Improvement In Bath Ankylosing Spondylitis Disease Activity Index Research Articles

Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis: A Real-World Clinical Context Multicenter Study.

Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting. In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICER drug ). Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICER drug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4. Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICER drug .

The effectiveness of hippotherapy simulation exercises for muscle strength, disease activity and quality of life in sedentary adults with ankylosing spondylitis

Introduction/Objective Newly created systems called hippotherapy simulators (HS) mimic the primitive movements of a live horse. As they are new systems, research examining their usefulness has been well received. The aim of this study is to research the effects of HS on disease activity, quality of life and muscle strength in patients with ankylosing spondylitis (AS). Methods In a prospective, assessor-blinded, block-randomized trial, 48 AS patients were randomly assigned in a 1:1 ratio to receive either HS or conventional home (CH) exercise therapy. All Participants received 48 sessions, that is 4 sessions a week for 12 consecutive weeks. The primary outcome measures included the quadriceps muscle strength, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI) and Ankylosing Spondylitis Quality of Life Scale (ASQoL). Results Both groups demonstrated significant improvement in BASDAI, BASFI, BASMI, ASQoL and muscle strength scores compared to the baseline (p < 0.05). BASDAI, BASFI and BASMI scores decreased significantly in the HS group compared to the CH group at week 12 (p=.005, p=.003, p=.045, respectively), but there was no significant difference between the groups in terms of ASQoL and muscle strength scores at week 12 (p=.245, p=.212, respectively). Conclusions The results of this clinical trial of HS exercises for AS patients indicate a positive effect on disease activity, quality of life and muscle strength. Therefore, horse-riding simulator exercises can be used as an alternative method for the management of individuals with AS.

The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2.

Psoriatic arthritis (PsA) is a chronic inflammatory condition predominantly affecting the peripheral joints. However, some patients with PsA can experience axial involvement which is manifested with back pain and associated with increased burden of illness. The aim of this post hoc analysis was to determine the efficacy of ixekizumab (IXE) up to 52 weeks in reducing axial symptoms in PsA patients, presenting with axial manifestations. This was a post hoc analysis of two pooled phase III clinical trials. Patients with axial manifestations, from two placebo-controlled, randomized, double-blind, phase III trials (SPIRIT-P1 and SPIRIT-P2), were defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Q2; back pain)] total score ⩾4 and average of BASDAI Q5 + Q6 (morning stiffness) ⩾4 at baseline. For this post hoc analysis, the efficacy of IXE was evaluated at weeks 16, 24, and 52 using separate BASDAI questions (including back pain and morning stiffness), total BASDAI and modified BASDAI (mBASDAI; without Q3), Ankylosing Spondylitis Disease Activity Score (ASDAS), and 50% improvement in BASDAI (BASDAI50) response. Treatment comparisons were performed using logistic regression and analysis of covariance model for categorical and continuous end points, respectively. In the post hoc analysis among PsA patients with axial manifestations at baseline (N = 313), improvements in back pain and morning stiffness at weeks 16 and 24 were significantly greater in patients receiving IXE versus placebo (both p < 0.001). Improvements in BASDAI individual scores and total scores, mBASDAI, and ASDAS were significantly greater in patients receiving IXE compared with placebo. Similarly, significantly more IXE-treated patients achieved BASDAI50 at weeks 16 and 24 versus placebo. The effect of IXE was sustained at week 52. Similar effects were observed in sensitivity analyses subgroups. IXE is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations.

