scholarly journals POS1451 DEVELOPING A TOOL TO MEASURE THE LEARNING CURVE: ENTHESITIS ULTRASOUND IN PSORIASIS ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1009.2-1010
Author(s):  
S. Brådland ◽  
P. Andel ◽  
A. Diamandopoulos ◽  
G. Haugeberg

Background:Enthesitis is defined as inflammation of the tendon inserting the bone encompassing the adjacent trabecular bone network, the fascia and surrounding soft tissues as the cartilage, the bursa and the fat pad. In enthesitis clinical examination alone is a method with significant limitations in terms of diagnostic accuracy and does not correlate strongly with imaging diagnostics (1,2).Ultrasound (US) is a widely used imaging technique in Rheumatology. But while learning curricula and standardization for joint US are available, other US techniques as vascular-, enthesis- or serosa-US gets usually less attention in rheumatologic US curricula. Though both OMERACT (4) and GRAPPA (3) have recently published qualitative and semi quantitative criteria in enthesitis US, few publications explicitly address the learning curves in these particular domain.Objectives:To describe the development of a tool to measure the learning curve for enthesitis US.Methods:3237 US images of 561 enthesis were obtained by one experienced ultrasonographer (PMA) in B- and color Doppler (CD) mode in longstanding psoriasis arthritis patients of different disease activity. Due to duplicity and poorer image quality 2115 images were eliminated. The remaining fully anonymized 1122 images (561 enthesis) were afterward implemented in a random multiple choice algorithm presenting a B-mode and a CD image of the same enthesis at the same time without timely limitation. Rating follows qualitative GRAPPA criteria as well as semiquantitative OMERACT criteria (3, 4). The enthesitis scoring application was than written in.NET/ C#, TypeScript and ReactJS and is hosted in Azure Cloud platform. The scoring is stored in a database allowing extraction to SPSS for statistical analysis.Results:The interface of the functional program is shown in image 1 (Screenshot). In a next step the program will be presented to different raters of different ultrasound experience (>10 years, 5-10 years, 1-5 years, <1 years). The program will be presented a multitude of times in different order to every rater to adjust for inter-rater reliability. Correlation between raters will be given to depict a learning curve on enthesitis ultrasound assuming the rater with the highest experience as gold standard.Image 1.Screenshot of grafical user interface of the scoring program.Conclusion:In this presentation we outline the successful development of a tool to measure the learning curve in enthesitis. We hypothesize that knowledge about the learning curve and inter-rater reliability in enthesitis US obtained by our tool might contribute to future US curricula, structured reporting and deep learning algorithms.References:[1]Achilles enthesitis defined by ultrasound is not associated with clinical enthesitis in patients with psoriatic arthritis, Brigitte Michelsen et al. RMD Open 2017;3[2]Ultrasonographic evaluation in psoriatic arthritis is of major importance in evaluating disease activity Brigitte Michelsen et al. Annals of the Rheumatic Diseases 12(2108-2113)[3]Development of a Preliminary Ultrasonographic Enthesitis Score in Psoriatic Arthritis -GRAPPA Ultrasound Working Group, Stephanie Tom et al. The Journal of Rheumatology; 4(384-390)[4]Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative, Peter V Balint et al. Annals of the Rheumatic Diseases, 12(1730-1735)Disclosure of Interests:None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 812.1-812
Author(s):  
F. Oliveira Pinheiro ◽  
B. M. Fernandes ◽  
S. Garcia ◽  
M. Rato ◽  
D. Fonseca ◽  
...  

