Emilio Martín-Mola

Hospital Universitario La Paz, Madrid, Madrid, Spain

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Publications (142)928.43 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: To compare clinical outcomes, incidence of flares, and administered drug reduction between patients with spondyloarthritis (SpA) under TNF inhibitor (TNFi) tapering strategy with patients receiving a standard regimen. In this retrospective study, 74 patients with SpA from Spain on tapering strategy (tapering group; TG) were compared with 43 patients from the Netherlands receiving a standard regimen (control group; CG). The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was measured at visit 0 (prior to starting the TNFi), visit 1 (prior to starting tapering strategy in TG and at least 6 months with BASDAI < 4 after starting the TNFi in the TG and CG), visit 2 (6 mos after visit 1), visit 3 (1 year after visit 1), and visit 4 (the last visit available after visit 1). An overall reduction of the administered drug was seen at visit 4 in the TG [dose reduction of 22% for infliximab (IFX) and an interval elongation of 28.7% for IFX, 45.2% for adalimumab, and 51.5% for etanercept] without significant differences in the BASDAI between the groups at visit 4 (2.15 ± 1.55 in TG vs 2.11 ± 1.31 in CG, p = 0.883). The number of patients with flares was similar in both groups [22/74 (30%) in the TG vs 8/43 (19%) in the CG, p = 0.184]. The tapering strategy in SpA results in an important reduction of the drug administered, and the disease control remains similar to that of the patients with SpA receiving the standard regimen.
    The Journal of Rheumatology 07/2015; 42(9). DOI:10.3899/jrheum.141128 · 3.19 Impact Factor
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    ABSTRACT: To evaluate the effectiveness of tapentadol prolonged release (PR) vs. oxycodone/naloxone PR in non-opioid-pretreated patients with severe chronic low back pain with a neuropathic pain component. Eligible patients (average pain intensity [numerical rating scale-3 (NRS-3)] ≥6; painDETECT positive/unclear) were randomized to twice-daily tapentadol PR 50 mg or oxycodone/naloxone PR 10 mg/5 mg. After a 21-day titration (maximum twice-daily doses: tapentadol PR 250 mg, or oxycodone/naloxone PR 40 mg/20 mg plus oxycodone PR 10 mg), target doses were continued for 9 weeks. The primary effectiveness endpoint was the change in NRS-3 from baseline to final evaluation; the exact repeated confidence interval (RCI) for tapentadol PR minus oxycodone/naloxone PR was used to establish noninferiority (upper limit <1.3) and superiority (confirmatory analyses). For the primary effectiveness endpoint, tapentadol PR was noninferior to oxycodone/naloxone PR (97.5% RCI: [-1.820, -0.184]; P < 0.001). This exact RCI also yielded evidence of superiority for tapentadol PR vs. oxycodone/naloxone PR (significantly greater reduction in pain intensity; P = 0.003). Improvements (baseline to final evaluation) in painDETECT and Neuropathic Pain Symptom Inventory scores were significantly greater with tapentadol PR vs. oxycodone/naloxone PR (all P ≤ 0.005). The study was formally shown to be positive and demonstrated, in the primary effectiveness endpoint, the noninferiority for tapentadol PR vs. oxycodone/naloxone PR. The effectiveness of tapentadol PR was superior to that of oxycodone/naloxone PR by means of clinical relevance and statistical significance (confirmatory evidence of superiority). Tapentadol PR was associated with significantly greater improvements in neuropathic pain-related symptoms and global health status than oxycodone/naloxone PR and with a significantly better gastrointestinal tolerability profile. Tapentadol PR may be considered a first-line option for managing severe chronic low back pain with a neuropathic pain component. © 2015 The authors. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.