Tele-yoga in the management of ankylosing spondylitis amidst COVID pandemic: A prospective randomized controlled trial

PurposeAnkylosing spondylitis (AS) signficantly affect day to day activities contributing to signficant disability. Patients with AS often report to have psychological problems and poor quality of life (QoL). This study investigates the effect of a three-month tele-yogic intervention on disease activity, functional index, inflammatory markers, quality of life and mental health measures in patients with AS. MethodsOne hundred and twenty AS patients were assigned to either the yoga intervention group (YG) or the control group (CG). The YG (n = 57) received a 60-min structured yoga module online for 3 months in addition to standard medical care. The CG participants (n = 52) received only standard care during the same period. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis-Quality of Life (ASQOL) and psychological and inflammatory biomarkers were assessed at baseline and after three months. ResultsYG showed significant improvement in BASDAI (p = 0.001), anxiety (p = 0.0004), and depression (p = 0.001) at three months compared to baseline. The CG showed no significant change in similar outcome measures. At three months, the intervention resulted in a significant improvement in BASDI (−0.79; 95% CI (−1.3, to −0.29); p = 0.0021), BASFI (−0.86, 95% CI (−1.59, to −0.14); p = 0.0193), anxiety (−0.42, 95% CI (−0.84 to −0.01), p = 0.0468), and AS-QoL (−3.37; 95% CI (−5.21 to 1.53); p = 0.0004) compared to the CG. ConclusionsThe present study suggests that yoga helps improve pain, functional index, and mental health in patients with AS. Tele-yoga intervention is feasible and effective in treating AS.

Early Improvements in Disease Activity Indices Predict Long-Term Clinical Remission Suggested by the Treat-to-Target Strategy in Patients with Ankylosing Spondylitis Receiving TNF-α Inhibitor Treatment.

This study evaluated the possibility of clinical remission suggested by the treat-to-target strategy and identified predictors of clinical remission in 139 patients with ankylosing spondylitis (AS) receiving tumor necrosis factor-α inhibitors (TNFi). Clinical remission criteria selected were AS Disease Activity Score Inactive Disease (ASDAS-ID) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 2 with normal C-reactive protein (CRP) levels (BASDAI-CRP). The longitudinal relationship between clinical parameters and clinical remission was assessed using generalized estimating equations (GEEs). Responders to ASDAS-ID and BASDAI-CRP increased from 32.4% to 68.9% and from 39.9% to 75.2% at months 3 and 33, respectively. Responders to ASDAS-ID and BASDAI-CRP almost overlapped. In the univariable GEE model, age and 3-month improvement in BASDAI, ASDAS-CRP, physician and patient global assessments, and spinal pain predicted clinical remission achievement, while the presence of syndesmophytes predicted ASDAS-CRP achievement, and normalized CRP at 3 months was associated with BASDAI-CRP achievement. Multivariable GEE analysis revealed age (odds ratio (OR): 0.67; 95% confidence interval (CI), 0.49–0.93) and 3-month BASDAI improvement (OR: 1.70; CI, 1.19–2.41) as independent predictors of ASDAS-ID achievement and age (OR: 0.69; CI, 0.54–0.89), 3-month BASDAI improvement (OR: 2.00; CI, 1.45–2.76), and normalized CRP at 3 months (OR: 3.72; CI, 1.39–9.95) as independent predictors of BASDAI-CRP achievement.

AB0524 EFFICACY OF GUSELKUMAB ACROSS BASDAI COMPONENTS IN TREATING AXIAL-RELATED SYMPTOMS OF PSORIATIC ARTHRITIS: RESULTS FROM TWO PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED STUDIES