Background:There is growing evidence that vitamin D [25(OH)D]) plays an important role in maintaining skeletal health and modulating the immune system. Epidemiological data indicate that vitamin D deficiency is common in immune-mediated rheumatic diseases, especially in rheumatoid arthritis, but there is little data regarding its association with disease activity and response to therapy in patients with psoriatic arthritis (PsA) under bDMARD therapy.Objectives:We aimed to assess whether 25(OH)D basal levels correlate with disease activity and clinical response to the first bDMARD, at 6 and 12 months of therapy, in a monocentric cohort of patients with PsA.Methods:This retrospective study was carried out on PsA patients from a Rheumatology department of a tertiary hospital, fulfilling CASPAR criteria and registered in our national database (Reuma.pt), who started the first bDMARD since 2008. Demographic, clinical and laboratory criteria were evaluated at 0, 6 and 12 months of biologic therapy. Disease activity was assessed using CDAI, SDAI, DAS28(4V), BASDAI, ASDAS, DAPSA and the response was measured using the EULAR, BASDAI50, ASDAS, ASAS, ACR and PsARC responses. Correlations were made between absolute serum levels of 25(OH)D and continuous variables, as well as associations between different vitamin D cutoffs and disease activity measures and response criteria. Multiple linear and logistic regression analyses were performed to determine whether vitamin D is a predictor of disease activity and therapeutic response.Results:We included 81 patients, 41 (50.6%) females; with a mean age of 48.0±11.7 years, a mean disease duration of 9.5±7.4 years and a mean body mass index of 28.4±5.2 kg/m2. Thirteen (16.0%) were smokers. The mean 25(OH)D basal level was 25.5±13.2 ng/ml, 21 (25.9%) had 25(OH)D basal levels ≥30 ng/mL and 31 (38.3%) ≤20 ng/mL. Sixty-two patients (76.5%) were under csDMARD therapy. Golimumab (29, 35,8%), etanercept (28, 34.6%) and adalimumab (10, 12.3%) were the most frequently prescribed bDMARDs. There were only very weak, albeit positive, correlations between 25(OH)D levels and measures of disease activity. The BASDAI50 response at 6 months was associated with higher basal 25(OH)D levels (29.5±14.5 vs 21.5±10.2 ng/mL, p = 0.013); the ASAS20 (33.9±15.9 vs 24.2±12.8 ng/mL; p = 0.023), ASAS40 (31.9±14.6 vs 25.0±13.8 ng/mL; p = 0.023) and ASAS70 (47.0±4.2 vs 26.6±14.2; p = 0.027) responses at 12 months were associated with higher basal levels of 25(OH)D; basal 25(OH)D levels were ≥ 30ng/mL in a significantly higher proportion of patients who achieved CDAI (38.9% vs 10.5%; p = 0.027) and SDAI (38.9% vs 7.7%; p = 0.008) remission and ASDAS disease inactive (29.4% vs 7.3%; p = 0.040) at 1 year. In the regression models, basal levels of 25(OH)D were found to be predictors of good EULAR responders (OR 1.315, 1.017-1.213 95% CI; p = 0.037) at 6 months. Basal levels of 25(OH)D were not significantly different in patients who discontinued bDMARD and no significant correlations or associations were identified regarding more specific PsA activity measures, such as DAPSA and PsARC, nor were they predictive of these responses.Conclusion:We can conclude that there is a global trend for an association between higher levels of vitamin D and lower measures of disease activity and better therapeutic responses to the first biologic. It was possible to find statistically significant associations with some disease activity measures and response criteria that, although primarily designed for other rheumatic diseases, are often used in PsA.Disclosure of Interests:None declared.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1685.1-1686
Author(s):  
K. Bonek ◽  
E. Kuca-Warnawin ◽  
E. Kontny ◽  
P. Głuszko

