Publications by authors named "Amaia Ugarte"

36 Publications

ANTIPHOSPHOLIPID ANTIBODIES DO NOT PREDICT DAMAGE IN SLE PATIENTS IN THE XXI CENTURY. AN OBSERVATIONAL STUDY FROM THE LUPUS-CRUCES COHORT.

Rheumatology (Oxford) 2021 Mar 26. Epub 2021 Mar 26.

Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Bizkaia Health Research Institute, Hospital Universitario Cruces, Bizkaia, The Basque Country, Spain.

Objective: To compare the influence of antiphospholipid antibodies (aPL) on global and cardiovascular damage in patients with systemic lupus erythematosus (SLE) diagnosed before and after year 2000.

Methods: 286 patients from the Lupus-Cruces cohort with a minimum follow-up of 5 years, divided into two sub-cohorts according to the date of diagnosis, before 2000 (<2000) and from 2000 on (≥2000). We compared the mean SDI score and global and cardiovascular damage-free survival rates in the presence/absence of aPL in both sub-cohorts. Variables potentially modulating damage among aPL-positive patients were analysed.

Results: The sub-cohorts were comparable for demographic and lupus-related variables except for treatment variables: the ≥2000 sub-cohort received lower doses of prednisone and more hydroxychloroquine, low-dose aspirin, statins, immunosuppressive agents and Vitamin D. aPL-positive patients in the <2000, but not in the ≥2000 sub-cohort, accrued more damage compared with aPL-negative. In the <2000 sub-cohort, the adjusted HRs for global and cardiovascular damage in aPL-positive vs. aPL-negative patients were 1.98 (95% CI 1.24-3.14) and 9.3 (95% CI 3.24-26.92), respectively. No differences in damage were seen between aPL-positive and aPL-negative patients in the ≥2000 sub-cohort. Hypertension (HR 4.64, 95%CI 1.33-16.19), lupus anticoagulant (HR 3.85, 95%CI 1.1-13.41) and the number of months on hydroxychloroquine (HR 0.97, 95%CI 0.95-0.99) were independent predictors of vascular damage in the combined analysis of all aPL-positive patients.

Conclusion: The effects of aPL on damage accrual in SLE patients have been reduced over the last years. The widespread use of hydroxychloroquine and a better thromboprophylaxis are likely causing this change.
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http://dx.doi.org/10.1093/rheumatology/keab307DOI Listing
March 2021

Antiphospholipid Antibody Profile Stability Over Time: Prospective Results From the APS ACTION Clinical Database and Repository.

J Rheumatol 2021 04 1;48(4):541-547. Epub 2020 Sep 1.

D. Erkan, MD, MPH, Barbara Volcker Center for Women and Rheumatic Diseases, Hospital for Special Surgery, Weill Cornell Medicine, New York, New York, USA.

Objective: The APS ACTION Registry studies long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients. Our primary objective was to determine whether clinically meaningful aPL profiles at baseline remain stable over time. Our secondary objectives were to determine (1) whether baseline characteristics differ between patients with stable and unstable aPL profiles, and (2) predictors of unstable aPL profiles over time.

Methods: A clinically meaningful aPL profile was defined as positive lupus anticoagulant (LAC) test and/or anticardiolipin (aCL)/anti-β glycoprotein-I (anti-β-GPI) IgG/M ≥ 40 U. Stable aPL profile was defined as a clinically meaningful aPL profile in at least two-thirds of follow-up measurements. Generalized linear mixed models with logit link were used for primary objective analysis.

Results: Of 472 patients with clinically meaningful aPL profile at baseline (median follow-up 5.1 yrs), 366/472 (78%) patients had stable aPL profiles over time, 54 (11%) unstable, and 52 (11%) inconclusive. Time did not significantly affect odds of maintaining a clinically meaningful aPL profile at follow-up in univariate ( = 0.906) and multivariable analysis ( = 0.790). Baseline triple aPL positivity decreased (OR 0.25, 95% CI 0.10-0.64, = 0.004) and isolated LAC test positivity increased (OR 3.3, 95% CI 1.53-7.13, = 0.002) the odds of an unstable aPL profile over time.

Conclusion: Approximately 80% of our international cohort patients with clinically meaningful aPL profiles at baseline remain stable at a median follow-up of 5 years; triple aPL-positivity increase the odds of a stable aPL profile. These results will guide future validation studies of stored blood samples through APS ACTION Core Laboratories.
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http://dx.doi.org/10.3899/jrheum.200513DOI Listing
April 2021

Characteristics of Antiphospholipid Antibody Positive Patients in AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking.

Arthritis Care Res (Hoboken) 2020 Sep 28. Epub 2020 Sep 28.

Barbara Volcker Center for Women and Rheumatic Disease, Hospital For Special Surgery, Weill Cornell Medicine, New York, NY, USA.

Objective: To describe baseline characteristics of antiphospholipid antibody (aPL)-positive patients, overall and by clinical and laboratory subtypes, enrolled in an international registry.

Methods: AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking Registry includes persistently aPL-positive adults. We evaluated baseline sociodemographic and aPL-related (APS classification criteria and "non-criteria") characteristics of patients overall and in subgroups (aPL-positive without APS, APS overall, thrombotic APS [TAPS] only, obstetric APS [OAPS] only, and both TAPS/OAPS). We assessed baseline characteristics of patients tested for three aPL (lupus anticoagulant test [LA], anticardiolipin antibody [aCL], and anti-β -Glycoprotein-I [aβ GPI]) by aPL profiles (LA only, single, double, and triple aPL positivity).

Results: Of 804 aPL-positive patients (mean age: 45 ± 13y; female: 74%; white 68%; other systemic autoimmune diseases: 36%), 80% were classified as APS (55% TAPS, 9% OAPS, and 15% TAPS/OAPS). In the overall cohort, 71% had vascular thrombosis, 50% with pregnancy history had obstetric morbidity, and 56% had at least one non-criteria manifestation. Among those with three aPL tested (n: 660), 42% were triple aPL positive. While single, double and triple aPL positive subgroups had similar frequencies of vascular, obstetric, and non-criteria events, these events were lowest in the single aPL subgroup consisting of aCL or aβ GPI only.