Background:The monoclonal antibody guselkumab (GUS; anti- IL-23p19-subunit) is approved to treat psoriatic arthritis (PsA). Post hoc analyses of DISCOVER-1&amp;2 suggested that GUS may be effective in improving symptoms of axial manifestation of PsA.Objectives:Evaluate the efficacy of GUS across components of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in improving symptoms of axial manifestations of active PsA patients (pts) using data from Phase 3, randomized, placebo (PBO)-controlled studies.Methods:DISCOVER-1&amp;2 enrolled pts with active PsA; pts were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W) or at Wk0, 4, and Q8W, or PBO. These post hoc analyses included pts who were identified by the investigator as having axial symptoms and sacroiliitis (prior X-ray or MRI or screening X-ray). BASDAI scores were assessed at Wks 0, 8, 16, 24, and 52. Mean BASDAI component scores through Wk52 are reported by treatment group. Pooled data from the two studies are reported. Mean BASDAI component scores are reported using observed data; total BASDAI scores with missing components were set to missing. The proportion of pts achieving ≥50% improvement in BASDAI (BASDAI 50) was also determined; pts with missing data or who met the treatment failure criteria (discontinued study agent or used prohibited medications) were considered nonresponders at all subsequent timepoints.Results:These analyses included 312 pts from DISCOVER-1&amp;2 (103 GUS Q4W, 91 GUS Q8W, 118 PBO); mean total BASDAI scores at Wk0 were 6.4, 6.5, and 6.6, respectively. Demographics and mean baseline BASDAI component scores (ie, fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness, and quantitative morning stiffness) were similar across treatment groups (Table 1). In comparison with the total study population, this subgroup of pts had a higher mean C-reactive protein level at baseline and a higher proportion of pts with enthesitis and included a slightly higher proportion of males. Mean scores for all six BASDAI components, including spinal pain, decreased through Wk24 in GUS-treated pts, with separation from PBO observed as early as Wk8; improvements were maintained at Wk52. At Wk24, BASDAI 50 response rates were higher in the Q4W and Q8W groups vs PBO (38% and 40% vs 19%).1 At WK52, mean BASDAI component scores for PBO pts who crossed over to GUS Q4W at Wk24 were similar to those for pts who were randomized to GUS.2 A similar trend was observed for BASDAI50 response.Conclusion:Among PsA pts with axial symptoms and sacroiliitis (via investigator-confirmed imaging) in the DISCOVER-1&amp;2 trials, GUS treatment resulted in lower mean scores for all six BASDAI components compared with PBO as early as Wk 8 and through Wk24, with mean scores maintained at Wk52.

Investigation of the effectiveness of aerobic exercise training in individuals with ankylosing spondylitis: Randomized controlled study

Objective To investigate the effect of the addition of aerobic training to spinal mobility exercises on disease-specific outcomes and functional exercise capacity, aerobic capacity and respiratory muscle strength of ankylosing spondylitis (AS) patients. Methods The study included 31 volunteers (mean age: 44.90 ± 11.52 years) diagnosed with AS. The demographic characteristics and disease-related data of all subjects were recorded, then, the Bath AS Disease Activity Index (BASDAI), Bath AS Metrology Index (BASMI) and Bath AS Disease Function Index (BASFI), the 6-minute walk test, the Bruce Treadmill Test and spirometry were used, respectively. The intervention group attended a 12-week program of aerobic exercise sessions, plus supervised spinal mobility exercises, 3 days a week. The control group performed the supervised spinal mobility exercises only, 3 times a week, for 12 weeks. Results There was a significant improvement in BASDAI (p = .002), BASMI (p = .021), 6 DYT (p = .036), VO2 max (p = .000), MIP (p = .005) and MEP (p = .022) results in the intervention group after 12 weeks of training. In the comparisons of the pre-treatment and post-treatment differences, BASDAI (p = .032) decreased and VO2 (p = .001) max increased, showing significant improvements in the intervention group and these values were maintained. Conclusion It is striking that improvements in all parameters except BASFI were achieved in the aerobic training group. These results demonstrate that an aerobic exercise program should be included in an individual exercise prescription for the management of AS.

EP12 Bilateral lipoma arborescens as a presenting feature of ankylosing spondylitis

