1. Active substance: Etanercept
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 50mg/mL
4. Route of administration: Subcutaneous injection

1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection

1. Active substance: Infliximab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 120mg/mL
4. Route of administration: Subcutaneous injection

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.

The Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) is a disease-specific measure to assess the level of enthesitis in Ankylosing Spondylitis. It is based on clinical examination by assessor who determined by presence (score 1) or absence (score 0) of enthesitis at 13 different sites as below:

• Both 1st costochondral
• Both 7th costochondral
• Both iliac crest
• Both anterior superior iliac spine
• Both posterior superior iliac spine
• Both proximal Achilles tendon
• 5th lumbar spinous process

The Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) is a disease-specific measure to assess the level of enthesitis in Ankylosing Spondylitis. It is based on clinical examination by assessor who determined by presence (score 1) or absence (score 0) of enthesitis at 13 different sites as below:

• Both 1st costochondral
• Both 7th costochondral
• Both iliac crest
• Both anterior superior iliac spine
• Both posterior superior iliac spine
• Both proximal Achilles tendon
• 5th lumbar spinous process

American College of Rheumatology (ACR), swollen joint count were an assessment of 44 joints. Joints are classified as either swollen or not swollen (tender or non-tender). An increase in swollen joints from baseline represented disease progression and/or joint worsening.

American College of Rheumatology (ACR), swollen joint count were an assessment of 44 joints. Joints are classified as either swollen or not swollen (tender or non-tender). An increase in swollen joints from baseline represented disease progression and/or joint worsening.

The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with spondyloarthritis. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self care, and community life.

The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with spondyloarthritis. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self care, and community life.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The general formula for the calculation is:

(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)

1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
2. A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
3. days of intake during the period of interest

For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:

100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1

The general formula for the calculation is:

(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)

1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
2. A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
3. days of intake during the period of interest

For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:

100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1

The general formula for the calculation is:

(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)

1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
2. A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
3. days of intake during the period of interest

For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:

100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1

The general formula for the calculation is:

(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)

1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
2. A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
3. days of intake during the period of interest

For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:

100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.