BackgroundAccording to different international registries, the frequency of use of biological agents in monotherapy in RA ranges from 12 to 39%. Targeted synthetic DMARDs (tsDMARDs-Jaki) have shown great efficacy when used as monotherapy. The rationale for this study is based on the fact that the frequency has increased with the appearance of the Jaki.ObjectivesTo estimate the frequency and reason of the use of biological drugs (bDMARDs) or tsDMARDs in monotherapy since 2013 (Year the Jaki were available in Argentina). To describe the frequency of monotherapy by treatment class and analyze the differential characteristics.MethodsRetrospective and cross-sectional multicenter study (10 reference centers from Argentina). Consecutive patients, ≥18 years, diagnosis of RA (ACR / EULAR 2010), who were under treatment with bDMARDs or tsDMARDs, started after 2013. Socio-demographic, disease and therapeutic data were collected.Statistical analysisdescriptive statistics, Chi2 test, Fisher’s exact test, Student’s T test and Mann Whitney were performed, according to the nature of the variables. A p <0.05 was considered significant.ResultsTotal 505 patients were included, 87.7% women, with a mean age 58 years (SD ± 13.5) and disease duration of 13 years (SD ± 7.8). Treatment: TNF blocker 42.1%, JAKi 30.3%, IL-6 blocker 10.9% and other treatments 16.8%.Since 2013, the frequency of monotherapy was 49% (95% CI: 45-53), in the last visit the current frequency was 41% (95% CI 37-45),of this 40% received JAKi. JAKi and IL-6 blocker were the treatments that were used more frequently in monotherapy vs combination modality (Figure 1).Figure 1.The main causes of monotherapy were intolerance (39.9%), adverse event (22%), physician’s decision (20.2%) and lack of adherence (17.7%) to DMARDs. Patients who were active workers (64% vs 55%, p <0.05), with higher socioeconomic status (31.4% vs 17.2% p <0.01), better mean HAQ at diagnosis (1.1 vs 1.3, p <0.05) an association was observed with monotherapy. In addition, an association was observed with the use of monotherapy in patients in the 2nd biological line or higher vs 1st line (53% vs 33%, p <0.01), lower polypharmacy (45.6% vs 60%, p <0.02) and a shorter mean time of biological treatment (47 months vs 39 months, p <0.01). These variables were entered in a logistic regression model, the results of the independently associated variables are shown in Table 1.Table 1.VariablepORCI 95%Employment status (active).0,1911,3270,8682,029Socioeconomic level (medium-high stratum)0,0022,151,3233,494HAQ at diagnosis, M (SD)0,0190,7040,5240,944First Line of biological treatment or Jaki (yes)0,020,4590,30,7Polypharmacy (>4 drugs) (yes)0,0180,6030,3950,918bDMARDs or tsDMARDs exposure time (months)0,0540,9940,9871ConclusionThe frequency of monotherapy, since the Jaki’s emergence, was 49% (all follow-up) and 41% (current-last visit). Intolerance to cDMARDs doctor and the patient decision were the main cause. The monotherapy use pattern was greater in those who received JAKi and anti IL6. The use of monotherapy was associated with work activity, socioeconomic status, and functional capacity at diagnosis. An association was also observed with less polypharmacy.References[1]Smolen JS, et al. Ann Rheum Dis 2020;79:685–699.[2]Emery P, Sebba A, Huizinga TW. Ann Rheum Dis.2013;72(12):1897–904.[3]F. Sommerfleck et al. Rev Arg Reumatol. 2013;24(4): 30-36[4]Aletaha D, Neogi T, Silman AJ,et al. Arthritis Rheum 2010. 2010;62(9):2569–81.Disclosure of InterestsRodrigo Garcia Salinas Speakers bureau: Abbvie, Lilly, BMS, Jassen, Novartis, boehringer ingelheim, Consultant of: Lilly, Jassen, Grant/research support from: Abbvie, Fernando Sommerfleck Speakers bureau: Abbvie, Janssen, Novartis, Grant/research support from: Abbvie, Alfredo Vargas Caselles: None declared, Luis Palomino Romero: None declared, Javier Rosa: None declared, Mariana Benegas: None declared, Etel Saturansky: None declared, Pamela Giorgis: None declared, Florencia Martinez: None declared, Marcelo Abdala: None declared, Jimena Sanchez Alcover: None declared, Emma Estela Civit De Garignani: None declared, Gabriela Vanesa Espasa: None declared, Verónica Inés Bellomio: None declared, Juan Manuel Bande: None declared, Silvia Papasidero: None declared, Veronica Saurit: None declared, Leticia Ibañez Zurlo: None declared, Emilio Buschiazzo: None declared
