ASAS20 Response Research Articles

Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial

Objectives: To compare the effect of golimumab (GLM) and pamidronate (PAM) on clinical efficacy and magnetic resonance imaging (MRI) inflammation in axial spondyloarthritis (aSpA).Method: Patients who fulfilled the Assessment of SpondyloArthritis Society (ASAS) criteria for aSpA and had active disease [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4] were randomized in a 2:1 ratio to receive either GLM (50 mg) or PAM (60 mg) 4 weekly for 48 weeks. Clinical efficacy was assessed at intervals. Inflammation of the spine and sacroiliac joints (SIJs) on MRI was graded by the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system.Results: Twenty patients were assigned to GLM and 10 to PAM (83% men; age 33.4 ± 10.9 years; disease duration 4.4 ± 3.4 years). The baseline characteristics of the two groups were similar. At week 48, the proportions of patients who achieved an ASAS20 response were not significantly different between the GLM and PAM groups (65% vs. 56%; p = 0.69). Although there were no differences in BASDAI, spinal pain, and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) scores between the two groups at week 48, the Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath AS Functional Index (BASFI), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels were significantly lower in GLM-treated patients. The SPARCC scores of the spine and SIJs decreased significantly in GLM- but not in PAM-treated patients. The differences in SPARCC scores between the two groups at week 48 were statistically significant. The frequency of adverse events (AEs) was similar in both arms.Conclusions: In patients with aSpA, the clinical response rate and improvement in pain and quality of life (QoL) were similar between GLM and PAM groups after 48 weeks. However, significant reduction in inflammatory markers and MRI inflammation was only observed with GLM treatment.

Long-term effects of secukinumab on MRI findings in relation to clinical efficacy in subjects with active ankylosing spondylitis: an observational study

IntroductionA 28-week study suggested efficacy of the anti-interleukin-17A monoclonal antibody secukinumab in active ankylosing spondylitis (AS). MRI-assessed inflammation was reduced at weeks 6, 28.ObjectiveTo analyse the longer-term effects of secukinumab...

A Prospective Double Blind Placebo Controlled Trial of Combination Disease Modifying Antirheumatic Drugs vs. Monotherapy (Sulfasalazine) in Patients with Inflammatory Low Backache in Ankylosing Spondylitis and Undifferentiated Spondyloarthropathy

Objective: Inflammatory back pain (IBP) in Ankylosing Spondylitis (AS) and Undifferentiated Spondyloarthritis (UspA) adversely affects the quality of life. Herein combination DMARD vs. sulfasalazine (SSZ) monotherapy was evaluated in treatment of axial symptoms of AS and UspA. Methods: Patients with AS/UspA with disease duration ≤ 8 years, IBP of atleast 6 months duration, and BASDAI ≥ 4 or early morning stiffness ≥ 1 hour despite NSAID therapy for 6 weeks were included. Patients were initiated on SSZ with either combination DMARD [MTX (10 mg escalated by 2.5 mg every week up to 20 mg/week) and HCQS 200 mg/day] or SSZ Monotherapy group [placebo MTX and placebo HCQS]. ASAS20 response was assessed at baseline and at the end of 6 months. Results: Of thirty three patients (31 males) with mean disease duration 39 months and mean BASDAI of 6 at baseline, 27 completed the study (16 in Combination DMARD and 11 in SSZ monotherapy group). ASAS 20 response, was achieved in 68.4% (13/19) and 50% (7/14) in the Combination DMARD and SSZ monotherapy groups (p=0.47), respectively. BASDAI scores decreased significantly in both the groups after therapy. A significant improvement in BASFI, patient pain VAS, patient global disease VAS, HAQ, and MCS of SF-36 was observed in both the groups. In the combination DMARD group, significant improvement in BASMI, FACIT and PCS of SF-36 and decrease in the serum MMP-3 levels was observed following therapy. Conclusion: SSZ monotherapy is equally efficacious as combination DMARD group in a significant proportion of patients with NSAID refractory IBP associated with AS/ USpA.

