Background:The optimization of biological agents (bDMARD), is a strategy that has proven to be cost effective and its use can reduce the risk related to drug exposure (1–3). It is included in the EULAR management guidelines and in the consensus of the Colombian Rheumatology Association.Objectives:To analyze optimization success of bDMARD therapies in patients with RA.Methods:Cohort study of RA patients in a specialized multicenter institution in Colombia, followed from January 2015 to December 2019. Patients in remission or low activity for at least 6 months with bDMARD, and with at least two consecutive medical visits, were included. Optimization types were dose decrease, application interval increments, or both. Patients who had disease reactivation (DAS28- CPR >3.2) and returned to standard dose, were considered a failure. By Kaplan-Meier analysis, the optimization failure was estimated according to bDMARD typeResults:92 patients were included, 78.26% were women, with a median age of 57 years (IQR 50-64), a disease evolution time of 15 years (IQR 10-21), a treatment of 5.6 years (IQR 2.7-8.0), and optimization of 7.75 months (IQR 3.25-15.75). The most commonly used bDMARD therapies were etanercept 36.96%, tocilizumab 30.43% and adalimumab 16.30%. 69.39% (34) were naive for biological treatment. The 53.26% (49) of patients had a follow-up time greater than 6 months.95.92% remained under optimization scheme without disease activity changes, and 4.08% of patients underwent definitive discontinuation of bDMARD, for sustained therapeutic objective. 8.16% (4) had relapses in the first 6 months after onset, of which 2 patients returned to standard doses. In survival analysis it was observed that patients who were optimized for antiTNF failed faster than the non-antiTNF, although this difference was not statistically significant (Log Rank test 0.003 p value = 0.959). Of the total patients, 28 have been optimized for 12 months or more, of these, 96.43% (27) continue in sustained remission, and 55.56% (15) received combined therapy with s synthetic DMARD (sDMARD).Figure 1.Kaplan MeierConclusion:During follow-up, most patients remain in optimization strategy. In those who continued in sustained remission, more than half received sDMARD, this suggests that their use may be a determining factor in preventing disease relapses. More studies are required to evaluate this hypothesis.References:[1]Niccoli L, Nannini C, Blandizzi C. Personalization of biologic therapy in patients with rheumatoid arthritis: Less frequently accounted choice-driving variables. Ther Clin Risk Manag. 2018;14:2097–111.[2]ASOREUMA. Asociación Colombiana de Reumatología. Consenso sobre recomendaciones para disminución y descontinuación de la terapia biológica en pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica. Rev Colomb Reumatol. 2019 Jan;26(1):11–23.[3]Cantini F, Niccoli L, Nannini C. Second-line biologic therapy optimization in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Semin Arthritis Rheum. 2017;47(2):183–92.Disclosure of Interests:None declared
BackgroundRheumatoid Arthritis (RA) patients are effectively treated with anti-TNF-α therapy. However, pharmacological non-adherence limits the achievement of the therapeutic objective. This is a multifactorial behavior where factors such as the route of administration, frequency, tolerance, perception of improvement, polypharmacy and social factors are involved [1,2].ObjectivesTo explore the factors associated with non-adherence to anti TNF-α in RA patients during the COVID-19 pandemic.MethodsThis is a cohort of RA patients treated with anti TNF-α in Medicarte SAS, a Colombian center for Immune-Mediated Diseases, between January to December 2021. The program implements strategies such as pharmacotherapeutic support, informed dispensing, phone calls, text messages and home care services to increase adherence. Adherence was defined as dispensing at least 10/12 (>0.80) prescribed monthly doses for 1 year. Sociodemographic characteristics, time in the program, DAS28-CRP, HAQ and treatment were included as exposure variables. For continuous variables, median and interquartile range (IQR) were calculated. Adjusted Odds Ratio (AOR) with logistic regression were calculated, and a p-value <0.05 was considered as statistically significant.Results565 patients were included, 85.8% (n=485) were women, median age 56 years (IQR: 49-65), disease evolution time 13.7 years (IQR: 7.7-20.8), 51% (n=288) had been in the program for more than 3 years, the median time in treatment with anti TNF-α was 3 years (IQR: 1-3) and DAS-28-CRP 2.4 (IQR: 1.6-3.4). The most frequently anti TNF-α prescribed was etanercept 46.0% (n=260), followed by adalimumab 23% (n=130), subcutaneous golimumab 13.3% (n=75), certolizumab 11.0% (n=62) and intravenous golimumab 6.7% (n=38). At the admission, 18.2% (n=103) of the patients had high activity, 38.6% (n=218) mild activity, 9.2% (n=52) low activity and 34% (n=192) were in remission. At the end of follow-up, 6.4% (n=36) of patients had high activity, 18.2% (n=103) mild activity, 14.3% (n= 81) low activity and 61.1% (n= 345) were in remission. The 51.5% (n=291) did not have pharmacological adherence. The use of etanercept (AOR 0.36 CI95% 0.23- 0.58, p < 0.001) and adequate functionality measured through HAQ (AOR 0.64 CI95% 0.42- 0.97, p < 0.04) were associated with a lower risk of non-adherence. Higher DAS28-CRP at the end of follow up was associated with non-adherence (AOR 1.29 CI95% 1.12 - 1.48, p < 0.001).ConclusionDuring COVID-19 pandemic, the implementation of strategies in the home care patient program guaranteed adherence close to 50% in our cohort. Higher values of DAS28-CRP were associated with non-adherence, whilst etanercept use and a normal HAQ value were associated with a higher probability of adherence.References[1]Marengo MF, Suarez-Almazor ME. Improving treatment adherence in patients with rheumatoid arthritis: what are the options? Int J Clin Rheumtol. 2015 Oct 1;10(5):345-356.[2]Smolen JS, Gladman D, McNeil HP, Mease PJ, Sieper J, Hojnik M, et al. Predicting adherence to therapy in rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis: a large cross-sectional study. RMD Open. 2019 Jan 11;5(1):e000585.Acknowledgements:NIL.Disclosure of InterestsWilmer Gerardo Rojas Zuleta Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Mario Barbosa: None declared, Oscar Jair Felipe Díaz Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Adelis Enrique Pantoja Marquez: None declared, Jeixa Canizales: None declared, Carolina Becerra-Arias: None declared, Jorge Hernando Donado Gómez: None declared, Natalia Duque Zapata: None declared.
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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