Background: There is an increasing interest in the use of eccentric muscle exercise to improve physical condition, especially with regards to its health-related benefits. However, it is known that unaccustomed eccentric exercise causes muscle damage and delayed pain, commonly defined as "delayed onset muscle soreness" (DOMS). The efficacy of herbal preparations in subjects suffering from DOMS has been reported in a few previous studies with small or moderate outcome measures related to muscle recovery. The present study aimed to evaluate the effects of a polyherbal mixture containing whole Zingiber officinale Roscoe and Bixa orellana L., powders called ReWin(d), in young male athletes suffering from DOMS induced by a 1 h session of plyometric exercises. Methods: Thirty-three young male athletes participated in this randomized, Triple-blind, placebo-controlled trial: 17 of them assigned to the ReWin(d) group and 16 of them to the placebo group. Creatine kinase (CK) was measured as a muscle damage marker, pain was assessed using the Visual Analog Scale (VAS), muscle performance was measured through half-squat exercise (HS) monitored with an accelerometer (Encoder), and heart rate variability (HRV) was monitored for 5 min with the subjects in the supine position. All determinations were performed before and after the eccentric session and 24, 48, and 72 h after the session.

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

No abstract

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

Background:The administration of intravenous biological therapies is based on the manufacturer’s instructions and the administration guidelines of Spanish Medicine Agency. We observed that a considerable amount of the solution remains in the tubing of the equipment after the administration of the drug. This amount depends on the drug and the solution used for the infusion. In the particular case of Infliximab is around 7% of the total solution to infuse, so it could potentially have a relevant therapeutic impact.Objectives:To assess the variation in serum trough levels of Infliximab after the systematic application of flush physiological serum after drug administration.Methods:The study was divided into two phases: a first phase in which the clinical and analytical variables (including the serum trough levels of infliximab) were measured before the application of the flush serum and a second stage in which the same variables were measured after the systematic implementation of an infusion of 50ml of 0.9% sodium chloride following the administration of infliximab.Results:A total of 35 patients were collected, including 6 rheumatoid arthritis (13.3%), 9 psoriatic arthritis (20%) and 20 ankylosing spondylitis (AS) (44.4%). Overall, 18 patients were women (40%), the mean age was 57.6 years (12.6) and the BMI was 30.5 (13.1). The mean dose of infliximab was 4.3 mg/kg (1.1) and the mean number of years of treatment was 10 (5).23 patients were taking infliximab on monotherapy (51.1%). The mean serum trough levels of infliximab pre-intervention with the dragging serum was 3.13 mg/dl (3.1), while postintervention levels were 3.66 mg/dl (3.9) (p = 0.071). In the subgroup of patients with AS there was a significant decrease in BASDAI between the pre and post intervention visit (3.4 vs 2.6, p <0.05).Conclusion:The use of flush serum after infliximab infusion increased serum drug levels. In the subgroup of patients with AS there was a clinically significant improvement measured by BASDAI.References:[1] Ficha técnica de Inflectra®. Disponible en: https://cima.aemps.es/cima/pdfs/es/ft/98067002/FT_98067002.pdf[2] Ficha técnica de Remicade®. Disponible en: https://cima.aemps.es/cima/dochtml/ft/99116001/FT_99116001.html[3] Grupo de Trabajo de Enfermeria de la Sociedad Española de Reumatología (GTESER). Manual de terapias parenterales y procedimientos en el paciente reumatológico 2018. Madrid, 2018.[4] Herrero Massari F, Lozano Serrano V, Rodruiguez Arteaga E. Guía de Manejo de Fármacos Biológicos para Enfermería en los Hospitales de Día. 2010[5] Moots RJ1, Xavier RM2, Mok CC3, Rahman MU4, Tsai WC5, Al-Maini MH6, Pavelka K7, Mahgoub E4, Kotak S4, Korth-Bradley J4, Pedersen R4, Mele L4, Shen Q4, Vlahos B4. The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study. PLoS One. 2017 Apr 27;12(4):e0175207. doi: 10.1371/journal.pone.0175207. eCollecti...