BackgroundThe impact of radiographic status on real-world secukinumab treatment effectiveness in axial spondyloarthritis (axSpA) patients is unknown.ObjectivesTo compare the treatment effectiveness of secukinumab in radiographic (r-)vs.non-radiographic (nr-) axSpA patients treated in routine care across Europe.MethodsProspectively collected data on secukinumab-treated axSpA patients with known radiographic status followed in routine care in the EuroSpA collaboration[1]were pooled from 9 countries. Patients were listed as r-axSpA if registered to fulfil the modified New York[2]or the radiographic ASAS classification[3]criteria. If patients were registered to fulfil neither criterion or if they did not fulfil one criterion and the other was unknown, patients were registered as nr-axSpA.Patient-reported outcome (PRO) remission rates including pain (VAS≤20), Bath Ankylosing Spondylitis Disease Activity (BASDAI≤20) and Functional Index (BASFI≤ 20) (all in the form of 0–100 visual analogue scale), and Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS inactive disease <1.3) after 6, 12 and 24 months of secukinumab treatment were calculated.Remission rates in r-axSpAvs.nr-axSpA patients were compared by logistic regression analyses in an unadjusted model (MODEL1), a model adjusted for age/gender (MODEL2) and a model adjusted for age/gender/country/previous bDMARD (yes/no)/baseline CRP/years since diagnosis to secukinumab initiation (MODEL3). For MODEL3, parameter estimates (CRP) from 100 imputed data sets were pooled using Multivariate Imputation by Chained Equations.ResultsPatients with r-axSpA had longer disease duration at secukinumab initiation, were more frequently males and HLA-B27 positive compared to nr-axSpA patients. PROs at baseline were largely similar between groups, while CRP and ASDAS-CRP were higher in r-axSpA patients. A higher percentage of nr-axSpA patients had received previous bDMARDs compared to r-axSpA patients.Crude PRO remission rates at 6/12/24-months were significantly lower in nr-axSpA compared to r-axSpA patients (Table 1, Figure 1 (MODEL1)) as were percentages of patients in ASDAS inactive disease (Table 1). However, when adjusting for age/gender (MODEL2) the difference in PROs diminished, and when adjusting for multiple possible confounders (MODEL3), no significant differences were found between the two groups (Figure 1). Differences in percentages of patients in ASDAS inactive disease in r-axSpAvs.nr-axSpA patients were almost unaffected by adjustments (Figure 1).ConclusionWhile crude remission rates in European secukinumab-treated patients followed in routine care were higher in r-axSpA compared to nr-axSpA patients, this difference disappeared after adjusting for multiple confounders, and, thus, appeared to be related to other factors than radiographic status.References[1]https://eurospa.eu/[2]van der Linden et al. Arthritis Rheum 1984.[3]Rudwaleit et al. Ann Rheum Dis 2009.Table 1.Baseline characteristics and remission rates for European secukinumab treated r- and nr-axSpA patients.Radiographic axSpA (n=899)Non-radiographic axSpA (n=236)BASELINEValue (%/ median (IQR))N availableValue (%/ median (IQR))N availableAge (years)47 (38–55)89946 (36–55)236Male (%)6189936236HLA–B27 pos (%)8075455214Years from diagnosis7 (3–14)8864 (2–8)231bDMARD naïve (%)4089926236Pain (VAS, 0-100)70 (55–85)61470 (51–80)128BASDAI (0-100)64 (50–76)68567 (49–76)139BASFI (0-100)55 (35–73)47654 (30–73)118CRP (mg/L)16 (5–31)6805 (2–15)151ASDAS–CRP4.0 (3.2–4.7)6233.6 (2.9–4.2)123FOLLOW-UPRemission rates(6m/ 12m/ 24m)N available(6m/ 12m/ 24m)Remission rates(6m/ 12m/ 24m)N available(6m/ 12m/ 24m)Pain remission (≤ 20), (%)39.2/ 46.1/ 47.7523/ 360/ 17422.8/ 25.0/ 27.6114/ 76/ 29BASDAI remission (≤ 20), (%)37.6/ 41.2/ 49.7603/ 408/ 19721.9/ 19.3/ 19.4128/ 83/ 31BASFI remission (≤ 20), (%)31.4/ 36.2/ 40.9376/ 240/ 11024.1/ 28.2/ 33.3108/ 71/ 27ASDAS inactive disease (<1.3), (%)11.4/ 12.5/ 18.9559/ 383/ 1906.5/ 5.7/ 7.7108/ 70/ 26AcknowledgementsNovartis Pharma AG for supporting the EuroSpA collaboration.Disclosure of InterestsSara Nysom Christiansen Speakers bureau: BMS, Novartid and GE, Grant/research support from: Novartis, Simon Horskjær Rasmussen: None declared, Mikkel Østergaard Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, Consultant of: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, Brigitte