Publications by authors named "Xavier Juanola"

49 Publications

Proposals for the incorporation of the nursing role in the certification of axial spondyloarthritis units. Literature review and expert consensus.

Reumatol Clin (Engl Ed) 2022 Apr 22. Epub 2022 Apr 22.

Departamento de Psicología de la Salud, Universidad Miguel Hernández de Elche, Elche, Spain; Departamento de Salud Alicante-Sant Joan d'Alacant, San Juan (Alicante), Spain.

Objective: To analyse the role of nursing in the approach to axial spondyloarthritis (axSpA) and to make proposals to include the role of rheumatology nursing consultations (RECs) in the quality certification of these specialized units.

Methods: A systematic review of the nursing role in quality certification systems in the management of axSpA was conducted. Subsequently a consensus conference was held with the participation of three rheumatology nurses to determine elements that should be considered in future revisions of certification standards.

Results: The systematic review yielded five papers as relevant. None of the publications reviewed explicitly proposed standards applicable to nursing care in the management of patients with axSpA, although they contemplated the activities of this professional group. The proposals agreed upon to incorporate the role of RECs in the certification standards for axSpA monographic units included the following: basic equipment and resources, organization, administration of pharmacological treatments and promotion of adherence, standardized programmes for axSpA, telematic consultation for monitoring the stable patient, registry of patient-reported outcome measures and e-consultation.

Conclusions: The literature on quality standards and certification standards for axSpA monographic units is scarce and hardly reflects the role of RECs in providing quality care. The consensus proposals in this study would incorporate RECs into quality certification standards. In the future, the increased presence of RECs in Spain should be accompanied by a review of the indicators regarding their role.
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http://dx.doi.org/10.1016/j.reumae.2021.09.004DOI Listing
April 2022

Treatment Failure in Axial Spondyloarthritis: Insights for a Standardized Definition.

Adv Ther 2022 Apr 24;39(4):1490-1501. Epub 2022 Feb 24.

Rheumatology Service, Medicine Department UAB, I3PT, University Hospital Parc Taulí Sabadell, Barcelona, Spain.

Axial spondyloarthritis is a chronic inflammatory rheumatic disease that affects the axial skeleton and causes severe pain and disability. It may be also associated with extra-articular manifestations. Early diagnosis and appropriate treatment can reduce the severity of the disease and the risk of progression. The biological disease-modifying antirheumatic drugs (bDMARDs) tumor necrosis factor alpha (TNFα) inhibitors (TNFi) and the anti-interleukin (IL)-17A antibodies secukinumab and ixekizumab are effective agents to reduce disease activity and minimize the inflammation that damages the joints. New alternatives such as Janus kinase (JAK) inhibitors are also available. Unfortunately, response rates to bDMARDs are far from optimal, and many patients experience so-called treatment failure. The definition of treatment failure definition is often vague and may depend on the rigorousness of the therapeutic goal, the inclusion or not of peripheral symptoms/extra-articular manifestations, or patients' overall health. After an exhaustive bibliographic review, we propose a definition based on loss of the following status: low disease activity assessed by Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP, absence of extra-articular manifestations, and low disease impact on the patients' general health. Apart from discontinuing the therapy because of safety or intolerance reasons, two types of treatment failure can be differentiated depending on when it occurs: primary failure (no response within 6 months after treatment initiation, or lack of efficacy) and secondary failure (response within 6 months but lost thereafter, or loss of efficacy over time). Physicians should carefully consider the moment and the reason for the treatment failure to decide the next therapeutic step. In the case of primary failure on a first TNFi, it seems reasonable to switch to another class of drugs, i.e., an anti-IL-17 agent, as phase III trials showed that the response to IL-17 blockade was higher than to placebo in patients previously exposed to TNFi. When secondary failure occurs, and loss of efficacy is suspected to be caused by antidrug antibodies (ADAs), it is advisable to analyze serum TNFi and ADAs concentrations, if possible; in the presence of ADAs and low TNFi levels, changing the TNFi is rational as it may restore the TNFα blocking capacity. If ADAs are absent/low with adequate drug therapeutic levels, switching to another target might be the best strategy.
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http://dx.doi.org/10.1007/s12325-022-02064-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8990961PMC
April 2022

Sustained low disease activity measured by ASDAS slow radiographic spinal progression in axial spondyloarthritis patients treated with TNF-inhibitors: data from REGISPONSERBIO.