Background:We have previously found that: (i) patients with spondyloarthritis (SpAs) have higher circulating levels of IL-18 and osteoprotegerin (OPG) than healthy controls (1), (ii) psoriatic arthritis (PsA) patients present with more proatherogenic lipid profile and higher IL-18 levels than ankylosing spondylitis (AS) patients (2)Objectives:To investigate the relationship between disease phenotype, i.e. peripheral arthritis (perPsA n=45), axial PsA (axPsA n=16) and ankylosing spondylitis (AS n=94), cardiovascular risk factors and serum concentrations of IL-18, IL-17.Methods:A group of 155 SpA patients (94 AS/61 PsA), of similar age (44.5 versus 44.9 years), disease duration (4.8 versus 6.8 years), and matched with high disease activity (AS ASDAS-CRP 3.62±0.94; PsA DAPSA 26.75±26.61) were included in the study. The lipid profile comprised triglycerides (TG), total cholesterol (tChol), low- and high-density lipoprotein (LDL and HDL, respectively) measurement. Ischemic Heart Disease (IHD) diagnosis was established from patient’s medical history. Serum concentrations of IL-17AF, IL-18 were measured by specific commercially available enzyme-linked immunosorbent assays (ELISA) and were expressed as medians (pg/ml). The Mann-Whitney test was applied for intergroup comparison, correlation was assessed using Spearman’s Rank tests (r value is shown) with linear regression model.Results:Patients with perPsA had higher rate of IHD than axPsA and AS patients (27% vs 0% vs 7.8%, respectively). perPsA patients had significantly higher diastolic blood pressure than AS patients (perPsA 131±13mmHg vs AS 121±14 mmHg), more severe cardiovascular burden than patients with axial disease, were characterised by higher occurrence of obesity (perPsA 42% vs axPsA o 18% vs 18% AS) and hypertriglyceridemia (perPsA 48% vs axPsA 14% vs 16%AS) as well as higher TG concentration (perPsA 165± 87 mg/dl vs axPsA 111± 63mg/dl vs 110± 57 AS mg/dl). Moreover, patients with perPsA had significantly higher serum concentrations of IL-18 than axPsA and AS groups (132.5pg/ml vs 79.2pg/ml vs 84.9pg/ml), but there were no differences between them in IL-17 concentrations. Interestingly, in patients with perPsA, but no other patients’ groups, statistically significant associations between IL-18 concentrations and proatherogenic risk factors were found, as IL-18 correlated positively with TC (r=0.31), TG (r=0.53) atherogenic index (r=0.6), and uric acid (r=0.3) concentrations, while negatively with HDL levels (r=-0.47). Although patients groups differ in cardiovascular risk profiles, there were no significant differences in CV risk estimation using SCORE scale (perPsA 2.3% vs 1.6% axPsA vs 2.1%AS)Conclusion:We conclude that in PsA peripheral joints inflammation is associated with more proatherogenic cardiovascular risk profile and higher IL-18 serum levels, that seem to be interrelated, while patient’s disease activity is associated with metabolic syndrome. Generally recommended SCORE scale is practically unable to indicate SpA patients with higher CV riskReferences:[1]Kontny E, et al. PAB0733 Associations of serum osteoprotegerin and IL-18 concentrations with cardiovascular risk in ankylosing spondylitis and psoriatic arthritis patientsAnnals of the Rheumatic Diseases2017;76:1310-1311.[2]Bonek K et al. ESAT0310 The associations of serumIL-l18 and osteoprotegerin (OPG) levels with the lipid profile in psoriatic arthritis (PSA) patientsAnnals of the Rheumatic Diseases2018;77:1019-1020.Disclosure of Interests:None declared


2021 ◽  
Vol 12 ◽  
Author(s):  
Milena Iwaszko ◽  
Joanna Wielińska ◽  
Jerzy Świerkot ◽  
Katarzyna Kolossa ◽  
Renata Sokolik ◽  
...  

ObjectiveRheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) belong to inflammatory rheumatic diseases, the group of conditions of unknown etiology. However, a strong genetic component in their pathogenesis has been well established. A dysregulation of cytokine networks plays an important role in the development of inflammatory arthritis. Interleukin 33 (IL-33) is a recently identified member of the IL-1 family. To date, the significance of IL-33 in inflammatory arthritis has been poorly studied. This research aimed to investigate the potential of IL-33 gene polymorphisms to serve as biomarkers for disease susceptibility and TNF inhibitor response in RA, AS, and PsA patients.Materials and MethodsIn total, 735 patients diagnosed with RA, AS, and PsA and 229 healthy individuals were enrolled in the study. Genotyping for three single nucleotide polymorphisms (SNPs) within the IL-33 gene, namely, rs16924159 (A/G), rs10975519 (T/C), and rs7044343 (C/T), was performed using polymerase chain reaction amplification employing LightSNiP assays.ResultsIn the present study, the IL-33 rs10975519 CC genotype was associated with a decreased risk of developing RA in females, while the IL-33 rs16924159 polymorphism was associated with the efficacy of anti-TNF therapy and clinical parameters for RA and AS patients. The IL-33 rs16924159 AA genotype correlated with higher disease activity and worse clinical outcomes in RA patients treated with TNF inhibitors, and AS patients carrying the IL-33 rs16924159 AA genotype had higher disease activity and a worse response to anti-TNF therapy. That indicates a deleterious role of the IL-33 rs16924159 AA genotype in the context of RA, as well as AS.ConclusionsThe obtained results suggest that IL-33 gene polymorphisms might be potential candidate biomarkers of disease susceptibility and anti-TNF treatment response in patients with inflammatory rheumatic diseases.


