Recombinant human erythropoietin is safe and effective in stimulating erythropoiesis, allowing preoperative donation of blood for autologous use, and reducing exposure to allogeneic blood for RA patients who are unable preoperatively to deposit blood because of anemia.
Lower dose of Epoetin alfa (reduced by 56%), supplemented by i.v. iron, is as effective and well tolerated as higher doses administered i.v., supplemented by i.v. iron.
The purpose of the study was to estimate the clinical profile of naïve biological patients with rheumatoid arthritis (RA) starting adalimumab through 3-year calendar periods and their clinical outcomes such as drug survival and global clinical disease control (GCDC). RA patients starting adalimumab as first biological drug between 2003 and 2012 were subdivided in 3-year calendar periods. Survival on therapy was estimated using the Kaplan-Meier analysis. One and 2-year clinical response was assessed by calculating percentage of patients attaining GCDC (28-joint Disease Activity Score (DAS28) ≤ 2.6 + Health Assessment Questionnaire (HAQ) ≤ 0.5), low disease activity (DAS28 ≤ 3.2), remission (DAS28 ≤ 2.6) and good European League Against Rheumatism (EULAR) response. Multivariate regression models were used to assess baseline predictors of drug discontinuation or achievement of clinical remission. We recruited 1695 RA patients. Overall drug persistence at 3 years was 40.6 %, while the global rate of nonswitching patients was 54.7 %. Compared to 2003-2005, initiators in more recent years had a significantly lower 3-year crude drug retention rate (log rank, p < 0.0001) and a significantly higher rate of switching to alternative biologics (log rank, p < 0.0001). No difference in adverse events or effectiveness rate among the calendar periods was found. A substantial proportion of patients (up to 27 %) achieved GCDC at 2 years, regardless of the calendar period. In real-life setting, RA patients starting adalimumab in more recent years had a higher rate of drug discontinuation not related to ineffectiveness or side effects but to switching, probably due to a wider availability of biologics. A meaningful proportion of patients attained GCDC without any difference across calendar periods.
BackgroundChronic rheumatic conditions such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are associated with severe morbidity and significant impairment of patients' health related quality of life (HRQoL). Several treatments are available but not all the patients respond positively to them. Biologic therapies such as anti-TNFα agents are shown to benefit who fail or have partial responses to standard DMARD therapy.ObjectivesWithin a multicenter stated preferences study (CARA Study), we assessed HRQoL in patients with RA, AS and PsA, and estimated relationship of HRQOL with the different diagnoses, clinical characteristics and biological treatment experience.MethodsPatients with RA, AS, or PsA, who at the time of enrollment were following a treatment (experienced) or received a first prescription (naïve) of treatment with biological drugs were enrolled. Together with preferences data, clinical and HRQOL information was reported. HRQoL was assessed with the recently developed and successfully validated version of the EQ-5D-5L, which allows to obtain a description of health (in 5 domains and 5 levels of severity each), a measure (EQ-VAS) and a valuation (utility) of health. Multiple linear regression analyses were conducted to assess the association between EQ-5D VAS score and the utility with age, sex, diagnosis, treatment experience, years from symptoms onset and years from diagnosis.Results513 patients were enrolled (mean±SD =50.0±13.6, 42.5% female). As regards the diagnosis, 33.9% had RA, 34.9% PsA and 31.2% AS. The mean±SD time from the symptoms onset was 10.8±9.4 and from the diagnosis was 8.0±8.2 years. Almost half of the patients (47.4%) were naïve to the biological treatment. Patients reporting severe or extreme problems were: 7.1% in mobility, 3.6% in self-care, 10.3% in usual activities, 18.6% in pain/discomfort, 5.5% in anxiety/depression. The mean±SD of the VAS was 60.4±20.5 and of the utility was 0.773±0.116. From the regression model the VAS and utility are significantly (p<0.05) associated with age, sex and treatment experience (table 1). In particular, the patients being naïve to the treatment with biological drugs had on average significant worse levels of HRQoL than experienced patients, adjusting for the other variables included in the model.Table 1.Results of the regression analysesVariblesEQ-5D VASEQ-5D UTILITY Coeff. Regrp-valueCoeff. regrp-value Constant92.4550.0000.9540.000Age-0.2050.002-0.0010.013Gender (Female)-7.4730.000-0.0550.000Psoriatic arthritis-3.9860.063-0.0090.448Ankylosing spondylitis-4.2360.076-0.0160.228Naïve patients-13.8730.000-0.0740.000Time from symptoms onset-0.1050.5570.0000.858Time from diagnosis0.0610.7680.0000.815ConclusionsPatients naïve to biological treatment have significat lower levels of HRQoL, suggesting that their current situation is not satisfactory and need to start with a more effective treatment.Disclosure of InterestL. Sinigaglia: None declared, L. Scalone: None declared, P. Sarzi-Puttini: None declared, C. Mo...
BackgroundThe development of biologic therapies has created a more complex decision-making process to select the treatment option for patients. In order to optimize the appropriateness of the decisions, it is necessary to be informed and aware of the preferences of the interested parties and the influence of their experiences on their preferences for the different treatments.ObjectivesTo estimate preferences of relevant treatment characteristics valued by the different subjects involved in the management of patients with rheumatic diseases. This abstract focuses on patients' preferences.MethodsWe involved patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA), who according to clinical practice, at the time of data collection had for the first time a prescription of (naïve), or received treatment with (experienced) biological drugs for at least 3 months in the last 12 months. Through a Discrete-Choice-Experiment, the participants valued 16 possible scenarios in which pairs of similarly effective treatments were described with 6 characteristics including 2–4 possible levels each: (1) frequency of administration; (2) mode and place of administration; (3) hospitality, service, efficiency and courtesy of health personnel; (4) frequency of reactions at the site of drug administration; (5) generalized undesired reactions or allergic reactions involving the whole body; (6) additional contribution added as healthcare taxes to be paid by all the citizens to make available the treatment to target patients.Results513 patients from 30 centres through Italy participated, balanced for diagnosis and treatment experience (around 20% of each subgroup). Characteristics 4, 3 and 6 were the first, second and third most important ones for every subgroup, the fourth most important characteristic was 1 (experienced RA), 5 (naïve AS), and 2 for the other subgroups. Across all the subgroups, patients generally preferred very satisfactory levels of (3), infrequent (4), mild (5), and no (6). Instead, for characteristics (1) and (2) the patients generally preferred the frequency, mode and place of administration that were closer to those actually experienced or prescribed.ConclusionsTaking into account the different opinions of patients on at least some treatment characteristics could guide the conduction of good choices aimed to optimize benefits and to allocate efficiently resources.Disclosure of InterestL. Sinigaglia: None declared, P. Sarzi-Puttini: None declared, L. Scalone: None declared, C. Montecucco: None declared, R. Giacomelli Grant/research support from: MSD, G. Lapadula: None declared, I. Olivieri: None declared, A. Giardino Employee of: MSD Italia, P. Cortesi Grant/research support from: Gilead, L. Mantovani: None declared, M. Mecchia Employee of: MSD Italia
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