Abstract Background Lipoma arborescens (LA) is a rare, slow growing lesion defined as a villous lipomatous proliferation of the synovial membrane with replacement of the synovial tissue by mature fatty cells. It usually involves the knee and can be associated with degenerative joint disease, trauma, diabetes mellitus and very occasionally with inflammatory arthritis. Diagnosis is made using MRI which shows a synovial mass that is isointense relative to fat and joint effusion. Histologically there is diffuse replacement of the subsynovial layer with mature adipocytes and infiltration of mononuclear cells. Treatment is with synovectomy and treating any underlying condition. Methods We present the first case bilateral knee LA as a presenting feature of ankylosing spondylitis. Results A 29-year-old Caucasian male presented to a knee orthopaedic surgeon with a two-year history of atraumatic bilateral knee swelling. He had a ten-year history of intermittent knee pain and stiffness which was unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. Examination revealed large bilateral knee effusions with restriction of movement. Plain radiographs of his knee joints showed minor osteophytic lipping laterally on his right knee. He had an MRI of both his knees which showed bilateral joint effusions and bilateral LA. He was referred to the rheumatology team for consideration of underlying inflammatory arthritis. Further questioning revealed no history of uveitis, dactylitis, psoriasis, inflammatory bowel disease but lower back pain which was long standing. Blood tests showed rheumatoid factor, anti-CCP, anti-DsDNA, ENA were negative with ANA positive in a homogenous pattern. C-reactive protein (CRP) was only slightly raised at 5.6mg/L. Knee aspirate showed mixed inflammatory cells. Radiographs of his spine showed no syndesmophytes but sacroiliac joints showed established bilateral sacroiliitis. A diagnosis of ankylosing spondylitis with secondary LA was made. He was commenced on sulfasalazine to treat his peripheral inflammatory arthritis along with continuation of NSAID. He remained symptomatic with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 8 and Spinal pain VAS of 9. As he fulfilled NICE guidelines for biologic use in AS, he was commenced on adalimumab 40 mg fortnightly injections and had a good response to treatment with improvement in BASDAI, pain VAS, knee swelling and normalisation of CRP. Conclusion There have been reports of LA in association with inflammatory joint disease. This is the first case of bilateral LA as a presenting feature of ankylosing spondylitis. It has been demonstrated that LA plays a role in joint inflammation and damage through tumour necrosis factor alpha (TNFα) and matrix metalloproteinase 3 (MMP3). MMP3 is known to cause joint erosion in inflammatory joint conditions such as rheumatoid arthritis and ankylosing spondylitis. It is therefore proposed that while managing LA, looking for underlying inflammatory arthritis may provide the answer. Disclosures S. Khalid None. M. Cox None. M. Kazmi None.

Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study

BackgroundWe assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices.MethodsThis was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [< 1.3], low [≥ 1.3 to < 2.1], high [≥ 2.1 to ≤3.5], and very high [> 3.5]), patient achievement of > 50% improvement in BASDAI (BASDAI50 responders), and > 40% improvement in ASAS (ASAS40 responders) at 104 weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast.ResultsHigher ASDAS disease activity at 104 weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): − 4.58 (− 4.95, − 4.21), − 3.86 (− 4.28, − 3.43), − 2.15 (− 2.68, − 1.61), and 1.30 (− 0.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: − 4.77 (− 5.70, − 3.84), − 2.96 (− 4.04, − 1.87), − 1.00 (− 2.32, 0.31), and 2.14 (− 2.10, 6.38); all p < 0.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.61 (− 2.05, − 1.18) vs. –4.43 (− 4.69, − 4.18); MFI general fatigue: − 0.01 (− 1.12, 1.09) vs. –4.30 (− 4.98, − 3.62); all p < 0.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.91 (− 2.30, − 1.52) vs. –4.75 (− 5.05, − 4.46); MFI general fatigue: − 0.63 (− 1.56, 0.30) vs. –4.64 (− 5.37, − 3.91); all p < 0.001).ConclusionComposite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA.Trial registrationClinicalTrials.gov identifier: NCT01258738. Registered 9 December 2010.

Aerobic exercise for axial spondyloarthritis - its effects on disease activity and function as compared to standard physiotherapy: A systematic review and meta-analysis.

