scholarly journals Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

2017 ◽  
Vol 77 (2) ◽  
pp. 221-227 ◽  
Author(s):  
Maxime Dougados ◽  
Walter P Maksymowych ◽  
Robert B M Landewé ◽  
Anna Moltó ◽  
Pascal Claudepierre ◽  
...  

ObjectiveTo compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR).MethodsEndpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates.ResultsAt 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: –0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was –0.22 (95% CI –0.38 to –0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: –1.9% versus 1.6% (adjusted difference for etanercept minus control: –4.7%,95% CI –9.9 to 0.5, p=0.07) for change in mNY criteria; –1.9% versus 7.8% (adjusted difference: –18.2%,95% CI –30.9 to –5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and –0.6% versus 6.7% (adjusted difference: –16.4%,95% CI –27.9 to –5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change.ConclusionDespite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy.Trial registration numbersNCT01258738, NCT01648907; Post-results.

2021 ◽  
pp. jrheum.201075
Author(s):  
Marie Wetterslev ◽  
Mikkel Østergaard ◽  
Inge Juul Sørensen ◽  
Ulrich Weber ◽  
Anne Gitte Loft ◽  
...  

Objective In axial spondyloarthritis (axSpA), sacroiliac joint (SIJ) erosion is often followed by fat metaplasia in an erosion cavity (backfill), and subsequently ankylosis. We aimed to combine Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ Structural score for Erosion, Backfill and Ankylosis into 3 versions of a novel preliminary Composite axSpA MRI SIJ Structural Damage Score (CSDS) and test these. Methods Thirty-three axSpA patients followed for 5 years after initiation of tumor necrosis factor inhibitor had MRI of SIJs at baseline, and yearly thereafter. Three versions of CSDSs were calculated based on different weightings of erosion, backfill and ankylosis: Equal weighting: CSDSequal=(erosion x0.5)+backfill+ankylosis; Advanced stages weighting more: CSDSstepwise=(erosion x1)+(backfill x4)+(ankylosis x6); Advanced stages overruling earlier stages (“hierarchical”) with “<” meaning “overruled by”: CSDShierarchical=(erosion x1)<(backfill x4)<(ankylosis x6). Results At baseline all CSDSs correlated positively with SPARCC Fat and Ankylosis, modified New Yorkradiography grading and negatively with BASDAI and SPARCC SIJ Inflammation. CSDSstepwise and CSDShierarchical (not CSDSequal) correlated positively with symptom duration and BASMI, and closer with SPARCC ankylosis and Modified New York-radiography grading than CSDSequal. The adjusted annual progression rate for CSDSstepwise and CSDShierarchical (not CSDSequal) was higher the first year compared with fourth year (p=0.04 and p=0.01). Standardized response mean (baselineweek 46) was moderate for CSDShierarchical (0.64) and CSDSstepwise (0.59) and small for CSDSequal (0.25). Conclusion Particularly CSDSstepwise and CSDShierarchical showed construct validity and responsiveness, encouraging further validation in larger clinical trials. The potential clinical implication is assessment of sacroiliac joint damage progression by one composite score.


RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000918 ◽  
Author(s):  
Anna Molto ◽  
Laure Gossec ◽  
Marie-Martine Lefèvre-Colau ◽  
Violaine Foltz ◽  
Romain Beaufort ◽  
...  

ObjectiveTo evaluate the prevalence and performance as axial Spondyloarthritis (axSpA) diagnostic feature of radiographic and MRI lesions ‘typical’ of axSpA of the sacroiliac joint (SIJ) and spine in a mechanical chronic back pain (CBP) population and in an axSpA cohort.MethodsCross-sectional multicentre study. Patients: (1) recent onset axSpA (DESIR cohort) and (2) mechanical non-axSpA CBP matched for age and gender (ILOS study). Imaging: radiographs and MR scans were performed identically in both groups. All images were centrally read, blinded for diagnosis and for other imaging findings in the same patient. Statistical analysis: prevalence of lesions ‘typical of axSpA’ were compared in both groups. Sensitivity, specificity and positive likelihood ratios (LR+) of each lesion (and combination of lesions) were calculated.ResultsA total of 98 patients with CBP were included, and compared with 100 patients with recent onset axSpA. SIJ lesions were consistently more frequent in the axSpA group (35.0% vs 11.8% p<0.001, 35.0% vs 8.4% p<0.001% and 32.0% vs 10.0%. p<0.001 for modified New York criteria, MRI sacroiliitis and ≥3 erosions of the SIJ on MRI, respectively), and performed well (LR+ for ≥3 erosions 3.0 (95% CI 1.6 to 5.8)). Spine lesions were comparable across groups: radiographic lesions were rare, while all MRI lesions were frequent.ConclusionOur study confirms that ‘typical’ lesions can also be observed in patients with non-axSpA CBP but that SIJ lesions by all modalities remain the most valuable for diagnosis, including structural lesions of the SIJ. This suggests the potential interest of adding MRI SIJ structural lesions in the definition of MRI abnormalities for axSpA classification.