Arthritis Res Ther 2022 01 21;24(1):30. Epub 2022 Jan 21.

Rheumatology, Parc Taulí Hospital Universitari, I3PT Research Institute (UAB), Universitat Autónoma de Barcelona (UAB), Sabadell, 08208, Spain.

Background: To evaluate the influence of the disease activity on radiographic progression in axial spondyloarthritis (axSpA) patients treated with TNF inhibitors (TNFi).

Methods: The study included 101 axSpA patients from the Spanish Register of Biological Therapy in Spondyloarthritides (REGISPONSERBIO), which had clinical data and radiographic assessment available. Patients were classified into 2 groups based on the duration of TNFi treatment at baseline: (i) long-term treatment (≥4 years) and (ii) no long-term treatment (< 4 years). Radiographs were scored by two readers according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) with known chronology. Disease activity differences between patients' groups at each time point were assessed using a linear mixed-effect model.

Results: Radiographic progression was defined as an increase in ≥2 mSASSS units. At inclusion, approximately half of the patients (45.5%) were receiving long-term treatment with TNFi (≥4 years). In this group of subjects, a significant difference in averaged Ankylosing Spondylitis disease Activity Score (ASDAS) across follow-up was found between progressors and non-progressors (2.33 vs 1.76, p=0.027, respectively). In patients not under long-term TNFi treatment (54.5%) though, no significant ASDAS differences were observed between progressors and non-progressors until the third year of follow-up. Furthermore, no significant differences were found in progression status, when disease activity was measured by Bath Ankylosing spondylitis Disease Activity Index (BASDAI) and C reactive protein (CRP).

Conclusions: Patients on long-term TNFi treatment with a mean sustained low disease activity measures by ASDAS presented lower radiographic progression than those with active disease.
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http://dx.doi.org/10.1186/s13075-021-02695-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8780330PMC
January 2022

Validation of screening criteria for spondyloarthritis in patients with inflammatory bowel disease in routine clinical practice.

Dig Liver Dis 2022 Jan 14. Epub 2022 Jan 14.

Department of Rheumatology, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain. Electronic address:

Background: Spondyloarthritis (SpA) is one of the most common extraintestinal manifestations of inflammatory bowel disease (IBD). Diagnostic delay must be avoided.

Aims: We assessed the validity of SpA screening criteria (any of the following characteristics: chronic low back pain with onset before 45 years of age; inflammatory lower back pain or alternating buttock pain; arthritis; heel enthesitis; dacylitis; HLA-B27 positivity; sacroiliitis on imaging).

Methods: This was a multicenter cross-sectional observational study in IBD patients aged ≥18 years. After evaluating the SpA screening criteria, the gastroenterologists referred the participants to the rheumatologists, who determined whether the patient fulfilled the screening criteria and carried out the necessary tests for SpA diagnosis.

Results: 35 (11.7%) out of 300 patients were diagnosed with SpA. The combination with the best balance between sensitivity and specificity (91.4% and 72.1%, respectively, when applied by the rheumatologists; 80% and 78.9%, when applied by the gastroenterologists) for SpA screening, was fulfillment of any of the following: chronic low back pain with onset before age 45 years, inflammatory low back pain or alternating buttock pain, arthritis, or dactylitis.

Conclusion: This is one of the first studies to validate SpA screening criteria in IBD patients in routine clinical practice.
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http://dx.doi.org/10.1016/j.dld.2021.12.010DOI Listing
January 2022

Identifying Clinicoradiological Phenotypes in Diffuse Idiopathic Skeletal Hyperostosis: A Cross-Sectional Study.

Medicina (Kaunas) 2021 Sep 24;57(10). Epub 2021 Sep 24.

Hospital Universitari de Bellvitge, Hospitalet de Llobregat, 08907 Barcelona, Spain.

