AScalate: Treat-to-target in Axial Spondyloarthritis

Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.

Time frame: Baseline, Week 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

The ASAS-HI is a disease-specific questionnaire that was developed based on the comprehensive International Classification of Functioning, Disability and Health Core Set (also known as the ICF Core Set) for AS. The ASAS HI is a linear composite measure and contains 17 items (dichotomous response option: I agree and I do not agree), which cover most of the ICF Core Set. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life. The total sum of the ASAS HI ranges from 0 to 17, with a lower score indicating a better health status. In addition, the Environmental Factor (EF) Item Set contains items addressing categories of support/relationships, attitudes and health services. The EF Item Set contains 9 dichotomous items with an identical response option but without a sum score because of its multidimensional nature.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS. The 10 questions were chosen with major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the patients' ability to cope with everyday life. A 0 through 10 scale (captured as a continuous VAS) is used to answer the questions. The mean of the 10 scales gives the BASFI score - a value between 0 and 10. A higher score on the VAS signifies higher severity.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

Chest expansion is measured as the cervical rotation angle (in degrees).

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

The patient's global assessment of disease activity was performed using a 100 mm (visual analog scale) VAS, ranging from not severe (0 mm) to very severe (100 mm), in response to the question, How active was your disease on average during the last week? A higher score indicates more disease activity.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

The physician's global assessment of disease activity was performed using a 100 mm VAS, ranging from not severe (0 mm) to very severe (100 mm), in response to the question, Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today. To enhance objectivity, the physician must not be aware of the specific patient's global assessment of disease activity when performing his own assessment on that patient. A higher score indicates more disease activity.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is at the moment, and the measure requires approximately 6 minutes to complete.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.

Time frame: Baseline, Week 12

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

Assessment of SpondyloArthritis International Society criteria (ASAS): 6 domains (4 main; 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (CRP, acute phase reactant). ASAS partial remission: a value not above 2 units in each of the four main domains on a scale of 10. Higher score on VAS = higher severity. Percentage calculated from a logistic regression model: logit(proportion) = treatment + baseline quick CRP + baseline weight.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of the disease. BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization.

Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for minimal clinically important improvement and a change of ≥ 2.0 units for major improvement. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for minimal clinically important improvement and a change of ≥ 2.0 units for major improvement. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.

Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were \< 1.3 between inactive disease and low disease activity, \< 2.1 between low disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for minimal clinically important improvement and a change of ≥ 2.0 units for major improvement. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline ASDAS + baseline weight.

Time frame: Baseline, Weeks 12 and 24

Population: Full Analysis Set (FAS): The FAS comprised all patients to whom study treatment/reference treatment was assigned by randomization. Data represent the number of patients with non-missing response at the specified visit.