Trial Outcomes & Findings for Defining Remission With Etanercept in AS in Real Life Clinical Practice (NCT NCT02202850)

NCT ID: NCT02202850

Last Updated: 2018-11-30

Results Overview

ASAS partial remission was defined as a score of less than or equal to (\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.

• Recruitment status: COMPLETED
• Target enrollment: 84 participants
• Primary outcome timeframe: Month 6 up to Month 12
• Results posted on: 2018-11-30

Participant Flow

Participant milestones

Measure	Etanercept First Cohort Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Overall Study STARTED	70	14
Overall Study COMPLETED	46	8
Overall Study NOT COMPLETED	24	6

Reasons for withdrawal

Measure	Etanercept First Cohort Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Overall Study Other	2	2
Overall Study Enbrel treatment discontinued	15	3
Overall Study Lost to Follow-up	7	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Etanercept First Cohort n=70 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=14 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.	Total n=84 Participants Total of all reporting groups
Age, Continuous	42.83 years STANDARD_DEVIATION 13.84 • n=70 Participants	41.37 years STANDARD_DEVIATION 9.74 • n=14 Participants	42.58 years STANDARD_DEVIATION 13.20 • n=84 Participants
Sex: Female, Male Female	37 Participants n=70 Participants	9 Participants n=14 Participants	46 Participants n=84 Participants
Sex: Female, Male Male	33 Participants n=70 Participants	5 Participants n=14 Participants	38 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASAS partial remission was defined as a score of less than or equal to (<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.

Outcome measures

Measure	Etanercept First Cohort n=34 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12	14.7 percentage of participants Interval 4.95 to 31.1	0.0 percentage of participants Interval 0.0 to 52.2

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASAS 5/6 was defined as at least greater than or equal to (>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.

Outcome measures

Measure	Etanercept First Cohort n=30 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12	43.3 percentage of participants Interval 25.5 to 62.6	60.0 percentage of participants Interval 14.7 to 94.7

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).

Outcome measures

Measure	Etanercept First Cohort n=34 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12	29.4 percentage of participants Interval 15.1 to 47.5	0.0 percentage of participants Interval 0.0 to 52.2

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).

Outcome measures

Measure	Etanercept First Cohort n=34 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12	32.4 percentage of participants Interval 17.4 to 50.5	20.0 percentage of participants Interval 0.51 to 71.6

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.

Outcome measures

Measure	Etanercept First Cohort n=36 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12	27.8 percentage of participants Interval 14.2 to 45.2	0.0 percentage of participants Interval 0.0 to 52.2

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=28 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=5 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12	10.7 percentage of participants Interval 2.27 to 28.2	0.0 percentage of participants Interval 0.0 to 52.2

PRIMARY outcome

Timeframe: Month 6 up to Month 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=20 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=4 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12	15.0 percentage of participants Interval 3.21 to 37.9	0.0 percentage of participants Interval 0.0 to 52.2

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASAS partial remission was defined as a score of <= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 Month 3	12.5 percentage of participants Interval 4.19 to 26.8	0.0 percentage of participants Interval 0.0 to 41.0
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 Month 6	17.7 percentage of participants Interval 6.76 to 34.5	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 Month 9	16.7 percentage of participants Interval 5.64 to 34.7	0.0 percentage of participants Interval 0.0 to 45.9
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 Month 12	21.4 percentage of participants Interval 10.3 to 36.8	14.3 percentage of participants Interval 0.36 to 57.9

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASAS 5/6 was defined as at least >= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 Month 3	51.4 percentage of participants Interval 34.0 to 68.6	20.0 percentage of participants Interval 0.51 to 71.6
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 Month 6	46.7 percentage of participants Interval 28.3 to 65.7	60.0 percentage of participants Interval 14.7 to 94.7
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 Month 9	57.7 percentage of participants Interval 36.9 to 76.7	33.3 percentage of participants Interval 4.33 to 77.7
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 Month 12	61.5 percentage of participants Interval 44.6 to 76.6	60.0 percentage of participants Interval 14.7 to 97.7

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 Month 3	30.0 percentage of participants Interval 16.6 to 46.5	0.0 percentage of participants Interval 0.0 to 41.0
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 Month 6	32.4 percentage of participants Interval 17.4 to 50.5	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 Month 9	33.3 percentage of participants Interval 17.3 to 52.8	0.0 percentage of participants Interval 0.0 to 45.9
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 Month 12	29.3 percentage of participants Interval 16.1 to 45.5	14.3 percentage of participants Interval 0.36 to 57.9

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 Month 3	37.5 percentage of participants Interval 22.7 to 54.2	28.6 percentage of participants Interval 3.67 to 71.0
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 Month 6	41.2 percentage of participants Interval 24.7 to 59.3	20.0 percentage of participants Interval 0.51 to 71.6
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 Month 9	46.7 percentage of participants Interval 28.3 to 65.7	16.7 percentage of participants Interval 0.42 to 64.1
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 Month 12	46.3 percentage of participants Interval 30.7 to 62.6	42.9 percentage of participants Interval 9.9 to 81.6

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 Month 3	41.5 percentage of participants Interval 26.3 to 57.9	14.3 percentage of participants Interval 0.36 to 57.9
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 Month 6	30.6 percentage of participants Interval 16.4 to 48.1	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 Month 9	45.2 percentage of participants Interval 27.3 to 64.0	0.0 percentage of participants Interval 0.0 to 45.9
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 Month 12	42.2 percentage of participants Interval 27.7 to 57.9	25.0 percentage of participants Interval 3.19 to 65.1