Conclusion: Our study demonstrates the heterogeneity of aPL-related clinical manifestations and laboratory profiles in a multicenter, international cohort. Within single aPL-positivity, LA may be a major contributor to clinical events. Future prospective analyses, using standardized core laboratory aPL tests, will help clarify aPL risk profiles and improve risk stratification.
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http://dx.doi.org/10.1002/acr.24468DOI Listing
September 2020

Second week methyl-prednisolone pulses improve prognosis in patients with severe coronavirus disease 2019 pneumonia: An observational comparative study using routine care data.

PLoS One 2020 22;15(9):e0239401. Epub 2020 Sep 22.

Clinical Epidemiology Unit, Hospital Universitario Cruces, Barakaldo, Bizkaia, Spain.

Objective: To analyze the effects of a short course of methyl-prednisolone pulses (MP) during the second week of disease (week-2) in patients with severe coronavirus disease 2019 (COVID-19) pneumonia.

Methods: Comparative observational study using data collected from routine care at Hospital Universitario Cruces, Barakaldo, Bizkaia, Spain in patients with COVID-19 pneumonia. We compared patients who received week-2-MP (125-250 mg/d x3) with those who did not, with the end-points time to death and time to death or endotracheal intubation.

Results: We included 242 patients with COVID-19 pneumonia and elevated inflammatory markers at admission. Sixty-one patients (25%) received week-2-MP. Twenty-two patients (9%) died and 31 (12.8%) suffered death or intubation. The adjusted HRs for death and death or intubation for patients in the week-2-MP group were 0.35 (95%CI 0.11 to 1.06, p = 0.064) and 0.33 (95%CI 0.13 to 0.84, p = 0.020), respectively. These differences were specifically seen in the subcohort of patients with a SpO2/FiO2 at day 7 lower than 353 (adjusted HR 0.31, 95% CI 0.08 to 1.12, p = 0.073 and HR 0.34, 95%CI 0.12 to 0.94, p = 0.038, respectively) but not in patients with higher SpO2/FiO2. Patients receiving out-of-week-2-MP, non-pulse glucocorticoids or no glucocorticoids had an increased adjusted risk for both outcomes compared with week-2-MP group: HR 5.04 (95% CI 0.91-27.86), HR 10.09 (95% CI 2.14-47.50), HR 4.14 (95% CI 0.81-21.23), respectively, for death; HR 7.38 (95% CI 1.86-29.29), HR 13.71 (95% CI 3.76-50.07), HR 3.58 (95% CI 0.89-14.32), respectively, for death or intubation. These differences were significant only in the subgroup with low SpO2/FiO2.

Conclusions: Week-2-MP are effective in improving the prognosis of patients with COVID-19 pneumonia with features of inflammatory activity and respiratory deterioration entering the second week of disease. The recognition of this high-risk population should prompt early use of MP at this point.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239401PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508405PMC
October 2020

Cluster analysis for the identification of clinical phenotypes among antiphospholipid antibody-positive patients from the APS ACTION Registry.

Lupus 2020 Jul 23:961203320940776. Epub 2020 Jul 23.

Barbara Volcker Centre for Women and Rheumatic Disease, Hospital for Special Surgery, Weill Cornell Medicine, New York, USA.

Objective: This study aimed to use cluster analysis (CA) to identify different clinical phenotypes among antiphospholipid antibodies (aPL)-positive patients.

Methods: The Alliance for Clinical Trials and International Networking (APS ACTION) Registry includes persistently positive aPL of any isotype based on the Sydney antiphospholipid syndrome (APS) classification criteria. We performed CA on the baseline characteristics collected retrospectively at the time of the registry entry of the first 500 patients included in the registry. A total of 30 clinical data points were included in the primary CA to cover the broad spectrum of aPL-positive patients.

Results: A total of 497 patients from international centres were analysed, resulting in three main exclusive clusters: (a) female patients with no other autoimmune diseases but with venous thromboembolism (VTE) and triple-aPL positivity; (b) female patients with systemic lupus erythematosus, VTE, aPL nephropathy, thrombocytopaenia, haemolytic anaemia and a positive lupus anticoagulant test; and (c) older men with arterial thrombosis, heart valve disease, livedo, skin ulcers, neurological manifestations and cardiovascular disease (CVD) risk factors.

Conclusions: Based on our hierarchical cluster analysis, we identified different clinical phenotypes of aPL-positive patients discriminated by aPL profile, lupus or CVD risk factors. Our results, while supporting the heterogeneity of aPL-positive patients, also provide a foundation to understand disease mechanisms, create new approaches for APS classification and ultimately develop new management approaches.
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http://dx.doi.org/10.1177/0961203320940776DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216235PMC
July 2020

Seventy years after Hench's Nobel prize: revisiting the use of glucocorticoids in systemic lupus erythematosus.

Lupus 2020 Sep 15;29(10):1155-1167. Epub 2020 Jun 15.

Department of Women and Children's Health, St Thomas Hospital, London.

In 1950, Hench, Kendall and Reichstein were awarded with the Nobel Prize in Physiology and Medicine for the isolation and first therapeutic use of glucocorticoids. Since then, they have become one of the main agents in the treatment of systemic lupus erythematosus (SLE). The use of high-dose oral glucocorticoids (usually 1 mg/kg/day of prednisone equivalent) have become the rule for treating moderate to severe lupus activity. In addition, tapering schemes have not been well defined, all this leading to prolonged exposures to potentially damaging amounts of glucocorticoids. Several studies have shown that glucocorticoids are a major cause of toxicity in SLE in a dose-dependent manner, with prolonged doses greater than 7.5 mg/day being associated with damage accrual. Thus, there is an urgent need for different therapeutic schedules that can achieve a rapid and durable control of lupus activity while reducing the many unwanted effects of glucocorticoids. Recent data show that pulses of methyl-prednisolone are an effective first-line therapy to treat lupus flares (not only severe ones) without major short or long-term toxicity and allowing a reduction in oral prednisone doses. Universal use of hydroxychloroquine - always recommended, infrequently accomplished - and early therapy with immunosuppressive drugs also help control SLE and reduce prednisone load. Results from observational studies confirm the more rapid achievement of remission and the reduction of long-term damage using these combination schedules with reduced prednisone doses. Seventy years after their first therapeutic use, we are learning to use glucocorticoids in a more efficient and safe manner.
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http://dx.doi.org/10.1177/0961203320930099DOI Listing
September 2020

Pregnancy control in Patients with Systemic Lupus Erythematosus/Antiphospholipid Syndrome. Part 3: Childbirth. Puerperium. Breastfeeding Contraception. Newborn.