    Pain Practice 06/2015; DOI:10.1111/papr.12308 · 2.36 Impact Factor
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    ABSTRACT: To establish recommendations for the management of patients with rheumatoid arthritis (RA) to serve as a reference for all health professionals involved in the care of these patients, and focusing on the role of available synthetic and biologic disease-modifying antirheumatic drugs (DMARDs). Consensual recommendations were agreed on by a panel of 14 experts selected by the Spanish Society of Rheumatology (SER). The available scientific evidence was collected by updating three systematic reviews (SR) used for the EULAR 2013 recommendations. A new SR was added to answer an additional question. The literature review of the scientific evidence was made by the SER reviewer's group. The level of evidence and the degree of recommendation was classified according to the Oxford Centre for Evidence-Based Medicine system. A Delphi panel was used to evaluate the level of agreement between panellists (strength of recommendation). Thirteen recommendations for the management of adult RA were emitted. The therapeutic objective should be to treat patients in the early phases of the disease with the aim of achieving clinical remission, with methotrexate playing a central role in the therapeutic strategy of RA as the reference synthetic DMARD. Indications for biologic DMARDs were updated and the concept of the optimization of biologicals was introduced. We present the fifth update of the SER recommendations for the management of RA with synthetic and biologic DMARDs. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.
    06/2015; 11(5). DOI:10.1016/j.reuma.2015.05.001
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):422.3-422. DOI:10.1136/annrheumdis-2015-eular.1612 · 10.38 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):1151.3-1151. DOI:10.1136/annrheumdis-2015-eular.2793 · 10.38 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):868.1-868. DOI:10.1136/annrheumdis-2015-eular.2879 · 10.38 Impact Factor
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    ABSTRACT: Background Biological agents against tumor necrosis factor (Anti-TNF) have revolutionized the treatment of Rheumatoid Arthritis (RA). Recent studies assess the possibility of reducing the dose or increase the interval of administration of biologics (optimization strategy: OS) in patients with at least sustained low disease activity (LDA) without relevant clinical worsening. One of the questions raised is whether the use of OS could increase the incidence of anti-drug antibodies (ADA) appearance with the consequent loss of efficacy. Objectives To evaluate the influence of the OS in a cohort of RA patients at least in LDA on the clinical activity (DAS28), incidence of flares, serum drug levels and ADA appearance. Methods A retrospective observational study of a cohort of RA patients in LDA or remission (measured by DAS28<3.2 or<2.6, respectively) for at least 6 months. Of the 283 RA patients treated in our Unit with Infliximab (Ifx), Adalimumab (Ada) and Etanercept (Etn), 54 patients treated with the 1st Anti-TNF fulfilled the previous criteria to be included and were under an OS. DAS28, C reactive protein (CRP) values and drug and ADA levels were evaluated at baseline before OS (pre-visit) and in the last available visit during the first 2 years of follow-up (pos-visit). Flares were monitored between pre and pos-visits. Results Of the 54 patients, 77.8% were women. Mean age was 60.2±12 years. The 79.6% (43) were antiCCP and FR positive. Regarding concomitant treatment 35 patients (64.8%) received methotrexate at baseline, 25 (46.3%) other DMARDs and 23 (42.6%) prednisone. Twenty-seven (50%) were treated with Ada, 16 (29.6%) with Etn and 11 (20.4%) with Ifx. No significant differences were observed in the control of DAS28 between the pre-visit and pos-visit in every Anti-TNF (Ada: 2,13±0,12 pre-visit vs 2,42±0,18 pos-visit, p=0,064; Ifx: 2,32±0,11 pre-visit vs 2,19±0,18 pos-visit, p=0,799; Etn: 2,36±0,12 pre-visit vs 2,93±0,20 pos-visit, p=0,056). There was no statistically a significant increase in CRP levels between pre and post visits in any Anti-TNF (Ada: p=0,629; Ifx: p=0,799; Etn: p=0,796). Nineteen (35.2%) developed flares during the follow-up (14 patients had one flare and 5 had 2 flares). All patients were negative for ADA at the pre-visit, 5 (9.25%) were positive at pos-visit associated with flares. Sixteen (29.6%) out of the 19 patients with flare required to shorten the interval or