2019 ◽  
Vol 47 (5) ◽  
pp. 690-700
Author(s):  
Elsa Vieira-Sousa ◽  
Mónica Eusébio ◽  
Pedro Ávila-Ribeiro ◽  
Nikita Khmelinskii ◽  
Rita Cruz-Machado ◽  
...  

Objective.To assess longterm effectiveness of tumor necrosis factor inhibitors (TNFi) in patients with psoriatic arthritis (PsA) registered in the Rheumatic Diseases Portuguese Register, exposed to at least 1 TNFi, prospectively followed between 2001 and 2017.Methods.Kaplan-Meier analysis was performed for first-, second-, and third-line TNFi. Responses included European League Against Rheumatism (EULAR) criteria, Disease Activity Index for Psoriatic Arthritis (DAPSA), minimal disease activity (MDA), and Ankylosing Spondylitis Disease Activity Score (ASDAS) at 3 and 6 months. Baseline predictors of discontinuation and response were studied using Cox and multivariable multinomial/logistic regression models.Results.The 750 patients with PsA showed drug retention of 4.1 ± 3.4 years (followup 5.8 ± 3.8 yrs) for first TNFi. Switching to a second (189 patients) or third (50 patients) TNFi further decreased survival by 1.1 years. Female sex, higher baseline 28-joint count Disease Activity Score, and infliximab were predictors of first TNFi discontinuation. After 6 months of the first TNFi, 48.7% of patients achieved a good EULAR criteria response and 20.9% were in DAPSA remission. There were 11.4% in MDA, and 56.4% had a good ASDAS. Responses to the second TNFi were significantly inferior compared to responses to the first TNFi. Female sex and higher baseline Health Assessment Questionnaire–Disability Index were negatively associated with good EULAR response at 3 months, and obesity decreased the chance of response at 6 months.Conclusion.In this study, switching to a second or third TNFi was associated with significantly lower drug survival and response rates for patients with axial and peripheral PsA subtypes. More successful therapeutic approaches will require considering the effect of sex and obesity on TNFi effectiveness.


2020 ◽  
pp. 83-94
Author(s):  
D. E. Karateev ◽  
E. L. Luchikhina

The treatment of immuno-inflammatory rheumatic diseases has advanced significantly in recent decades due to development of biological medications, which, however, are not without some weak points. They include immunogenicity, parenteral administration, and potentially insufficient stability of the composition of the drug. Great hopes are related to a relatively new class of targeted synthetic immunomodulatory drugs, currently represented in rheumatology by JAK kinase inhibitors (tofacitinib, baricitinib, upadacitinib) and phosphodiesterase 4 inhibitor (apremilast). The most actively developed group is JAK inhibitors that influence one of the most important signal pathway of immune system. This family includes 4 subtypes: JAK1, JAK2, JAK3 и tyrosine-kinase2 (TYK2). JAK-kinases selectively aggregate with cytoplasmic domains of different cytokine receptors, activation of which includes intracellular signal pathway JAK-STAT (Signal Transducer and Activator of Transcription). STAT proteins are responsible for transduction of the signals from more than 50 cytokines, hormones and growth factors that regulate key processes of survival, proliferation and differentiation of immune cells. The greatest practical experience achieved on tofacitinib. This medication approved inRussiafor several indications: rheumatoid arthritis, psoriatic arthritis, psoriasis, ulcerative colitis. Clinical trials of III phase of ORAL series in rheumatoid arthritis and OPAL series in psoriatic arthritis showed high efficacy of Tofacitinib in different clinical situations. In Russian strategic trial REMARKA after treatment with Tofacitinib very fast improvement of the signs of activity was observed, 68,8% patients achieved low disease activity or remission at 6th month of follow-up. Russian open multi-center observational study of Tofacitinib in 101 patients with rheumatoid arthritis and insufficient efficacy of basic and biologic drugs showed achievement of low disease activity or remission in 60% patients, as well as significant improvement of quality of life with a very low frequency of withdrawals due to adverse events (less than 2%).