Reumatol Clin (Engl Ed) 2021 Apr 10;17(4):183-186. Epub 2019 Dec 10.

Servicio de Obstetricia y Ginecología, Hospital Universitario La Paz, Madrid, España.

Objective: In order to agree on the fundamental aspects related to the management of pregnancy in patients with systemic lupus erythematosus and antiphospholipid syndrome, the Spanish Societies of Gynaecology and Obstetrics, Internal Medicine and Rheumatology have set up a working group for the preparation of three consensus documents.

Methods: Each of the Scientific Societies involved proposed five representatives based on their experience in the field of pregnancy control in patients with autoimmune diseases. The recommendations were developed following the Delphi methodology.

Results: This third document contains the recommendations regarding the management of delivery, puerperium and lactation, including medication use during these periods and the care of the newborn. In addition, a section on contraception is included.

Conclusions: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with systemic lupus erythematosus/antiphospholipid syndrome during pregnancy.
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http://dx.doi.org/10.1016/j.reuma.2019.09.004DOI Listing
April 2021

Pregnancy Control in Patients with Systemic Lupus Erythematosus and Antiphospholipid Syndrome. Part 1: Infertility, Ovarian Preservation and Preconception Assessment. Consensus Document of the Spanish Society of Gynaecology and Obstetrics (SEGO), the Spanish Society of Internal Medicine (SEMI) and the Spanish Society of Rheumatology (SER).

Reumatol Clin (Engl Ed) 2021 Feb 26;17(2):61-66. Epub 2019 Nov 26.

Servicio de Reumatología, Hospital Universitario Marqués de Valdecilla, IDIVAL, Facultad de Medicina, Universidad de Cantabria, Santander, España. Electronic address:

Objective: Pregnancy and puerperium are considered a risk situation in women with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). Therefore, specialized assessment is essential both preconception and during pregnancy and the puerperium. Likewise, it is very important that different specialists in autoimmune diseases and high-risk pregnancies participate in the follow-up of these patients in a coordinated manner. The Spanish Society of Gynaecology and Obstetrics, the Spanish Society of Internal Medicine, and the Spanish Society of Rheumatology have set up a working group for the preparation of three consensus documents.

Methods: The stages of the work were: distribution of work in three groups corresponding to the three periods related to pregnancy (preconception, during pregnancy and childbirth and puerperium), identification of key areas, exhaustive review of the literature and formulation of recommendations.

Results: This first document includes the 48 recommendations that address aspects related to infertility, the need for and treatments for gonadal preservation and preconception assessment.

Conclusions: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with SLE/APS during pregnancy.
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http://dx.doi.org/10.1016/j.reuma.2019.09.002DOI Listing
February 2021

Pregnancy control in patients with systemic lupus erythematosus/antiphospholipid syndrome. Part 2: Pregnancy follow-up.

Reumatol Clin (Engl Ed) 2021 Mar 25;17(3):125-131. Epub 2019 Nov 25.

Unidad de Enfermedades Autoinmunes, Servicio de Medicina Interna, BioCruces Bizkaia Health Research Institute, Hospital Universitario Cruces, UPV/EHU, Barakaldo, Bizkaia, España. Electronic address:

Objective: In order to agree on the fundamental aspects related to the management of pregnancy in patients with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS), the Spanish Societies of Gynaecology and Obstetrics, Internal Medicine and Rheumatology set up a working group for the preparation of three consensus documents.

Methods: Each of the Scientific Societies involved proposed five representatives based on their experience in the field of pregnancy control in patients with autoimmune diseases. The recommendations were developed following the Delphi methodology.

Results: This second document contains the recommendations regarding the management of pregnancy in women with SLE and APS, including complications such as lupus activity, congenital heart block, thrombotic and obstetric manifestations of APS and placental vascular disease.

Conclusions: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with SLE/APS during pregnancy.
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http://dx.doi.org/10.1016/j.reuma.2019.09.003DOI Listing
March 2021

Comparison of real world and core laboratory lupus anticoagulant results from the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) clinical database and repository.

J Thromb Haemost 2019 12 8;17(12):2069-2080. Epub 2019 Sep 8.

Academic Department of Vascular Surgery, School of Cardiovascular Medicine & Sciences, King's College London, London, UK.

Background: Variability remains a challenge in lupus anticoagulant (LA) testing.

Objective: To validate LA test performance between Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Core laboratories and examine agreement in LA status between Core and local/hospital laboratories contributing patients to this prospective registry.

Methods: Five Core laboratories used the same reagents, analyzer type, protocols, and characterized samples for LA validation. Non-anticoagulated registry samples were retested at the corresponding regional Core laboratories and anticoagulated samples at a single Core laboratory. Categorical agreement and discrepancies in LA status between Core and local/hospital laboratories were analyzed.

Results: Clotting times for the reference/characterized plasmas used for normalized ratios were similar between Core laboratories (CV <4%); precision and agreement for LA positive/negative plasma were similar (all CV ≤5%) in the four laboratories that completed both parts of the validation exercise; 418 registry samples underwent LA testing. Agreement for LA positive/negative status between Core and local/hospital laboratories was observed in 87% (115/132) non-anticoagulated and 77% (183/237) anticoagulated samples. However, 28.7% (120/418) of samples showed discordance between the Core and local/hospital laboratories or equivocal LA results. Some of the results of the local/hospital laboratories might have been unreliable in 24.7% (41/166) and 23% (58/252) of the total non-anticoagulated and anticoagulated samples, respectively. Equivocal results by the Core laboratory might have also contributed to discordance.

Conclusions: Laboratories can achieve good agreement in LA performance by use of the same reagents, analyzer type, and protocols. The standardized Core laboratory results underpin accurate interpretation of APS ACTION clinical data.
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http://dx.doi.org/10.1111/jth.14596DOI Listing
December 2019

Prolonged remission in SLE is possible by using reduced doses of prednisone: An observational study from the Lupus-Cruces and Lupus-Bordeaux inception cohorts.

Autoimmun Rev 2019 Sep 16;18(9):102359. Epub 2019 Jul 16.