2017 ◽  
Vol 76 (11) ◽  
pp. 1823-1828 ◽  
Author(s):  
Maxime Dougados ◽  
Alexandre Sepriano ◽  
Anna Molto ◽  
Miranda van Lunteren ◽  
Sofia Ramiro ◽  
...  

ObjectiveTo estimate sacroiliac joint radiographic (X-SIJ) progression in patients with axial spondyloarthritis (axSpA) and to evaluate the effects of inflammation on MRI (MRI-SIJ) on X-SIJ progression.MethodsX-SIJ and MRI-SIJ at baseline and after 2 and 5 years in patients with recent onset axSpA from the DESIR cohort were scored by three central readers. Progression was defined as (1) the shift from non-radiographic (nr) to radiographic (r) sacroiliitis (by modified New York (mNY) criteria) or alternative criteria, (2) a change of at least one grade or (3) a change of at least one grade but ignoring a change from grade 0 to 1. The effects of baseline inflammation on MRI-SIJ on 5-year X-SIJ damage (mNY) were tested by generalised estimating equations.ResultsIn 416 patients with pairs of baseline and 5-year X-SIJ present, net progression occurred in 5.1% (1), 13.0% (2) and 10.3% (3) respectively, regarding a shift from nr-axSpA to r-axSpA (1), a change of at least one grade (2) or a change of at least one grade but ignoring a change from grade 0 to 1 (3). Baseline MRI-SIJ predicted structural damage after 5 years in human leukocyte antigen-B27 (HLA-B27) positive (OR 5.39 (95% CI 3.25 to 8.94)) and in HLA-B27 negative (OR 2.16 (95% CI 1.04 to 4.51)) patients.ConclusionsFive-year progression of X-SIJ damage in patients with recent onset axSpA is limited but present beyond measurement error. Baseline MRI-SIJ inflammation drives 5-year radiographic changes.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Walter P. Maksymowych ◽  
Pascal Claudepierre ◽  
Manouk de Hooge ◽  
Robert G. Lambert ◽  
Robert Landewé ◽  
...  

Abstract Background Limited information is available on the impact of treatment with a tumor necrosis factor inhibitor (TNFi) on structural lesions in patients with recent-onset axial spondyloarthritis (axSpA). We compared 2-year structural lesion changes on magnetic resonance imaging (MRI) in the sacroiliac joints (SIJ) of patients with recent-onset axSpA receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). We also evaluated the relationship between the Ankylosing Spondylitis Disease Activity Score (ASDAS) and change in MRI structural parameters. Methods The difference between etanercept (EMBARK) and control (DESIR) in the net percentage of patients with structural lesion change was determined using the SpondyloArthritis Research Consortium of Canada SIJ Structural Score, with and without adjustment for baseline covariates. The relationship between sustained ASDAS inactive disease, defined as the presence of ASDAS < 1.3 for at least 2 consecutive time points 6 months apart, and structural lesion change was evaluated. Results This study included 163 patients from the EMBARK trial and 76 from DESIR. The net percentage of patients with erosion decrease was significantly greater for etanercept vs control: unadjusted: 23.9% vs 5.3%; P = 0.01, adjusted: 23.1% vs 2.9%; P = 0.01. For the patients attaining sustained ASDAS inactive disease on etanercept, erosion decrease was evident in significantly more than erosion increase: 34/104 (32.7%) vs 5/104 (4.8%); P < 0.001. A higher proportion had erosion decrease and backfill increase than patients in other ASDAS status categories. However, the trend across ASDAS categories was not significant and decrease in erosion was observed even in patients without a sustained ASDAS response. Conclusions These data show that a greater proportion of patients achieved regression of erosion with versus without etanercept. However, the link between achieving sustained ASDAS inactive disease and structural lesion change on MRI could not be clearly established. Trial registration EMBARK: ClinicalTrials.gov identifier: NCT01258738, Registered 13 December 2010; DESIR: ClinicalTrials.gov identifier: NCT01648907, Registered 24 July 2012.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 754.2-754
Author(s):  
C. Tornero ◽  
M. D. C. Castro Villegas ◽  
X. Juanola-Roura ◽  
M. L. García-Vivar ◽  
C. Fernández-Carballido ◽  
...  