2021 ◽  
pp. 105177
Author(s):  
Mehmet Tuncay Duruöz ◽  
Halise Hande Gezer ◽  
Kemal Nas ◽  
Erkan Kılıç ◽  
Betül Sargın ◽  
...  

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1160.2-1161
Author(s):  
I. Fairushina ◽  
D. Abdulganieva ◽  
E. Kirillova ◽  
R. Abdrakipov

Background:Detection of subclinical enthesitis and synovitis in psoriatic arthritis (PsA) is prevalent and ultrasound (US) examination is informative tool for it diagnosing. Aging positively affects degenerative changes.Objectives:To study relationship between US articular and entheseal findings with age in patients with PsA.Methods:57 patients were enrolled to study with fulfilled PsA criteria (CASPAR, 2009). Data collection: demographical, clinical (current psoriasis, axial involvement, enthesitis, dactylitis), US (synovitis count (by Grey Scale), Power Doppler(PD)+ synovitis), thickening and hypoechogenicity at enthesis, PD+ enthesitis, entheses with structural components); biological (high sensitive C-reactive protein (hsCRP), Erythrocyte Sedimentation Rate (ESR).US examination included 798 joints and 3078 entheses (bilateral shoulders, acromioclavicular joints, elbows, wrists, hips, knees, ankles; entheses at the projection of these joints (total number - 54). US entheseal findings were fixed according to consensus-based US definition and scoring for enthesitis in spondyloarthritis and PsA (OMERACT US)1.Results:In all 57 patients: male - 25 (43.9%), mean age 43.4±10.3(SD) years (y), PsA duration was 7 (3;10) y, Ps duration 10 (8; 22) y; 53 (41.1%) had axial involvement, 42 (73.7%) dactylitis, 8 (14%) clinical enthesitis, and 56 (98.2 %) skin psoriasis, Psoriasis Activity and Severity Index score 6.4 (2;14.4), Disease Activity in PsA score 18.1 (10.2;26.1), hsCRP 10.1(2.4;21.4), ESR 20 (11.3;31.5).Synovitis count increased with age noticeably (r=0.508, p<0.01), and weak correlation of PD+ synovitis (r=0.262, p=0.049) and age was found. The entheseal thickening and hypoechogenicity and structural findings increased with age respectively (r=0.345, p=0.009; r=0.337, p=0.01). There was no correlation between PD+ enthesitis and age. The assosiation between PD+ enthesitis and blood biomarkers of inflammation (hs-CRP (r=0.364, p=0.008); ESR (p=0.358, p=0.008) was found.Conclusion:Our study found significant relationship between age and US synovitis. Association between age and US entheseal involvement was noted. Only PD+ enthesitis was not related with age in comparison with other US entheseal findings. The presence of PD US signal at enthesitis in association with increased inflammatory blood biomarkers can be evaluated as the sign of disease activity regardless of age and not as age-related lesion in PsA patients.References:[1]Balint PV, Terslev L, Aegerter P et al. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative. Ann Rheum Dis.;2018;77(12):1730-1735.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 508-508
Author(s):  
M. Moly ◽  
C. Lukas ◽  
J. Morel ◽  
B. Combe ◽  
G. Mouterde

