (measured in degrees), 2. tragus to wall distance (in centimeters \[cm\]) 3. lumbar side flexion (in cm), 4. lumbar flexion (modified Schober's) (in cm) and 5. intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=205 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=201 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14	-0.48 score on a scale Interval -0.58 to -0.38	-0.16 score on a scale Interval -0.26 to -0.06

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with Baseline enthesitis and at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=148 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=162 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14	-2.6 score on a scale Interval -3.0 to -2.2	-1.1 score on a scale Interval -1.5 to -0.8

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data.

In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema. Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=181 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=186 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14	-2.26 score on a scale Interval -3.1 to -1.41	1.05 score on a scale Interval 0.22 to 1.89

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=154 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=156 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in ASDAS at Week 14	-1.36 score on a scale Interval -1.5 to -1.21	-0.71 score on a scale Interval -0.85 to -0.56

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=140 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=148 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14	-2.49 score on a scale Interval -3.22 to -1.77	0.57 score on a scale Interval -0.17 to 1.3

SECONDARY outcome

Timeframe: Baseline and Week 14

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14	42.3 percentage of participants Interval 34.6 to 50.1	22.1 percentage of participants Interval 15.5 to 28.6

SECONDARY outcome

Timeframe: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score \< 1.3.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14	14.1 percentage of participants Interval 8.6 to 19.6	5.2 percentage of participants Interval 1.7 to 8.7

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=154 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=156 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14	-2.91 score on a scale Interval -3.27 to -2.56	-2.00 score on a scale Interval -2.35 to -1.65

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=151 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=154 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14	-2.96 score on a scale Interval -3.36 to -2.56	-1.84 score on a scale Interval -2.23 to -1.44

SECONDARY outcome

Timeframe: Week 14

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score \< 2.1.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14	42.3 percentage of participants Interval 34.6 to 50.1	18.3 percentage of participants Interval 12.2 to 24.4

SECONDARY outcome

Timeframe: Week 14

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14	18.6 percentage of participants Interval 12.5 to 24.7	7.6 percentage of participants Interval 3.5 to 11.8

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=154 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=156 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in BASFI at Week 14	-2.61 score on a scale Interval -2.94 to -2.29	-1.47 score on a scale Interval -1.79 to -1.15

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=151 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=154 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in ASQoL at Week 14	-5.38 score on a scale Interval -6.11 to -4.65	-3.15 score on a scale Interval -3.87 to -2.43

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.

The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=150 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=154 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in ASAS Health Index at Week 14	-3.26 score on a scale Interval -3.81 to -2.7	-1.48 score on a scale Interval -2.02 to -0.93

SECONDARY outcome

Timeframe: Baseline and Week 14

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14	66.7 percentage of participants Interval 59.3 to 74.1	43.8 percentage of participants Interval 36.0 to 51.5

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=144 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=148 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in BASMI(Lin) at Week 14	-0.29 score on a scale Interval -0.4 to -0.18	-0.19 score on a scale Interval -0.29 to -0.08

SECONDARY outcome

Timeframe: Baseline and Week 14

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=124 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=125 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in MASES at Week 14	-2.3 score on a scale Interval -2.7 to -1.9	-1.6 score on a scale Interval -2.0 to -1.2

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set; participants who discontinued study drug prior to Week 52 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52	62.8 percentage of participants Interval 55.2 to 70.4	42.7 percentage of participants Interval 34.9 to 50.4

SECONDARY outcome

Timeframe: Baseline and Week 14

Population: Full analysis set participants with available change from Baseline data

In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice. The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=136 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=146 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14	-0.79 score on a scale Interval -1.48 to -0.11	0.34 score on a scale Interval -0.32 to 1.0

SECONDARY outcome

Timeframe: Week 24, Week 32, Week 40, and Week 52

Population: The analysis population is the Full Analysis Set, which includes all participants who were randomized and received at least one dose of study drug. Even though rescue was not assessed until after Week 24, the interpretation of the analysis is based on the percentage of participants who were rescued out of those who were randomized and received study drug, similar to the analysis of other binary endpoints.

Participants who did not achieve an ASAS20 response at any 2 consecutive scheduled visits from Week 24 through Week 52 were to be rescued with standard of care treatment as described in the protocol.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52 Week 24	5.1 percentage of participants Interval 2.2 to 9.9	13.4 percentage of participants Interval 8.5 to 19.7
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52 Week 32	3.2 percentage of participants Interval 1.0 to 7.3	1.9 percentage of participants Interval 0.4 to 5.5
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52 Week 40	0.6 percentage of participants Interval 0.0 to 3.5	0.6 percentage of participants Interval 0.0 to 3.5
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52 Week 52	0 percentage of participants Interval 0.0 to 2.3	1.3 percentage of participants Interval 0.2 to 4.5

SECONDARY outcome

Timeframe: Baseline and Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS \< 1.3) and very high disease (ASDAS \> 3.5). Major Improvement is defined as a change from Baseline of ≤ -2.0.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52	37.8 percentage of participants Interval 30.2 to 45.4	20.4 percentage of participants Interval 14.1 to 26.7

SECONDARY outcome

Timeframe: Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score \< 1.3.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52	32.7 percentage of participants Interval 25.3 to 40.1	10.8 percentage of participants Interval 6.0 to 15.7

SECONDARY outcome

Timeframe: Week 52

ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score \< 2.1.

