AB0700 RADIOGRAPHIC PROGRESSION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS UNDER TREATMENT WITH TNF INHIBITORS. DATA FROM REGISPONSERBIO (SPANISH REGISTER OF BIOLOGICAL THERAPY IN SPONDYLOARTHRITIDES)

Background:Clinical efficacy of TNF inhibitors (TNFi) in axial spondyloarthritis (axSpA) has been widely probed in randomized control trials. In clinical practice, some studies suggested that long-term (more than 4 years) treatment with TNFi could slow down radiographic progression in axSpA; however, whether this treatment inhibits structural damage remains unclear.Objectives:To evaluate radiographic progression in axSpA patients receiving long-term TNFi (over 4 years) in comparison with patients starting TNFi.Methods:A total of 204 patients with axSpA were included in the Spanish Register of Biological Therapy in Spondyloarthritides (REGISPONSERBIO). Out of these, 80 patients (31 starting TNFi and 49 under long-term TNFi) were included in this study based on the availability of spinal radiographs (cervical and lumbar lateral views), at two time points. Radiographs in patients starting TNFi were available: i) at baseline (before TNFi) and ii) after 3 to 5 years of TNFi therapy (mean follow-up 3.7±0.8), while in long-term TNFi patients, these were available: i) at one follow-up visit at least 4 years later since TNFi was started and ii) after 3 to 5 years of this visit (mean follow-up 3.5±1.1). Two trained readers, not blinded for chronological order, independently scored lateral cervical and lumbar spine images according to the mSASSS system (0-72). Following definitions for progression were used: change of the absolute scores, change of ≥2 units, development of new syndesmophytes, and development of new syndesmophytes or growth of the existing syndesmophytes.Results:Reliability of both readers was excellent with intraclass correlation coefficients (ICCs) of 0.98 (0.98-0.99) at inclusion and 0.98 (0.97-0.99) at follow-up. Most patients (82.5%) were classified as radiographic axSpA. Mean BASDAI at first visit (i) was of 5.0±2.4 for starting TNFi patients and of 3.2±1.9 for long-term TNFi patients. The table depicted the results for radiographic scores and progression. Mean mSASSS score at first visit (i) was 15.8±21.5 and 15.1±18.4 units for starting TNFi and long-term TNFi patients, respectively. The change score between both visits was 2.3±4.2 and 2.3±4.1, respectively. Similarly, no differences were found for change of ≥2 points (32.3% in starting TNFi and 35% in long-term TNFi patients). However, development of new syndesmophytes or growth of the existing syndesmophytes were found to be more frequently (but not significant) in starting TNFi patients compare to long-term TNFi patients.Conclusion:In patients with axSpA treated with TNFi in clinical practice radiographic progression is observed, independently of the time under this therapy. Nevertheless, the development and growth of syndesmophytes seem to be lower in long-term treated patients.Table.Starting TNFi patientsLong-term TNFi patients*p-valuePresence of syndesmophytes at first visit, % (n)45.2% (14)53.1% (26)NSPresence of syndesmophytes at follow up, %51.6% (16)55.1% (27)NSMean change score, mean ± SD2.32 ± 4.192.26 ± 4.09NSChange of ≥ 2 units in the score % (n)32.3% (10)34.7% (17)NSDevelopment of new syndesmophytes, % (n)29% (9)18.4% (9)0.3Progression or development of new syndesmopyhtes % (n)29% (9)22.4% (11)0.5* Patients with more than 4 years under TNFi treatmentDisclosure of Interests:María LLop Vilaltella Speakers bureau: Janssen and Pfizer, Mireia Moreno: None declared, Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, 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), Font Ugalde Pilar: None declared, Teresa Clavaguera Speakers bureau: novartis, BMS, Faes, Luis F. Linares Ferrando: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Xavier Juanola-Roura: None declared

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Sustained Low Disease Activity Measured By ASDAS Slow Radiographic Spinal Progression in Axial Spondyloarthritis Patients Treated With TNF-inhibitors. Data from REGISPONSERBIO

10.21203/rs.3.rs-705421/v1 ◽

2021 ◽

Author(s):

Maria Llop ◽

Mireia Moreno ◽

Victoria Navarro-Compán ◽

Xavier Juanola ◽

Eugenio de Miguel ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Radiographic Progression ◽