Background:Longitudinal studies about the change from non-radiographic axial Spondyloarthritis (nr-axSpA) to r-axSpA (radiographic axial Spondyloarthritis) are scarce but show a 9-10% progression rate over 2 years (1-2) and a 24% progression rate over 10 years in another study (3). However, in early cohorts such as DESIR, this only represents a 5% over 5 years (4).Objectives:The aim of this study was to know the rate of progression from nr-axSpA to r-axSpA over 6 years in the early Esperanza cohort.Methods:This study included 94 patients of the Spanish early spondyloarthritis (SpA) Esperanza cohort, 60 fulfilled the ASAS classification criteria for SpA. Every patient had a baseline and a six years sacroiliac X-ray. Nine readers, blinded for the diagnosis, participated in the reliability exercise, all of them experienced rheumatologists and members of the Spanish spondyloarthritis working group (GRESSER). Patients with SpA were classified as having r-axSpA, at baseline or after 6 years of follow-up, if they fulfilled the radiographic item of the modified New York criteria (mNY) (presence of radiographic changes in the sacroiliac joints -SIJ- of at least grade II bilaterally or grade III or IV unilaterally). The gold standard of SIJ X-Ray was the categorical opinion of at least five of the expert readers. For the statistical analysis, the Chi-square and Kappa tests were performed.Results:Demographic data of the SpA patients were: mean age 33.4±7.5 years; 37 (61.7%) male; mean CRP 6.4±6.5 mg/dl and ESR 10.3±10.6. Present smokers 30.6%; and past smokers 16.3%. HLA-B27 (+) 56.7%. Regarding the presence of X-Ray sacroilitis: 20 patients had baseline sacroilitis and 18 at the final visit; 11 had sacroiliitis at both baseline and final visits; 9 patients changed from baseline sacroiliitis to no-sacroiliitis and 7 changed from baseline no-sacroiliitis to sacroiliitis at the 6 year visit. The reliability of the readers was fair with a mean inter-reader kappa test of 0.375 (range 0.146 - 0.652) and a mean agreement of 73.7% (range 58.7% - 90%).Conclusion:In this group of patients with early SpA no progression from nr-axSpA to r-axSpA over 6 years was observed. It appears that early diagnosis and standard treatment seem to reduce SIJ radiographic progression.References:[1]Poddubnyy D, Rudwaleit M, Haibel H, et al. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis 2011;70:1369–74.[2]Sampaio-Barros PD, Conde RA, Donadi EA, et al. Undifferentiated spondyloarthropathies in Brazilians: importance of HLA-B27 and the B7-CREG alleles in characterization and disease progression. J Rheumatol 2003;30:2632–7.[3]Sampaio-Barros PD, Bortoluzzo AB, Conde RA, et al. Undifferentiated spondyloarthritis: a longterm followup. J Rheumatol 2010;37:1195–9.[4]Dougados M, et al. Ann Rheum Dis 2017;76:1823–1828.Disclosure of Interests:Carolina Tornero: None declared, María del Carmen Castro Villegas: None declared, Xavier Juanola-Roura: None declared, Maria Luz García-Vivar: None declared, Cristina Fernández-Carballido Consultant of: Yes, I have received fees for scientific advice (Abbvie, Celgene, Janssen, Lilly and Novartis), Speakers bureau: Yes, I have received fees as a speaker (Abbvie, Celgene, Janssen, Lilly, MSD, Novartis), Jose Francisco Garcia LLorente: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, E. Galindez: None declared, Claudia Urrego-Laurín: None declared, Eugenio de Miguel Grant/research support from: Yes (Abbvie, Novartis, Pfizer), Consultant of: Yes (Abbvie, Novartis, Pfizer), Paid instructor for: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Speakers bureau: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi)


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1852-1852
Author(s):  
A. Rischin ◽  
E. Kathpal ◽  
S. Vogrin ◽  
L. Bentley ◽  
V. Master ◽  
...  