: Diffuse idiopathic skeletal hyperostosis (DISH) is a bone formation disease in which only skeletal signs are considered in classification criteria. The aim of the study was to describe different phenotypes in DISH patients based on clinicoradiological features. : We evaluated 97 patients who met the Resnick or modified Utsinger classification criteria for DISH and were diagnosed at our hospital from 2004 to 2015. Patients were stratified into: (a) peripheral pattern (PP)-Resnick criteria not met but presenting ≥3 peripheral enthesopathies; (b) axial pattern (AP)-Resnick criteria met but <3 enthesopathies; and (c) mixed pattern (MP)-Resnick criteria met with ≥3 enthesopathies. Statistical analysis was carried out to identify variables that might predict classification in a given group. Fifty-six of the 97 patients included (57.7%) were male and 72.2% fulfilled the Resnick criteria. Applying our classification, 39.7% were stratified as MP, 30.9% as AP and 29.4% as PP. Clinical enthesopathy was reported in 40.2% of patients during the course of the disease. Sixty-eight patients were included in a comparative analysis of variables between DISH patterns. The results showed a predominance of women ( < 0.004), early onset ( < 0.03), hip involvement ( < 0.003) and enthesitis ( < 0.001) as hallmarks of PP. Asymptomatic patients were most frequently observed in AP (28.6%, MP 3.8%, PP 5.0%) while MP was characterized by a more extensive disease. : We believe DISH has distinct phenotypes and describe a PP phenotype that is not usually considered. Extravertebral manifestations should be included in the new classification criteria in order to cover the entire spectrum of the disease.
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http://dx.doi.org/10.3390/medicina57101005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8538653PMC
September 2021

Remission in axial spondyloarthritis: Developing a consensus definition.

Reumatol Clin (Engl Ed) 2021 Aug-Sep;17(7):380-387

Rheumatology Service, University Hospital Fundación Alcorcón, Madrid, Spain.

Objective: To reach a consensus on the tools available to evaluate disease activity in patients with axial spondyloarthritis (axSpA), and to develop a consensus definition of remission in axSpA.

Methods: A modified Delphi method was used. A scientific committee proposed statements addressing the assessment of axSpA in clinical practice and the definition of remission. The questionnaire was evaluated in 2 rounds by rheumatologists from GRESSER (GRupo de Estudio de ESpondiloartritis de la Sociedad Española de Reumatología).

Results: After 2 rounds of evaluation, a panel of 81 rheumatologists reached agreement on 56 out of the 80 proposed items (72.0%). There was agreement that the definition of remission in axSpA should include: disease activity, pain, fatigue, peripheral involvement, extra-articular manifestations, laboratory tests, functional impairment, mobility, quality of life, need for treatment, radiographic progression, and patient and physician global assessments. It is recommended to set a therapeutic goal when starting a treatment. The ideal goal is remission although low disease activity may also be an acceptable alternative. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is the preferred tool to assess disease activity. The panel made a proposal for clinical remission in axSpA based on the ASDAS cut-off value for inactive disease, the absence of extra-articular (acute anterior uveitis, psoriasis, inflammatory bowel disease) and peripheral (arthritis, enthesitis, dactylitis) manifestations, plus normal C-reactive protein levels and absence of radiographic progression.

Conclusion: This work offers consensus recommendations and a proposal of clinical remission that may be useful in the management of patients with axSpA.
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http://dx.doi.org/10.1016/j.reumae.2020.01.008DOI Listing
December 2021

Effectiveness and persistence of golimumab as a second biological drug in patients with spondyloarthritis: A retrospective study.

Medicine (Baltimore) 2021 Apr;100(13):e25223

Department of Rheumatology, Hospital Universitario Gregorio Marañón, Complutense University, Madrid, Spain.

Abstract: This observational, longitudinal retrospective, noncomparative study was designed to assess the persistence and effectiveness of golimumab as a second anti-tumor necrosis factor (TNF) drug in patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug.Data were collected retrospectively for all patients with axial spondyloarthritis or psoriatic arthritis from 20 rheumatology clinics in Spain who started golimumab as a second anti-TNF drug between January 2013 and December 2015. Golimumab persistence was assessed with Kaplan-Meier survival analysis, and associated factors were assessed with Cox regression analysis.210 patients started golimumab as a second anti-TNF drug: 131 with axial spondyloarthritis and 79 with psoriatic arthritis. In axial spondyloarthritis patients, the mean (standard deviation) Bath Ankylosing Spondylitis Disease Activity Index score at baseline was 5.5 (2.1), decreasing to 3.9 (2.0) at month 3 and 3.5 (2.0) at year 1, and remaining stable thereafter. In psoriatic arthritis patients, mean (standard deviation) baseline Disease Activity Score was 4.0 (1.3), reducing to 2.5 (1.2) at month 3 and to 2.2 (1.3) at year 1. Corresponding improvements were recorded from baseline in C-reactive protein levels and erythrocyte sedimentation rates. The probability of persistence of treatment with golimumab was 80% at year 1, 70% at year 2 and 65% at years 3 and year 4, and was similar in those who had stopped the first anti-TNF due to loss of efficacy or other reasons. Cox regression analysis showed that the probability of survival with golimumab was higher in patients with higher erythrocyte sedimentation rate, in patients with axial spondyloarthritis than with psoriatic arthritis, and in those who had discontinued adalimumab as first anti-TNF. Seventy-two patients (34.3%) discontinued golimumab during follow-up, 50 of them due to lack of efficacy.In patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug, treatment with golimumab was effective and showed a high probability of persistence up to 4 years of treatment.
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http://dx.doi.org/10.1097/MD.0000000000025223DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021319PMC
April 2021

Risk of infection associated with Janus Kinase (JAK) inhibitors and biological therapies in inflammatory intestinal disease and rheumatoid arthritis. Prevention strategies.

Gastroenterol Hepatol 2021 Oct 25;44(8):587-598. Epub 2021 Feb 25.

Servicio de Reumatología, Hospital Universitario Parc Taulí, Departamento de Medicina, Universidad Autónoma de Barcelona, Sabadell, Barcelona, España.

Patients with certain immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), have an increased risk of severe infectious diseases than the general population, which are mainly associated with the immunosuppressive treatments that they receive. These treatments act on the immune system through different mechanisms, causing different degrees of immunosuppression and a variable risk depending on whether the pathogen is a virus, bacteria or fungus. This article reviews the most relevant literature on the subject, which was selected and discussed by a panel of experts. The aim of this article is to review the risk of infections in patients with IBD and RA, and the potential preventive measures.
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http://dx.doi.org/10.1016/j.gastrohep.2021.01.007DOI Listing
October 2021

No radiographic sacroiliitis progression was observed in patients with early spondyloarthritis at 6 years: results of the Esperanza multicentric prospective cohort.

RMD Open 2020 09;6(2)

Rheumatology Department, Hospital Universitario La Paz, Madrid, Spain.

Objective: To estimate the 6-year radiographic progression of sacroiliitis in patients with early spondyloarthritis (SpA).

Patients And Methods: Sacroiliac joint (SIJ) radiographs (baseline and 6 years) of 94 patients with recent-onset SpA from the Esperanza cohort were scored, blindly and in a random order, by nine readers. The modified New York criteria were used to define the presence of sacroiliitis. As the gold standard for radiographic (r) sacroiliitis, the categorical opinion of at least five readers was used. Progression was defined as the shift from non-radiographic (nr) to r-sacroiliitis.

Results: In the 94 SIJ radiographs (baseline and 6 years), 78/94 (83%) pairs of radiographs had not changed from baseline to 6 years. Sacroiliitis was present in 20 patients at baseline (21.3%) and in 18 (19.2%) patients at 6 years; 11 patients had sacroiliitis at both the baseline and final visits; 9 patients changed from baseline r-sacroiliitis to nr-sacroiliitis at 6 years, and 7 changed from baseline nr-sacroiliitis to r-sacroiliitis at 6 years. The mean continuous change score (range: -8 to +8) was 2.80 at baseline and 2.55 at 6 years (mean net progression of -0.25). The reliability of the readers was fair (mean inter-reader kappa of 0.375 (0.146-0.652) and mean agreement of 73.7% (58.7-90%)).

Conclusion: In the early SpA Esperanza cohort, progression from nr-axSpA to r-axSpA over 6 years was not observed, although the SIJ radiographs scoring has limitations to detect low levels of radiographic progression.
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http://dx.doi.org/10.1136/rmdopen-2020-001345DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520544PMC
September 2020

Recommendations by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) on the treatment of patients with inflammatory bowel disease associated with spondyloarthritis.

Gastroenterol Hepatol 2020 May 1;43(5):273-283. Epub 2020 Apr 1.

Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Clínico Universitario Lozano Blesa, IIS Aragón. CIBEREHD, Zaragoza, España.