Outcome measures

Outcome measures
Measure	Study 2: Upadacitinib 15 mg n=156 Participants Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.	Study 2: Placebo n=157 Participants Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52	55.8 percentage of participants Interval 48.0 to 63.6	32.5 percentage of participants Interval 25.2 to 39.9

Adverse Events

Study 1 Week 1 - 14: Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Study 1 Week 1 - 14: Upadacitinib 15 mg

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Study 1 Week 1 - 52: Upadacitinib 15 mg

Serious events: 43 serious events

Other events: 96 other events

Deaths: 1 deaths

Study 2 Week 1 - 52: Placebo

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Study 2 Week 1 - 52: Upadacitinib 15 mg

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study 1 Week 1 - 14: Placebo n=209 participants at risk Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.	Study 1 Week 1 - 14: Upadacitinib 15 mg n=211 participants at risk Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.	Study 1 Week 1 - 52: Upadacitinib 15 mg n=414 participants at risk Participants with bDMARD-IR AS originally assigned to placebo received 15 mg upadacitinib from Week 14 to Week 52 and participants originally assigned to upadacitinib received 15 mg upadacitinib from Week 1 to Week 52.	Study 2 Week 1 - 52: Placebo n=157 participants at risk Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.	Study 2 Week 1 - 52: Upadacitinib 15 mg n=156 participants at risk Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Blood and lymphatic system disorders BLOOD LOSS ANAEMIA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders CATARACT	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders IRIDOCYCLITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.48% 2/414 • Number of events 2 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders OPHTHALMOPLEGIA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders REFRACTION DISORDER	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders STRABISMUS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Eye disorders UVEITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.47% 1/211 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.48% 2/414 • Number of events 2 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Gastrointestinal disorders GASTRITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Gastrointestinal disorders PANCREATITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Gastrointestinal disorders VARICES OESOPHAGEAL	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Hepatobiliary disorders CHOLANGITIS ACUTE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.47% 1/211 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Hepatobiliary disorders HEPATIC CYST	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations COVID-19	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.47% 1/211 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.97% 4/414 • Number of events 4 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	1.9% 4/211 • Number of events 4 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	2.4% 10/414 • Number of events 10 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations COMPLICATED APPENDICITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.48% 2/414 • Number of events 2 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations DIVERTICULITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations HAEMORRHAGIC FEVER WITH RENAL SYNDROME	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations PERITONITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations PYELONEPHRITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications ANIMAL BITE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications FOOT FRACTURE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/157 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Musculoskeletal and connective tissue disorders OSTEOPOROTIC FRACTURE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.48% 2/414 • Number of events 2 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOPROLIFERATIVE DISORDER	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO LIVER	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TONSIL CANCER	0.48% 1/209 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Nervous system disorders BASAL GANGLIA HAEMORRHAGE	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Renal and urinary disorders URETEROLITHIASIS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.48% 2/414 • Number of events 2 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/414 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.64% 1/156 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/209 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/211 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.24% 1/414 • Number of events 1 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/157 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.00% 0/156 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)

Other adverse events

Other adverse events
Measure	Study 1 Week 1 - 14: Placebo n=209 participants at risk Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.	Study 1 Week 1 - 14: Upadacitinib 15 mg n=211 participants at risk Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.	Study 1 Week 1 - 52: Upadacitinib 15 mg n=414 participants at risk Participants with bDMARD-IR AS originally assigned to placebo received 15 mg upadacitinib from Week 14 to Week 52 and participants originally assigned to upadacitinib received 15 mg upadacitinib from Week 1 to Week 52.	Study 2 Week 1 - 52: Placebo n=157 participants at risk Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.	Study 2 Week 1 - 52: Upadacitinib 15 mg n=156 participants at risk Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Infections and infestations COVID-19	2.4% 5/209 • Number of events 5 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	2.8% 6/211 • Number of events 6 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	11.4% 47/414 • Number of events 48 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	13.4% 21/157 • Number of events 21 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	12.2% 19/156 • Number of events 19 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations NASOPHARYNGITIS	1.4% 3/209 • Number of events 3 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	2.4% 5/211 • Number of events 5 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	5.6% 23/414 • Number of events 35 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	5.1% 8/157 • Number of events 8 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	7.7% 12/156 • Number of events 15 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.9% 4/209 • Number of events 4 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	0.95% 2/211 • Number of events 3 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	5.3% 22/414 • Number of events 30 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	5.1% 8/157 • Number of events 9 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	4.5% 7/156 • Number of events 8 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)
Nervous system disorders HEADACHE	1.4% 3/209 • Number of events 3 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	3.3% 7/211 • Number of events 7 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	3.6% 15/414 • Number of events 16 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	3.8% 6/157 • Number of events 6 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)	6.4% 10/156 • Number of events 20 • From first dose of study drug up to Week 14 (Study 1 Week 1 - 14 groups) or Week 52 (for Study 1 Week 1 - 52 and Study 2 groups)

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