Background:Conventional radiography remains part of the diagnosis of axial spondyloarthritis and determines qualification for biologic disease modifying anti-rheumatic drugs in many countries. The standard anteroposterior radiograph (XR) incompletely images the complex sacroiliac joint with recognised unacceptably low levels of agreement between readers. Digital tomosynthesis (DTS) uses conventional radiographic projections to create a three-dimensional image and is a potential alternative for the initial radiographic detection and grading of sacroiliitis.Objectives:To compare the level of agreement between two radiologists when reporting sacroiliac joint imaging with digital tomosynthesis versus conventional radiography, as well as to compare the diagnostic accuracy of each imaging modality.Methods:229 consecutive patients that had radiography and digital tomosynthesis performed at Footscray Hospital, Melbourne, Australia were included. Two blinded radiologists independently re-reported all images according to the modified New York criteria, or listed an alternative diagnosis. An overall assessment of each image as inflammatory sacroiliitis, normal or non-inflammatory disease was also recorded. Demographic and clinical data were extracted from medical records. Agreement between and within readers was evaluated using kappa (κ) statistic. Diagnostic accuracy was calculated by comparing each reader’s overall assessment against 2 reference standard comparators: most recent rheumatologist diagnosis and fulfillment of ASAS criteria at any time point.Results:The intra-reader agreement of reader 1 was almost perfect for the left, right and overall sacroiliac joint assessments (κ 0.77 - 0.94), with DTS outperforming XR. Reader 2 agreement was mostly moderate (κ 0.39 - 0.69), with DTS and XR better on the left and right sacroiliac joint respectively, but XR having better overall assessment. The inter-reader agreement of DTS for all patients was moderate and better than XR as shown in the Table. When excluding non-spondyloarthritis patients, inter-reader agreement improved (κ 0.50 to 0.58) but there was no significant difference between DTS and XR. Using reader 1, the sensitivity of DTS (64.8 - 66.7%) was better than XR (54.9 - 60.7%) but low, in keeping with what is known about radiographic sacroiliitis and axial spondyloarthritis. The specificity of XR (78.5 – 80.3%) was better than DTS (72.3 – 73.1%). There were no significant differences when fulfillment of modified New York Criteria was used as a reader’s positive test.Table.Inter-rater reliability between the readersAll patients(N=229)*Inflammatory sacroiliitis & normal patients (N=164)**Inflammatory sacroiliitis patients (N=92)**XR Right0.360.520.56DTS Right0.390.500.51XR Left0.340.550.56DTS Left0.420.550.58XR Overall0.40DTS Overall0.45*Non-weighted kappa statistic**Weighted kappa statisticConclusion:DTS demonstrated moderate reliability for assessment of sacroiliitis, marginally better than conventional radiography. Overall levels of agreement for both imaging modalities were however lower than radiography in previous studies, with several possible contributing factors. A prospective study in a selected spondyloarthritis cohort may better determine any benefit of DTS.References:[1]Christiansen AA, Hendricks O, Kuettel D, Horslev-Petersen K, Jurik AG, Nielsen S, et al. Limited Reliability of Radiographic Assessment of Sacroiliac Joints in Patients with Suspected Early Spondyloarthritis. The Journal of rheumatology. 2017;44(1):70-7.[2]van Tubergen A, Heuft-Dorenbosch L, Schulpen G, Landewe R, Wijers R, van der Heijde D, et al. Radiographic assessment of sacroiliitis by radiologists and rheumatologists: does training improve quality? Annals of the rheumatic diseases. 2003;62(6):519-25.Disclosure of Interests:None declared


2018 ◽  
Vol 77 (5) ◽  
pp. 699-705 ◽  
Author(s):  
Désirée van der Heijde ◽  
Xenofon Baraliakos ◽  
Kay-Geert A Hermann ◽  
Robert B M Landewé ◽  
Pedro M Machado ◽  
...  

ObjectivesTo report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).MethodsThis phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).ResultsMRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI −0.17,0.28), –0.01 (95% CI −0.19,0.17) and 0.07 (95% CI −0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.ConclusionsIn patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2–4 than 0–2. Radiographic SIJ grading changes demonstrated limited progression.Trial registration numberNCT01087762; Post-results.


Mediaevistik ◽  
2020 ◽  
Vol 32 (1) ◽  
pp. 279-281
Author(s):  
Albrecht Classen
Keyword(s):  
New York ◽  

Kaum ein anderes Thema als Sexualität hat sich so fruchtbringend in der Forschung zu Wort gemeldet, und dies schon seit weit mehr als hundert Jahren. Die Regale füllen sich inzwischen mit einschlägigen Studien, denn mittels Sexualität lassen sich viele Einblicke in die Mentalitäts-, Religions-, Medizin- und Emotionsgeschichte gewinnen. Ein Ende der Bemühungen, sich wissenschaftlich mit diesem Aspekt auseinanderzusetzen, ist kaum abzusehen, und Franz X. Eder, der bereits eine Fülle an einschlägigen Arbeiten dazu veröffentlicht hat, bietet nun erneut eine größere Überblicksdarstellung, die uns von der Antike bis ins 16. und 17. Jahrhundert führt und dabei primär auf einen großen Fundus an relevanter wissenschaftlicher Literatur zurückgreift, die mittlerweile sehr praktisch auf einer vom Autor selbst betriebenen Webseite (nur auf Englisch: <ext-link ext-link-type="uri" xlink:href="https://www.univie.ac.at/Wirtschaftsgeschichte/Sexbibl/search.html">https://www.univie.ac.at/Wirtschaftsgeschichte/Sexbibl/search.html</ext-link>) abrufbar ist (4. Auflage im Februar 2014 abgeschlossen, also seitdem nicht weiter fortgeführt, wie es scheint).