Background:Psoriatic arthritis (PsA) is a heterogeneous disease and its assessment is sometimes difficult. Perception of disease activity by patient and physician is frequently discordant in patients in clinical remission. Ultrasound (US) is an imaging technique, which can detect inflammation in PsA.Objectives:The aim of our study was to assess whether persistence of disease activity evaluated by the patient, considered in remission by his rheumatologist, was associated with inflammation measured by US.Methods:We performed a transversal monocentric study. PsA patients were included if they met the CASPAR criteria and were considered in remission by their rheumatologist. Demographic data, characteristics of the disease and treatments were collected. Discordance was defined by a difference between patient’s and rheumatologist’s global assessment ≥30/100 on a Visual Analogic Scale. An US examination was performed on 50 joints, 28 tendons and 14 entheses by an independent investigator. Synovial or tendon sheath hypertrophy and PD signal were evaluated on a semi-quantitative scale, B Mode and PD signal abnormalities on entheses were searched, according to the EULAR-OMERACT scoring system. US remission was defined by no power Doppler (PD) signal on joints, tendons and entheses and minimal US activity by maximum one PD signal on the same sites. Univariate and multivariate analyses were performed to evaluate factors associated with US abnormalities.Results:Sixty-two PsA patients were included. 40.3% were women, the mean (SD) age was 55 (14) years, 42% were in US remission and 71% in minimal US activity (Table 1), 19.4% had ≥1 PD synovitis and 88.7% had a B mode synovitis, 95.2% had a B mode abnormality on entheses and 51.6% had ≥1 PD signal on entheses. Thirty nine percent had a discordant disease activity assessment with their rheumatologist. In univariate analysis, discordance was not associated with US remission (OR=1.71 (95%CI 0.61-4.83), p=0.224) or US minimal disease activity (OR=0.99 (95%CI 0.32-3.05), p=0.602). In multivariate analysis, US remission was independently associated with female gender (OR=3.94 (95%CI 1.20-12.9), p=0.024) and younger age (OR=0.95 (95%CI 0.91-0.99), p=0.027). Minimal US activity was associated with history of enthesis lesion (OR=11.26 (95%CI 1.34-94.93), p=0.026) and age (OR=0.95 (95%CI 0.90-1), p=0.044).Table 1.Ultrasound characteristics of the 62 PsA patients.N (%)Ultrasound remission26 (41.9)Ultrasound minimal disease activity44 (71)Patients with ≥1 grey scale synovitis55 (88.7)Patients with ≥1 Power Doppler synovitis12 (19.4)Patients with ≥1 grey scale tenosynovitis15 (24.2)Patients with ≥1 Power Doppler tenosynovitis1 (1.6)Patients with ≥1 grey scale enthesitis lesion (thickness, hypo echogenicity, calcification, enthesophyte, erosion, bursitis)59 (95.2)Patients with ≥1 Power Doppler enthesitis32 (51.6)Conclusion:Our study showed persistent inflammation evaluated by US in PsA patients considered in remission by their rheumatologist. However, prevalence of residual inflammation evaluated by US was not higher in patients with self-assessment of their disease discordant from their rheumatologist.Disclosure of Interests:Marie Moly: None declared, Cédric Lukas: None declared, Jacques Morel: None declared, 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, Gael Mouterde: None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1303.2-1304
Author(s):  
J. Gratacos-Masmitja ◽  
J. L. Álvarez Vega ◽  
E. Beltrán ◽  
A. Urruticoechea-Arana ◽  
C. Fito-Manteca ◽  
...  

