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Rome, Italy

Fabbroni M.,University of Siena | Cantarini L.,University of Siena | Caso F.,University of Siena | Caso F.,University of Padua | And 5 more authors.
Mediators of Inflammation | Year: 2014

Objective. The study aim was to determine treatment persistence rates and to identify causes of discontinuation in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients in clinical practice. Methods. Patients treated with adalimumab (ADA), etanercept (ETA), or infliximab (INF) were retrospectively included. Treatment persistence rates were analyzed by means of a stepwise logistic regression. Differences between therapy duration were assessed by means of an analysis of variance model (ANOVA), while a chi-square test was used to evaluate relationships between therapies and causes of treatment discontinuation and the administration of concomitant disease-modifying antirheumatic drugs (DMARDs) among therapies and types of disease considering completed courses of therapy versus courses that were discontinued. Results. 268 patients received a total of 353 anti-TNF treatment courses (97 ADA, 180 ETA, and 76 INF). Comparison among therapies showed significant difference regarding the treatment persistence rates due to the contrast between ETA and INF (P = 0.0062). We observed that 84.7% of patients were still responding after 6 months of follow-up. Comparison among diseases showed that there were significant differences between PsA and AS (P = 0.0073) and PsA and PsA with predominant axial involvement (P = 0.0467) in terms of duration of the therapy, while there were no significant differences with regard to the persistence rate. Conclusions. In this cohort, anti-TNF-α therapy was associated with high drug persistence rates. As in rheumatoid arthritis, switching to another anti-TNF-α agent can be an effective option when, during the treatment of AS or PsA, therapy is suspended because of inefficacy or an adverse event. Combination therapy with DMARDs was associated with a better persistence rate. © 2014 Marta Fabbroni et al. Source


Davila I.,Hospital Universitario Of Salamanca | Valero A.,University of Barcelona | Valero A.,Institute dinvestigacions Biomediques August Pi i Sunyer IDIBAPS | Entrenas L.M.,Hospital Universitario Of Reina Sofia | And 2 more authors.
Journal of Investigational Allergology and Clinical Immunology | Year: 2015

Objectives: To evaluate the association between serum total IgE levels and disease severity in adult patients with persistent allergic asthma and to explore the main predictors of IgE levels. Methods: We performed a multicenter, retrospective, observational study including adult patients diagnosed ≥1 year previously with persistent allergic asthma who were positive to ≥1 allergen. Patients also had serum total IgE and spirometry results available from the previous 12 months. Inclusion was stratified by asthma severity according to the GEMA 2009 criteria. Results: We included 383 patients with allergic asthma (129 mild, 82 moderate, and 172 severe). Mean (SD) age was 38 (15), 46 (16), and 45 (15) years, respectively (P<0.001). Serum total IgE levels varied markedly (coefficient of variation, 147%). No association was observed with forced expiratory volume in 1 second (FEV1) or asthma severity: mean (SD)/median (IQR) of 403 (616)/214 (108-409), 361 (516)/204 (126-361), and 473 (676)/211 (98-545) IU/mL in the mild, moderate, and severe subgroups, respectively (P=.951). The severe subgroup had a higher percentage of patients with >400 IU/mL (36% vs 26.4% [mild] and 18.3% [moderate], P=.010). In a multivariate multiple regression model, the independent predictors of higher IgE were younger age (P=.004), sensitization to ≥2 allergens (P=.009), male gender (P=.025), and family history of asthma (P=.122). Conclusion: Serum total IgE levels in adult patients with persistent allergic asthma were high (two-thirds with levels >150 IU/mL) and extremely variable. We did not find a significant association between serum total IgE levels and asthma severity or airflow limitation, except for a higher percentage of patients with IgE >400 IU/mL in the severe subgroup. © 2015 Esmon Publicidad. Source


Lanas A.,University of Zaragoza | Plazas M.J.,Laboratorios Almirall S.A. | Gimeno E.,Biometria Clinica S.L. | Munoz-Tuduri M.,TFS Develop
Gastroenterologia y Hepatologia | Year: 2012

Gastrointestinal (GI) complications are common side effects related to non-steroidal anti-inflammatory drugs (NSAID) and low-dose aspirin (LDA) use. The guidelines to prevent GI complications establish that patients at high risk should receive gastroprotection. However, different reports have suggested that these strategies are not greatly executed. To determine the prevalence of use of preventive strategies to reduce GI complications in NSAID and/or LDA users in primary care in Spain, we performed an observational, cross-sectional, multicentre study in which primary care physicians from Spain participated. From January 2009 to May 2009, physicians collected demographic, clinical and treatment data from the last visit in 2008 of the first 5 consecutive patients who met the selection criteria. A multivariate logistic regression was carried out to identify independent predictors of the preventive strategies used. A total of 713 primary care physicians included 3357 patients: 68% NSAID users, 19.1% LDA users and 12.9% NSAID/LDA users. 31.5% of patients did not have a risk factor for GI complications, 25.6% had one risk factor and 42.9% had 2 or more risk factors. The overall prevalence of preventive strategy use was 75.8%. The prevalence of gastroprotection use increased with the number of risk factors. The underutilization of gastroprotection in at-risk patients treated with NSAIDs is low and not as marked as those previously reported at the primary care level in other countries. We also found high rates of gastroprotection use in LDA users. © 2011 Elsevier España, S.L. Source


Nell A.S.,PAREXEL | D'Lom E.,Parexel International | Bouic P.,Synexa Life science | Sabate M.,TFS Develop | And 6 more authors.
PLoS ONE | Year: 2014

Objectives: To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 μg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Methods and Findings: Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 μg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. Conclusion: This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase. © 2014 Nell et al. Source


Perez C.,Hospital Universitario La Paz | Navarro A.,Care Angel | Saldana M.T.,Primary Care Health Center Raices | Figueras-Balsells M.,TFS Develop | And 2 more authors.
Clinical Journal of Pain | Year: 2013

Objective: Peripheral neuropathic pain (PNP) is associated with significant economic burden. Guidelines recommend the early adoption of appropriate pharmacological interventions. The aim of this study was to explore whether early initiation of pregabalin was associated with lower economic burden, than later initiation, in the management of refractory chronic PNP. Methods: A secondary analysis of a multicenter, observational cost-of-illness study was carried out in adults older than 18 years of age with refractory chronic PNP. Patients were pregabalin naive, with a poor response to previous analgesic therapy, defined as pain >40 in a 0 to 100 mm visual analog scale after, at least, 1 analgesic. The total costs, health care and indirect, assessed 12 weeks before the initiation of pregabalin were analyzed according to the time elapsed since diagnosis. Results: One thousand one hundred thirty-nine outpatients, 59.3 (12.8) years old, 59.3% women, 2.0 (3.5) years with a diagnosis of PNP, fulfilled the criteria for analysis. Adjusted (pain intensity, sex, age, and body mass index) mean total costs 12 weeks before the baseline visit were significantly lower when pregabalin was initiated early (<6 mo; n=389) in comparison with later initiation; 6 to 12 months (n=328), or >12 months (n=422) after diagnosis; &OV0556;2439 (2197; 2681) versus &OV0556;3011 (2758; 3264) and &OV0556;2945 (2717; 3173), respectively (P<0.01 in both cases). Lower health care costs and fewer lost-workday equivalents with early initiation of pregabalin were the main factors contributing to these findings. Discussion: Early initiation of pregabalin treatment after diagnosis in patients with refractory chronic PNP may result in substantial cost savings from a societal perspective in daily practice in Spain. © 2013 by Lippincott Williams & Wilkins. Source

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