Michelsen Grant/research support from: Novartis, Karel Pavelka Speakers bureau: Pfizer, MSD, BMS, UCB, Amgen, Egis, Roche, AbbVie, Consultant of: Pfizer, MSD, BMS, UCB, Amgen, Egis, Roche, AbbVie, Catalin Codreanu Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Adrian Ciurea Speakers bureau: AbbVie, Novartis, Bente Glintborg Grant/research support from: Pfizer, Abbvie, BMS, Maria Jose Santos Speakers bureau: Abbvie, AstraZeneca, Lilly, Novartis, Pfizer, İsmail Sari: None declared, Ziga Rotar Speakers bureau: Abbvie, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen, Consultant of: Abbvie, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen, Björn Gudbjornsson Speakers bureau: Novartis and Nordic Pharma, Consultant of: Novartis and Nordic Pharma, Jakub Zavada Speakers bureau: Abbvie, Elli-Lilly, Sandoz, Novartis, Egis, UCB., Consultant of: Abbvie, Elli-Lilly, Sandoz, Novartis, Egis, UCB., Corina Mogosan: None declared, Michael J. Nissen Speakers bureau: AbbVie, Eli Lilly, Janssens, Novartis, Pfizer, Consultant of: AbbVie, Eli Lilly, Janssens, Novartis, Pfizer, Anne Gitte Loft Speakers bureau: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Anabela Barcelos Speakers bureau: Abbvie, Janssen, Novartis, Consultant of: Abbvie, Lilly and Novartis, Yesim Erez: None declared, Katja Pirkmajer Speakers bureau: Abbvie, Novartis, MSD, Medis, Eli Lilly, Pfizer, Lek, Janssen, Consultant of: Abbvie, Novartis, Medis, Eli Lilly, Pfize, Boehringer Ingelheim, Gerdur Gröndal: None declared, Merete Lund Hetland Speakers bureau: Pfizer, Medac, Sandoz, Grant/research support from: Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis.
Background:SSc (systemic sclerosis) is a connective tissue disease characterized by small vessel vasculopathy, production of autoantibodies, and fibroblast dysfunction leading to increased deposition of extracellular matrix in the skin and internal organs mainly. Therewithal, many SSc patients develop musculoskeletal symptoms during the course of their illness. Different rheumatic complaints such as arthralgia, arthritis, contractures, tendon friction rubs, calcinosis, and acroosteolysis can be seen as musculoskeletal symptoms in SSc patients [1].Objectives:To provide an overview of the spectrum of articular involvement in SSc and determine the relationship between these involvements and Rheumatoid factor (RF) and Anti-cyclic citrullinated peptide (Anti-CCP) positivity and organ involvements.Methods:We performed a retrospective cohort study involving 232 SSc patients who were followed up in our department of rheumatology between 2000 and 2020 years. The patients were divided into two groups as limited and diffuse SSc. Age, gender, weight, height, smoking habits, duration of illness, follow-up duration, other systemic organ involvement, and radiographic findings were recorded. Diagnostic tests such as RF, Anti-CCP, ANA, ENA panel tests, direct radiographs were examined.Results:The mean age of the patients was 59.9 ± 12.8 and 88.4% of them were women. 69.3% of patients were limited SSc. At any stage of the disease, 39.1% of all patients had arthralgia and 34.1% had arthritis. The arthritis rate was similar between the SSc groups (p = 0.396). RF and anti-CCP positivity rates were similar between the SSc groups. Although RF and anti-CCP positivity rates were higher in the patient group with arthritis, it was not statistically significant (respectively p=0.563, p=0.072). Interestingly, the lung involvement rate was higher in patients with arthritis (63.3% versus 46.4%) (p=0.015). Other clinical, demographic characteristics, laboratory, and radiographic findings of the patients are shown in Table 1.Conclusion:Articular involvement in SSc is a common clinical feature seen in one-third of patients regardless of the type of disease. Although RF and Anti-CCP positivity are more common in patients with arthritis, it was not statistically significant. Interestingly, arthritis is a more common manifestation in patients with lung involvement.References:[1]R. D. Sandler, M. Matucci-Cerinic, and M. Hughes, “Musculoskeletal hand involvement in systemic sclerosis,” Seminars in Arthritis and Rheumatism, vol. 50, no. 2. 