Objective Few studies examine psychopathology in different juvenile idiopathic arthritis (JIA) subtypes and disease activity states. We aimed to 1) Evaluate emotional and behavioral symptoms in children with spondyloarthritis (SpA) and polyarticular arthritis (PolyA) as compared to a national normative population using the Child Behavior Checklist (CBCL), and 2) Evaluate the relationship between CBCL scores and disease activity. Methods JIA patients aged 6-17 years with SpA or PolyA were recruited from our Pediatric Rheumatology clinic from April 2018 to April 2019 and the CBCL and Juvenile Arthritis Disease Activity Score (cJADAS10) were completed. Primary outcome measures were CBCL total competence, internalizing, externalizing and total problems raw scores. We compared outcomes from each group to national CBCL normative data. To investigate the relationship between CBCL scores and disease activity, we ran a generalized linear regression model for all arthritis patients with cJADAS10 as the main predictor. Results There were 111 patients and 1753 healthy controls. Compared to healthy controls, SpA or PolyA patients had worse total competence and internalizing scores. Higher cJADAS10 scores were associated with worse total competence, worse internalizing, and higher total problems scores. Most of these differences reached statistical significance (p<0.01). Self-harm/ suicidality was almost four-fold higher in patients with PolyA than healthy controls (OR 3.6, 95% CI 1.3-9.6, p=0.011). Conclusion Our study shows that SpA and PolyA patients with more active disease have worse psychological functioning in activities, school and social arenas and more internalized emotional disturbances suggesting the need for regular mental health screening by rheumatologists.
Background:Biological therapy revolutionized the treatment and prognosis of inflammatory arthropathies; however, its high cost has an economic impact on health system and limits its access. Biosimilars are products with similar molecular structure, equivalent efficacy, and comparable safety and immunogenicity, which arise as a necessity to reduce costs. Although, their long-term safety is still to be confirmed1.Objectives:Our aim is to compare the safety and effectiveness between adalimumab reference product and biosimilar in patients with inflammatory arthropathies.Methods:Cohort study of 92 patients with ankylosing spondylitis (AS), rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in a specialized multicenter health institution in Colombia. Ratio of incidence rates (IR) for Adverse Drug Reactions (ADR) and therapeutic failure (TF) is estimated among patients exposed to reference product and biosimilar. 95% confidence interval (CI) for the ratio is also calculated. ADR and TF Incidences in both groups were calculated using the Kaplan Meier curve.Results:Between October 2019 and October of 2020, 92 patients started adalimumab, 64% (n = 59) reference product and 36% (n = 33) biosimilar (18 naive and 15 switch). 41.3% of patients had a diagnosis of RA, 35% AS and 24% PAs. Additionally, 62% were women, with median age of 53 years (Interquartile Range (IQR): 41-62); disease evolution time of 9 years (IQR: 5-20); and treatment time of 0.8 years (IQR: 0.4-1.04). No statistically significant differences were found according to the drug between diagnosis, evolution time, or disease activity. Of all patients 21 presented ADR; 11 events with reference product (IR 0.18 per 100 person-years), and 10 with biosimilar (IR 0.30 per 100 person-years), IR ratio of 0.61 (95%CI 0.26-1.44; p-value = 0.36). From ADR reactions, 35% were infections, 13% skin disorders and 7.4% hepatobiliary disorders; all were classified as non-serious ADR. 5 TF events were presented, 3 with reference product (IR 0.05 per 100 person-years) and 2 with biosimilar (IR 0.06 per 100 person-years); IR ratio of 0.83 (95% CI 0.09-10.04; p value= 1.00). There was no statistically significant between reference product and biosimilar in time of ADR presentation (Log Rank Test 0.74; p= 0.39) or on TF (Log Rank Test 0.55; p= 0.45).Conclusion:Results shown that analyzed biosimilar is a safe product with a similar rate of ADR and without differences in effectiveness evaluated by TF, although 95% CIs are imprecise. This suggests that use of biosimilars in a real-life setting could be safe and with similar effectiveness, which is correlated with other studies carried out in RA and is an appropriate measure to reduce treatment costs in patients with inflammatory arthropathy.References:[1]Cohen, S. B. et al. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opin. Biol. Ther.19, 1097–1105 (2019).Acknowledgements:To Medicarte for the supportDisclosure of Interests:Wilmer Gerardo Rojas Zuleta Speakers bureau: Pfizer, Jannsen Cilag, Novartis, Bristol Myers Squibb, Biopass, Amgen, Paid instructor for: Pfizer, Jannsen Cilag, Novartis, Bristol Myers Squibb, Biopass, Amgen, Oscar Jair Felipe Díaz Speakers bureau: Amgen, Jannsen Cilag, Bristol Myers Squibb, Novartis, Ely-Lilly, Catalina Orozco Gonzalez: None declared, Jhyld Barbosa Camacho: None declared, Claudia Lucía Giraldo Herrera Speakers bureau: Jannsen Cilag, Bristol Myers Squib, Amgen, Pfizer, Novartis, Roche, Paid instructor for: Jannsen Cilag, Bristol Myers Squib, Amgen, Pfizer, Novartis, Roche, Jesús G Ballesteros Speakers bureau: Bristol Myers, Pfizar, Amgen, Jannsen Cilag, Paid instructor for: Bristol Myers, Pfizar, Amgen, Jannsen Cilag, Jorge Hernando Donado Gómez: None declared, Natalia Duque Zapata: None declared
BackgroundSpondyloarthritis (SpA) is a group of inflamatory diseases with multiple clinical manifestations (axial, peripheral, skin, eye, and intestine) including ankylosing spondylitis (AS), reactive arthritis, psoriatic arthritis (PsA), arthritis associated with inflammatory bowel disease, and non-radiographic axial spondyloarthritis. SpA is genetically related to HLA-B*27 as more tan 95% of the cases have it, while in general population its frequency is below 10%. The etiology and pathogenesis of this disease are unknown. Notwithstanding, the misfolding hypothesis suggests that it may be triggered by the formation of HLA-B*27 homodimers. The risk of developing SpA is 5-7% in positive HLA-B*27 individuals (1,2).ObjectivesExplore the relapse incidence and its associations with HLA-B*27 in SpA patients.MethodsSpA patient cohort in a specialized multicentric health institution in Colombia (November 2011 to June 2021). Relapse was defined as the BASDAI increment ≥1 + 2≤ final BASDAI ≤4. A stratified analysis was performed for HLA-B*27 between diagnosis, current medication, and relapse. For group comparisons χ2 and Wilcoxon tests were used, according to variable distribution. A logistic regression model was run in order to explain relapse incidence.Results515 patients were included, among whom 60.9% were HLA-B*27 positive. 87.0% had an AS diagnosis (53.3% of men), 11.4% (64.4% of women) non-radiographic axial spondyloarthritis and 1.55% PsA (62.5% of women). Table 1 shows demographic and clinical characteristics. The relapse incidence was associated with positive HLA (Odss Ratio-OR 2.14 CI95% 0.982-4.674, p=0.055) and with time of disease evolution (OR 1.05 IC95% 1.02-1.091, p= 0.001) adjusting for sex.Table 1.Demographic and clinical characteristicsHLA-B*27p value*Negative (n=201)Positive (n=314)CharacteristicsMedianIQRMedianIQRAge4940 to 584637 to 550.020Time of disease evolution6.64.6 to 10.68.65.6 to 14.60.000Treatment time3.22.1 to 6.43.32 to 5.60.648BASDAI at entry4.101.1 to 6.54.201.6 to 6.30.510Current BASDAI1.20 to 3.30.40 to 2.00.113n%n%SexWomen13366.1711937.90.000Men6833.8319562.1DiagnosisNon-radiographic axial spondyloarthritis3215.92278.60.013Psoriatic arthritis52.4930.96Ankylosing spondylitis16481.5928490.45Current medicationSynthetic DMARD136.47196.050.780Anti-TNF15476.6225179.94Anti-IL172411.94299.24Without treatment104.98154.78RelapseYes104.98319.870.045* p value for the difference between HLA-B*27 positive and negative groups. IQR: interquartile rangeConclusionIn SpA patients, HLA-B*27 frequency is higher in AS patients compared to other SpA forms. Furthermore, this is associated with a higher relapse risk and longer time of disease evolution.References[1]Sharip A, Kunz J. Understanding the Pathogenesis of Spondyloarthritis. Biomolecules. 2020 Oct 20;10(10):1461.[2]Colbert RA, Navid F, Gill T. The role of HLA-B*27 in spondyloarthritis. Best Pract Res Clin Rheumatol. 2017 Dec;31(6):797-815.Disclosure of InterestsNone declared
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