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 Month 3	24.2 percentage of participants Interval 11.1 to 42.3	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 Month 6	17.9 percentage of participants Interval 6.06 to 36.9	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 Month 9	26.1 percentage of participants Interval 10.2 to 48.4	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 Month 12	30.8 percentage of participants Interval 17.0 to 47.6	0.0 percentage of participants Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Month 3, 6, 9 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 Month 3	16.0 percentage of participants Interval 4.54 to 36.1	0.0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 Month 6	20.0 percentage of participants Interval 5.73 to 43.7	0.0 percentage of participants Interval 0.0 to 60.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 Month 9	15.4 percentage of participants Interval 1.92 to 45.5	0.0 percentage of participants Interval 0.0 to 60.2
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 Month 12	19.4 percentage of participants Interval 7.45 to 37.5	20.0 percentage of participants Interval 0.51 to 71.6

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 Baseline	7.61 Units on a scale Standard Deviation 1.78	7.63 Units on a scale Standard Deviation 0.92
Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 Change at Month 6	3.62 Units on a scale Standard Deviation 2.81	2.60 Units on a scale Standard Deviation 2.30
Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 Change at Month 12	3.43 Units on a scale Standard Deviation 2.96	3.00 Units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 Baseline	6.40 Units on a scale Standard Deviation 2.05	7.00 Units on a scale Standard Deviation 1.39
Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 Change at Month 6	2.15 Units on a scale Standard Deviation 2.61	1.70 Units on a scale Standard Deviation 1.57
Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 Change at Month 12	2.60 Units on a scale Standard Deviation 2.96	2.81 Units on a scale Standard Deviation 2.17

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 Baseline	5.90 Units on a scale Standard Deviation 2.35	7.34 Units on a scale Standard Deviation 1.15
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 Change at Month 6	2.07 Units on a scale Standard Deviation 2.50	1.90 Units on a scale Standard Deviation 0.47
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 Change at Month 12	2.15 Units on a scale Standard Deviation 2.65	2.39 Units on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline, Month 6 and12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 Baseline	5.98 Units on a scale Standard Deviation 2.24	6.81 Units on a scale Standard Deviation 1.56
Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 Change at Month 6	2.71 Units on a scale Standard Deviation 2.34	3.40 Units on a scale Standard Deviation 1.95
Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 Change at Month 12	3.07 Units on a scale Standard Deviation 2.60	2.50 Units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

CRP is a protein marker in the blood for inflammation.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 Baseline	14.49 milligrams per liter Standard Deviation 14.14	6.06 milligrams per liter Standard Deviation 4.83
Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 Change at Month 6	1.45 milligrams per liter Standard Deviation 46.86	5.04 milligrams per liter Standard Deviation 1.28
Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 Change at Month 12	11.50 milligrams per liter Standard Deviation 14.70	-2.03 milligrams per liter Standard Deviation 9.47

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 Baseline	10.04 centimeters Standard Deviation 4.87	10.80 centimeters Standard Deviation 4.51
Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 Change at Month 6	-3.13 centimeters Standard Deviation 3.41	-0.83 centimeters Standard Deviation 3.82
Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 Change at Month 12	-3.73 centimeters Standard Deviation 5.30	1.08 centimeters Standard Deviation 4.68

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 Baseline	6.45 Units on a scale Standard Deviation 1.61	7.14 Units on a scale Standard Deviation 0.90
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 Change at Month 6	2.16 Units on a scale Standard Deviation 2.36	2.16 Units on a scale Standard Deviation 1.47
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 Change at Month 12	2.62 Units on a scale Standard Deviation 2.53	2.48 Units on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 Baseline	3.73 Units on a scale Standard Deviation 0.86	3.54 Units on a scale Standard Deviation 0.87
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 Change at Month 6	1.44 Units on a scale Standard Deviation 1.06	1.54 Units on a scale Standard Deviation 0.61
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 Change at Month 12	1.70 Units on a scale Standard Deviation 1.15	1.17 Units on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline, Month 6 and 12

Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.

ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.

Outcome measures

Measure	Etanercept First Cohort n=46 Participants Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=8 Participants Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 Baseline	3.25 Units on a scale Standard Deviation 0.75	3.51 Units on a scale Standard Deviation 0.69
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 Change at Month 6	1.17 Units on a scale Standard Deviation 0.65	1.11 Units on a scale Standard Deviation 0.45
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 Change at Month 12	1.18 Units on a scale Standard Deviation 0.87	1.25 Units on a scale Standard Deviation 0.94

Adverse Events

Etanercept First Cohort

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Etanercept Second Cohort

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept First Cohort n=70 participants at risk Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=14 participants at risk Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Hepatobiliary disorders Cholecystitis	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Periorbital cellulitis	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Hyperventilation	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Pyelonephritis	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	Etanercept First Cohort n=70 participants at risk Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection.	Etanercept Second Cohort n=14 participants at risk Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection.
Gastrointestinal disorders Abdominal pain upper	2.9% 2/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Hemorrhoids	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Odynophagia	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Oral pain	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhea	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection site hypersensitivity	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Pyrexia	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection site inflammation	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Fatigue	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Injection Site Erythema	0.00% 0/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.1% 1/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Bronchitis	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Gastroenteritis	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Tooth abscess	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Upper respiratory tract infection	4.3% 3/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Respiratory tract infection	0.00% 0/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	7.1% 1/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Liver function test abnormal	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Muscular Weakness	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Paresthesia	2.9% 2/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Reproductive system and breast disorders Cervical dysplasia	2.7% 1/37 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/9 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	4.3% 3/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Skin irritation	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Surgical and medical procedures Large Intestinal Polypectomy	1.4% 1/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Uveitis	2.9% 2/70 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/14 • Baseline up to Month 12 Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER