FRI0114 Reaching A Status of Low Disease Activity Spontaneously over Two Year Follow-Up in Active Patients with Non-Radiographic Axial Spondyloarthritis in Comparison to Ankylosing Spondylitis not Treated with TNF Blockers

2014 ◽  
Vol 73 (Suppl 2) ◽  
pp. 422.3-423 ◽  
Author(s):  
D. Poddubnyy ◽  
H. Haibel ◽  
J. Braun ◽  
M. Rudwaleit ◽  
J. Sieper
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Low Disease Activity ◽  
Tnf Blockers ◽  
Active Patients

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

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.

scholarly journals SAT0364 DATA TO BE COLLECTED FOR AN OPTIMAL MANAGEMENT OF AXIAL SPONDYLOARTHRITIS IN DAILY PRACTICE: PROPOSAL FROM AN EVIDENCE BASED AND CONSENSUAL APPROACHES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1129.1-1129
Author(s):  
A. Baillet ◽  
X. Romand ◽  
A. Pfimlin ◽  
M. Dalecky ◽  
M. Dougados
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Daily Practice ◽  
Evidence Based ◽  
Periodic Review ◽  
Grade Scale

Background:Standardization of clinical practice has been proven to be effective in management of chronic diseases. This is particularly true at the time where the concept of treat to target is becoming more and more important in the field of axial spondyloarthritis (ax-SpA).Objectives:To propose a list of variables to be collected at the time of the diagnosis and over the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice.Methods:The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of axSpA via a systematic literature research, (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of the variable in a 4 grade scale from ”potentially useful” to “mandatory”, (3) a consensus on optimal timeline for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”.Results:The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Concerning the data to be collected at the time of the diagnosis and during follow-up, we proposed to differentiate the results based on a) the way of collection of the variables (e.g. questionnaires by the patient, interview by the physician, physical examination, investigations) b) the usefulness these variables in daily practice based on the opinion of the rheumatologists ” c) the optimal timeline between 2 evaluations of the variable based on the opinion of the rheumatologists. In the initial systematic review, symptoms of heart failure history of inflammatory bowel disease, psoriasis or uveitis, patient global visual analogic scale, spine radiographs, modified Schöber test, coxo-femoral rotations, swollen joint count, urine strip test, BASDAI and ASDAS global scores were considered very useful and nocturnal back pain/morning stiffness, sacro-iliac joints radiographs and CRP were considered mandatory (Figure 1). Timeline between 2 evaluations of variables to collect in the periodic review are summarized inFigure 2.Figure 1.Core sets of items to collect and report in the systematic review in axial spondyloarthritis management in daily practice ASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, BASFI=Bath Ankylosing Spondylitis Functionnal Index, BASMI=Bath Ankylosing Spondylitis Metrology Index, CRP=C Reactive Protein, CT=computerized tomography, FIRST=Fibromyalgia Rapid Screening Tool, HLA=Human Leukocyte Antigen, MRI=Magnetic resonance imaging, PET=positron emission tomography.Figure 2.Periodic review timeline of variables to collectASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, Spondylitis Metrology Index, CRP=C Reactive Protein, IBD = inflammatory bowel diseases, PRO = Patient Reported OutcomesConclusion:Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported at the time of the diagnosis and during follow-up of patients with ax-SpA in daily practice.Acknowledgments:this study has been conducted in two parts: the first one (evidence-based) was conducted thanks to a support from Abbvie France. AbbVie did not review the content or have influence on this manuscript. The second part of this initiative (consensus) has been conducted thanks to a support from the scientific non-profit organization: Association de Recherche Clinique en RhumatologieDisclosure of Interests:Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

scholarly journals IMPACT OF THE FREQUENCY OF USING NONSTEROIDAL ANTI-INFLAMMATORY DRUGS ON THE RADIOGRAPHIC PROGRESSION OF SACROILIITIS IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS

2018 ◽  
Vol 56 (3) ◽  
pp. 346-350 ◽  
Author(s):  
D. G. Rumyantseva ◽  
T. V. Dubinina ◽  
Sh. F. Erdes
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Radiographic Progression ◽  
Axial Spondyloarthritis ◽  
On Demand ◽  
Number Of Patients ◽  
Inflammatory Drugs ◽  
The Mean ◽  
Group 1

Objective: to compare the impact of continuous or on-demand use of nonsteroidal anti-inflammatory drugs (NSAIDs) on the activity and radiographic progression of early axial spondyloarthritis (axSpA).Subjects and methods. The investigation enrolled patients from the early spondyloarthritis cohort who met the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria for axSpA. This analysis included 68 patients who had been followed up for at least 24 months. The mean age at the time of inclusion in the investigation was 28.5±5.8 years; the mean disease duration was 24.1±15.4 months; 63 (92.6%) patients were HLA-B27-positive. The patients were divided into two groups: 1) 35 patients used NSAIDs at maximum therapeutic doses continuously during the follow-up period; 2) 33 patients received these drugs on-demand, depending on the presence and severity of back pain.Results and discussion. After 2-year follow-up, the median stage of radiographic sacroiliitis (SI) in Group 1 was unchanged and remained equal to 4; that in Group 2 in this period significantly increased from 3 to 4 scores (p < 0.05). At baseline, the patient groups did not differ in C-reactive protein (CRP) levels, the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP), and the Bath Ankylosing Spondylitis Functional Index (BASFI); however, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was higher in Group 1 (p < 0.05). The number of patients with active SI, as evidenced by magnetic resonance imaging (MRI), and the degree of its severity did not differ significantly between groups. After 2 years, all the patients retained low disease activity according to ASDAS-CRP, BASDAI, and CRP levels; and these measures did not differ significantly between groups either; the BASFI became higher in Group 1. MRI findings indicated that the number of patients with active SI decreased, but no differences were found between the groups.Conclusion. In patients with early axSpA, the continuous intake of NSAIDs can slow radiographic progression to a greater extent than their on-demand use. 

scholarly journals AB0683 IS THE NEW ASDAS NOMENCLATURE IN LINE WITH THERAPEUTIC DECISION MAKING IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1637.1-1637
Author(s):  
B. Garcia-Magallon ◽  
M. D. C. Castro Villegas ◽  
R. Rosselló ◽  
V. Navarro-Compán
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Axial Spondyloarthritis ◽  
Therapeutic Decision ◽  
Low Disease Activity ◽  
Moderate Disease ◽  
Therapeutic Attitude ◽  
Very High ◽  
Moderate Disease Activity

Background:The Assessment of SpondyloArthritis international Society (ASAS) proposed in 2018 a change in the nomenclature of the Ankylosing Spondylitis Disease Activity Score (ASDAS) for monitoring disease activity in axial spondyloarthritis (axSpA), renaming the previously status of moderate disease activity as low disease activity status, with the presumption that this better reflects the perception that the doctor and the patient have about the disease situation. However, this decision was not data-driven.Objectives:To evaluate the association between the state of low disease activity according to the new ASDAS nomenclature and the therapeutic decision in patients with axSpA.Methods:Longitudinal retrospective study in which patients with axSpA recruited in a secondary hospital were included. All patients with clinical diagnosis of axSpA who started treatment with a first inhibitor of tumor necrosis factor between January 2014 and June 2019 were included. At each follow-up visit, disease activity assessments (including BASDAI and CRP) and the therapeutic decision of the doctor were collected. Later, the ASDAS was calculated and disease status at each visit was classified according to the new nomenclature (inactive, low, high and very high activity). Using descriptive statistics, the association between the disease activity status and the therapeutic decision was evaluated.Results:A total of 304 visits were analyzed in 104 patients with axSpA. Out of these, 57% were women, 47% had a subtype of non-radiographic axSpA and 42% were HLA-B27 positive. The mean (standard deviation) age at diagnosis was 46.9 (12.5) years. In the visits with an ASDAS showing a status of low activity, the therapeutic attitude was not to intensify the treatment in 98.2% of the cases. However, in visits with an ASDAS status of high or very high disease activity, treatment was intensified in 33.7% and 82.8% of cases, respectively.Conclusion:In clinical practice, the status of disease activity initially classified by the ASDAS as moderate disease activity is currently considered to represent low disease activity status based on the therapeutic attitude of following a non-intensification strategy in this situation. These data support the recent change in the nomenclature of disease activity states according to the ASDAS.References:[1]Machado PM, Landewé R, van der Heijde D. Assessment of Spondyloarthritis international Society (ASAS). Ankylosing Spondylitis Disease Activity Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis 2018; 77:1539-1540.Figure 1.Association between the state of disease activity according to the new ASDAS nomenclature and the therapeutic decision.Disclosure of Interests:Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, María del Carmen Castro Villegas: None declared, Rosa Rosselló: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB

scholarly journals POS0927 EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN NAïVE OR TNF-INHIBITORS FAILURE AXIAL SPONDYLOARTHRITIS PATIENTS IN REAL LIFE: A 24-MONTHS PROSPECTIVE MULTICENTRIC STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 726.1-726
Author(s):  
M. Lorenzin ◽  
A. Ortolan ◽  
M. S. Chimenti ◽  
A. Marchesoni ◽  
E. Lubrano ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Real Life ◽  
X Rays ◽  
Research Support ◽  
Group A ◽  
Group B ◽  
Activity Indices

Background:Axial Spondyloarthritis (axSpA) can be distinguished in radiographic axSpA (r-axSpA) and non-radiographic (nr-axSpA). Secukinumab (SEC) is a novel treatment for axSpA, but data from real-life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of axSpA patients on SEC followed in 8 Italian Rheumatologic centers for 24-months;2)to compare the features and disease-activity indices of SEC-treated axSpA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors failure patients (group B).Methods:Consecutive patients with active axSpA (diagnosis according Assessment of SpondyloArthritis International Society ASAS criteria), who started SEC treatment, were evaluated prospectively.Data on disease characteristics, previous/ongoing treatments and imaging were collected. Disease-activity/functional/clinical scores and biochemical values were recorded at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Effectiveness was evaluated over-time with descriptive statistics. Anova (Kruskal Wallis) and generalized linear models were used to compare variables over-time. Infections,adverse events were collected.Results:One-hundred-seven patients [49.53% men; median age 49years; median treatment duration 18.5years] were enrolled;53(49.53%) had HLA-B27, 47.66% were r-axSpA and 52.34% nr-axSpA. Signs of sacroiliitis were present on MRI in 97 (90.65%) and X-rays in 51 (47.66%). SEC was prescribed as first line biologic treatment in 32 (29.9%) patients and as second or more line biological treatment in 75 (70.1%) patients (Figure 1). In all population significant decrease was achieved in:Visual Analogue Scale of pain and general-health; Leeds Enthesitis Index;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-s);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein. Bath Ankylosing Spondylitis Metrology Index and Erythrocyte-sedimentation-rate not significantly decreased. Effectiveness was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [T0=3.4 (2.9-3.9) vs T24=1.9 (1.2-2.7);p=0.02] and in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [T0=6.6 (5.0-7.8) vs T24=3.2 (2.0-5.0);p=0.03].At T0 group B had a longer disease duration (p=0.04),a greater prevalence of peripheral arthritis (p=0.02),enthesitis (p=0.04) and psoriasis (p=0.05) and was mostly male (p=0.05),while no significant difference was observed for functional and disease-activity indices and signs of sacroiliitis on MRI/X-rays. At T24 group A showed better physical functioning and lower disease activity compared to group B [HAQs A vs. B=0.1(0.0-0.5) vs 0.3(0.1-0.8); BASFI A vs B=1.6(0.8-4.8) vs 4.0(2.5-4.6); BASDAI A vs B=2.2(1.0-3.8) vs 3.9(2.7-5.0);ASDAS A vs B=1.3(1.0-2.2) vs 2.1(1.6-2.9)].After T24 of treatment 70.2% of Group A and 68.4% of Group B had a low disease activity,accordingly to ASDAS<2.1. Twenty-three patients (21.5%) stopped the treatment during the follow-up mainly because of primary (7) or secondary loss of efficacy (9).Only 7 patients suspended SEC because of adverse events.A low number of episodes of mild infections (19) occurred;SEC was instead permanently discontinued in 4 cases for:oral refractory mucositis (2);recurrent aphthosis (1);recurrent broncopneumoniae (1).The retention rate at t24 was good in the whole population (73%).Survival curves for Group A and B were similar (log-rank test=0.81;p=0.69).Conclusion:In a real-life clinical setting,SEC was safe and effective in axSpA, as shown by a significant decrease of BASDAI and ASDAS over a 24-months follow-up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Augusta Ortolan: None declared, Maria Sole Chimenti: None declared, Antonio Marchesoni Grant/research support from: AM has received honoraria and speaker fees from Abbvie, Pfizer, MSD, UCB, Novartis, Janssen, Eli-Lilly., Ennio Lubrano: None declared, Leonardo Santo Speakers bureau: Speaker from Jansen, Novartis, Pfizer, UCB, MSD, Sanofi, Angelo Semeraro: None declared, Carlo Salvarani: None declared, Nicolò Girolimetto: None declared, Emanuela Praino: None declared, Giulia Lavinia Fonti: None declared, Rosario Foti: None declared, Antonio Carletto: None declared, Andrea Doria Grant/research support from: ADhas received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen., Roberta Ramonda Grant/research support from: RR has received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen.

Evaluation of the relationship between TNFα, sTNFR1, sTNFR2, sIL2R, IL6, neopterin with disease activity in ankylosing spondylitis

2018 ◽  
Vol 43 (5) ◽  
pp. 487-494
Author(s):  
Nergiz Zorbozan ◽  
Süleyman Demir ◽  
Veli Çobankara
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Biological Indicator ◽  
Tnf Blockers ◽  
Patient Groups ◽  
Group 3 ◽  
Inflammatory Drugs ◽  
The Relationship ◽  
Active Patients ◽  
Group 1

Abstract Objective We aimed to evaluate the relationship among TNFα, sTNFR1, sTNFR2, sIL2R, IL6, neopterin and disease activity in ankylosing spondylitis (AS). Materials and methods TNFα, sTNFR1, sTNFR2, sIL2R, IL6 and neopterin were measured in patients and controls. Patients were grouped according to disease activity and medication. Results Neopterin and sTNFR1 were not different while TNFα, sTNFR2, sIL2R and IL6 were high in patients than controls. There was no difference between active and inactive patients for TNFα, sIL2R and IL6. sTNFR2 was significantly lower in active patients. There was no relationship between CRP positivity and disease activity. AS patient groups are; 1: TNF blockers, 2: nonsteroidal anti-inflammatory drugs (NSAIDs), 3: disease modifying anti-rheumatic drugs (DMARDs), 4: TNF blockers and NSAIDs, 5: DMARDs and NSAIDs. sTNFR2 was significantly lower in active patients than in inactive, in Group 1. ESR levels were significantly lower in inactive patients compared to active in group 3 and 4. There was no significant association between CRP positivity and disease activity. Conclusion According to our study, CRP is insufficient in evaluating AS disease activity. ESR can be useful in evaluating the disease activity. sTNFR2 might be useful as a biological indicator of disease activity in AS treated with TNF inhibitors alone.

scholarly journals OP0138 FEASIBILITY OF PROGRESSIVE ANTI-TNF TAPERING IN AXIAL SPONDYLOARTHRITIS PATIENTS IN LOW DISEASE ACTIVITY: RESULTS FROM THE MULTICENTER NON-INFERIORITY PROSPECTIVE RANDOMIZED CONTROLLED TRIAL SPACING

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 80.1-81
Author(s):  
C. Lukas ◽  
A. Tournadre ◽  
M. C. Picot ◽  
E. Nogué ◽  
E. Dernis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Research Support ◽  
Low Disease Activity ◽  
Randomized Controlled ◽  
The Difference ◽  
Activity State

Background:Anti-TNF treatments (TNFi) have shown high efficacy in axial spondyloarthritis (ax-SpA) with inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). However their effect remains predominantly symptomatic, and their long-term tolerance as well as significant societal cost justify investigation about a potential reduction in drug dosage, or –most feasible and comfortable for the patient– increase in intervals between doses.Objectives:To assess if a progressive and monitored reduction of administered TNFi by increase of intervals between injections results in a comparable proportion of patients remaining after 12 months (m) in low disease activity state despite a decreased cumulative treatment dose received.Methods:Non-inferiority randomized controlled trial, having included adult patients with ax-SpA fulfilling ASAS criteria, already treated by anti-TNF, and in stable low disease activity for at least 6 m (current and at least 6 m old BASDAI<4/10), who were randomized into 2 groups: either keeping on their usual treatment with stable doses (“unchanged” group), or progressive spacing of injections of their treatment (“spacing” group). Follow-up was done every 3 m during 12 m, with regular monitoring of disease activity and, in patients from the group “spacing”, modification of the rhythm of injections according to disease activity and predefined standardized protocol (either increase or decrease (step-back) of intervals between injections). The primary endpoint was the difference of proportions of patients having a low disease activity state (BASDAI<4/10) after 12 m of follow-up between the 2 groups. It was estimated on the ITT population after multiple imputation. The 90% confidence interval associated was calculated using the Farrington-Manning method and the lower bound was compared to the non-inferiority margin of -20%. With an expected proportion of 85% patients remaining in low disease activity in the unchanged group, and α and β risks at respectively 5% and 90%, the required number of patients was calculated at 358, and thus 398 had to be included with a 10% expected proportion of patients with unavailable data.Results:398 patients were randomized in 23 French rheumatology units (197 and 201 in the spacing and unchanged groups respectively), and 389 included in analyses (9 did not receive the allocated treatment). Mean (SD) age was 44.3 (12.4) years, 71.2% were males. Mean (SD) BASDAI at inclusion was 1.45 (1.02). TNFi used were etanercept (35.7%), adalimumab (33.9%), infliximab (20.6%), golimumab (9.3%) and certolizumab (0.5%). For the 373 patients with complete follow-up (93.7%), 162/184 (88.0%) had a low disease activity in the “spacing” group vs. 173/189 (91.5%) in the “unchanged” group at 12 m. After multiple imputation for the 16 patients with missing data, the difference of proportion between the two groups was estimated to -4.18% [CI90% -10.0; 1.7], thus confirming the non-inferiority of the “spacing” procedure. In the “spacing” group at 12 m, 134/162 (82.7%) patients in low disease activity were still receiving a lowered TNFi dose.Conclusion:In ax-SpA patients with BASDAI<4 for at least 6 months under TNFi, it is possible to increase intervals between injections while maintaining a low disease activity by adjusting treatment with quarterly monitoring of SpA activity.Disclosure of Interests:Cédric Lukas Speakers bureau: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Consultant of: Abbvie, Amgen, Janssen, Lilly, MSD, Novartis, Pfizer, Roche-Chugai, UCB, Grant/research support from: Pfizer, Novartis and Roche-Chugai, Anne Tournadre Speakers bureau: Abbvie, Fresenius, Janssen, MSD, Pfizer, Roche Chugai, Sanofi, Paid instructor for: Fresenius, Consultant of: Abbvie, Fresenius, Lilly, Novartis, Sanofi, Grant/research support from: Fresenius, Novartis, Pfizer, UCB, Marie Christine Picot: None declared, Erika Nogué: None declared, Emmanuelle Dernis Speakers bureau: Roche chugai, UCB, BMS, Novartis, Lilly, Mylan, Pfizer, Celgène, Consultant of: UCB, MSD, BMS, Lilly, Novartis, Philippe Goupille Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Bernard Combe Speakers bureau: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Consultant of: AbbVie; Bristol-Myers Squibb; Gilead; Janssen; Lilly; Merck; Novartis; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche-Chugai, Jacques Morel Speakers bureau: Abbvie, Biogen, BMS, Fresenius Kabi, Lilly, Mylan, Novartis, Pfizer, Sanofi, Consultant of: Abbvie, BMS, Boerhinger Ingelheim, Galpaagos, GSK, Lilly, Novartis, Sanofi

scholarly journals SAT0501 EARLY START OF BIOLOGICAL TREATMENT IN JUVENILE IDIOPHATIC ARTHRITIS: DOES A THERAPEUTIC WINDOW EXIST IN REAL LIFE?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1207.2-1207
Author(s):  
A. García Fernández ◽  
A. Briones-Figueroa ◽  
L. Calvo Sanz ◽  
Á. Andreu-Suárez ◽  
J. Bachiller-Corral ◽  
...  
Keyword(s):  
Disease Activity ◽  
Biological Treatment ◽  
Real Life ◽  
Therapeutic Window ◽  
Systemic Jia ◽  
Active Arthritis ◽  
The Impact ◽  
Active Patients ◽  
Active Disease

Background:Biological therapy (BT) has changed the treatment and perspectives of JIA patients but little is known about when is the best moment to start BT and the impact of this prompt iniciation.Objectives:To analyze the response to BT of Juvenile Idiophatic Arthritis (JIA) patients according to the time when the BT was started.Methods:A retrospective, descriptive study was conducted on JIA patients followed up in a referal hospital that started BT up to 24 months after diagnosis from 2000 to 2018. Disease activity was measured, at 2 years after diagnosis, according to Wallace criteria for remission (absence of: active arthritis, active uveitis, fever, rash or any other manifestation attributable to JIA, normal CRP and ESR, PGA indicating no active disease) for at least 6 months.Results:55 JIA patients that started BT up to 24 months from diagnosis were analyzed. 69,1% were girls with a median age at diagnosis of 8 years old IQR(3-13), median age at the start of BT of 9 years old IQR(3-13). Regarding JIA categories: 25,5% were Oligoarticular Persistent (OligP), 18,2% Systemic JIA (sJIA), 16,4% Entesitis related Arthritis (ERA), 12,7% Psoriatic Arthritis (APso) and Polyarticular RF- (PolyRF-), 5,5% Oligoarticular Extended (OligE) and Polyarticular RF+ (PolyRF+), 3,6% Undifferentiated (Und). 20% of patients had uveitis during followup. Conventional DMARD (cDMARD) was indicated in 83,6% of patients (95,7% Methotrexate) at diagnosis [median 0 months IQR(0-2,3)]. At the end of followup (2 years) only 30,9% of patients continued with cDMARDs. The main causes of discontinuation were: adverse events (46,7%), remission (36,7%). TNF inhibitors were precribed in 81,8% of patients and 18,2% of patients recieved two BT during the first 2 years from diagnosis. 54,5% of BT were indicated during the first 6 months from diagnosis, 27,3% from 7 to 12 months, 12,7% from 13 to 18 months, 5,5% from 19 to 24 months.After 2 years from diagnosis, 78,2% of patients were on remission and 21,8% active. Among patients with active disease: 75% had arthritis, 16,7% had uveitis and 8,3% had both. There were no differences regarding disease activity among patients with uveitis and neither taking cDMARDs. Regarding JIA categories: 66,7% of OligE, 57,1% of PolyRF- and 57,1% of APso patients were active at 2 years from diagnosis when compared to the other categories (p=0.004).Patients on remission at 24 months from diagnosis started sooner the BT than active patients [CI 95% (0,46-8,29) p=0,029]. The time when the BT was started was correlated to the activity at 2 years (K= 0,294 p=0,029). When the BT was prescribed after 7,5months from diagnosis it was correlated, in a COR curve, with a higher probability of active disease at 2 years (S= 0,67 E= 0,63). There was a correlation, among patients on remission at 2 years, between prompt start of BT and less time to reach remission (K= -0,345 p=0,024). Patients with active disease at 2 years, regardless of moment of BT iniciation, required more BT during follow-up (p=0,002).Conclusion:Prompt iniciation of BT was correlated with a better outcome. JIA patients that started BT early after diagnosis had a higher probability of remission after 2 years. Starting BT after 7,5 months was correlated with a higher probability of active disease at 2 years. Active disease at 24 months was correlated with persistent active disease during follow-up.Disclosure of Interests:None declared

scholarly journals THU0395 EFFICACY OF IXEKIZUMAB ON DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND OBJECTIVE SIGNS OF INFLAMMATION, STRATIFIED BY BASELINE CRP/SACROILIAC JOINT MRI STATUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 432-433
Author(s):  
W. P. Maksymowych ◽  
H. Marzo-Ortega ◽  
M. Ǿstergaard ◽  
L. S. Gensler ◽  
J. Ermann ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Treatment Group ◽  
Disease Activity ◽  
Sacroiliac Joint ◽  
Axial Spondyloarthritis ◽  
Physical Component Score ◽  
Research Support ◽  
Advisory Boards ◽  
Sf 36 ◽  
Active Sacroiliitis

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

scholarly journals OP0008 DEVELOPMENT AND VALIDATION OF AN ALTERNATIVE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE WHEN PATIENT GLOBAL ASSESSMENT IS UNAVAILABLE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Psychometric Properties ◽  
Global Assessment ◽  
Disease Activity Score ◽  
Validation Cohort ◽  
Patient Global Assessment ◽  
Activity Score ◽  
Research Support ◽  
Low Disease Activity

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

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