To evaluate the impact of an aerobic fitness program on disease activity, defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and on C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in case of axial spondyloarthritis. A systematic review of the literature, following the Prisma recommendations, was performed by two reviewers on the PubMed and Embase databases. Controlled trials assessing the efficacy of aerobic exercises compared to physiotherapy on axial spondyloarthritis disease activity were included. The diagnosis of axial spondyloarthritis was meeting the New York criteria and/or the Assessment in Axial Spondyloarthritis International Working Group criteria. Aerobic fitness was defined as an exercise performed at 50%-90% of the maximal heart rate or between 50% and 80% oxygen consumption (VO2 ) peak. Five hundred and twenty abstracts were identified and 93 abstracts were analyzed. Eight studies met the selection criteria and 6 were finally included in this study because of the presence of a control group. Both groups were similar in terms of age, sex ratio, disease duration. Aerobic exercise provided a positive impact on the BASDAI in the intervention group (148 patients) (weighted mean difference [WMD]: -0.52 [95% CI: -0.9 to -0.13]) (I2 : 10.3%, P=0.35). However, when compared to a control group (152 patients), the improvement of BASDAI didn't reach significance (WMD: -0.25 [95% CI: -0.83 to 0.32]) (I2 : 0%, P=0.41). Aerobic exercise did not improve BASFI, CRP or ESR. Aerobic exercise did not provide beneficial effects either on disease activity or on physical function and biological parameters when compared to a control group in axial spondyloarthritis.

Age determines response to anti-TNF\u03b1 treatment in patients with ankylosing spondylitis and is related to TNF\u03b1-producing CD8 cells

Younger age is a predictor of good clinical response to treatment with tumour necrosis factor (TNF) α inhibitors in ankylosing spondylitis (AS) patients; therefore, the aim of the study was to determine age-related differences in cellular functions, which can predict the response. High disease activity AS patients were treated with TNFα inhibitors for 12 weeks. Based on the percentage of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) improvement, patients were divided into responding or non-responding groups. Cytometric and clinical assessment were determined at baseline, 4, and 12 weeks after initiation of anti-TNFα treatment. Expression of activation markers on T cells and intracellular cytokine staining was performed. Baseline percentage of TNFα-producing CD8 cells was lower in responders than in non-responders (20.8 ± 2.9 vs 40.7 ± 8.2; P = 0.04 in T test) and increased in the responding group during the first month of treatment (20.8 ± 2.9 vs 30.3 ± 2.5; P = 0.02). Moreover, its baseline level correlated with age (r = 0.7; P = 0.0009) but not with BASDAI improvement adjusted for age. There were no differences in the baseline percentage of IL-4, IL-17A, and IFNγ within CD4 and CD8 cells nor in the expression of CD25, CD28, and CD69 on these cells between responders and non-responders. However, baseline level of CD4+CD28null cells correlated with the percentage of BASDAI improvement while analysed as a continuous variable adjusted for age (r = − 0.4; P = 0.048). Clinical predictors of response were also determined. Influence of age on the response to anti-TNFα treatment in AS patients could be mediated by TNFα-producing CD8 cells.

Serum biomarkers and changes in clinical/MRI evidence of golimumab-treated patients with ankylosing spondylitis: results of the randomized, placebo-controlled GO-RAISE study.

BackgroundIn the present study, we evaluated relationships between serum biomarkers and clinical/magnetic resonance imaging (MRI) findings in golimumab-treated patients with ankylosing spondylitis.MethodsIn the GO-RAISE study, 356 patients with ankylosing spondylitis randomly received either placebo (n = 78) or golimumab 50 mg or 100 mg (n = 278) injections every 4 weeks through week 24 (placebo-controlled); patients continuing GO-RAISE received golimumab through week 252. Up to 139/125 patients had sera collected for biomarkers/serial spine MRI scans (sagittal plane, 1.5-T scanner). Two blinded readers employed modified ankylosing spondylitis spine magnetic resonance imaging score for activity (ASspiMRI-a) and ankylosing spondylitis spine magnetic resonance imaging score for chronicity. Spearman correlations (r s) were assessed between serum biomarkers (n = 73) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), C-reactive-protein (CRP)-based Ankylosing Spondylitis Disease Activity Score (ASDAS), modified Stokes Ankylosing Spondylitis Spine Score (mSASSS), and ASspiMRI scores. Serum biomarkers predicting postbaseline spinal fatty lesion development and inflammation were analyzed by logistic regression.ResultsSignificant, moderately strong correlations were observed between baseline inflammatory markers interleukin (IL)-6, intracellular adhesion molecule-1, complement component 3 (C3), CRP, haptoglobin, and serum amyloid-P and baseline ASDAS (r s = 0.39–0.66, p ≤ 0.01). Only baseline leptin significantly correlated with ASDAS improvement at week 104 (r s = 0.55, p = 0.040), and only baseline IL-6 significantly predicted mSASSS week 104 change (β = 0.236, SE = 0.073, p = 0.002, model R 2 = 0.093). By logistic regression, baseline leptin, C3, and tissue inhibitor of metalloproteinase (TIMP)-1 correlated with new fatty lesions per spinal MRI at week 14 and week 104 (both p < 0.01). Changes in serum C3 levels at week 4 (r s = 0.55, p = 0.001) and week 14 (r s = 0.49, p = 0.040) significantly correlated with BASDAI improvement at week 14. Baseline IL-6 and TIMP-1 (r s = −0.63, −0.67; p < 0.05) and reductions at week 4 in IL-6 (r s = 0.61, p < 0.05) and C3 (r s = 0.72; p < 0.05) significantly correlated with week 14 ASspiMRI-a improvement.ConclusionsExtensive serum biomarker multiparametric analyses in golimumab-treated patients with ankylosing spondylitis demonstrated few correlations with disease activity or MRI changes; IL-6 weakly correlated with radiographic progression.Trial registrationClinicalTrials.gov identifier: NCT00265083. Registered on 12 December 2005.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-016-1200-1) contains supplementary material, which is available to authorized users.