UMR CNRS5164, ImmunoconcEpT, Bordeaux University, Bordeaux, France; Immunology Department, Pellegrin Hospital, Bordeaux, France; ACRONIM University Hospital Federation, Bordeaux, France.

Objective: The aim of this study is to compare the frequency of remission, according to DORIS definitions, of inception patients from two European SLE cohorts, with a special focus on the differences between the therapeutic schemes of both Units.

Methods: Inception patients enrolled after 2000 from the longitudinal Cruces Lupus Cohort (CC) and Bordeaux Lupus Cohort (BC) were included. The main endpoint was the achievement of clinical remission on treatment (ClinROnT). ClinROnT was assessed yearly from the 1st until the 5th year following the diagnosis of SLE.

Results: 173 patients, 92 CC and 81 BC, were studied. The clinical presentation of both cohorts was similar, with no significant differences in the mean SLEDAI score at diagnosis (6.6 vs. 8.1, p = 0.06). Patients from CC were treated more frequently with hydroxychloroquine (mean 57 vs. 43 months), methotrexate (24% vs. 11%) and pulse methyl-prednisolone (42% vs. 26%), and received lower doses of oral prednisone (average dose during the follow up 2.3 vs. 7.2 mg/d, p < 0.001). Patients in CC were more likely to achieve ClinROnT at year one, 84% vs. 43% (p < 0.001). Prolonged ClinROnT during the 5 years of follow up was more frequent in CC: 70% vs. 28%, p < 0.001. Patients in CC were also more likely to achieve ClinROnT after controlling for baseline SLEDAI (adjusted HR 1.69, 95%CI 1.21-2.35) and for the presenting clinical manifestations (adjusted HR 1.72, 95% CI 1.2-2.4).

Conclusion: Prolonged ClinROnT was achievable by using a therapeutic regime consisting of lower doses of oral prednisone and maximizing the use of hydroxychloroquine, pulse methyl-prednisolone and methotrexate.
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http://dx.doi.org/10.1016/j.autrev.2019.102359DOI Listing
September 2019

The adjusted global antiphospholipid syndrome score (aGAPSS) and the risk of recurrent thrombosis: Results from the APS ACTION cohort.

Semin Arthritis Rheum 2019 12 2;49(3):464-468. Epub 2019 May 2.

Academic Department of Vascular Surgery, School of Cardiovascular Medicine & Sciences, King's College London, London, United Kingdom.

Objectives: To assess whether patients with antiphospholipid syndrome (APS) and history of recurrent thrombosis have higher levels of adjusted Global AntiphosPholipid Syndrome Score (aGAPSS) when compared to patients without recurrent thrombosis.

Methods: In this cross-sectional study of antiphospholipid antibody (aPL)-positive patients, we identified APS patients with a history of documented thrombosis from the AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository ("Registry"). Data on aPL-related medical history and cardiovascular risk factors were retrospectively collected. The aGAPSS was calculated at Registry entry by adding the points corresponding to the risk factors: three for hyperlipidemia, one for arterial hypertension, five for positive anticardiolipin antibodies, four for positive anti-β glycoprotein-I antibodies and four for positive lupus anticoagulant test.

Results: The analysis included 379 APS patients who presented with arterial and/or venous thrombosis. Overall, significantly higher aGAPSS were seen in patients with recurrent thrombosis (arterial or venous) compared to those without recurrence (7.8 ± 3.3 vs. 6 ± 3.9, p<0.05). When analyzed based on the site of the recurrence, patients with recurrent arterial, but not venous, thrombosis had higher aGAPSS (8.1 ± SD 2.9 vs. 6 ± 3.9; p<0.05).

Conclusions: Based on analysis of our international large-scale Registry of aPL-positive patients, the aGAPSS might help risk stratifying patients based on the likelihood of developing recurrent thrombosis in APS.
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http://dx.doi.org/10.1016/j.semarthrit.2019.04.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402528PMC
December 2019

The comparison of real world and core laboratory antiphospholipid antibody ELISA results from antiphospholipid syndrome alliance for clinical trials & international networking (APS ACTION) clinical database and repository analysis.

Thromb Res 2019 Mar 18;175:32-36. Epub 2019 Jan 18.

Academic Department of Vascular Surgery, Cardiovascular School of Medicine & Sciences, King's College London, UK.

Background: The APS ACTION International Clinical Database and Repository includes a secure web-based data capture system storing patient information including demographics, antiphospholipid antibodies (aPL)-related medical history, and aPL tests. Despite efforts at harmonization, inter-assay variability remains a problem in aPL testing. As a clinical repository open to researchers, ensuring comparability between assays and consistency in results between APS ACTION laboratories is essential to the validity of studies emerging from this network.

Objective: To assess the level of agreement between an aPL-registry inclusion and core laboratory (core lab) anticardiolipin antibody (aCL) and anti-β-glycoprotein-I antibody (aβGPI) ELISA testing results.

Methods: Patients are recruited from 25 international centers based on positive aPL tests at inclusion. All samples are retested at the corresponding national APS ACTION core lab to confirm aPL positivity based on standard validated protocols. We analysed the categorical agreement, degree of linear association, and correlation between inclusion (local laboratory) and core lab aPL tests. Samples were included in this study only if results of aPL testing with ELISA at baseline were available.

Results: 497 registry samples underwent confirmatory aPL tests. Categorical agreement between the inclusion and core lab values, as expressed by Cohen's kappa coefficients, ranged between 0.61 and 0.80 (as substantial agreement). The correlation between quantitative results in the aCL and aβGPI was better for IgM and IgA compared to IgG (Spearman rho 0.789 and 0.666 vs. 0.600 for aCL and rho 0.892 and 0.744 vs. 0.432 for aβGPI).

Conclusions: The results of inclusion for aCL and aβGPI tests used for recruitment into the registry were in agreement to the results obtained by the APS ACTION core laboratories; aCL and aβGPI results showed very good categorical agreement. This agreement increased when considering high titer (>40 units) samples. APS ACTION is a reliable and useful research resource for APS.
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http://dx.doi.org/10.1016/j.thromres.2019.01.010DOI Listing
March 2019

Correlates of neurocognitive functions in individuals at ultra-high risk for psychosis - A 6-month follow-up study.

Psychiatry Res 2018 10 28;268:1-7. Epub 2018 Jun 28.

