BackgroundIn 2015 it began to be used in many EU countries the first biosimilar antiTNF (Infliximab) approved by the EMA. The Korean company owns the molecule under the trademark Remsima® was widely used for replacing existing treatments with infliximab molecule marketed since 1999 as Remicade in the approved indications in sheet for this purpose, RA, AS and PsA.ObjectivesControl the security and survival of the drug in patients Remsima® in which replaced the molecule Remicade infliximab. Settled visits every 3 months to monitor the occurrence of adverse events with possible association to the drug. Patients were followed in routine clinical practice for 8 different doctors.Methods78 patients began treatment with Remsima® since March 2015. Of these, 25 were suffering from Rheumatoid Arthritis, Psoriatic Arthritis 8, SpA 41 and severe uveitis 2. 53 of these patients had already been treated with Remicade and 25 were “naive” to IFX, having been previously treated with other biological therapy or were naive to this.Results37 patients, less than half have associated a DMARD in the 9th month of follow-up (70'2% MTX). 11 patients with Remsima not reached 37 weeks of follow-up and were removed (5 of these patients had replaced Remicade). None of them was removed for serious adverse effect. Overall 86% survival at 9 months. No patient dropped the sheet approved for disease Remsima 3mg/kg body weight or Remsima 5mg/kg dose before 6 months of treatment.The reasons for medication discontinuation were in the 5 cases of replacement Remicade by Remsima: 4 loss efficacy and cutaneous leishmaniasis.For patients naive to Remicade, 1 case of possible photosensitivity, 1 case of bronchospasm during infusion, one case of urticaria, 1 case of hip replacement surgery, one transfer to another country of residence and a loss of effectiveness.The reasons for medication discontinuation were in the 5 cases of replacement Remicade by Remsima: 4 loss efficacy and cutaneous leishmaniasis.For patients naive to Remicade, 1 case of possible photosensitivity, 1 case of bronchospasm during infusion, one case of urticaria, 1 case of hip replacement surgery, one transfer to another country of residence and a loss of effectiveness. 4 patients showed in repeated infusions dizziness, headache or neck stiffness within 48 hours of infusion Remsima. However they asked to continue with medication.Overall 86% survival at 9 months.Only 23% of patients needed glucocorticoid use at 9 months. 22% of patients required to reduce the infusion period IFX-Remsima 7 weeks or less. Finally in 4 patients an optimization of treatment extending to more than 8 weeks was achieved infusions. It is worth drawing attention to the small variation of CRP level (Δ <5mg/dl) at 9 months of initiation of Remsima treatment.ConclusionsThe results of safety and survival of biosimilar infliximab Remsima® are similar to those shown in their pivotal trials PLANETRAS and PLANETAS, both in patients with prior use of infliximab as another patient who has not used this. Although the follow-up...
BackgroundGreater knowledge of the behavior of rheumatoid arthritis in his response to biological therapy and the need to improve the resource efficiency of national health systems has led in recent years to implement optimization strategies with the treatments most overburdened financially to social security systems.ObjectivesThe aim of this study is to describe what the status of such optimization and clinical conditions that takes place in a hospital serving the healthcare demands of nearly one million inhabitants.MethodsAll patients with a diagnosis of RA (ACR/EULAR 2010), served in the Clinical Management HUVR in Seville, during the period January 2008 to May 2014 and received at least one dose of etanercept with indication sheet in Spain.Design: Observational, longitudinal, retrospective and analytical study.Patients and methods: Five rheumatologists, after defining the project and the variables to obtain reviewed the medical records of patients and collected them in a database designed exprofeso sociodemographic variables, RA and clinics. As part of clinical management, to achieve remission defined as =1 =1 and swollen joint painful joint sustained for at least two consecutive visits, was decided to reduce the biological dose.Statistical analysis: descriptive, univariate tests according to the distribution of variables anResultsResults: 130 patients were included, excluded 4 (3%) by incomplete data for analysis. The median age (p25-p75) of the 126 (97%) patients was 55.9 (47-65), 79% female, 72% FR +, 49% received etanercept as first biological and the rest as second or third 44% were treated with concomitant MTX and 28% with low doses of corticosteroids. The duration of RA was 10.9 (6.9 to 20) years. Remission was found and it was possible to reduce the dose of etanercept in 92 (73%) cases. Of these, only 1 (0.8) discontinued treatment due to persistence of remission and the majority (48%) received doses of 25 mg of etanercept every 7 days. The main characteristics of the two groups of patients are shown in the table. In multivariate analysis that shorter duration of RA greater chance of remission (OR 0.98 95% CI 0.97 to 1.001) and smoking as a factor of no remission (OR 2.54 95% CI 1,1 5 found, 8), but the predictive capabilities of the models were low (11%).Conclusion: In patients with RA treated in routine clinical practice and appropriate response to etanercept, remission is possible and reduces the dose of biological two-thirds of patients with RA, although the definitive discontinuation is rare.In multivariate analysis that shorter duration of RA greater chance of remission (OR 0.98 95% CI 0.97 to 1.001) and smoking as a factor of no remission (OR 2.54 95% CI 1,1 5 found, 8), but the predictive capabilities of the models were low (11%).ConclusionsIn patients with RA treated in routine clinical practice and appropriate response to etanercept, remission is possible and reduces the dose of biological two-thirds of patients with RA, although the definitive discontinuation is rare.Disclosure of InterestNo...