Background:Apremilast is a non-biologic systemic agent approved for the treatment of plaque psoriasis, oral ulcers of Behcet’s disease and PsA with proven efficacy in clinical trials [1,2]. However, more real-world evidence of apremilast use and effectiveness is needed to identify the patient profile most likely to benefit from this treatment [3].Objectives:To evaluate the persistence of apremilast treatment in patients with PsA naïve to biological treatments in routine clinical practice and assess its effectiveness. Baseline clinical characteristics on patients who started apremilast were also evaluated.Methods:Observational, prospective, multicenter (20 centers) study including consecutive adult patients with PsA naïve to biological therapies who had started treatment with apremilast during the previous 5 to 7 months and were followed-up during 12 months. Variables recorded were persistence of treatment with apremilast at 6 months (6mo) and number of swelling joints, presence of enthesitis and dactylitis, and disease activity, measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score and Physician Global Assessment (PGA) of psoriasis, collected at baseline (BL) (i.e., apremilast treatment start) and 6mo; comorbidities were retrospectively collected at BL. Categorical and quantitative variables were compared using McNemar’s and Wilcoxon test, respectively. Data sets analyzed included all assessable patients.Results:Of the 60 patients recruited at the time of this interim analysis, 54 (90.0%) [mean (SD) age 53.4 (13.9) years] were assessable; 41 (75.9%) of these continued treatment with apremilast at 6mo. At BL, 34 (63.0%) patients had at least one comorbidity, the most frequent being cardiovascular disease (n=15, 27.8%), including hypertension (n=8, 14.8%), metabolic/endocrine disease (n=18, 33.3%), including obesity (n=8, 14.8%) and dyslipidemia (n=10, 18.5%). Psychiatric disease (i.e., depression) (n=5, 9.3%) and neoplasia (n=8, 14.8%) were also observed. The number of swelling joints decreased from median (Q1, Q3) 4.0 (2.0, 7.0) at BL to 1.5 (0.0, 4.0) at 6mo (p=0.0012). Patients with dactylitis and enthesitis decreased from 19 (35.2%) and 16 (29.6%) at BL to 10 (18.5%) and 9 (16.7%) at 6mo (p=0.0225 and p=0.0391), respectively. The distribution of patients in the different disease activity categories according to DAPSA scale changed between BL and 6mo, indicating a favorable disease evolution (Figure 1 next page). According to PGA, at BL (n=53), disease activity was categorized as mild in 18.0%, as moderate in 72.0%, and as severe in 10% of patients and, at 6mo (n=54), as mild in 70.6%, as moderate in 25.5%, and as severe in 3.9% of patients. Fifteen (27.8%) patients interrupted treatment permanently (n=13, 24.1%) or temporarily (n=2, 3.7%), due to no/partial response (n=8, 14.8%), tolerability issues leading to adverse events (n=3, 5.6%), patient decision (n=2, 3.7%), and other reasons (n=2, 3.7%) after a mean (SD) treatment of 3.05 (2.20) months.Conclusion:Forty-one (75.9%) patients with PsA naïve to biological therapies were treated with apremilast during ≥6 months. After treatment, the number of swelling joints, and dactylitis and enthesitis decreased and changes in disease activity according to DAPSA and PGA pointed to a favorable disease evolution. Apremilast treatment provides a clinical benefit to patients with PsA treated in clinical practice.References:[1]Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Feb 10;75(3):499 LP-510[2]Torres T and Puig L. Apremilast: A novel oral treatment for psoriasis and psoriatic arthritis. Am J clin Dermatol. 2018 Feb;19(1):23-32[3]Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015. Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol. 2016;68(5):1060– 71.Disclosure of Interests:Jordi Gratacos-Masmitja Speakers bureau: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., Consultant of: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., José Luis Álvarez Vega Speakers bureau: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Consultant of: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Grant/research support from: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, ANA URRUTICOECHEA-ARANA: None declared., C. Fito-Manteca: None declared., Francisco Maceiras: None declared., Joaquin Maria Belzunegui Otano Speakers bureau: Lilly, Amgen, Novartis, Abbvie, Janssen., J. Fernández-Melón Speakers bureau: Amgen SL, Eugenio Chamizo Carmona: None declared., Abad Hernández Speakers bureau: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Consultant of: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Grant/research support from: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Inmaculada Ros Consultant of: Amgen, Grant/research support from: MSD, Roche, Novartis, lilly, Pfizer, Amgen, Eva Pascual Shareholder of: Amgen, Employee of: Amgen, Juan Carlos Torre Speakers bureau: Amgen, Lilly, Novartis, Janssen, Pfizer, Consultant of: Amgen, Lilly, Novartis, Janssen, Pfizer, Grant/research support from: Amgen, Lilly, Novartis, Janssen, Pfizer.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 320.1-321
Author(s):  
E. Loibner ◽  
V. Ritschl ◽  
B. Leeb ◽  
P. Spellitz ◽  
G. Eichbauer-Sturm ◽  
...  