Department of Psychiatry, Araba University Hospital, BioAraba Research Institute, OSI Araba Vitoria, Spain; Biomedical Research Networking Centre in Mental Health (CIBERSAM), Madrid, Spain; University of the Basque Country. Electronic address:

Cognitive deficits are evident at the prodromal phase of psychosis. It has been noted that brain-derived neurotrophic factor (BDNF) is correlated with cognition in both preclinical and clinical studies. However, to our knowledge, no study has evaluated blood BDNF levels and their association with cognitive impairment in individuals at ultra-high risk for psychosis (UHR). We included 13 individuals at UHR and 30 healthy controls (HC) matched by sex, age, and educational level. Plasma BDNF levels were measured at baseline and 6 months. Neurocognitive functions (executive functions, speed of processing, verbal learning and memory, working memory) were examined at 6 months. Regression analyses were conducted to examine the relationship between BDNF levels and cognitive performance. BDNF levels were lower in UHR group than in HC group both at baseline and at 6 months (P = 0.001, and P = 0.007, respectively). There were no associations between plasma BDNF levels and all of the cognitive domains in both groups. Our findings showed that peripheral BDNF levels were not related to cognitive deficits in UHR and HC groups while the lower BDNF level in the former persisted up to 6 months. Further research is needed in a large sample.
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http://dx.doi.org/10.1016/j.psychres.2018.06.053DOI Listing
October 2018

Comment on: The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults.

Rheumatology (Oxford) 2018 08;57(8):1501-1502

Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, UPV/EHU, Bizkaia, The Basque Country, Spain.

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http://dx.doi.org/10.1093/rheumatology/key168DOI Listing
August 2018

Glucocorticoids and antimalarials in systemic lupus erythematosus: an update and future directions.

Curr Opin Rheumatol 2018 09;30(5):482-489

Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University of The Basque Country, Bizkaia, The Basque Country, Spain.

Purpose Of Review: The purpose of this review is highlighting the most recent evidence on the clinical efficacy and toxicity of glucocorticoids and antimalarials in systemic lupus erythematosus (SLE) and provide recommendations on their current use.

Recent Findings: Glucocorticoid toxicity is well known. Recent data confirm the increased risk of infection and damage accrual. An observational study form Hong Kong has seen increased mortality among users of high-dose prednisone regimes. Several studies support the efficacy of medium-low doses and methyl-prednisolone pulses in lupus patients, both with and without nephritis.New data confirm the effects of antimalarials in preventing SLE activity, damage and infections, and in decreasing mortality. New screening recommendations for hydroxychloroquine maculopathy have been recently published. Combining mepacrine and hydroxychloroquine in patients with refractory cutaneous and/or articular lupus activity has proved highly effective.

Summary: Universal therapy with hydroxychloroquine should be aimed to patients with SLE without contraindications. Doses greater than 4 mg/kg/day should be avoided and regular eye screening warranted to minimize the risk of macular toxicity. Every effort should be made to reduce the dose of oral glucocorticoids. In moderate-severe flares, pulse methyl-prednisolone are more effective and much less toxic than increasing the oral doses of prednisone.
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http://dx.doi.org/10.1097/BOR.0000000000000527DOI Listing
September 2018

The Impact of Systemic Lupus Erythematosus on the Clinical Phenotype of Antiphospholipid Antibody-Positive Patients: Results From the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Clinical Database and Repository.

Arthritis Care Res (Hoboken) 2019 01;71(1):134-141

National and Kapodistrian University of Athens, Athens, Greece.

Objective: Although systemic lupus erythematosus (SLE) is the most common autoimmune disease associated with antiphospholipid antibodies (aPL), limited data exist regarding the impact of SLE on the clinical phenotype of aPL-positive patients. The primary objective of this study was to compare the clinical, laboratory, and treatment characteristics of aPL-positive patients with SLE with those of aPL-positive patients without SLE.

Methods: A secure web-based data capture system was used to store patient demographic characteristics and aPL-related clinical and laboratory characteristics. Inclusion criteria included positive aPL according to the updated Sapporo classification criteria. Antiphospholipid antibody-positive patients fulfilling the American College of Rheumatology criteria for the classification of SLE ("aPL with SLE") and those with no other autoimmune diseases ("aPL only") were included in the analysis.

Results: Six hundred seventy-two aPL-positive patients were recruited from 24 international centers; 426 of these patients did not have other autoimmune disease, and 197 had SLE. The frequency of thrombocytopenia, hemolytic anemia, low complement levels, and IgA anti-β -glycoprotein I (anti-β GPI) antibodies was higher in the aPL-positive patients with SLE, whereas the frequency of cognitive dysfunction and IgG anti-β GPI antibodies was higher in the aPL-only group. The frequency of arterial and venous thromboses (including recurrent) as well as pregnancy morbidity was similar in the 2 groups. The prevalence of cardiovascular disease risk factors at the time of entry into the registry entry did not differ between the 2 groups, with the exception of current smoking, which was more frequent in aPL-positive patients with SLE.

Conclusion: Although the frequencies of thrombosis and pregnancy morbidity are similar in aPL-positive patients with and those without SLE, the diagnosis of SLE in patients with persistently positive aPL is associated with an increased frequency of thrombocytopenia, hemolytic anemia, low complement levels, and positive IgA anti-β GPI antibodies.
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http://dx.doi.org/10.1002/acr.23584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6484425PMC
January 2019

A Pilot Study of the Usefulness of a Single Olanzapine Plasma Concentration as an Indicator of Early Drug Effect in a Small Sample of First-Episode Psychosis Patients.

J Clin Psychopharmacol 2017 Oct;37(5):569-577

From the *Department of Neurosciences, University of the Basque Country, UPV/EHU, Bizkaia; †Early Psychosis Unit, BioCruces Health Research Institute, Barakaldo, Bizkaia; ‡Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Madrid; §Department of Psychiatry, Donostia University Hospital; and ∥Biodonostia Health Research Institute, Gipuzkoa; ¶Department of Psychiatry, Cruces University Hospital, Barakaldo, Bizkaia; #Department of Psychiatry, Araba University Hospital; and **BioAraba Health Research Institute, Araba; and ††Department of Pharmacology, University of the Basque Country, UPV/EHU, Bizkaia, Spain.