BackgroundDistal radius fracture is considered the first fragility fracture. A linear increase of these fractures in women over age 55 is observed.ObjectivesTo describe the baseline characteristics of patients over 55 years with a diagnosis of Distal radius fracture initially treated in the Emergency area and required hospitalization in 2009 in the Traumatology and Rehabilitation Hospital Virgen del Rocío de Sevilla and monitoring after over 5 years.MethodsProspective observational study of 5-year follow-up of a cohort of patients, women older than 55 years who required surgery in 2009 of Distal radius fracture occurred by accidental fall, excluding traffic accidents and precipitation and if the risk of osteoporosis was evaluated during follow-up over the next 5 years.Baseline characteristics were studied: age, smoking, taking steroids, personal history of Rheumatoid Arthritis, if they had previous bone densitometry and the presence of previous fragility fractures. During follow assessed whether patients were referred to Rheumatology to assess risk of Osteoporosis, if bone densitometry later, if presented after osteoporotic fractures (vertebral, non hip peripheral fractures and hip fractures) and if received specific treatment for the OsteoporosisResults52 women were included in the study with a mean age of 69.69±8.748 years. 55-88 years range. Between baseline characteristics studied were found 5.8% (3 patients.) Were smokers, 13.2% (7 patients.) Were steroid takers regularly, 3.8% (2 patients.) With Rheumatoid Arthritis, 9.6% (5 patients.) had a history of previous fragility fractures. During the follow up period of 5 years 14 patients (26.9%) had osteoporotic fractures, including vertebral fractures 6 patients found. (11.5%), peripheral non hip fractures 5 patients. (9.6%) and hip fractures 4 patients. (7.7%). 12 patients were derived. (23.1%) a Rheumatology specialist for risk assessment of Osteoporosis, 9 patients. (17.3%) underwent bone densitometry and 10 patients (19.2%) received specific treatment for Osteoporosis.ConclusionsDistal radius fracture is the result of a fall on an outstretched arm. It is considered the first fragility fracture. Presents an increased incidence after 55 years.In our study, it is noteworthy that 26.9% of patients who suffered a Distal radius fractured submitted an osteoporotic fracture during the follow up period of 5 years, including 7.7% were hip fractures in consequent increase in morbidity and mortality. However, only 23% of patients were referred to Rheumatology for risk assessment of Osteoporosis.Therefore, we must continue to emphasize proper evaluation of Osteoporosis risk of these fractures in the Emergency area.Disclosure of InterestNone declared
BackgroundDisease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), leflunomide (LFN) or antiTNFα have been implicated in development/exacerbation of Interstitial lung disease (ILD)of rheumatoid arthritis (RA). Several radiological patterns of ILD have been described: i) usual interstitial pneumonia (UIP), ii) nonspecific interstitial pneumonia (NSIP), iii) obliterating bronchitis (OB), and iv) Organized pneumonia (OP)ObjectivesTo assess the response to Abatacept (ABA) in these patterns of ILDMethodsMulticenter study of RA-ILD treated with ABA. ILD was diagnosed by high-resolution CT scan (HRCT) and classified in radiological patterns (Travis et al). We consider 3 subgroups: a) UIP, b) NSIP and c) “other” (OB, OP or mixed). ABA was used at iv or sc standard dose. We assessed: a) Dyspnea (Medical Research Council-modified scale; significant variations≥1); B) Respiratory function tests; significant changes≥10% in forced vital capacity (FVC) and DLCO≤10%, c) HRCT, d) DAS28. A comparative study was performed for the quantitative (U-Mann-Whitney) and qualitative variables (Fisher test) between the baseline and 3, 6 and 12 months.ResultsWe included 63 patients (27 women/36 men), mean age; 63.1±9.6 years. At ABA onset the RA had a median evolution of 6.8 [2–13.6] years and the ILD of 1 [0.3–3.03]. RA was seropositive in 85.7%. The diagnosis of ILD was confirmed by biopsy (n=18). The ILD was related to DMARDs: MTX (4), etanercept (3), adalimumab (3), certolizumab (2), Infliximab (1). ABA was used in monotherapy (26) or combined with other DMARDs (37); LFN (15), Cyclosporin (1), sulfasalazine (4), MTX (6), hydroxychloroquine (10), azathioprine (4), chloroquine (1). Table 1 shows the evolution in the available cases. A significant improvement in dyspnea and HRCT was observed in the NIU type. DLCO remained stable in most patients regardless of the radiological pattern. The activity of RA (DAS28) also improved.Table 1ConclusionsABA appears to be effective in ILD associated-RA, including the pattern of poor prognosis (UIP).References Travis WD et al. J Respir Crit Care Med 2013 188:733–748. Disclosure of InterestNone declared
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