The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
Study Type
OBSERVATIONAL
Enrollment
132
If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria
Pfizer Investigational Site
Madrid, Madrid, Spain
Percentage of Participants With a Clinical Response
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
Time frame: Week 16
Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment
High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) \>15 mg/Liter (mg/L);time from onset of disease \<10 years;total spinal pain \>30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) \<4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.
Time frame: Week 32
Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment
Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP \> 15 mg/L; time from onset of disease less than \< 10 years; total spinal pain \> 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI \> 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI \< 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
Time frame: Week 32
Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16
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Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP \> 15 mg/L; time from onset of disease less than \< 10 years; total spinal pain \> 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI \> 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI \< 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
Time frame: Week 16
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (\>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.
Time frame: Week 16
Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy
Time frame: Week 16
Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks
ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (\>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.
Time frame: Week 32