BackgroundThere is scarce evidence on the rate of adverse events and the consequences on disease activity after vaccination against covid19ObjectivesTo evaluate adverse events to vaccination and disease flares after vaccination in patients with axial spondyloarthritis (axSpA), peripheral spondyloarthritis (pSpA) and psoriatic arthritis (PsA) and to evaluate factors associated with adverse event.MethodsCross-sectional, observational, descriptive study. Consecutive patients with diagnosis of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) according to ASAS 2009 criteria; pSpA according to ASAS 2011 criteria and PsA according to CASPAR criteria were included. Demographic data, disease clinimetry, treatments, vaccination received and post-vaccination adverse events were recorded. We evaluated, according to medical criteria, whether the patient presented a flare disease after vaccination and whether it was mild, moderate or severe. We also evaluated the factors associated with the presence of at least one mild adverse event. Statistical analysis: descriptive statistics were performed, qualitative variables were expressed as frequency and percentage (%), numerical variables as mean and standard deviation (SD) or median and percentile25-75. Binary logistic regression was performed using the presence of at least one mild adverse event to vaccination as the dependent variable.Results210 patients were included with a mean age of 45 (SD 15) years. The diagnoses were: AS 50 (23.8%), nr-axSpA 10 (4.8), pSpA 9 (4.3%), PsA 141 (67%) and time of disease evolution in months 109 (SD 96). Regarding comorbidities, the following frequencies were reported: arterial hypertension 60 (30%), diabetes mellitus 25 (12%), heart failure 4 (2%), asthma/EPOC 15 (7%), inflammatory bowel disease 2 (1%), acute anterior uveitis 20 (9.5%), psoriasis 128 (61%). Sixteen percent (n=33) of the patients had SARS-CoV-2 infection prior to vaccination. Regarding treatments, those used were: antiTNF 88 (42%), Tofacitinib 6 (2.9%), Ustekinumab 2 (1%), Secukinumab 35 (17%), Ixekizumab 2 (1%), methotrexate 98 (47%), leflunomide 7 (3. 3), sulfasalazine 7 (3.3), apremilast 1 (0.5%), continuous NSAIDs 26 (12.4%) and NSAIDs on demand 103 (49%). Vaccines received were: Sputnik V 109 (51.9%), Oxford Vaccine, AstraZeneca 63 (30%), Janssen 1 (0.5%), BioNTech Vaccine, Pfizer 1 (0.5%), Sinopharm 33 (15.7%), Moderna 0%, Novavax 0% and others; 3 (1.4%). Thirty-eight percent (n=80) of patients reported having mild post-vaccination symptoms, of which 3.75% did not resolve, 41% resolved with medication and 39% resolved ad integrum without medication. The presence of mild adverse event to the vaccine was associated with lower use of methotrexate (31% vs 56 %, p<0.001), and lower age (54 (SD 14) vs 47 (SD 12), p<0.001), and lower BMI (25 (24-30.5) vs 28 (25-31), p<0.001); while no association was found with sex, diagnosis, comorbidities, treatments, desease activity or vaccines. In the logistic regression analysis all the variables remained independently associated with a lower probability of presenting a mild adverse event: methotrexate: OR: 0.30, 95%CI 0.15-0.58, p<0.001, age: OR: 0.97, 95%CI 0.95-0.99, p: 0.03, BMI: OR: 0.92, 95%CI 0.95-0.99, p: 0.02. Sixty-one percent (n=129) of patients received the 2nd dose of vaccination, which 27% (n=35) presented mild adverse event and only 1 (0.8%) patient suffered post vaccination disease flare.ConclusionVaccination against COVID19 appears to be safe in this population, with only mild adverse events and low frequency of flare disease. Mild adverse events were associated with less use of methotrexate, younger age and lower BMI.Disclosure of InterestsNone declared
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