Axial Spondyloarthritis ◽

Term Treatment ◽

Tnf Inhibitors ◽

Low Disease Activity ◽

Long Term Treatment

Abstract Background: To evaluate the influence of the disease activity on radiographic progression in axial spondyloarthritis (axSpA) patients treated with TNF inhibitors (TNFi).Methods: The study included 101 axSpA patients from the Spanish Register of Biological Therapy in Spondyloarthritides (REGISPONSERBIO), which had clinical data and radiographic assessment available. Patients were classified into 2 groups based on the duration of TNFi treatment at baseline: i) long-term treatment (≥4 years) and ii) no long-term treatment (< 4 years). Radiographs were scored by two readers according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) with known chronology. Disease activity differences between patients’ groups at each time point were assessed using a linear mixed-effect model.Results: Radiographic progression was defined as an increase in ≥2 mSASSS units. At inclusion, approximately half of the patients (45.5%) were receiving long-term treatment with TNFi (≥4 years). In this group of subjects, a significant difference in averaged Ankylosing Spondylitis disease Activity Score (ASDAS) across follow-up was found between progressors and non-progressors (2.33 vs 1.76, p=0.027, respectively). In patients not under long-term TNFi treatment (54.5%) though, no significant ASDAS differences were observed between progressors and non-progressors until the third year of follow-up. Furthermore, no significant differences were found in progression status, when disease activity was measured by Bath Ankylosing spondylitis Disease Activity Index (BASDAI) and C reactive protein (CRP).Conclusions: Patients on long-term TNFi treatment with a mean sustained low disease activity measures by ASDAS presented lower radiographic progression than those with active disease.

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SAT0369 SPINAL RADIOGRAPHIC PROGRESSION IN EARLY SPONDYLOARTHRITIS: SIX-YEAR RESULTS FROM THE ESPERANZA COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5501 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1132.2-1132

Author(s):

E. De Miguel ◽

J. F. Garcia Llorente ◽

C. Urrego-Laurín ◽

M. L. García-Vivar ◽

C. Fernández-Carballido ◽

...

Keyword(s):

Structural Damage ◽

Radiographic Progression ◽

Intraclass Correlation ◽

Hla B27 ◽

Research Support ◽

Bone Bridge ◽

X Ray ◽

Structural Progression ◽

Absolute Agreement

Background:There are few studies focused on the development of structural damage over time in patients with early SpAObjectives:The aim of this study is to analyze the mSASSS radiographic progression of spine in patients with early spondyloarthritis (SpA) in the Esperanza cohort.Methods:In this longitudinal study, 49 patients of the Spanish early spondyloarthritis (SpA) Esperanza cohort were included. Every patient had a baseline and a six years lateral X-Ray of the cervical and lumbar of spine. The assessment of spine structural damage was done by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). 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). The mSASSS progression and development of new syndesmophytes was analyzed. The gold standard of every elemental lesion of the mSASSS and the total mSASSS score was the agreement achieved by the independent categorical opinion of at least five of the nine readers. For reliability, intraclass correlation coefficient (ICC) two-way mixed, absolute agreement was used.Results:Forty-nine patients were included, 69 % were males and 49%, HLA B27 positive. Mean ± SD baseline ESR, CRP, BASDAI, BASFI and mSASSS were 10.7±11.7, 5.4±7.1, 3.7±2.5, 2.1±2.0 and 0.326±0.85, respectively. Inter-reader ICC reliability of the 9 readers was 0.812 (CI 95%; 0.764-0.857). The mSASSS score at the six-year visit was 0.67 ± 1.6: thirty-nine patients did not present any changes in this score at the end of the follow-up, two patients had Δ mSASSS of – 1 and eight patients, an increase in this score (four patients, +1; three patients, +2 and one patient, +9 points).At baseline, five patients presented one syndesmophyte; at the six-year visit, seven had one syndesmophyte; one patient, two syndesmophytes and another one, one bone bridge. Only 2/5 patients (40%) with syndesmophytes at baseline showed an increase in Δ mSASSS; the two patients with a Δ mSASSS of -1 did not have syndesmophytes at baseline. Five out of eight patients (62.5%) with an increase of the Δ mSASSS presented this lesion at the six-year visit but only two of them showed syndesmophytes at baseline. On the other hand, two of the three patients who showed an increase of the ΔmSASSS without syndesmophytes at baseline presented an erosion in the anterior vertebral corner and the patient with the bone bridge had a previous syndesmophyte. Our results indicate that in early SpA much of the progression appears in patients without previous syndesmophytes.Conclusion:Spinal radiographic progression was very low in our early SpA cohort, with a mean progression of 0.3 mSASSS units. Only eight patients (16.3%) presented spinal structural progression, most of them not showing syndesmophytes at baseline. It is reasonable to consider that an early diagnosis and monitoring could result in a low radiographic progression.Disclosure of Interests: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), Jose Francisco Garcia LLorente: None declared, Claudia Urrego-Laurín: 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), María del Carmen Castro Villegas: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Xavier Juanola-Roura: None declared, Carolina Tornero: None declared, E. Galindez: None declared

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FRI0303 PERIPHERAL SYMPTOMS ARE ASSOCIATED WITH LESS SPINAL RADIOGRAPHIC PROGRESSION IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3397 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 741-741

Author(s):

M. Torgutalp ◽

M. Protopopov ◽

F. Proft ◽

J. Sieper ◽

V. Rios Rodriguez ◽

...

Keyword(s):

Regression Analysis ◽

Ankylosing Spondylitis ◽

Radiographic Progression ◽

Axial Spondyloarthritis ◽

Smoking Status ◽

Hla B27 ◽

Research Support ◽

Sum Score ◽

Multivariable Regression

Background:Peripheral symptoms (PS), such as arthritis, enthesitis, and dactylitis, are common in axial spondyloarthritis (axSpA); data showing the association of PS and spinal radiographic progression in axSpA are controversial.Objectives:To analyze the association of PS and spinal radiographic progression in patients with axSpA.Methods:A total of 210 patients with axSpA (115 with radiographic and 95 with non-radiographic axSpA) were selected for analysis. Spinal radiographs were scored by two readers in a random order according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Pelvic radiographs were scored according to the grading system of the modified New York criteria; a sacroiliitis sum score was calculated as a sum of the grades for both sacroiliac joints. Mann-Whitney and Fisher exact tests were performed for group comparisons. A multivariable regression analysis was performed to analyze the influence of PS on radiographic progression.Results:Of the 101 (48.1%) patients with PS, 78 had peripheral arthritis, 48 - enthesitis, 12 - dactylitis. 32 patients had ≤1 PS. Patients with PS were older, less frequently HLA-B27 positive, compared with patients with no PS (73 (73.0%) vs. 93 (85.3%), p=0.028), had higher disease activity (time-averaged ASDAS over 2 years 2.6 ± 0.9 vs. 2.3 ± 0.9; p=0.032), worse physical function (BASFI 3.5 ± 2.3 vs. 2.3 ± 2.2, p<0.001), higher exposure to disease modifying anti-rheumatic drugs (39 (38.6%) vs. 22 (20.2%), p=0.003) and lower baseline radiographic sacroiliitis sum score (3.8 ± 1.9 vs. 4.4 ± 2.1, p=0.026); other baseline characteristics were similar. Patients with PS had lower absolute progression in mSASSS after 2 years of follow-up than those without (0.28 ± 1.39 vs 1.15 ± 2.9, p=0.045); 7.9% of patients with PS had a progression of mSASSS by ≥2 points compared to 20.2% in patients without PS (p=0.011). Radiographic progression of sacroiliitis was similar in both groups. In a multivariable regression analysis, presence of PS was associated with a lower mSASSS progression and lower odds for the mSASSS progression by ≥2 points after 2 years of follow-up: β=-0.98 (95% -1.68 to -0.28) OR=0.33 (95% CI 0.12 to 0.91), respectively – Table 1.Table 1.Association of peripheral symptoms with radiographic progression in axial spondyloarthritis after 2 years of follow-up.Multivariable linear regression analysisOutcomeβ (95 %CI)mSASSS change score−0.98 (-1.68 to -0.28)*Change of the sacroiliitis sum score−0.06 (-0.32 to 0.20)**Multivariable logistic regression analysisOutcomeOdds ratio (95 %CI)Progression of mSASSS by ≥2 points0.33 (0.12 to 0.91)*Progression of sacroiliitis by at least 1 grade in opinion of both readers0.84 (0.33 to 2.09)**mSASSS - modified Stoke Ankylosing Spondylitis Spine Score.*Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, baseline syndesmophytes, and time-averaged ASDAS.**Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, sacroiliitis sum score at baseline, and time-averaged ASDAS.Conclusion:Presence of PS is associated with distinct characteristics of SpA including slower radiographic spinal progression which might be explained partly by the numerically lower mSASSS score at baseline.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research (BMBF). As funding by BMBF was reduced in 2005 and stopped in 2007, financial support has been obtained from Abbott / Abbvie, Amgen, Centocor, Schering-Plough, and Wyeth. Since 2010 GESPIC is supported by Abbvie.Dr. Murat Torgutalp was supported by the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, 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

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Primary inefficacy of TNF inhibitors in patients with axial spondyloarthritis: a long-term follow-up of 25 patients

Rheumatology ◽

10.1093/rheumatology/kew456 ◽

2017 ◽

pp. kew456

Author(s):

Sandra Kossi ◽

Sabrina Dadoun ◽

Guillaume Geri ◽

Aurore Hermet ◽

Bruno Fautrel ◽

...

Keyword(s):

Axial Spondyloarthritis ◽

Tnf Inhibitors ◽

Long Term Follow Up

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AB0662 TREATMENT AND FOLLOW-UP OF AXIAL SPONDYLOARTHRITIS IN DAILY CLINICAL PRACTICE - A SURVEY AMONG DUTCH RHEUMATOLOGISTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4295 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1626-1626

Author(s):

A. Spoorenberg ◽

S. Arends ◽

R. Bruin ◽

M. De Hair

Keyword(s):

Bone Marrow ◽

Clinical Practice ◽

The Netherlands ◽

Bone Marrow Edema ◽

Axial Spondyloarthritis ◽

Daily Practice ◽

Research Support ◽

Insight Into ◽

Marrow Edema

Background:ASAS-EULAR have developed management recommendations for axial spondyloarthritis (axSpA) to provide guidance to the management of patients with axSpA1. However, there is limited insight into how rheumatologists treat axSpA patients in daily clinical practice and if these recommendations are used.Objectives:To get insight into the management of axSpA patients in daily practice in the Netherlands.Methods:We performed a survey among rheumatologists in the Netherlands with 21 multiple choice questions; 5 general questions on characteristics of their practice and 16 questions addressing treatment and follow-up of axSpA patients in daily practice. The questionnaire was taken during structured face-to-face interviews by employees of the medical department of Novartis NL Rheumatologists in the Netherlands were invited to participate, aiming to get a sample of rheumatologists varying in geographical location and hospital type, as well as a mix of SpA-experts and non-SpA-experts. Rheumatologists gave approval for anonymous use of the data, which were entered in a database and analyzed using descriptive statistics.Results:Between October 15 2019 and January 16 2020, 36 rheumatologists participated; 6 from university hospitals, 27 from general hospitals and 3 from private care centers.81% of the rheumatologists referred most of their axSpA patients (76-100%) after diagnosis for information and education concerning axSpA, exercise and lifestyle to a specialized nurse practitioner. Furthermore, 53% of rheumatologists referred most of their axSpA patients (76-100%) to a physiotherapist for exercise therapy. At diagnosis, approximately 55% of axSpA patients used the daily maximum dose of NSAIDs, compared to 25% for patients on biological treatment.The reported level of importance of different axSpA related aspects for starting a biological was largely similar for AS and nr-axSpA, although some differences could be observed (Figure 1): Most rheumatologists graded insufficient response to 2 NSAIDs during 4 weeks (94% for AS and 92% for nr-AxSpA) and bone marrow edema on MRI (75% and 89%) as important for starting a biological. About 60% of rheumatologists considered active disease using ASDAS/BASDAI important for the decision to start a biological, which was similar to the importance of the level of pain. For nr-axSpA, more rheumatologists graded elevated CRP and bone marrow edema on MRI as important for starting a biological, than for AS.Most rheumatologists (67%) do not base a decision that a biological is ineffective on ASDAS or BASDAI. To assess disease activity in axSpA, 86% of the rheumatologists always measured C-reactive protein (CRP), compared to 42% and 31% for BASDAI and ASDAS, respectively. 77% of rheumatologists reported to follow the 2016 ASAS-EULAR treatment recommendations for axSpA for treatment and follow-up of axSpA patients.Conclusion:This survey among Dutch rheumatologists suggests that ASDAS and BASDAI are as important for starting a biological in axSpA as is the level of pain. Moreover, in contrast to ASAS-EULAR treatment recommendations, most rheumatologists do not use validated disease activity instruments to assess biological ineffectiveness, which may be a topic for increasing awareness and education.References:[1]Van der Heijde D et al, Ann Rheum Dis 2017;76:978-91.Acknowledgments:We would like to thank all participating rheumatologists.Disclosure of Interests:Anneke Spoorenberg: None declared, Suzanne Arends Grant/research support from: Grant/research support from Pfizer, Reindert Bruin Employee of: Current employee of Novartis Pharma B.V., Marjolein de Hair Employee of: Current employee of Novartis Pharma B.V.

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EVALUATION OF THE PROGRESSION OF AXIAL SPONDYLOARTHRITIS IN THE EARLY STAGES OF THE DISEASE IN REAL CLINICAL PRACTICE: THE POSSIBILITIES OF USING THE SUMMARY SCORE OF RADIOGRAPHIC SACROILIITIS

Rheumatology Science and Practice ◽

10.14412/1995-4484-2018-461-465 ◽

2018 ◽

Vol 56 (4) ◽

pp. 461-465 ◽

Cited By ~ 4

Author(s):

Sh. F. Erdes ◽

D. G. Rumyantseva ◽

A. V. Smirnov

Keyword(s):

Clinical Practice ◽

Radiographic Progression ◽

Axial Spondyloarthritis ◽

Early Stage ◽

Summary Score ◽

Pelvic Bone ◽

Progression Rate ◽

Real Practice ◽

Real Clinical Practice

The currently used methods for evaluating the progression of structural damages in early axial spondyloarthritis (axSpA) are little suitable to real practice since they require specially trained radiologists and increase a patient's exposure to radiation due to the need for radiography of three regions of the axial skeleton. In addition, the first radiological bone changes in the sacroiliac joints (SIJ) appear only many years after the onset of the disease, the overlying spine areas are involved in the pathological process. Objective: to develop a method for evaluating the radiographic progression of sacroiliitis (SI) in early axSpA for real clinical practice. Subjects and methods. The investigation enrolled patients from the early spondyloarthritis cohort (ESAC) formed at the V.A. Nasonova Research Institute of Rheumatology. The current ESAC comprised 164 patients; the analysis included 68 patients who had been followed up for at least 2 years and had plain pelvic bone films at the inclusion in the cohort and at 2-year follow-up. To evaluate disease progression, the investigators used the sum of radiographic SI stages in the left and right SIJs (the summary stage of radiographic SI (ssrSI), which was calculated at baseline and at 2-year follow-up. A formula for determining the rate of radiographic progression was derived. Results and discussion. At baseline and at 2-year follow-up, the median ssrSI difference (ΔssrSI) in 68 patients was 0 [0; 1.0]. During the study period, almost 60% of the patients had no progression of ssrSI, i.e. ΔssrSI was 0 in these patients, 1 and 2 scores in 12 (18%) and 13 (19%) patients, respectively, and there were singly cases, in which this figure was equal to 3, 4 and 7. The mean value of ssrSI was 3.5±1.6 at baseline and increased by 0.8, reaching 4.3±1.5 at 2 years (p = 0.006). Before included into the investigation, the patients had a progression rate of 1.75 during 1 year, which decreased to 0.4 per year in the active follow-up period. At the time of inclusion in the study, 40 (58.8%) of the 68 patients had ankylosing spondylitis (AS), and at 2 years their number increased to 51 (75.0%); i.e. 11 (39%) patients were observed to have progression of non-radiographic axSpA to AS. Conclusion. The proposed procedure to calculate ssrSI is easily feasible in real practice; it fails to lead to additional radiation exposure, is economically feasible, and allows one to monitor the rate of progression of axSpA in the early stage of the disease.

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POS1002 BASELINE CALPROTECTIN AND VISFATIN LEVELS PREDICT RADIOGRAPHIC SPINAL PROGRESSION AFTER 2 YEARS IN ANKYLOSING SPONDYLITIS PATIENTS ON TNF INHIBITOR THERAPY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3059 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 769.2-770

Author(s):

J. Rademacher ◽

M. Siderius ◽

L. Gellert ◽

F. Wink ◽

M. Verba ◽

...

Keyword(s):