Background:Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results.Objectives:The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-modifying antirheumatic drugs (bDMARDs) and apremilast in bDMARD-naïve patients could be observed across the three most prevalent inflammatory arthritis diseases: rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA). Additionally, a response to individual TNF blockers was investigated in this respect.Methods:Data from bDMARD-naïve RA-, SpA- and PsA-patients from Bioreg, the Austrian registry for biological DMARDs in rheumatic diseases, were used. Patients with a baseline (Visit 1=V1) and follow-up visits at 6 months (Visit 2=V2) and 12 months (Visit 3=V3) were included and response to therapy with TNF-inhibitors (TNFi), furthermore to therapy with rituximab, tocilizumab and apremilast was analyzed according to gender. The remaining bDMARDs were not analyzed due to small numbers. Key response-parameter for RA was disease activity score (DAS28), whereas for PsoA the Stockerau Activity Score for Psoriatic Arthritis (SASPA) and for SpA the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were employed; in addition, the Health assessment Questionnaire (HAQ) was used. Data were analyzed in R Statistic stratified by gender using Kruskal-Wallis and Wilcoxon tests.Results:354 women and 123 men with RA (n=477), 81 women and 69 men with PsA (n=150), 121 women and 191 men with SpA (n=312) were included. No significant differences in biometrics was seen between female and male patients at baseline in all diseases.In RA patients overall DAS28 decreased from baseline (V1) to V2 and V3 (DAS28: V1: male: 4.38 [3.66, 5.11], female: 4.30 [3.68, 5.03], p(m/f) = 0.905; V2: male: 2.66 [1.73, 3.63], female: 3.10 [2.17, 3.98], p(m/f) = 0.015; V3: male: 2.25 [1.39, 3.36], female: 3.01 [1.87, 3.87], p(m/f) = 0.002). For TNF inhibitors (n=311), there was a significant difference between genders at V2 (Fig.1a). Patients receiving Rituximab (n=41) displayed a significantly higher DAS28 at baseline in females, which diminished in the follow up: V1: (p(m/f) p=0.002; V2: p=0.019; V3: p=0.13); response to tocilizumab (n=63) did not show any gender differences.In PsA patients overall SASPA decreased from baseline (V1) to V2 and V3 (SASPA: V1: male: 4.00 [2.80, 5.20], female: 4.40 [2.80, 5.80], p(m/f) = 0.399; V2: male: 2.20 [1.20, 3.50], female: 3.40 [2.00, 5.00], p(m/f) = 0.071; V3: male: 1.80 [0.80, 2.70], female: 3.01 [2.35, 4.80], p(m/f) = 0.001). For TNF inhibitors (n=79), there was a significant difference between genders at V3 (Fig 1a). For Apremilast (n=39), there was a significant difference between genders at V2 (Fig.1c).In SpA patients overall BASDAI decreased from baseline (V1) to V2 and V3 (BASDAI: V1: male: 4.70 [2.88, 6.18], female: 4.80 [3.30, 6.20], p(m/f) = 0.463; V2: male: 3.05 [2.00, 4.60], female: 3.64 [2.62, 5.41], p(m/f) = 0.039; V3: male: 3.02 [1.67, 4.20], female: 3.65 [2.18, 5.47], p(m/f) = 0.016). In V3 a differential BASDAI in response to TNFi (n=299) was observed (Fig.1a).Possible differences of response to individual TNFi (etanercept, infliximab, other TNFi) measured by HAQ were investigated in all diseases together. The difference between male and females was significant at baseline for all 3 TNFi; whereas with the use of ETA the significant difference was carried through to V2 and V3, it was lost with the use of IFX and was variable with the other TNFi (Fig.1b)Figure 1.Conclusion:Female patients showed a statistically lower response to TNFi in all three disease entities (RA, SpA and PsoA) to a variable degree in our homogenous central european population. Interestingly, the difference was not uniform across individual TNFi when measured by HAQ. Gender differences were also seen in response to Apremilast.Disclosure of Interests:Elisabeth Loibner: None declared, Valentin Ritschl: None declared, Burkhard Leeb Speakers bureau: AbbVie, Roche, MSD, Pfizer, Actiopharm, Boehringer-Ingelheim, Kwizda, Celgene, Sandoz, Grünenthal, Eli-Lilly, Grant/research support from: TRB, Roche, Consultancies: AbbVie, Amgen, Roche, MSD, Pfizer, Celgene, Grünenthal, Kwizda, Eli-Lilly, Novartis, Sandoz;, Peter Spellitz: None declared, Gabriela Eichbauer-Sturm: None declared, Jochen Zwerina: None declared, Manfred Herold: None declared, Miriam Stetter: None declared, Rudolf Puchner Speakers bureau: AbbVie, BMS, Janssen, Kwizda, MSD, Pfizer, Celgene, Grünenthal, Eli-Lilly, Consultant of: AbbVie, Amgen, Pfizer, Celgene, Grünenthal, Eli-Lilly, Franz Singer: None declared, Ruth Fritsch-Stork: None declared


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