Extraintestinal manifestations, in general, and in particular arthropathies, are a common problem in patients with inflammatory bowel disease. In fact, the relationship between those 2entities is close and there are increasingly more data which suggest that the bowel plays a significant role in the aetiopathogenesis of spondyloarthritis. The association of inflammatory bowel disease with any kind of spondyloarthritis represents a challenging clinical scenario. It is therefore necessary that both gastroenterologists and rheumatologists work together and establish a fluent communication that enables the patient to receive the most appropriate treatment for each specific situation. The aim of this review is to make some recommendations about the treatment of patients with inflammatory bowel disease and associated spondyloarthritis, in each different clinical scenario.
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http://dx.doi.org/10.1016/j.gastrohep.2020.01.005DOI Listing
May 2020

Renal Impairment in Axial Spondyloarthritis: A Prevalent Condition to Consider.

J Rheumatol 2020 02 1;47(2):301-302. Epub 2019 Nov 1.

Hospital Universitari de Bellvitge-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.

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http://dx.doi.org/10.3899/jrheum.191016DOI Listing
February 2020

How to calculate the ASDAS based on C-reactive protein without individual questions from the BASDAI: the BASDAI-based ASDAS formula.

Rheumatology (Oxford) 2020 07;59(7):1545-1549

Department of Rheumatology, Reina Sofia University Hospital, Cordoba, Spain.

Objectives: To develop a new equation to calculate the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) using only the BASDAI total score and CRP.

Methods: Axial SpA (axSpA) patients from the Cordoba Spondyloarthritis Registry cohort were recruited as a derivation cohort, while a retrospective sample from the Spanish Rheumatology Society National Registry of Spondyloarthropathies and Ibero American Spondyloarhtritis Registry registers was used as a validation cohort. We built a new equation based only on the BASDAI and CRP, defining a new formula: the BASDAI-based ASDAS (BASDAS). Linear regression analysis was used to determine the coefficients of the equation in the derivation cohort and it was subsequently validated in the validation cohort.

Results: A total of 52 axSpA patients in the derivation cohort and 3359 patients in the validation cohort were included. In the derivation cohort, the mean BASDAS [2.24 (s.d. 0.90)] was very similar to the ASDAS-CRP [2.23 (s.d. 0.95)], with a very strong correlation (r = 0.96, P < 0.001). In the validation cohort, the mean BASDAS was 3.31 (s.d. 1.37) and the ASDAS-CRP was 3.19 (s.d. 1.27), which also had a very strong correlation (r = 0.95, P < 0.001). Intraclass correlation coefficients were excellent in both cohorts (0.963 and 0.947, respectively).

Conclusion: The BASDAS performs similarly to the ASDAS-CRP and can be calculated with only the BASDAI total score and CRP, allowing evaluation of disease activity in retrospective studies where the individual items of the BASDAI are not available.
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http://dx.doi.org/10.1093/rheumatology/kez480DOI Listing
July 2020

Magnetic resonance imaging assessment in patients with axial spondyloarthritis: development of checklists for use in clinical practice.

Rheumatol Int 2019 Dec 18;39(12):2119-2127. Epub 2019 Sep 18.

Rheumatology Unit, Hospital Universitario Fundación Alcorcón, C/Budapest S/N, 28922, Alcorcón, Madrid, Spain.

The objective of our study was to standardize magnetic resonance imaging (MRI) assessment of spine and sacroiliac joints in patients with axial spondyloarthritis (axSpA) and/or inflammatory spinal pain, by creating checklists and templates based on the opinions of rheumatologists and radiologists. A scientific committee developed a series of questionnaires with multiple items regarding MRI in patients with axial inflammatory pain and/or axSpA. Then an expert panel of rheumatologists and radiologists rated all items in a 9-point Likert scale. Finally, the scientific committee and the expert panel met to create the definitive documents. Several definitive checklists and templates were generated for rheumatologist-requested MRI and for radiologist-requested MRI reports of sacroiliac joint and spinal examinations. A technical requirement protocol was also agreed on. Our results could be useful in increasing understanding between rheumatologists and radiologists regarding MRI in axSpA diagnosis and follow-up.
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http://dx.doi.org/10.1007/s00296-019-04441-2DOI Listing
December 2019

Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results from the REMINEA study.

Arthritis Res Ther 2019 04 5;21(1):88. Epub 2019 Apr 5.

Rheumatology Department, Hospital Universitari de Bellvitge, IDIBELL, Universitat de Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.