Risk Factors ◽

Logistic Regression ◽

Ankylosing Spondylitis ◽

Bone Formation ◽

Bone Turnover ◽

Radiographic Progression ◽

Serum Levels ◽

Tnf Inhibitor ◽

Research Support

Background:Radiographic spinal progression determinates functional status and mobility in ankylosing spondylitis (AS)1.Objectives:To analyse whether biomarker of inflammation, bone turnover and adipokines at baseline or their change after 3 months or 2 years can predict spinal radiographic progression after 2 years in AS patients treated with TNF-α inhibitors (TNFi).Methods:Consecutive AS patients from the Groningen Leeuwarden Axial Spondyloarthritis (GLAS) cohort2 starting TNFi between 2004 and 2012 were included. The following serum biomarkers were measured at baseline, 3 months and 2 years of follow-up with ELISA: - Markers of inflammation: calprotectin, matrix metalloproteinase-3 (MMP-3), vascular endothelial growth factor (VEGF) - Markers of bone turnover: bone-specific alkaline phosphatase (BALP), serum C-terminal telopeptide (sCTX), osteocalcin (OC), osteoprotegerin (OPG), procollagen typ I and II N-terminal propeptide (PINP; PIINP), sclerostin. - Adipokines: high molecular weight (HMW) adiponectin, leptin, visfatinTwo independent readers assessed spinal radiographs at baseline and 2 years of follow-up according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Radiographic spinal progression was defined as mSASSS change ≥2 units or the formation of ≥1 new syndesmophyte over 2 years. Logistic regression was performed to examine the association between biomarker values at baseline, their change after 3 months and 2 years and radiographic spinal progression. Multivariable models for each biomarker were adjusted for mSASSS or syndesmophytes at baseline, elevated CRP (≥5mg/l), smoking status, male gender, symptom duration, BMI, and baseline biomarker level (the latter only in models with biomarker change).Results:Of the 137 included AS patients, 72% were male, 79% HLAB27+; mean age at baseline was 42 years (SD 10.8), ASDAScrp 3.8 (0.8) and mSASSS 10.6 (16.1). After 2 years of follow-up, 33% showed mSASSS change ≥2 units and 24% had developed ≥1 new syndesmophyte. Serum levels of biomarkers of inflammation and bone formation showed significant changes under TNFi therapy, whereas adipokine levels were not altered from baseline (Figure 1).Univariable logistic regression revealed a significant association of baseline visfatin (odds ratio OR [95% confidence interval] 1.106 [1.007-1.215]) and sclerostin serum levels (OR 1.006 [1.001-1.011]) with mSASSS progression after 2 years. Baseline sclerostin levels were also associated with syndesmophyte progression (OR 1.007 [1.001-1.013]). In multivariable logistic analysis, only baseline visfatin level remained significantly associated (OR 1.465 [1.137-1.889]) with mSASSS progression. Furthermore, baseline calprotectin showed a positive association with both, mSASSS (OR 1.195 [1.055-1.355]) and syndesmophyte progression (OR 1.107 [1.001-1.225]) when adjusting for known risk factors for radiographic progression.Univariable logistic regression showed that change of sclerostin after 3 months was associated with syndesmophytes progression (OR 1.007 [1.000-1.015), change of PINP level after 2 years was associated with mSASSS progression (OR 1.027 [1.003-1.052]) and change of visfatin after 2 years was associated with both measures of radiographic progression – mSASSS (OR 1.108 [1.004-1.224]) and syndesmophyte formation (OR 1.115; [1.002-1.24]). However, those associations were lost in multivariable analysis.Conclusion:Independent of known risk factors, baseline calprotectin and visfatin levels were associated with radiographic spinal progression after 2 years of TNFi. Although biomarkers of inflammation and bone formation showed significant changes under TNFi therapy, these changes were not significantly related to radiographic spinal progression in our cohort of AS patients.References:[1]Poddubnyy et al 2018[2]Maas et al 2019Acknowledgements:Dr. Judith Rademacher is participant in the BIH-Charité Clinician Scientist Program funded by the Charité –Universitätsmedizin Berlin and the Berlin Institute of Health.Disclosure of Interests:Judith Rademacher: None declared, Mark Siderius: None declared, Laura Gellert: None declared, Freke Wink Consultant of: AbbVie, Maryna Verba: None declared, Fiona Maas: None declared, Lorraine M Tietz: None declared, Denis Poddubnyy: None declared, Anneke Spoorenberg Consultant of: Abbvie, Pfizer, MSD, UCB, Lilly and Novartis, Grant/research support from: Abbvie, Pfizer, UCB, Novartis, Suzanne Arends Grant/research support from: Pfizer.

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AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4592 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1552.3-1552

Author(s):

A. Mekinian ◽

D. Saadoun ◽

J. C. N. F. [email protected] ◽

I. Q. M. F. [email protected] ◽

P. Jégo ◽

...