increase the dose to control DAS28. A statistically significant decrease was observed in drug levels between the pre-visit and post-visit in patients treated with Ada and Etn (Ada: 5127.88±1542.65 pre-visit vs 1200.29±276.52 pos-visit, p=0.003; Etn: 2794.46±367.07 pre-visit vs 1359.38±375.121 pos-visit, p=0.023). Conclusions OS seems to be feasible in RA patients in LDA treated with Anti-TNF, reducing the amount of drug administered with low incidence of ADA and without impact on clinical and serological markers such as CRP. In most patients with flares, the clinical activity appears to be controlled by shortening the interval of administration without increasing the therapy discontinuation. Disclosure of Interest B. Paredes Grant/research support from: This study has received unrestricted grants from Pfizer
    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):458.1-458. DOI:10.1136/annrheumdis-2015-eular.5515 · 10.38 Impact Factor
  • I. Ibero · E. Raya · J.M. Nolla · E. Martin-Mola · M. Rodriguez · G. Nocea · B. Aragon
    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):320.1-320. DOI:10.1136/annrheumdis-2015-eular.3063 · 10.38 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):234.1-234. DOI:10.1136/annrheumdis-2015-eular.4905 · 10.38 Impact Factor
  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):280.1-280. DOI:10.1136/annrheumdis-2015-eular.3524 · 10.38 Impact Factor
  • Diana Peiteado · Alejandro Villalba · Emilio Martín-Mola · Eugenio de Miguel
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    ABSTRACT: We undertook this study to evaluate the responsiveness of Doppler ultrasound (US) to urate lowering therapy (ULT) in gout patients. Twenty-four consecutive patients were prospectively included from an outpatient clinic. The patients underwent clinical, and US assessment at baseline and after 6, 12 and 24 months of ULT. The US assessment was made by another rheumatologist blinded to the clinical data. Standardised examinations were performed in four joints (both first metatarso-phalangeals and knees) and the patellar tendons. The Doppler signals were scored. The mean and standard deviation were calculated for each parameter. The comparison between the quantitative values was performed by Student's t-test. Sensitivity to change in the US examinations was assessed by estimating the smallest detectable difference (SDD) in the total Doppler score. A Doppler signal was detected in 95.8% of the patients at the baseline. A significant parallel improvement in the serum urate level, clinical parameters and in Doppler scores was found at the follow-up assessment. 62% of the patients had achieved a uric concentration level below 6 mg/dl at one year. At two years, persistence of a Doppler signal was found in 72.7% of the patients. The SDD in the Doppler score at 2 years was 1.92, lower than the difference achieved. The Doppler US findings show significant improvement and responsiveness after ULT in gout patients. The Doppler signal persistence after two years of treatment is marked. This finding introduces a reflection on the accuracy of the current outcome measures and treatments.
    Clinical and experimental rheumatology 04/2015; 33(3). · 2.72 Impact Factor
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    ABSTRACT: Objective The ability to interpret scores from Patient Reported Outcome Measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state-attainment. The goal was to develop multinational estimates for Minimal Clinically Important Improvement (MCII) and Patient Acceptable Symptomatic State (PASS). Methods A multinational sample of patients with osteoarthritis (OA), were evaluated before and 4 weeks after treatment with nonsteroidal anti-inflammatory drugs. Patients completed either the Western Ontario and McMaster (WOMAC) NRS3.1 Index (hip and knee OA) or the Australian/Canadian (AUSCAN) NRS3.1 Index (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN Indices. A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (and percentage) change for MCII ranged between 6 to 9 (10% to 17%) for WOMAC and 4 to 9 (8% to 15%) for AUSCAN. PASS estimates ranged from 39 to 48 for WOMAC and 38 to 45 for AUSCAN. Some between-country variation was observed in MCII and PASS. Conclusion Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency and age- and gender-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions and other condition-specific outcome measures. This article is protected by copyright. All rights reserved. Copyright © 2014 American College of Rheumatology.