Efficiency and safety of different etoricoxib regimens in patients with axial spondyloarthritis, including ankylosing spondylitis

To study the clinical and laboratory efficiency and safety of different etoricoxib (ET) regimens in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis. Forty patients with high axSpA activity (Bath Ankylosing Disease Activity Index (BASDAI 4) were examined and randomized to 2 groups: 1) 30 patients who received ET 90 mg continuously every day; 2) 10 patients who took the drug in the same dose intermittently 1-3 times weekly. The activity of axSpA (BASDAI, Ankylosing Spondylitis Disease Activity Score (ASDAS), erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (hs-CRP)) was evaluated at baseline, 2 and 12 weeks; adverse events were recorded at baseline, 2, 6, and 12 weeks. The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration. RESULTS At 12 weeks, the continuous administration group displayed decreases in BASDAI from 8 to 4, in ASDAS from 3.8 to 2.6, and in hs-CRP levels from 9.5 to 3.9 mg/l; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0, in ASDAS from 3.5 to 3.1, and hs-CRP from 8.8 to 4.5 mg/l (p<0.05). At this time, an AS40 response was achieved by 22 (73.3%) and 2 (20%) patients in Groups 1 and 2, respectively (p<0.05 for all). No serious adverse events were recorded. The efficacy of ET given in a daily dose of 90 mg was much higher than that of the drug used thrice or less weekly in the patients with axSpA.

Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study

ObjectiveAssess golimumab efficacy/safety through 5 years in patients with active ankylosing spondylitis (AS).Methods356 patients with AS were randomly assigned to placebo, golimumab 50 mg or 100 mg every 4 weeks....

Effects and Safety of Allogenic Mesenchymal Stem Cell Intravenous Infusion in Active Ankylosing Spondylitis Patients who Failed NSAIDs: A 20-Week Clinical Trial

Our objective was to evaluate the feasibility, safety, and efficacy of intravenous (IV) infusion of allogenic mesenchymal stem cells (MSCs) in ankylosing spondylitis (AS) patients who are refractory to or cannot tolerate the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). AS patients enrolled in this study received four IV infusions of MSCs on days 0, 7, 14, and 21. The percentage of ASAS20 responders (the primary endpoint) at the fourth week and the mean ASAS20 response duration (the secondary endpoint) were used to assess treatment response to MSC infusion and duration of the therapeutic effects. Ankylosing Spondylitis Disease Activity Score Containing C-reactive Protein (ASDAS-CRP) and other preestablished evaluation indices were also adopted to evaluate the clinical effects. Magnetic resonance imaging (MRI) was performed to detect changes of bone marrow edema in the spine. The safety of this treatment was also evaluated. Thirty-one patients were included, and the percentage of ASAS20 responders reached 77.4% at the fourth week, and the mean ASAS20 response duration was 7.1 weeks. The mean ASDAS-CRP score decreased from 3.6 ± 0.6 to 2.4 ± 0.5 at the fourth week and then increased to 3.2 ± 0.8 at the 20th week. The average total inflammation extent (TIE) detected by MRI decreased from 533,482.5 at baseline to 480,692.3 at the fourth week (p > 0.05) and 400,547.2 at the 20th week (p < 0.05). No adverse effects were noted. IV infusion of MSCs is a feasible, safe, and promising treatment for patients with AS.

Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial.

To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA). The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of ≥4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with ≥2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); during the subsequent open-label period, all patients received etanercept 50 mg/week. The primary study end point was meeting the ASAS criteria for 40% improvement (ASAS40) at week 12. Magnetic resonance imaging (MRI) of the sacroiliac joints and spine was performed at baseline and week 12. One hundred six patients were randomized to the etanercept group and 109 to the placebo group. Of the 215 patients, the mean ± SD age at baseline was 32.0 ± 7.8 years, 154 (72%) were HLA-B27 positive, and 174 (81%) had MRI-confirmed sacroiliitis. At 12 weeks, the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group (34 of 105 [32%] versus 17 of 108 [16%]; P = 0.006). Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation (-46.9% versus -10.9%; P < 0.001) and spinal inflammation (-45.4% versus -33.4%; P = 0.04) compared with placebo-treated patients at week 12. Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept. At week 24, patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks. In patients with nonradiographic axial SpA, etanercept treatment was associated with rapid, significant improvement in symptomatic disease activity, function, and systemic and skeletal inflammation over 12 weeks; clinical/functional improvement was sustained over 24 weeks.

SAT0339 Asas40 and ASDAS Responses Are Associated with Improved Physical Function, Hrqol, and Work Productivity in Patients with Non-Radiographic Axial Spondyloarthritis

BackgroundASAS40 response has been used as a primary endpoint in clinical trials of patients (pts) with axial spondyloarthritis (axSpA), and ASDAS inactive disease is recommended as a treatment target. However,...

AB0655 Are Patients with as Willing to Pay for Treatment with Infliximab?