Keyword(s):

Disease Activity ◽

Takayasu Arteritis ◽

Immunosuppressive Drugs ◽

Relapse Free Survival ◽

Research Support ◽

Free Survival ◽

Treatment Naïve ◽

Steroid Sparing

Objectives:To assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).Methods:In this multicenter, prospective, open-labelled trial, we aim to evaluate the benefit of adding tocilizumab to steroids in treatment-naïve patients with TAK, on discontinuation of steroids after 6 months of tocilizumab treatment, and to assess relapse-free survival following tocilizumab discontinuation.Results:Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. Among 11 (85%) patients which achieved remission at 6 months, 6 (54%) have reached primary endpoint.. Among the 5 remaining patients which continued steroids, 3 had a prednisone-equivalent dosage < 5mg/day. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. All patients discontinued tocilizumab after 7 infusions, and no other immunosuppressive drugs was introduced, except for 1 patient which received methotrexate. After 9 and 12 months, respectively 7 (54%) and 6 (50%) patients achieved remission with less than 7.5 mg/day of prednisone, and 9 (69%) and 9 (75%) with doses <10 mg/day. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.No severe AEs were considered related to study treatment and none required tocilizumab interruption or dose reduction. No deaths have occurred during the study period.Conclusion:Tocilizumab seems an effective steroid sparing therapy in TAK but its effect appears to be suspensive.Disclosure of Interests:Arsene Mekinian: None declared, david Saadoun: None declared, [email protected] [email protected]: None declared, [email protected] [email protected]: None declared, Patrick Jégo: None declared, [email protected] [email protected]: None declared, wxv wxv: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Mathieu Vautier: None declared, [email protected]>; [email protected]>;: None declared, Patrice cacoub: None declared, olivier fain: None declared

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THU0207 SUSTAINABILITY OF RESPONSE TO UPADACITINIB AS MONOTHERAPY OR IN COMBINATION AMONG PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO CONVENTIONAL SYNTHETIC DMARDS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1233 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 327.1-328

Author(s):

A. Kavanaugh ◽

M. H. Buch ◽

B. Combe ◽

L. Bessette ◽

I. H. Song ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Inadequate Response ◽

Research Support ◽

Two Phase ◽

First Occurrence ◽

Activity Measures ◽

Disease Activity Measures

Background:The primary treatment goal for patients (pts) with rheumatoid arthritis (RA) is a state of sustained clinical remission (REM) or low disease activity (LDA).1,2Objectives:To assess the long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in pts with RA.Methods:Data are from two phase 3 randomized, controlled trials of UPA in RA pts with roughly similar baseline disease characteristics: SELECT-NEXT enrolled pts with an inadequate response (IR) to csDMARD(s) on background stable csDMARD(s) receiving UPA 15 mg or 30 mg once daily or placebo for 12 weeks (wks); SELECT-MONOTHERAPY enrolled methotrexate (MTX)-IR pts receiving UPA 15 mg or 30 mg monotherapy or blinded MTX for 14 wks. After 12/14 wks, pts could enter a blinded long-term extension and receive UPA 15 mg or 30 mg for up to 5 years. This post hoc analysis evaluated clinical REM (CDAI ≤2.8; SDAI ≤3.3), LDA (CDAI≤10; SDAI≤11), and DAS28(CRP) <2.6/≤3.2 at first occurrence before Wk 84; additionally, these measures were evaluated at 3, 6, and 12 months after the first occurrence for the total number of pts randomized to UPA 15 mg. Sustainability of response was evaluated by Kaplan-Meier only for those pts who achieved REM/LDA and was defined as time to the earliest date of losing response at two consecutive visits or discontinuation of study drug. The predictive ability of time to clinical REM/LDA was assessed using Harrell’s concordance (c)-index (for reference, an index ~ 0.5, indicates no ability to predict; an index of 1 or -1 would be a perfect prediction). The last follow up dates were 22 March, 2018 (SELECT-NEXT) and 25 May, 2019 (SELECT-MONOTHERAPY), when all pts had reached the Wk 84 visit.Results:Through Wk 84, the percent of treated pts achieving CDAI REM/LDA was 43%/79% for those receiving UPA 15 mg with background csDMARD(s) (SELECT-NEXT) and 37%/76% for those receiving UPA 15 mg without background csDMARD(s) (SELECT-MONOTHERAPY). 35%/25% of pts randomized to UPA 15 mg with background csDMARD(s) and 27%/23% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI REM through 6/12 months after the first occurrence. 64%/56% of pts randomized to UPA 15 mg with background csDMARD(s) and 61%/56% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI LDA through 6/12 months after the first occurrence (Figure 1). Time to initial clinical REM/LDA did not appear to be associated with sustained disease control. The c-indices (95%CI) for CDAI REM in the UPA 15 mg with background csDMARD(s) and UPA 15 mg without background csDMARD(s) groups were 0.541 (0.47, 0.62) and 0.568 (0.49, 0.65) and that of LDA were 0.521 (0.46, 0.58) and 0.498 (0.43, 0.56), respectively. Through last follow-up visit, 55% of pts receiving UPA 15 mg with background csDMARD(s) and 62% of pts receiving UPA 15 mg without background csDMARD(s) remained in CDAI REM while 72% and 70% of pts remained in CDAI LDA, respectively (Figure 2). Similar results were observed across other disease activity measures (SDAI REM/LDA and DAS28(CRP) <2.6/≤3.2).Conclusion:More than a quarter and more than a half of pts with RA and prior IR to csDMARD(s) receiving UPA with or without background csDMARD therapy achieved sustained clinical REM and LDA, respectively, across disease activity measures. Sustainability of responses appeared comparable among pts receiving UPA with or without background csDMARDs through up to 84 wks.References:[1]EULAR: Smolen JS, et al. Ann Rheum Dis 2017;76:960–977.[2]ACR: Singh et al. Arthritis & Rheumatology Vol. 68, No. 1, January 2016, pp 1–26.Disclosure of Interests: :Arthur Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB – grant/research support, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yanna Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jessica Suboticki Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB

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P181 Long-term improvement in axial spondyloarthritis clinical outcomes following 2-weeks of intensive education and rehabilitation: results from the Bath residential rehabilitation programme

Rheumatology ◽

10.1093/rheumatology/keab247.176 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Rosie Barnett ◽

Anita McGrogan ◽

Matthew Young ◽

Charlotte Cavill ◽

Mandy Freeth ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Rehabilitation Programme ◽

Spinal Mobility ◽

The Impact

Abstract Background/Aims Axial spondyloarthritis (axSpA) is a chronic rheumatic condition, characterised by inflammatory back pain - often associated with impaired function and mobility, sleep disturbance, fatigue, and reduced quality of life. Despite the vast advances in pharmacological treatments for axSpA over the last few decades, physical activity and rehabilitation remain vital for effective disease management. At the Royal National Hospital for Rheumatic Diseases in Bath (RNHRD), the 2-week inpatient axSpA rehabilitation programme has been integral to axSpA care since the 1970’s. Prior research has demonstrated significant short-term improvements in spinal mobility (BASMI), function (BASFI) and disease activity (BASDAI) following course attendance. However, the long-term outcomes are yet to be evaluated in this unique cohort. Methods Since the early 1990’s, clinical measures of spinal mobility, function and disease activity have been routinely collected at the RNHRD at all clinical appointments through administration of the BASMI, BASFI and BASDAI, respectively. Dates of attending the axSpA course and standard clinical and treatment follow-up data were also collected. Multiple linear regression models were used to investigate the impact of course attendance on final reported BASMI, BASDAI and BASFI scores (final score=most recent). Length of follow-up was defined as time between first and last recorded BASMI. Results Of the 203 patients within the Bath SPARC200 cohort, 77.8% (158/203) had attended at least one rehabilitation course throughout follow-up. 70.0% (140/203) of patients were male. The mean duration of follow-up was 13.5 years (range 0-35 years); 28.1% (57/203) of individuals with 20+ years of follow-up. Course attendance (yes versus no) significantly reduced final BASMI score by 0.84 (p = 0.001, 95%CI -1.31 to -0.37) and final BASDAI score by 0.74 (p = 0.018, 95%CI -1.34 to -0.13). Although course attendance reduced final BASFI by 0.45 (95%CI -1.17 to 0.28), this relationship did not reach significance (p = 0.225). Whilst minimally clinically important difference (MCID) is, to our knowledge, yet to be defined for BASMI, MCIDs were achieved long-term for both BASDAI and BASFI - defined by van der Heijde and colleagues in 2016 as 0.7 and 0.4 for BASDAI and BASFI, respectively. Conclusion These results provide novel evidence to support the integral role of education, physical activity and rehabilitation in the management of axSpA. Future work should investigate additional outcomes of critical importance to patients and clinicians, such as fatigue, quality of life and work productivity. Furthermore, a greater understanding of the factors that confound these outcomes may provide insights into those patients who may most benefit from attending a 2-week rehabilitation course. In addition to facilitating identification of those patients who may require additional clinical support. Disclosure R. Barnett: None. A. McGrogan: None. M. Young: None. C. Cavill: None. M. Freeth: None. R. Sengupta: Honoraria; Biogen, Celgene, AbbVie, Novartis, MSD. Grants/research support; Novartis, UCB.

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