TFS Develop

Barcelona, Spain

TFS Develop

Barcelona, Spain
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Vogelmeier C.F.,University of Marburg | Gaga M.,Athens Chest Hospital Sotiria | Aalamian-Mattheis M.,Novartis | Greulich T.,University of Marburg | And 9 more authors.
Respiratory Research | Year: 2017

Background: Dual bronchodilation combining a long-acting β2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) is the preferred choice of treatment recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines for the management of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The once-daily (q.d.) fixed-dose combination (FDC) of LABA, indacaterol 110 μg and LAMA, glycopyrronium 50 μg (IND/GLY 110/50 μg q.d.) demonstrated superior improvements in lung function, dyspnoea and overall health status and better tolerability against LABA or LAMA monotherapies and combination of LABA and inhaled corticosteroid (ICS) in more than 11,000 patients with moderate-to-severe COPD in several randomised controlled clinical trials. Methods: The CRYSTAL study was the first, 12-week, randomised, open-label trial that evaluated the efficacy and safety of a direct switch from previous treatments to IND/GLY 110/50 μg q.d. on lung function and dyspnoea in patients with moderate COPD and a history of up to one exacerbation in the previous year. Patients were divided into 2 groups according to their background therapy and symptom scores and were randomised (3:1) to IND/GLY or to continue with their previous treatments. Results: The study included 4389 randomised patients, of whom 2160 were in groups switched to IND/GLY (intention-to-treat population). The effect of IND/GLY was superior to LABA + ICS on trough forced expiratory volume in 1 s (FEV1; treatment difference, Δ = +71 mL) and transition dyspnoea index (TDI; [Δ = 1.09 units]), and to LABA or LAMA on trough FEV1 (Δ = +101 mL) and a TDI (Δ = 1.26 units). Improvements in health status and lower rescue medication use were also observed with IND/GLY. The safety profile of the study medication was similar to that observed in previous studies. Conclusions: IND/GLY demonstrated superior improvements in lung function and dyspnoea after direct switch from previous treatments. Trial registration: ClinicalTrials.gov number: NCT01985334. © 2017 The Author(s).


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.


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.


PubMed | TFS Develop, Autonomous University of Barcelona, Synexa Life science, The Aurum Institute and 4 more.
Type: Clinical Trial, Phase II | Journal: PloS one | Year: 2014

To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 g) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection.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 g RUTI, especially in HIV-positive subjects which was not increased after the second inoculation.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.ClinicalTrials.gov NCT01136161.


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.


Ferrandiz C.,Hospital Universitari Germans Trias i Pujol | Ferrandiz C.,Autonomous University of Barcelona | Plazas M.J.,Almirall | Sabate M.,TFS Develop | Palomino R.,Area de investigacion aplicada
Actas Dermo-Sifiliograficas | Year: 2016

Background Actinic keratoses (AKs) are common skin lesions associated with an increased risk of developing squamous cell carcinoma. Few studies in Europe have focused on AK prevalence. Aim To determine the point prevalence of AKs in a dermatology outpatient population in Spain, to describe the clinical characteristics of these lesions and to characterise the profile of AK patients. Methods Observational, cross-sectional, multicentre study conducted in 19 hospitals (dermatology outpatient services) around Spain. A total of 204 consecutive patients per hospital who were ≥45 years old were screened for the presence of AKs. Results 3877 patients were assessed and the overall AKs prevalence was 28.6%. Prevalence was significantly higher in men than women (38.4% vs. 20.8%, p < 0.0001) and increased with age for both sexes (45.2% in 71–80 years). Scalp and ear lesion locations were significantly more frequent in men (51.9% vs. 2.7% and 16.9% vs. 2.4%, respectively, p < 0.0001 both cases) and the cheek, nose and neckline in women (46.3% vs. 34.0% [p < 0.0001], 43.0% vs. 24.8% [p < 0.0001] and 5.3% vs. 1.8% [p = 0.002]). Men showed a significantly higher frequency of ≥2 affected areas than women (42.7% vs. 20.3%, p < 0.0001). Among patients with AK lesions, only 65% confirmed that they were the reason for the visit to the clinic. Conclusions Approximately a quarter of the dermatology outpatient population in Spain aged ≥45 years old have AKs, with the prevalence rate being highest in men and in older age groups. AK is underdiagnosed and a proactive strategy is needed for the diagnosis and early treatment of these lesions. © 2016 AEDV


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.


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.


PubMed | University of Padua, University of Naples Federico II, University of Siena and TFS Develop
Type: | Journal: Mediators of inflammation | Year: 2014

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.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.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.In this cohort, anti-TNF- therapy was associated with high drug persistence rates. As in rheumatoid arthritis, switching to another anti-TNF- 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.


PubMed | Almirall, Area de investigacion aplicada, TFS Develop and Autonomous University of Barcelona
Type: Journal Article | Journal: Actas dermo-sifiliograficas | Year: 2016

Actinic keratoses (AKs) are common skin lesions associated with an increased risk of developing squamous cell carcinoma. Few studies in Europe have focused on AK prevalence.To determine the point prevalence of AKs in a dermatology outpatient population in Spain, to describe the clinical characteristics of these lesions and to characterise the profile of AK patients.Observational, cross-sectional, multicentre study conducted in 19 hospitals (dermatology outpatient services) around Spain. A total of 204 consecutive patients per hospital who were 45 years old were screened for the presence of AKs.3877 patients were assessed and the overall AKs prevalence was 28.6%. Prevalence was significantly higher in men than women (38.4% vs. 20.8%, p<0.0001) and increased with age for both sexes (45.2% in 71-80 years). Scalp and ear lesion locations were significantly more frequent in men (51.9% vs. 2.7% and 16.9% vs. 2.4%, respectively, p<0.0001 both cases) and the cheek, nose and neckline in women (46.3% vs. 34.0% [p<0.0001], 43.0% vs. 24.8% [p<0.0001] and 5.3% vs. 1.8% [p=0.002]). Men showed a significantly higher frequency of 2 affected areas than women (42.7% vs. 20.3%, p<0.0001). Among patients with AK lesions, only 65% confirmed that they were the reason for the visit to the clinic.Approximately a quarter of the dermatology outpatient population in Spain aged 45 years old have AKs, with the prevalence rate being highest in men and in older age groups. AK is underdiagnosed and a proactive strategy is needed for the diagnosis and early treatment of these lesions.

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