Author:
Manrique Arija S.,Cabezas-Lucena A. M.,Godoy-Navarrete F.,Morales-Águila M.,Redondo R.,Mena-Vázquez N.
Abstract
BackgroundThe long-term use of standard dosing of TNFi therapy is costly and not without side effects, including infections, tuberculosis and potential malignancies(1,2,). Hence, we undertook this study to determine whether dose reduction of TNFi therapy may be possible in a realworld setting and if REDOSER tool(3) is an appropriateness criteria for reducing the dose of BT.ObjectivesDescribe the percentage of patients with inflammatory rheumatic diseases (IRD) who continue with dose reduction of biological therapy (BT). Evaluate relapse in clinical practice after 2 years of follow-up. Identify factors associated with relapse.MethodsRetrospective observational study. Patients with axial spondyloarthritis (axial SpA), psoriatic arthritis (PSA) and rheumatoid arthritis (RA) in BT dose reduction. Inclusion criteria: Axial SpA according to ASAS criteria, APS according to CASPAR criteria and RA according to ACR2010 criteria, who have started reducing the dose of BT treatment between 2009-2019 at the Hospital Regional Universitario de Málaga, Spain. Protocol: patients with TB are followed prospectively in a monographic consultation with a pre-established protocol. The day of dose reduction = baseline visit (v0). Variables:Maintained dose reduction: % of patients who maintained dose reduction from the start of optimization to the index date (data collection). Relapse at 12 and 24 months: % of patients who, after starting dose reduction, returned to the previous or usual dose. Other variables: Demographic, time to diagnosis and evolution of the disease, clinical-analytical: disease activity (DAS28, DAPSA and BASDAI) and physical function (HAQ, BASFI). Previous treatments. Appropriateness criteria for reducing the dose of BT according to REDOSER (1): 1.appropriate, 2. inappropiate, 3. uncertain. Statistical analysis: Descriptive, bivariate, multivariate logistic regression (VD: relapse).ResultsOne hundred twenty-nine patients with axial SpA, PSA and RA in BT dose reduction were included. The mean time from the start of BT to dose reduction was 38.1 months (16.6-73.1). The mean time in dose optimization was 19.5(±15.7) months. At the end of follow-up, 70.2% of the patients (87pts) achieved a sustained dose reduction. At 12 months and 24 months, 12.4% and 11.6% of patients relapsed, respectively. At the end of follow-up, there were no differences between baseline inflammatory activity and after 24 months in dose reduction measured by the different indexes: DAS28 (1.9[0.7] Vs 2.1[1, 7], p=0.323; DAPSA (5.4[4.9] Vs 4.8[4. 7], p=0.718, and BASDAI (1.5[1.1] Vs 1.4[1.3], p=0.867). Retrospectively, we evaluated the appropriateness of optimization according to the REDOSER tool (1) at the end of follow-up and it was observed that 85% of patients who maintained the dose reduction had an appropriate REDOSER and 14.5% uncertain and none inappropriate p<0.001.ConclusionDose reduction of BT in IRD is possible in most patients, maintaining low disease activity or remission at 24 months, compared to baseline.Relapse was associated with a longer evolution time of the IRD, a longer diagnostic delay, a higher inflammatory activity measured by the respective indices and a uncertain or inappropriate result of the REDOSER tool. This tool can be very useful used prior to the assessment of TB dose reductionReferences[1]Galloway JB, et al. Ann Rheum Dis 2011;70:1810_4.[2]Dixon WG, et al. Ann RheumDis 2010;69:522_8.[3]González-Álvaro I, Blasco AJ, Lázaro et al. Heliyon. 2017 Nov 14;3(11):e00452.Disclosure of InterestsSara Manrique Arija Speakers bureau: Abbvie, Gedeon, Jansen, Lilly, Menarini, MSD, Novartis, Pfizer, Roche, Sanofi, UCB.Consultant of: Abbvie, Jansen, Lilly, Novartis, Sanofi.Alba María Cabezas-Lucena: None declared, FJavier Godoy-Navarrete: None declared, Maria Morales-Águila: None declared, Rocio Redondo: None declared, Natalia Mena-Vázquez: None declared
Subject
General Biochemistry, Genetics and Molecular Biology,Immunology,Immunology and Allergy,Rheumatology