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...

Randomized, placebo controlled and double‐blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: a meta‐analysis

Adalimumab is a fully human, anti-TNF monoclonal antibody of proven efficacy and safety in the treatment of the signs, symptoms and functional disability of ankylosing spondylitis (AS). A systematic review and meta-analysis was performed to assess the efficacy and safety of adalimumab treatment, relative to a placebo, in adult patients with AS. In the efficacy meta-analysis, significantly more patients in the adalimumab group achieved Assessment in AS International Working Group (ASAS)20 and Bath AS Disease Activity Index (BASDAI)50 compared with patients in the placebo group. Patients in the adalimumab group also showed significant improvement in BASDAI and health-related quality of life. With regard to adverse events, any adverse events and injection-site reaction were significantly higher in the adalimumab group compared with the control group. This meta-analysis shows a higher efficacy of adalimumab relative to placebo, but clinicians should be careful regarding adverse events in adalimumab-treated patients.

Anti-TNF-α Therapy for Ankylosing Spondylitis

BackgroundThis review evaluated the safety and efficacy of etanercept in patients with ankylosing spondylitis (AS).MethodsOf 59 patients with AS, this study reviewed 11 patients who were refractory to conventional therapy and treated with etanercept from September 2005 to January 2008. The mean follow-up duration was 13.6 months. The general improvement was evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and adverse effects, complications and inflammatory markers were also assessed.ResultsThe mean BASDAI decreased from 7.1 ± 1.6 before treatment to 4.2 ± 1.8 at 3 months after the etanercept treatment (p = 0.001). The mean erythrocyte sedimentation rate and C-reactive protein were decreased significantly by the etanercept treatment. The greatest improvement in symptoms was enthesitis, followed by skin involvement and morning stiffness. There was a significant difference in the improvement in BASDAI along with the follow up duration (p = 0.04). A serious infection was observed as a complication in 1 case.ConclusionsThese results suggest that etanercept can induce significant improvement in most patients with less damage. A trial of tumor necrosis factor inhibition is indicated in all AS patients who do not achieve adequate disease control with disease-modifying antirheumatic drugs, such as methotrexate, leflunomide etc. The patients treated with etanercept should be educated about the possibility of infection and monitored closely.