    Arthritis Care and Research 01/2015; 67(7). DOI:10.1002/acr.22538 · 4.71 Impact Factor
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    ABSTRACT: The aim of this study was to establish guidelines for the optimization of biologic therapies for health professionals involved in the management of patients with RA, AS and PsA. Recommendations were established via consensus by a panel of experts in rheumatology and hospital pharmacy, based on analysis of available scientific evidence obtained from four systematic reviews and on the clinical experience of panellists. The Delphi method was used to evaluate these recommendations, both between panellists and among a wider group of rheumatologists. Previous concepts concerning better management of RA, AS and PsA were reviewed and, more specifically, guidelines for the optimization of biologic therapies used to treat these diseases were formulated. Recommendations were made with the aim of establishing a plan for when and how to taper biologic treatment in patients with these diseases. The recommendations established herein aim not only to provide advice on how to improve the risk:benefit ratio and efficiency of such treatments, but also to reduce variability in daily clinical practice in the use of biologic therapies for rheumatic diseases. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology.
    Rheumatology (Oxford, England) 12/2014; 54(7). DOI:10.1093/rheumatology/keu461 · 4.48 Impact Factor
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    ABSTRACT: IntroductionCirculating CD4 T cells expressing CXCR5, ICOS and/or PD-1 are counterparts of follicular helper T cells (Tfh). There are three subpopulations of circulating Tfh (cTfh): CXCR5¿+¿CXCR3¿+¿CCR6- (Tfh-Th1), CXCR5¿+¿CXCR3-CCR6- (Tfh-Th2) and CXCR5¿+¿CXCR3-CCR6+ (Tfh-Th17). Our objective was to study the B cell helping capacity of cTfh subsets, and examine their frequency in Rheumatoid Arthritis (RA) patients, together with the frequency of circulating plasmablasts (CD19¿+¿CD20-CD38high).Methods Peripheral blood was drawn from RA patients with active disease (RA-a, DAS28¿>¿2.6) (n¿=¿17), RA in remission (RA-r, DAS28¿<¿2.6) (n¿=¿17) and healthy controls (HC) (n¿=¿34). cTfh and plasmablast frequencies were determined by flow cytometry. Cocultures of sorted CD4¿+¿CXCR5+ T cell subpopulations were established with autologous CD19¿+¿CD27- naïve B cells of HC, and concentrations of IgG, A and M were measured in supernatants.ResultsIsolated Tfh-Th2 and Tfh-Th17 but not Tfh-Th1 cells, induced naïve B cells to secrete IgG and IgA. The frequency of CXCR5+ cells gated for CD4+ T cells was not different among HC, RA-a and RA-r. In contrast, both RA-a and RA-r patients demonstrated an increased frequency of CD4¿+¿CXCR5¿+¿ICOS+ T cells and augmented (%Tfh-Th2¿+¿%Tfh-Th17)/%Tfh-Th1 ratio as compared with HC. In addition, RA-a but not RA-r patients, showed an increased frequency of circulating plasmablasts.Conclusion Both RA-a and RA-r patients demonstrate an increased frequency of cTfh and overrepresentation of cTfh subsets bearing a B cell helper phenotype, suggesting that altered germinal center dynamics play a role in RA pathogenesis. In contrast, only RA-a patients show an increased proportion of circulating plasmablasts.
    Arthritis Research & Therapy 12/2014; 16(6):500. DOI:10.1186/s13075-014-0500-6 · 3.75 Impact Factor
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    ABSTRACT: Background: We assessed the effects of reduction and withdrawal of treatment in patients with rheumatoid arthritis who had a remission while receiving etanercept-plus-methotrexate therapy. Methods: Patients with early active disease who had not previously received methotrexate or biologic therapy received 50 mg of etanercept plus methotrexate weekly for 52 weeks (open-label phase). We then randomly assigned patients who had qualifying responses at weeks 39 and 52 to receive 25 mg of etanercept plus methotrexate (combination-therapy group), methotrexate alone, or placebo for 39 weeks (double-blind phase). Patients who had qualifying responses at week 39 of the double-blind phase had all treatment withdrawn at that time and were followed to week 65 (treatment-withdrawal phase). The primary end point was the proportion of patients with sustained remission in the double-blind phase. Results: Of 306 patients enrolled, 193 underwent randomization in the double-blind phase; 131 qualified for the treatment-withdrawal phase. More patients in the combination-therapy group than in the methotrexate-alone group or the placebo group met the criterion for the primary end point (40 of 63 [63%] vs. 26 of 65 [40%] and 15 of 65 [23%], respectively; P=0.009 for combination therapy vs. methotrexate alone; P<0.001 for combination therapy vs. placebo). At 65 weeks, 28 patients (44%) who had received combination therapy, 19 (29%) who had received methotrexate alone, and 15 (23%) who had received placebo were in remission (P=0.10 for combination therapy vs. methotrexate alone; P=0.02 for combination therapy vs. placebo; P=0.55 for methotrexate alone vs. placebo). No significant between-group differences were observed in radiographic progression of disease. Serious adverse events were reported in 3 patients (5%) in the combination-therapy group, 2 (3%) in the methotrexate-alone group, and 2 (3%) in the placebo group. Conclusions: In patients with early rheumatoid arthritis who had a remission while receiving full-dose etanercept-plus-methotrexate therapy, continuing combination therapy at a reduced dose resulted in better disease control than switching to methotrexate alone or placebo, but no significant difference was observed in radiographic progression. (Funded by Pfizer; ClinicalTrials.gov number, NCT00913458.).
    New England Journal of Medicine 11/2014; 371(19):1781-92. DOI:10.1056/NEJMoa1316133 · 55.87 Impact Factor
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    ABSTRACT: Follicular helper T cells (Tfh), localized in lymphoid organs, promote B cell differentiation and function. Circulating CD4 T cells expressing CXCR5, ICOS and/or PD-1 are counterparts of Tfh. Three subpopulations of circulating CD4+CXCR5+ cells have been described: CXCR3+CCR6- (Tfh-Th1), CXCR3-CCR6+ (Tfh-Th17), and CXCR3-CCR6- (Tfh-Th2). Only Tfh-Th17 and Tfh-Th2 function as B cell helpers. Our objective was to study the frequencies of circulating Tfh (cTfh), cTfh subsets and plasmablasts (CD19+CD20-CD27+CD38high cells), and the function of cTfh cells, in patients with Ankylosing Spondylitis (AS). To this end, peripheral blood was drawn from healthy controls (HC) (n = 50), AS patients naïve for TNF blockers (AS/nb) (n = 25) and AS patients treated with TNF blockers (AS/b) (n = 25). The frequencies of cTfh and plasmablasts were determined by flow cytometry. Cocultures of magnetically sorted CD4+CXCR5+ T cells with autologous CD19+CD27- naïve B cells were established from 3 AS/nb patients and 3 HC, and concentrations of IgG, A and M were measured in supernatants. We obseved that AS/nb but not AS/b patients, demonstrated decreased frequencies of circulating CD4+CXCR5+ICOS+PD-1+ cells and plasmablasts, together with a decreased (Tfh-Th17+Tfh-Th2)/Tfh-Th1 ratio. The amounts of IgG and IgA produced in cocultures of CD4+CXCR5+ T cells with CD19+CD27- B cells of AS/nb patients were significantly lower than observed in cocultures established from HC. In summary, AS/nb but not AS/b patients, demonstrate a decreased frequency of cTfh and plasmablasts, and an underrepresentation of cTfh subsets bearing a B helper phenotype. In addition, peripheral blood CD4+CXCR5+ T cells of AS/nb patients showed a decreased capacity to help B cells ex vivo.