Purpose/background: Studies analyzing concentration-effect relationships in second-generation antipsychotics have reported contradictory results in chronic schizophrenia. No data are available for the early stages of the disease. The present study aims to evaluate the association between a single olanzapine plasma concentration, clinical response, and severity of adverse effects in first-episode psychosis (FEP); to test the utility of various plasma breakpoints as markers of early response to treatment; and to identify variables affecting olanzapine concentrations.

Methods: Data from 23 compliant FEP patients receiving olanzapine monotherapy (5-30 mg/d) were evaluated 2 months after beginning treatment. Clinical symptoms were assessed using the Positive and Negative Syndrome Scale and the Montgomery-Åsberg Depression Rating Scale. Adverse effects were rated using the Udvalg for Kliniske Undersøgelser scale. Plasma samples were drawn at 11 (SD, 1) hours after dosing and analyzed with high-performance liquid chromatography/tandem mass spectrometry.

Findings: Consistent with findings on chronic disease, dose, age, sex, weight, and cigarettes/day accounted for some of the variability in olanzapine concentrations. While no relationship was found between olanzapine concentrations and adverse effects or improvement of depressive symptoms, response of psychotic symptoms was associated with concentrations between 22.56 and 77.92 ng/mL. Plasma breakpoints did not show sufficiently high specificity, resulting in a large number of false-positive results.

Implications: Although olanzapine concentrations do not seem to be reliable indicators of early drug effect in FEP, they may still prove useful for detecting noncompliance, as well as pharmacokinetically relevant comorbidities or genetic particularities in drug metabolism.
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http://dx.doi.org/10.1097/JCP.0000000000000770DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596831PMC
October 2017

Restrictive Use of Oral Glucocorticoids in Systemic Lupus Erythematosus and Prevention of Damage Without Worsening Long-Term Disease Control: An Observational Study.

Arthritis Care Res (Hoboken) 2018 04 7;70(4):582-591. Epub 2018 Mar 7.

Biocruces Health Research Institute, Hospital Universitario Cruces, University of The Basque Country, Bizkaia, The Basque Country, Spain.

Objective: To analyze the influence of 2 different treatment strategies on general and specific damage accrual in patients with systemic lupus erythematosus (SLE).

Methods: Two cohorts were identified according to the responsible physicians: patients treated at the autoimmune diseases unit (ADU), and patients treated by other members of the internal medicine (IM) department. Members of the ADU worked with a protocol including the universal prescription of hydroxychloroquine (HCQ), the use of maximum oral prednisone dosages ≤30 mg/day and maintenance therapy with ≤5 mg/day, by using methylprednisolone pulses and/or early immunosuppressive (IS) drugs. We analyzed the influence of these 2 treatment strategies on damage accrual, both general and domain specific, attributed to glucocorticoids, cardiovascular (CV) disease, SLE, and unclassified, since the diagnosis of disease in patients with a followup ≥5 years.

Results: A total of 74 patients were included in the ADU group and 213 in the IM group. They were comparable for most demographic and lupus-related variables. ADU patients received prednisone later and at lower doses, more methylprednisolone pulses, earlier IS drugs and more HCQ (P < 0.05 for all comparisons). The Systemic Lupus Erythematosus Disease Activity Index score decreased similarly in both cohorts (P = 0.4). Patients in the ADU group were less likely to accrue any damage (P = 0.007). They accrued less glucocorticoid-related (adjusted hazard ratio [HR] 0.23 [95% confidence interval (95% CI) 0.07-0.80]), CV disease (adjusted HR 0.28 [95% CI 0.08-0.95]), and unclassified damage (adjusted HR 0.58 [95% CI 0.3-1.1]). Both groups accrued similar SLE-related damage (adjusted HR 0.84 [95% CI 0.40-1.75]).

Conclusion: The use of reduced oral prednisone doses, which was possible by combining different therapies, reduced glucocorticoid-related damage and improved CV prognosis without increasing damage caused by SLE.
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http://dx.doi.org/10.1002/acr.23322DOI Listing
April 2018

Repeated pulses of methyl-prednisolone with reduced doses of prednisone improve the outcome of class III, IV and V lupus nephritis: An observational comparative study of the Lupus-Cruces and lupus-Bordeaux cohorts.

Autoimmun Rev 2017 Aug 28;16(8):826-832. Epub 2017 May 28.

UMR CNRS 5164, ImmunoconcEpT, Bordeaux University, Bordeaux, France; Immunology Department, FHU ACRONIM, Pellegrin Hospital, Bordeaux, France.

Objective: To compare the clinical course of patients with class III, IV and V lupus nephritis (LN) treated at Hospital Universitario Cruces (CC) and at Bordeaux University Hospital (BC).

Methods: The Lupus-Cruces nephritis protocol combines pulses of 125mg of methyl-prednisolone with each fortnightly pulse of cyclophosphamide and prednisone ≤30mg/day with tapering over 12-14weeks until 2.5-5mg/day. The BC followed international lupus nephritis guidelines, combining high-dose prednisone and either mycophenolate mofetil or cyclophosphamide, followed by maintenance therapy with low dose prednisone and immunosuppressive drugs. The main outcomes were complete renal remission (CR) and glucocorticoid toxicity.

Results: 44 patients from BC and 29 from CC were included. The mean maximum prednisone dose was 42.5 (BC) vs. 21mg/day (CC), p<0.001. The average 6-month prednisone dose was 21 (BC) vs. 8.3mg/d (CC), p<0.001.The mean number of methyl-prednisolone pulses was 3 (BC) vs. 9.3 (CC), p<0.001. HCQ was used by 64% (BC) vs. 100% (CC), p<0.001. CR rates were 30% (BC) vs. 69% (CC), p=0.001, and 42% (BC) vs. 86% (CC), p<0.001, at 6 and 12months, respectively. Patients from the CC more frequently achieved CR (adjusted HR 3.8, 95%CI 2.05-7-09). The number of pulses of methyl-prednisolone were associated with CR (adjusted HR 1.09, 95%CI 1.03-1.15). Patients in the CC had a lower risk of GC-related side effects (adjusted HR 0.19, 95%CI 0.04-0.89).

Conclusion: The Lupus-Cruces nephritis protocol improves the outcome of LN. Repeated methyl-prednisolone pulses help reduce the dose of oral glucocorticoids and enhance clinical response.
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http://dx.doi.org/10.1016/j.autrev.2017.05.017DOI Listing
August 2017

Psychoeducational preventive treatment for women at risk of postpartum depression: study protocol for a randomized controlled trial, PROGEA.