BackgroundUse of anti-TNF agents has shown substantial and longstanding improvement in pain and function in Ankylosing Spondylitis (AS). However, these agents are costly, and in some countries the use of...

SAT0348 Efficacy and Safety of Different Schemes of Etoricoxib Administration in Patients with Axial Spondyloarthritis - Results of A 12-Week, Prospective, Open-Label Study

BackgroundGuidelines for the treatment of spondyloarthritis with predominantly axial lesion (axSpA) consider non-steroid anti-inflammatory drugs (NSAIDs) as a first-line medication [1]. However, currently unknown what scheme of NSAIDs administration in...

AB0664 Efficacy and Safety of Methylprednisolone Administered Intravenously for the Treatment of Patients with Active Ankylosing Spondylitis: Results of A 12-Week, Prospective, Open-Label Study (METALL)

BackgroundTreatment options for patients with ankylosing spondylitis (AS) are limited to non-steroidal anti-inflammatory drugs (NSAIDs) and to tumour necrosis factor (TNF) α blockers. Treatment of the patients with contraindications/intolerance/absence of...

SAT0353 Meta-Analysis Comparing the Efficacy of Tnf-Blockers in as and Nr-Axspa Patients

BackgroundTumor necrosis factor α (TNFα) blockers are known to reduce disease activity in patients with ankylosing spondylitis (AS). Data from a growing number of randomised controlled trials (RCTs) suggest them...

AB0656 Golimumab versus Pamidronate for the Treatment of Axial Spondyloarthropathy (SPA): A 48-Week Randomized Controlled Trial

ObjectivesTo compare the efficacy of golimumab (GLM) and pamidronate (PAM) in the treatment of SpA.MethodsStudy design: an open randomized controlled trial Patients and methods: Inclusion criteria: (1) ≥18 years of...

AB0659 Predictors for Metrological Outcome in Ankylosing Spondylitis after Treatment with Tumor Necrosis Factor Inhibitors

BackgroundTumor necrosis factor (TNF) inhibitors provide effective therapeutic benefit in reducing clinical symptoms of ankylosing spondylitis (AS), especially in the amelioration of spinal inflammation. Metrological measures represent a clinically useful...

THU0418 Variable Selection is not Useful in the Construction of a Propensity Score for the Evaluation of TNF-Alpha Blockers' Treatment Effect of in Early Spondyloarthritis: Data from the DESIR Cohort

BackgroundThe use of propensity scores (PS) to balance covariates in the groups of treatment in order to address the indication bias in treatment effect evaluation in longitudinal studies, are more...

SAT0361 Short Term Efficacy of Tumor Necrosis Factor Inhibitors in Patients with Non–Radiographic Axial Spondylarthritis and Ankylosing Spondylitis; Results from TURKBIO Registry

BackgroundAxial spondylarthritis (AxSpA) has been proposed as an umbrella term for ankylosing spondylitis (AS) and non-radiographic (nr) AxSpA. This new concept makes diagnosis of AS possible at an early stage...

SAT0337 Clinical Response and Remission in Patients with Non-Radiographic Axial Spondyloarthritis after Three Years of Adalimumab Therapy

BackgroundAdalimumab (ADA) has been previously shown to be effective for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) patients (pts) in the ABILITY-1 trial.1 Week (wk) 12 results were further supported...

SAT0351 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 96-Week Outcomes of the Rapid-Axspa Trial

BackgroundPrevious reports of RAPID-axSpA (NCT01087762) demonstrated efficacy and safety of certolizumab pegol (CZP) in patients (pts) with axial spondyloarthritis (axSpA) including pts with ankylosing spondylitis (AS) and pts with non-radiographic...

SAT0360 Combined Therapy with Rituximab and NSAIDS in Treatment of Active Ankylosing Spondylitis: Better than NSAIDS Alone, Worse than Combination of Tnf-Inhibitors and Nsaids

BackgroundSeveral reports have shown that rituximab may have some efficacy in patients with active ankylosing spondylitis (AS), mainly in tumor necrosis factor alpha (TNF-α) inhibitor naïve. No direct comparisons of...

SAT0374 Do Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis Respond Similarly Well to Nsaids? A Prospective Study Including Magnetic Resonance Imaging

BackgroundPatients classified as axial spondyloarthritis (axSpA) may have ankylosing spondylitis (AS) or non-radiographic axSpA (nr-axSpA). Treatment recommendations for AS consider non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy. After an unsatisfactory...