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Zhiwang Zhang ◽  
Lingyan Huang ◽  
Yu Liu ◽  
Lin Wang

Tai Chi is an available method for the treatment of knee osteoarthritis (KOA). The impacts of Tai Chi on plantar loads of individuals with KOA are not fully understood. 46 participants with knee osteoarthritis were randomly assigned into the Tai Chi group (n=23) or the control group (n=23). The Tai Chi group attended a 6-month Tai Chi program, and the control group participated in a wellness education program. Novel Pedar-X system was used to collect the peak pressure (PP) and maximum force (MF) during walking before and 6 months after the intervention. Significant higher peak pressure and maximum force were observed in the 4th and 5th metatarsophalangeal joints in the Tai Chi group. However, there were significant declines in the peak pressure of the whole foot and the 2nd and 3rd metatarsophalangeal joints and maximum force of the heel in the control group. These results suggested that individuals with KOA might change the pattern of plantar loads during walking through Tai Chi, and plantar loads would be useful as a parameter to assess the effect of Tai Chi on knee osteoarthritis. This trial is registered with Clinical Trials: CHiCTR-TRC-13003264.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 432-433
Author(s):  
W. P. Maksymowych ◽  
H. Marzo-Ortega ◽  
M. Ǿstergaard ◽  
L. S. Gensler ◽  
J. Ermann ◽  
...  

Background:Ixekizumab (IXE), a high-affinity anti-interleukin-17A monoclonal antibody, is effective in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA), who had elevated C-reactive protein (CRP) and/or active sacroiliitis on magnetic resonance imaging (MRI).1Objectives:To determine if disease activity and patient-reported outcomes at Week 16 were similar between groups after stratifying pts by CRP/sacroiliac joint (SIJ) MRI status at baseline.Methods:COAST-X (NCT02757352) included pts with active nr-axSpA and objective signs of inflammation, i.e. presence of sacroiliitis on MRI (Assessment of Spondyloarthritis International Society [ASAS]/ Outcome Measures in Rheumatology criteria) or elevation of serum CRP (>5.0 mg/L). Pts were randomized 1:1:1 to receive subcutaneous 80 mg IXE every 4 weeks (Q4W) or Q2W, or placebo (PBO). Depending on the baseline values of CRP and MRI SIJ (Spondyloarthritis Research Consortium of Canada [SPARCC] score), pts in the intent-to-treat population (N=239) were divided into 3 subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2). Logistic regression analysis with treatment, subgroup, and treatment-by-subgroup interaction was used to detect treatment group differences in ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 (low disease activity), and Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) responses at Week 16. Analysis of covariance model with baseline value, treatment, subgroup, and treatment-by-subgroup interaction was used to detect the treatment group difference in change from baseline in Short Form-36 physical component score (SF-36 PCS).Results:The proportion of pts achieving ASAS40 (primary endpoint), ASDAS <2.1, and BASDAI50 (secondary endpoints) was higher in IXE treatment groups compared to PBO at Week 16 (Figure 1). The response rates in IXE-treated subjects were higher in all subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2) without consistent differences in efficacy between the subgroups. Similarly, pts in the IXE groups showed improvement in SF-36 PCS scores (secondary endpoint) versus pts on PBO at Week 16 (Figure 2).Conclusion:Pts with active nr-axSpA and objective signs of inflammation at baseline who were treated with IXE showed an overall improvement in the signs and symptoms of the disease. The efficacy was not different between pts with both elevated CRP and active sacroiliitis on MRI and pts with either elevated CRP or active sacroiliitis on MRI.References:[1]Deodhar A, et al.Lancet.2020.Disclosure of Interests:Walter P Maksymowych Grant/research support from: Received research and/or educational grants from Abbvie, Novartis, Pfizer, UCB, Consultant of: WPM is Chief Medical Officer of CARE Arthritis Limited, has received consultant/participated in advisory boards for Abbvie, Boehringer, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Received speaker fees from Abbvie, Janssen, Novartis, Pfizer, UCB., Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Joerg Ermann Grant/research support from: Boehringer-Ingelheim, Pfizer, Consultant of: Abbvie, Eli Lilly, Janssen, Novartis,Pfizer, Takeda, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma


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