Background: Recent data suggest that anti-TNF doses can be reduced in ankylosing spondylitis (AS) patients. Some authors even propose withdrawing treatment in patients in clinical remission; however, at present there is no evidence to support this.

Objective: To assess how long AS patients with persistent clinical remission remained free of flares after anti-TNF withdrawal and to evaluate the effects of treatment reintroduction. We also analyze the characteristics of patients who did not present clinical relapse.

Methods: Multicenter, prospective, observational study of a cohort of patients with active AS who had received infliximab as a first anti-TNF treatment and who presented persistent remission (more than 6 months). We recorded at baseline and every 6-8 weeks over the 12-month period the age, gender, disease duration, peripheral arthritis or enthesitis, HLA-B27 status, BASDAI, CRP, ESR, BASFI, and three visual analogue scales, spine global pain, spinal night time pain, and patient's global assessment.

Results: Thirty-six out of 107 patients (34%) presented persistent remission and were included in our study. After treatment withdrawal, 21 of these 36 patients (58%) presented clinical relapse during follow-up. Infliximab therapy was reintroduced and only 52% achieved clinical remission, as they had before the discontinuation of infliximab; in an additional 10%, reintroduction of infliximab was ineffective, obliging us to change the anti-TNF therapy. No clinical or biological factors were associated with the occurrence of relapse during the follow-up.

Conclusions: Two thirds of patients in clinical remission presented clinical relapse shortly after infliximab withdrawal. Although the reintroduction of infliximab treatment was safe, half of the patients did not present the same clinical response that they had achieved prior to treatment withdrawal.
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http://dx.doi.org/10.1186/s13075-019-1873-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6451276PMC
April 2019

Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis.

Arthritis Res Ther 2019 01 8;21(1):11. Epub 2019 Jan 8.

Rheumatology Department, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain.

Objective: The objective was to determine if dose reduction is non-inferior to full-dose TNFi to maintain low disease activity (LDA) in patients already in remission with TNFi, in axial spondyloarthritis.

Methods: Randomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if they had axial spondyloarthritis and had been in clinical remission for ≥ 6 months with any available TNFi (adalimumab, etanercept, infliximab, golimumab) at the dose recommended by product labelling. Patients were randomized by automated central allocation to continue the same TNFi dose schedule, or to reduce the dose by roughly half according to the protocol. The main outcome was the proportion of subjects with LDA after 1 year. Serious adverse reactions or infections were recorded.

Results: The trial stopped due to end of the funding period, after 126 patients were randomized; 113 patients (84.1% male, mean age (SD) 45.6 (13.0) years) were included in the main per-protocol subset. Non-inferiority was concluded for LDA at 1 year (47/55 (83.8%) patients in the full-dose and 48/58 (81.3%) patients in the reduced-dose arm, adjusted difference (95% CI) - 2.5% (- 16.6% to 11.7%)). Serious adverse reactions or infections were reported in 7/62 patients (11.3%) assigned to full dose and 2/61 patients (3.3%) assigned to reduced dose (p value = 0.164).

Conclusion: In patients with ankylosing spondylitis in clinical remission for at least 6 months, dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1 year. Serious adverse events may be less frequent with reduced doses.

Trial Registration: EU Clinical Trials Registry, EudraCT 2011-005871-18 and ClinicalTrials.gov, NCT01604629 .
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http://dx.doi.org/10.1186/s13075-018-1772-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6323809PMC
January 2019

Assessment of SpondyloArthritis International Society (ASAS) Consensus on Spanish Nomenclature for Spondyloarthritis.

Reumatol Clin (Engl Ed) 2020 Sep - Oct;16(5 Pt 1):333-338. Epub 2018 Sep 5.

NIHR Biomedical Research Centre, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, Reino Unido.

Objective: To develop a consensus to standardize the use of Spanish terms, abbreviations and acronyms in the field of spondyloarthritis (SpA).

Methods: An international task force comprising all native Spanish-speaking Assessment of SpondyloArthritis International Society (ASAS) members, the executive committee of Grupo para el estudio de la Espondiloartritis de la Sociedad Española de Reumatología (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de España (RANM) and two patients from the Spanish Coordinator of Spondylitis Associations (CEADE) was established. A literature review was performed to identify the conflicting terms/abbreviations/acronyms in SpA. This review examined written sources in Spanish including manuscripts, ICF and ICD, guidelines, recommendations and consensuses. This was followed by a nominal group meeting and a three-round Delphi. The recommendations from the RANM based on the Panhispanic dictionary were followed throughout the process.