2020, doi: 10.1016/j.semarthrit.2019.11.003.Table 1.Demographic and clinical characteristics of b/tsDMARDs patientsTable-1Limited SSc(n=161)Diffuse SSc(n=71)All patients(n=232)PAge (years) (Mean±SD)60.5 ± 12.758.6 ± 12.959.9 ± 12,80.295Disease duration (years) (Mean±SD)11.5 ± 6.612.4 ± 8.111.8 ± 7,10.384Weight (kg) (Mean±SD)68.2 ± 13.366.2 ± 15.667.6 ± 14.10.331BMI (kg/m2) (Mean±SD)27.6 ± 5.526.2 ± 6.127.1 ± 5.70.102Female, n (%)146 (90.7)59 (83.1205 (88.4)0.097Current and ex smoker, n (%)60 (37.2)18 (25.4)78 (33.6)0.077Digital ulcer, n (%)53 (32.9)34 (47.9)87 (37.5)0.03*Contracture on hand28 (17.4)28 (39.4)56 (24.1)<0,001*Arthralgia, n (%)63 (39.1)29 (31.5)92 (39.7)0.806Arthritis, n (%)52 (32.3)27 (38)79 (34.1)0.396Joint space narrowing on X-ray, n (%)44 (51.2)30 (63.8)74 (55.6)0.160Joint erosion on X-ray, n (%)17 (19.8)14 (29.8)31 (23.3)0.205Acroosteolysis on X-ray, n (%)9 (10.5)16 (34)25 (18.8)0.001*ANA positivity, n (%)155 (96.3)69 (97.2)224 (96.6)0.728Anti-Scl positivity, n (%)41 (28.7)48 (71.6)89 (42.4)<0.001*Anti-centromere positivity, n (%)65 (45.5)10 (14.9)75 (35.7)<0.001*RF positivity, n (%)27 (17.5)14 (20.6)41 (18.5)0.589Anti-CCP positivity, n (%)16 (12.7)7 (11.3)23 (12.2)0.782P*Independent Samples t Test, Pearson Chi-Square Test, BMI; Body mass index, ANA; Anti nuclear antibody,RF; Rheumatoid factor, Anti-CCP;Anti- Cyclic citrullinated peptideDisclosure of Interests:None declared.
Background:Systemic sclerosis (SSc) is chronic, autoimmun multisystem disorder presented by thickening and fibrosis of the skin and internal organs. Esophageal involvement is one of the most common manifestation. Esophageal enlargement on HRCT is a common finding in scleroderma patients and may also be associated with other scleroderma-related clinical findings (1).Objectives:The aim of this study to evaluate the association between esophageal dilatation on chest HRCT at diagnosis with the other SSc features.Methods:The study was planned for SSc patients registered between October 2007 and September 2020 in Dokuz Eylul University Rheumatology Department database. Demographics, clinical features and medical history were recorded. The baseline HRCT reports were screened in terms of esophageal dilatation. Then, the initial HRCT images were assessed for esophageal dilatation by an experienced chest radiologist according to recommendation of Pitrez et al.Results:In our study, there were 233 SSc patients (f:206 M:27, mean age 59.9±12.7 years) 71 (31.4%) of them diagnosed with diffuse disease. Median follow-up of study was 73 (1-272) months. Esophageal dilatation on HRCT was detected in 60 (25.8%) of SSc patients. 67 out of 155 patients (43.2%) had proof of esophageal involvement in esophageal transit scintigraphy. There is no statistical correlation was found between esophageal dilatation on HRCT with gender, smoking, arthritis, pulmonary hypertension and autoantibody subtypes. Development of digital ulcer and telangiectasia is statistically higher in SSc patients with oesophageal dilatation on baseline chest HRCT (p=0.001 and p=0.039, respectively). There was a positive correlation between Modified Rodnan Skin Score (mRss) and esophageal dilatation (r=0.213, p: 0.004).Conclusion:HRCT can be a reproducible and non-invasive method for evaluating esophageal dilatation. Presence of esophageal dilatation at baseline HRCT might be indicative for pulmonary involvement and SSc related gastrointestinal complications. Consecutive chest HCRT should be evaluated to obtain more reliable data about the relationship between esophageal dilatation and SSc related clinical features.References:[1]Pitrez EH, Bredemeier M, Xavier RM et al.Ooesophageal dysmotility in systemic sclerosis:comparison of HRCT and scintigraphy. Br J Radiol 2006; 79: 719–24.Table 1.Clinical and demographic characteristics of the presence of esophageal dilatation on HRCTEsophageal dilatation on HRCTTotal (n=233)Yes (n=60, 25.8%)No (n=173, 74.2%)pMean±SD.Mean±SD.Mean±SD.Age, years59.9±12.759.7±12.260.1 ±12.6>0.05n%n%n%Female20688,4%5388,3%14986,1%>0.05Smoking7933,9%1931,7%6034,7%>0.05Diffuse SSc7130,5%2338,3%4425,4%>0.05Overlap syndrome3314,2%813,3%2514,5%>0.05Pulmonary fibrosis11850,6%4270,0%7643,9%>0.05Arthritis8034,3%2338,3%5632,4%>0.05Telengiectasia15667,0%4880,0%10560,7%0,039Digital ulcer8737,3%3456,7%5129,5%0,001Anti-Scl 70 (+)8938,2%2846,7%5934,1%>0.05Anti-centromer (+)7532,2%1525,0%5934,1%>0.05Disclosure of Interests:None declared
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