Predictors of response to anti-TNF therapy in ankylosing spondylitis: results from the British Society for Rheumatology Biologics Register

Objective. Few data exist on the use of anti-TNF drugs for AS during routine clinical use in the UK. This report describes an improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) after 6 months of therapy in 261 patients enrolled in a national prospective observational register.Methods. The British Society for Rheumatology Biologics Register (BSRBR) recruited patients starting anti-TNF therapy for AS between 2002 and 2006. Multivariable linear regression models were used to estimate the predictors of absolute improvement in BASDAI and BASFI at 6 months. Covariates included age, gender, disease duration, baseline BASDAI and BASFI, presence of raised inflammatory markers (defined as twice the upper limit of normal) and DMARD therapy.Results. The cohort was young (median age 43 years) and 82% were males. Median baseline BASDAI was 7.6 and BASFI 7.9. At 6 months, the mean improvements in BASDAI and BASFI were 3.6 and 2.6 U, respectively; 52% reached a BASDAI50. Patients with raised inflammatory markers at the start of therapy had a 0.9-U (95% CI 0.2, 1.5) better improvement in BASDAI compared with those without. Lesser responses were seen in those with higher baseline BASFI scores. Women had a 1.1-U (95% CI 0.3, 2.0) greater improvement in BASFI at 6 months, as did those who were receiving concurrent DMARD therapy [0.9 U (95% CI 0.2, 1.7)].Conclusions. The majority of patients receiving anti-TNF therapy for AS during routine care demonstrated an improvement in disease activity. Raised inflammatory markers at the start of therapy predicted a greater improvement in BASDAI, identifying a group of patients who may be more responsive to anti-TNF therapies, although the results were not confined to this group.

Low-dose infliximab treatment for ankylosing spondylitis--clinically- and cost-effective

Infliximab has been shown to be effective in the treatment of ankylosing spondylitis (AS) when treated in a dose of 5 mg/kg at 6 weekly intervals. This dose of infliximab has not been determined by any structured randomized trials and has significant cost implications. We describe our experience of treating AS with low-dose infliximab (3mg/kg at 8 weekly intervals). The efficacy and cost implications are discussed. Patients who had active AS [Bath AS Disease Activity Index (BASDAI) > or = 4] were treated with infliximab 3 mg/kg at 0, 2, 6 weeks and thereafter at 8 weekly intervals. Response to treatment was defined as 50% improvement in BASDAI. Other response criteria such as ASAS 20, 40 and five of the six criteria were also assessed. Direct drug costs for infliximab were determined. Twenty-two consecutive AS patients received infliximab. All 22 completed treatment for 3 months, 15 patients for 6 months and 14 for 12 months. Mean age was 45 years (range 21-62) and mean disease duration 14.5 years (range 2-43). Of the patients, 54% achieved a 50% BASDAI response at 3 months and the benefit was sustained at 12 months in 63%. Similar response rate was seen with the other assessment criteria. Direct drug costs were significantly lower when low-dose infliximab regimen was used. Low-dose infliximab (3 mg/kg at 8 weekly infusions) is effective in the treatment of AS. Higher doses are required in a small proportion of patients when treatment is only partially effective. Titrating the dose and frequency of infusions may be required in individual patients to achieve optimal response. Using low-dose infliximab has significant economic implications.

Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis

Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor alpha (TNF-alpha) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration. In this 54-week open observational study, 26 AS patients received 25 mg etanercept subcutaneously twice weekly after several months of discontinuation following a 6-month RCT with the same agent. All patients who developed high disease activity after cessation of etanercept, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > or = 4 and pain > or = 4 on a numerical rating scale, entered the study. Standard assessment tools, such as the Bath Ankylosing Spondylitis functional index (BASFI), were used. An intention-to-treat (ITT) and a completer analysis were performed. The results were compared with the baseline values of the open study. Out of the initial 30 patients, 26 (87%) were eligible for the open extension study after a mean of about 27 weeks. At week 54, 23/26 patients (88%) were still on treatment with etanercept. The ITT analysis showed that 58% (95% confidence interval 39-74%) of the patients achieved a 50% improvement of BASDAI at week 54. According to the Assessments in Ankylosing Spondylitis working group criteria, 8/26 patients (31%) were in partial remission at week 54. Function, metrology and quality of life improved significantly. Only one patient had a serious adverse event that resulted in discontinuation. This study shows that treatment with etanercept is efficacious and safe after readministration over 1 yr in patients with active AS not taking DMARDs or steroids.