BMC Psychiatry 2017 01 13;17(1):13. Epub 2017 Jan 13.

Department of Psychiatry, University Hospital of Alava-Santiago, Vitoria, Spain.

Background: Postpartum depression is a disease with a prevalence of 20% that has deleterious consequences not only for the mother but also for the baby and can cause delays in physical, social and cognitive development. In this context, the European Union Committee on Public Health has declared it essential that preventative measures are taken by centres providing care for women with a multidisciplinary approach. PROGEA is a multicentre, single-blind randomized, 3-year, longitudinal clinical trial aiming to evaluate the efficacy of a psychoeducational programme in preventing postpartum depression in at-risk women, based on a range of clinical variables, and explore prognostic factors. This paper describes the methods and rationale behind the study.

Methods: We will study women receiving treatment as usual plus a psychoeducation cognitive behavioural therapy (CBT)-based intervention and a control group receiving only treatment as usual. The sample will be recruited from an incidental sampling of pregnant women in two health regions. We will recruit 600 women in the third trimester of pregnancy who consent to take part in the study. Almost half of the women, about 280, would be expected to have some risk factors for postpartum depression. All those found to have risk factors will be evaluated, and we estimate that a quarter will be classified as at-risk of developing postpartum depression as measured with the Edinburgh Postnatal Depression Scale. This subset will be randomly allocated to receive treatment as usual with or without the CBT intervention. Six sessions of CBT (1 individual and 5 group) will be offered by a psychologist.

Discussion: Findings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT-based intervention in improving the mood of women in the postpartum period.

Trial Registration: ClinicalTrials.gov Identifier: NCT02323152 ; Date: December 2014.
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http://dx.doi.org/10.1186/s12888-016-1162-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237273PMC
January 2017

Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.

BMC Psychiatry 2016 12 22;16(1):452. Epub 2016 Dec 22.

Center for Biomedical Research in the Mental Health Network (CIBERSAM), Department of Psychiatry, Araba University Hospital, University of the Basque Country, Olaguibel Street 29, 01004, Vitoria, Spain.

Background: Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used.

Methods: This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment.

Discussion: This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients.

Trial Registration: NCT02924415 . Retrospectively registered 27 September 2016.
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http://dx.doi.org/10.1186/s12888-016-1159-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178094PMC
December 2016

Psychometric properties and validation of a four-item version of the Strauss-Carpenter scale in bipolar disorder.

Int J Bipolar Disord 2016 Dec 18;4(1):22. Epub 2016 Oct 18.

Department of Psychiatry, Bioaraba Research Institute, Araba University Hospital, Olaguibel Street 29, 01004, Vitoria, Spain.

Background: Bipolar disorder is a chronic illness that impairs functioning and affects the quality of life of patients. The onset of this illness usually occurs at an early age, and the risk of relapse remains high for decades. Thus, due to the great clinical relevance of identifying long-term predictors of functioning in bipolar disorder, Strauss and Carpenter developed a scale composed of items known to have prognostic value.

Methods: To determine the clinical usefulness of the four-item Strauss-Carpenter scale in bipolar disorder, a 1-year prospective follow-up study was carried out. The internal consistency, convergent and discriminant validity, and test-retest reliability of the scale were assessed. We also compared the Strauss-Carpenter scale with the reference scales Global Assessment Functioning (GAF), Clinical Global Impression for Bipolar Disorder, the Modified Version (CGI-BIP-M) and the Sheehan Disability Scale (Sheehan). Additionally, a cut-off point for remission was established.

Results: The total sample was composed of 98 patients with a diagnosis of bipolar disorder. The four-item version of the Strauss-Carpenter scale showed to have appropriate psychometric properties, comparable to those of reference scales. The best cut-off point for remission was 14.

Conclusions: The four-item version of the Strauss-Carpenter scale has suitable validity and reliability for the assessment of functioning in patients with bipolar disorder.
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http://dx.doi.org/10.1186/s40345-016-0063-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5069208PMC
December 2016

Prevention of Recurrent Thrombosis in Antiphospholipid Syndrome: Different from the General Population?

Curr Rheumatol Rep 2016 May;18(5):26

Autoimmune Diseases Research Unit, Department of Internal Medicine, BioCruces Health Research Institute, Hospital Universitario Cruces, University of the Basque Country, Bizkaia, The Basque Country, Spain.

Antiphospholipid syndrome (APS) is characterized by arterial and/or venous thrombosis with or without pregnancy morbidity in the presence of autoantibodies targeting proteins that associate with membrane phospholipids, termed "antiphospholipid antibodies" (aPL). Management of arterial and venous thromboses shares some similarities with management of arterial and venous thromboses in the general population; however, there are key differences. The majority of studies addressing management of thrombotic APS focus on secondary prevention. Vitamin K antagonists (VKA) are typically used for secondary prevention of venous thromboembolism in APS. Optimal management of isolated arterial thrombosis, in particular ischemic stroke, in patients with APS is controversial, and proposed therapeutic options have included antiplatelet agents and VKA. Primary prophylaxis in aPL-positive patients should be an individualized decision taking into account patient-specific risks. There may be a role for adjuvant therapies such as hydroxychloroquine, vitamin D, statins, or novel therapeutics in specific patient populations.
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http://dx.doi.org/10.1007/s11926-016-0573-0DOI Listing
May 2016

Rituximab-refractory lupus nephritis successfully treated with belimumab.

Clin Exp Rheumatol 2016 Mar-Apr;34(2):355-6. Epub 2016 Feb 9.

Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University of The Basque Country, Spain.

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July 2016

Comparison of high versus low-medium prednisone doses for the treatment of systemic lupus erythematosus patients with high activity at diagnosis.

Autoimmun Rev 2015 Oct 1;14(10):875-9. Epub 2015 Jun 1.

Autoimmune Diseases Research Unit, Department Of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University Of The Basque Country, Bizkaia, The Basque Country, Spain. Electronic address:

Objective: To compare the efficacy and safety of high vs. low-moderate oral doses of prednisone to treat patients with highly active lupus at diagnosis.