    PLoS ONE 09/2014; 9(9):e107086. DOI:10.1371/journal.pone.0107086 · 3.23 Impact Factor
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    ABSTRACT: Objective To assess the efficacy and safety of tocilizumab (TCZ) plus methotrexate/placebo (MTX/PBO) over 2 years and the course of disease activity in patients who discontinued TCZ due to sustained remission. Methods ACT-RAY was a double-blind 3-year trial. Patients with active rheumatoid arthritis despite MTX were randomised to add TCZ to ongoing MTX (add-on strategy) or switch to TCZ plus PBO (switch strategy). Using a treat-to-target approach, open-label conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), other than MTX, were added from week 24 if Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) >3.2. Between weeks 52 and 104, patients in sustained clinical remission (DAS28-ESR <2.6 at two consecutive visits 12 weeks apart) discontinued TCZ and were assessed every 4 weeks for 1 year. If sustained remission was maintained, added csDMARDs, then MTX/PBO, were discontinued. Results Of the 556 randomised patients, 76% completed year 2. Of patients entering year 2, 50.4% discontinued TCZ after achieving sustained remission and 5.9% achieved drug-free remission. Most patients who discontinued TCZ (84.0%) had a subsequent flare, but responded well to TCZ reintroduction. Despite many patients temporarily stopping TCZ, radiographic progression was minimal, with differences favouring add-on treatment. Rates of serious adverse events and serious infections per 100 patient-years were 12.2 and 4.4 in add-on and 15.0 and 3.7 in switch patients. In patients with normal baseline values, alanine aminotransferase elevations >3×upper limit of normal were more frequent in add-on (14.3%) versus switch patients (5.4%). Conclusions Treat-to-target strategies could be successfully implemented with TCZ to achieve sustained remission, after which TCZ was stopped. Biologic-free remission was maintained for about 3 months, but most patients eventually flared. TCZ restart led to rapid improvement. Trial registration number NCT00810199.
    Annals of the Rheumatic Diseases 08/2014; 74(1). DOI:10.1136/annrheumdis-2014-205752 · 10.38 Impact Factor
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    ABSTRACT: Background The development of the ASAS classification criteria has facilitated the diagnosis of Spondyloarthritis (SpA) at early and non-radiological stages. Despite these non-radiological forms are considered as less aggressive by Rheumatologists, their clinical relevance is still discussed and besides, the accuracy of radiological diagnosis of sacroiliitis at the early stages of the disease has been questioned in some forums. Objectives The aim of this study is to asses the diagnostic reliability of pelvis x-Rays and sacroiliac magnetic resonance imaging (MRI) in an early axial SpA cohort. Methods Patients included in the study came from three Spanish early SpA units, as part of the ESPERANZA programme, a nationwide health management programme designed to provide excellence in care for early SpA. One of the inclusion criteria was symptom duration between 3 and 24 months. All patients fulfilled ASAS criteria for axial SpA at baseline. Radiographs of pelvis at baseline and at follow up were done for every patient. These x-Rays were centrally digitized and the SIJ were scored according to the grading system of the modified New York criteria by two independent and blinded readers. MRIs of SIJ were assessed according to ASAS definition for bone marrow oedema (BME) by two independent and blinded readers. BME was also scored using the Leeds MRI scoring system. Fatty lesions within the sacroiliac joints were assessed in the T1 sequences. SPSS program version 17.0 was used for Statistical analysis. Kappa test was used for reliability analysis. Results 48 patients were included, 25 of them (52.1%) were male. The mean age was 33.9 years (range: 20-45; SD 6.51) and 46-9% were HLA B27 positive. The average evolution time since onset of symptoms until baseline clinic visit was 10.21 months (range: 3-24; SD 6.83). The mean follow up time (between baseline and follow up x-Rays) was 3.25 years (range: 1-5; SD 