The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
Male or female at least 18 years old;
diagnosed with AS according to the 1984 New York Modified Criteria;
Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
With unstable vital signs, coma, mental and cognitive impairment;
Patients with severe systemic diseases and other serious chronic diseases;
Pregnant or lactating patients;
History of malignant tumor in the past 5 years;
Single group
Secukinumab
DrugThe subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.
Adalimumab
DrugThe subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.
Assessment of SpondyloArthritis International Society 40 (ASAS 40)
Proportion of subjects achieving ASAS 40 at Week 52. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
ASAS40
1\. Proportion of subjects achieving ASAS 40 at Week 104. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
The mSASSS is a method used to assess spinal damage and function in patients with ankylosing spondylitis. The assessment Items includes: * Vertebral Scoring: It evaluates the morphology of each vertebra from T1 to L5. Each vertebra is scored from 0 to 3 based on the presence and degree of squaring, erosions, and syndesmophytes. For example, 0 means normal vertebra, and 3 indicates severe structural changes. * Intervertebral Disc Scoring: The intervertebral discs between the vertebrae are also assessed. The score ranges from 0 to 2, depending on the presence and extent of disc space narrowing and bridging syndesmophytes. Total Score Calculation: The scores of all vertebrae and intervertebral discs are summed up to obtain the mSASSS total score. The higher the score, the more severe the spinal damage.
Spondyloarthritis Research Consortium of Canada (SPARCC)
The SPARCC assessment method is a valuable tool in the field of spondyloarthritis research and diagnosis. The assessment Items include: * Sacroiliac Joint Assessment: It evaluates the sacroiliac joints using magnetic resonance imaging (MRI). The assessment includes aspects such as bone marrow edema, erosion, and fatty infiltration in the sacroiliac joints. Each feature is scored based on its severity and extent. * Spinal Assessment: For the spine, SPARCC also uses MRI to assess inflammation. It focuses on detecting signs like vertebral corner inflammation (enthesitis) and discitis. Similar to the sacroiliac joint assessment, specific features are scored according to their characteristics. Scoring System: The total SPARCC score is obtained by summing up the scores of different items. Higher scores indicate more severe inflammation and greater disease activity.
Assessment of SpondyloArthritis International Society 20 (ASAS20)
Proportion of subjects achieving ASAS 40 at week 12, week 24, week 52. ASAS 20 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 20% improvement in disease activity. Key Components of ASAS20: -Patient Global Assessment:Patient's overall assessment of disease activity -Pain: Assessment of spinal pain. -Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). -Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS20 responder if they achieve at least a 20% improvement or an absolute improvement of ≥1 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6)
Proportion of subjects achieving ASAS5/6 at week 12, week 24, week 52. A patient is considered an ASAS5/6 responder if they achieve at least a 20% improvement in at least five of the six items mentioned below： * Patient's Global Score: The patient's overall pain level is assessed by the Visual Analogue Score (VAS). * Patient's nocturnal back pain and overall back pain VAS score: special attention is paid to the condition of nocturnal back pain. * BASFI (Bath Ankylosing Spondylitis Functional Index): Evaluates the patient's ability to perform daily activities, such as wearing socks, bending over to pick up objects, etc. * Inflammatory response: by the mean score of inflammatory indicators and morning stiffness time in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index). * CRP (C-reactive protein): assesses the level of inflammatory markers. * Spinal range of motion: By measuring the range of motion of the spine, such as scoliosis.
Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR)
Proportion of subjects achieving ASAS PR at week 12, week 24, week 52 (The absolute score for each of the 4 indicators identified in ASAS 40 ≤ 2 units)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50
Proportion of subjects achieving BASDAI 50 at week 12, week 24, week 52. BASDAI50 is defined as a patient who has at least a 50% improvement from baseline in BASDAI score over the course of treatment. Assessment Domains (each scale from 0 to 10, the higher the score, the more severe the symptom): * Fatigue: Patients are asked to rate their level of fatigue in the past week. * Spinal Pain: score the average spinal pain they have experienced in the past week. * Joint Pain/Swelling: Patients rate the degree of pain and swelling in their joints in the past week. * Localized Tenderness: The pain at the sites where tendons and ligaments attach to bones is evaluated. * Morning Stiffness: This is divided into two parts: duration and severity. Scoring Calculation: The scores of the five aspects above are added together, resulting in a total score ranging from 0 to 50. This total score is then divided by 5 to obtain the final BASDAI score, which ranges from 0 to 10.
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