Patients And Methods: Patients from the Lupus-Cruces cohort with an SLEDAI score ≥6 at diagnosis and treated with regimes containing low-medium prednisone doses (≤30 mg/day) were identified (group M). They were matched by sex and SLEDAI score with historical patients treated with high doses (>30 mg/day) at diagnosis (group H). Patients with proliferative nephritis were excluded. The difference in SLEDAI scores between baseline (SLEDAI-0) and year one (SLEDAI-1) was the efficacy variable. Damage at 5 years was calculated using the SLICC damage index (SDI) and regarded as the safety variable. Glucocorticoid related damage was considered in the presence of cataracts, osteonecrosis, osteoporotic fractures and/or diabetes mellitus.

Results: 30 patients were included in each group. Patients in group H received 5-fold higher doses of prednisone, less hydroxychloroquine and less methyl-prednisolone pulses. SLEDAI improvement was similar in both groups. Patients in group H were more likely to accrue new damage (adjusted HR 3.85 (95% CI 1.03-14.2)). No patients in group M suffered glucocorticoid-related damage, vs. 5 patients in group H (p=0.02). The average daily prednisone dose during the first year predicted accrual of new damage (adjusted HR 1.03, 95% CI 1.0-1.07, p=0.056) and accrual of glucocorticoid-related damage (adjusted HR 1.06, 95% CI 1.01-1.13, p=0.03). Likewise, average doses of prednisone >7.5mg/day were an independent predictor of new damage (adjusted HR 4.8, 95% CI 1.2-19.1).

Conclusion: Prednisone doses ≤30 mg/day are similarly effective and safer than higher doses for treating active lupus.
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http://dx.doi.org/10.1016/j.autrev.2015.05.011DOI Listing
October 2015

Prevalence and significance of persistently positive antiphospholipid antibodies in women with preeclampsia.

J Rheumatol 2015 Feb 15;42(2):210-3. Epub 2014 Dec 15.

From the Autoimmune Diseases Research Unit, Department of Internal Medicine, and the Department of Obstetrics, BioCruces Health Research Institute, Hospital Universitario Cruces, University of the Basque Country, Universidad del País Vasco (UPV)/ Euskal Herriko Unibertsitatea (EHU), Bizkaia, Spain.C. Gonzalez-Echavarri, MD, Senior Registrar; I. Villar, MD, Consultant Physician; A. Ugarte, MD, Consultant Physician; G. Ruiz-Irastorza, MD, PhD, Professor of Medicine, Head of the Autoimmune Diseases Research Unit, Autoimmune Diseases Research Unit, Department of Internal Medicine, BioCruces Health Research Institute, Hospital Universitario Cruces, University of the Basque Country, UPV/EHU; R. Larrieta, MD, Consultant Physician, Department of Obstetrics, BioCruces Health Research Institute, Hospital Universitario Cruces.

Objective: To determine the prevalence of antiphospholipid antibodies (aPL) and their association with obstetric outcomes in women with preeclampsia.

Methods: The study included 150 patients. Clinical variables, risk factors, and severity criteria for preeclampsia and aPL were analyzed.

Results: We found aPL in 4% of patients without risk factors for preeclampsia and in no women with risk factors (p = 0.03). Fifty percent of aPL-positive patients had a fetus with intrauterine growth restriction versus 13.9% (p = 0.04). No relation between aPL and severe preeclampsia was found.

Conclusion: The prevalence of aPL among women with preeclampsia is low. aPL can predispose women without risk factors to preeclampsia.
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http://dx.doi.org/10.3899/jrheum.140737DOI Listing
February 2015

Novel association of Neuregulin 1 gene with bipolar disorder but not with schizophrenia.

Schizophr Res 2014 Nov 20;159(2-3):552-3. Epub 2014 Sep 20.

Neurotek UPV-EHU, Departamento de Neurociencias, CIBERNED and Achucarro Basque Center for Neuroscience, Parque Tecnológico de Bizkaia, E-48170 Zamudio, Vizcaya, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.schres.2014.09.001DOI Listing
November 2014

[Rituximab in antiphospholipid syndrome: always, never, sometimes?].

Med Clin (Barc) 2015 Feb 20;144(3):115-7. Epub 2014 Aug 20.

Unidad de Investigación de Enfermedades Autoinmunes, Servicio de Medicina Interna, BioCruces Health Research Institute, Hospital Universitario Cruces, Universidad del País Vasco/Euskal Herriko Unibertsitatea, Barakaldo, Bizkaia, España. Electronic address:

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http://dx.doi.org/10.1016/j.medcli.2014.04.014DOI Listing
February 2015

Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial.

BMC Psychiatry 2014 Aug 15;14:215. Epub 2014 Aug 15.

University Hospital La Paz, IDIPAZ, Madrid, Spain.

Background: The presence of depressive subsyndromal symptoms (SS) in bipolar disorder (BD) increases the risk of affective relapse and worsens social, cognitive functioning, and quality of life. Nonetheless, there are limited data on how to optimize the treatment of subthreshold depressive symptoms in BD. Mindfulness-Based Cognitive Therapy (MBCT) is a psychotherapeutic intervention that has been shown effective in unipolar depression. The assessment of its clinical effectiveness and its impact on biomarkers in bipolar disorder patients with subsyndromal depressive symptoms and psychopharmacological treatment is needed.

Methods/design: A randomized, multicenter, prospective, versus active comparator, evaluator-blinded clinical trial is proposed. Patients with BD and subclinical or mild depressive symptoms will be randomly allocated to: 1) MBCT added to psychopharmacological treatment; 2) a brief structured group psychoeducational intervention added to psychopharmacological treatment; 3) standard clinical management, including psychopharmacological treatment. Assessments will be conducted at screening, baseline, post-intervention (8 weeks) and 4 month follow-up post-intervention. The aim is to compare MBCT intervention versus a brief structured group psychoeducation. Our hypothesis is that MBCT will be more effective in reducing the subsyndromal depressive symptoms and will improve cognitive performance to a higher degree than the psychoeducational treatment. It is also hypothesized that a significant increase of BDNF levels will be found after the MBCT intervention.

Discussion: This is the first randomized controlled trial to evaluate the effects of MBCT compared to an active control group on depressive subthreshold depressive symptoms in patients with bipolar disorder.

Trial Registration: ClinicalTrials.gov: NCT02133170. Registered 04/30/2014.
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http://dx.doi.org/10.1186/s12888-014-0215-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4154516PMC
August 2014
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