1.08).The global Kappa coefficient of the x-Rays reading, taking into account both visits together (48 baseline x-Rays and 48 follow-up x-Rays) was 0.699, which is a good result. When we analysed the x-Rays reading of both visits separately, we found that the kappa coefficient of the x-Ray reading corresponding to the baseline visit (48 x-Rays) was 0.5, which is a moderate result, but it increased to 0.869 when we analysed the x-Rays reading corresponding to the follow-up visit, which is an excellent result. Regarding MRI, there were 27 available for analysis and the agreement for the ASAS definition of BME was excellent (Kappa 1.00). The kappa coefficient obtained with the Leeds MRI scoring system was 0.686 and the intraclass correlation coefficient was 0.807. The agreement obtained for the fatty lesions was fair (Kappa 0.34). Conclusions The inter-reader reliability of sacroiliac x-Ray improves as disease progresses, and, regarding to these results, it has a limited utility at the early stages of SpA. In the other hand, sacroiliac MRI is a reliable tool for diagnosis at early stages and in non-radiological axial SpA. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.5949
    Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):1031-1032. DOI:10.1136/annrheumdis-2014-eular.5949 · 10.38 Impact Factor
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    ABSTRACT: Background There is limited evidence regarding longterm effects of tapering of TNF inhibitors (TNFi) in Spondyloarthritis (SpA) patients Objectives To compare longterm clinical outcomes in SpA patients on tapering strategy with SpA patients on standard regimen Methods In this observational study, 117 SpA patients (pts) treated with TNFi [infliximab (Ifx), adalimumab (Ada) and etanercept (Etn)] were included. Two groups were compared: TNFi tapering strategy (Group 1: 74 pts from Spain) vs the control group on standard treatment regimen (Group 2: 43 pts from the Netherlands). A control group for the Ifx was not available. Pts were matched on duration of inactive disease prior to inclusion and duration of followup. All SpA pts had to be at least 6 months in inactive disease (BASDAI<4) to be included. The tapering strategy included dose reduction and/or interval prolongation, in case a flare (BASDAI>4)appeared, the TNFi dose could be increased or the interval could be shortenned to regain low disease activity. The clinical activity was measured, using BASDAI, at different time points: visit-0 (baseline, prior starting the biological therapy), visit-1 (Group1: just before starting tapering; Group 2: after at least 6 months in inactive disease) and visit-2 (the last visit available after visit-1) Results Seventy four pts were included in tapering group (Group 1: 35 with Ifx, 17 with Ada and 22 with Etn) and 43 pts in control group (Group 2: 21 with Ada and 22 with Etn). No statistical differences were seen in the time (years) in inactive disease prior visit-1 (1.23±1.09 in Group 1 vs 0.73±0.18 in Group 2, p=0.243) and followup (years) between visit-1and visit-2 (2.33±1.12 in Group 1 vs 2.40±0.99 in Group 2, p=0.567).No significant differences were found in clinical activity and percentage of pts with flares (see Table 1). The dropout tended to be higher in pts on tapering, being the secondary inefficacy more frequent in this group, but also the remission (see Table 1).The overall drug administered was reduced in tapering group at visit-2 in comparison with the group on standard protocol (dose reduction of 22% in Ifx and an elongation in administration interval of 28.7% in Ifx, 45.2% in Ada and 51.5% in Etn) Conclusions The tapering strategy in inactive SpA pts results in an important reduction of the drug administered while the disease control remains similar to SpA on standard regimen. However, a small percentage of SpA pts on tapering seems to be more prone to dropout due to secondary inefficacy and also the remission was more often Disclosure of Interest C. Plasencia Grant/research support: Pfizer, G. Wolbink Grant/research support: Pfizer, Speakers bureau: Pfizer, Amgen, E. Kneepkens: None declared, C. Krieckaert Speakers bureau: Abbvie, Pfizer, M. l'Ami: None declared, D. Peiteado: None declared, L. Nuno: None declared, F. Arribas: None declared, M. Nurmohamed Grant/research support: Abbvie, BMS, MSD, Pfizer, UCB, Roche, Consultant for: Abbott, BMS, Pfizer, Roche, Speakers bureau: Abbvie, Pfizer, Roche, E. Martín-Mola Speakers bureau: Pfizer, Abbvie, Roche, UCB, A. Balsa Grant/research support: Pfizer, Speakers bureau: Pfizer, Abbvie, Roche, D. Pascual-Salcedo Grant/research support: Pfizer, Speakers bureau: Pfizer DOI 10.1136/annrheumdis-2014-eular.3208
    Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):713-713. DOI:10.1136/annrheumdis-2014-eular.3208 · 10.38 Impact Factor
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    ABSTRACT: Background There is strong evidence that correlates the antibodies to infliximab appearance (ATI) with a poor clinical response, but for now sparse literature has demonstrated the predictive value of early serum infliximab (Ifx) levels monitoring with the ADA development Objectives To analize if serum Ifx levels at weeks 2, 6 and 14 can predict the ADA appearance at 6 months and 1 year in rheumatoid arthritis (RA) patients.and to define a predictive cutt-off Methods In this restrospective observational study, 83 RA patients (pts) under Ifx therapy were included. All patients fulfilled the 1987 ACR criteria to be included. The clinical activity was measured by DAS28. The drug and ATI levels were measured at baseline and before each infusion by capture and bridging ELISA, respectively. The data about ATI status were available in 44 patients at 6 months and 42 patients at 1 year. In the statistical study was used receiver-operator characteristics (ROC) analysis to obtain a representative cut-off value for Ifx levels between ATIpositive(+) and negative(−) patients at 6 months and 1 year Results Seventy four out of 83 RA patients were female and most of patients had positive rheumatoid factor (62/83, 74.7%) and ACPA (70/83, 84.3%).The mean of the disease duration was 15.46±8.96 years and the time on biological therapy 5.42±3.49 years. At baseline, all patients had active disease measured by DAS28 (5.49±1.35). Fourteen out of 44 (31.8%)patients were ATI+ at 6 months and 12 out of 42 (28.6%) at 1 year. The area under the curve to predict presence of ATI at 6 months was 0.790 (95%CI 0.624-0.957,p=0.002) at week 2, 0.885 (95%CI 0.766-1.000,p=0.001)at week 6 and 0.966 (95%CI 0.913-1.000,p=0.0001) at week 14. For the predictive value of ATI development at 1 year, the area under the curve was 0.773 (95%CI 0.604-0.942,p=0.002)at week 2, 0.853 (95%CI 0.725-0.982,p=0.001) at week 6 and 0.951 (95%CI 0.877-1.000,p=0.001) at week 14. The cut off of Ifx levels to predict ATI appearance at 6 months and 1 year are shown in Table Conclusions The early Ifx levels monitoring has a high value to discriminate what RA patients on Ifx therapy will develop ATI during the treatment. These findings can help to know what patients are more likely to develop a secondary inefficacy associated to immunogenicity Disclosure of Interest P.-R. Chamaida Grant/research support: Pfizer, D. Pascual-Salcedo Grant/research support: Pfizer, Speakers bureau: Pfizer, M. Bonilla: None declared, A. Villalba: None declared, M. Lόpez-Casla: None declared, D. Peiteado: None declared, S. García-Carazo: None declared, S. Ramiro: None declared, K. Franco: None declared, D. Cajigas: None declared, E. Martín-Mola Speakers bureau: Pfizer, Roche, Abbvie, UCB, A. Balsa Grant/research support: Pfizer, Speakers bureau: Pfizer, Roche, Abbvie DOI 10.1136/annrheumdis-2014-eular.3237
    Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):157-157. DOI:10.1136/annrheumdis-2014-eular.3237 · 10.38 Impact Factor

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  • 1993–2015
    • Hospital Universitario La Paz
      • Servicio de Reumatología
      Madrid, Madrid, Spain
  • 2014
    • Universidad Tecnológica de La Paz
      Сан-Хосе-дель-Кабо, Baja California Sur, Mexico
  • 2002–2012
    • Universidad Autónoma de Madrid
      • Department of Pathology
      Madrid, Madrid, Spain
  • 2003
    • Sociedad Española de Reumatología
      Madrid, Madrid, Spain
  • 2001
    • Hospital General Universitario Gregorio Marañón
      Madrid, Madrid, Spain