Results: Consensus was reached for 46 terms, abbreviations or acronyms related to the field of SpA. A Spanish translation was accepted for 6 terms and 6 abbreviations to name or classify the disease, and for 6 terms and 4 abbreviations related to SpA. It was agreed not to translate 15 acronyms into Spanish. However, when mentioning them, it was recommended to follow this structure: type of acronym in Spanish and acronym and expanded form in English. With regard to 7 terms or abbreviations attached to acronyms, it was agreed to translate only the expanded form and a translation was also selected for each of them.

Conclusions: Through this standardization, it is expected to establish a common use of the Spanish nomenclature for SpA. The implementation of this consensus across the community will be of substantial benefit, avoiding misunderstandings and time-consuming processes.
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http://dx.doi.org/10.1016/j.reuma.2018.07.014DOI Listing
July 2021

The EJES-3D tool for personalized prescription of exercise in axial spondyloarthritis through multimedia animations: pilot study.

Rheumatol Int 2018 07 21;38(7):1277-1284. Epub 2018 May 21.

Unidad de Reumatología, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.

To develop and evaluate a web application based on multimedia animations, combined with a training program, to improve the prescription of exercises in spondyloarthritis (SpA). After a review of exercises included in the main clinical trials and recommendations of international societies, a multidisciplinary team-rehabilitators, rheumatologists, physiotherapists, computer scientists and graphic designers-developed a web application for the prescription of exercises (EJES-3D). Once completed, this was presented to 12 pairs of rehabilitators-rheumatologists from the same hospital in a workshop. Knowledge about exercise was tested in rheumatologists before and 6 months after the workshop, when they also evaluated the application. The EJES-3D application includes 38 multimedia videos and allows prescribing predesigned programs or customizing them. A patient can consult the prescribed exercises at any time from a device with internet connection (mobile, tablet, or computer). The vast majority of the evaluators (89%) were satisfied or very satisfied and considered that their expectations regarding the usefulness of the web application had been met. They highlighted the ability to tailor exercises adapted to the different stages of the disease and the quality and variety of the videos. They also indicated some limitations of the application and operational problems. The EJES-3D tool was positively evaluated by experts in SpA, potentially the most demanding group of users with the most critical capacity. This allows a preliminary validation of the contents, usefulness, and ease of use. Analyzing and correcting the errors and limitations detected is allowing us to improve the EJES-3D tool.
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http://dx.doi.org/10.1007/s00296-018-4049-6DOI Listing
July 2018

Should over-treatment of axial spondyloarthritis with biologics remain a concern after the issue of the new ASAS criteria? Data from REGISPONSERBIO (Spanish Register of Biological Therapy in Spondyloarthritides).

Clin Exp Rheumatol 2018 Nov-Dec;36(6):1038-1042. Epub 2018 May 8.

Rheumatology Department, University Hospital Bellvitge, Barcelona, Spain.

Objectives: To study whether disease status at treatment initiation has changed after the issue of the ASAS classification criteria.

Methods: REGISPONSERBIO registers patients with axial spondyloarthritis (axSpA) on biological treatment since 2013. It includes patients starting biological treatment (incident) or already on biological therapies (prevalent). Patients in both groups were compared in terms of: age at disease onset and at treatment start, disease duration, gender, HLA-B27, body mass index (BMI), BASDAI, BASFI, C-reactive protein, ESR, metrological data, ASQoL, WAPAI, extra-articular manifestations, comorbidities, radiological study, type of biological treatment and concomitant treatments.

Results: 256 patients were included, of whom 174 (65%) were already on biologic therapy. Compared to incident patients, prevalent patients started treatment with longer disease duration (15 vs. 8.6 years; p<0.001), a higher proportion of them were men (83% vs. 67%; p=0.01), a smaller proportion of them showed non-radiographic axial spondylarthritis (nr-axSpA)(17% vs. 32%; p<0.01), and a higher proportion had HLAB27 (85% vs. 73%; p=0.02). There were no statistically significant differences in terms of disease activity, degree of disability, quality of life, or prevalence of extra-articular manifestations.

Conclusions: Data suggest that, after the issue of the new classification criteria for SpA, biological therapy is being administered earlier than previously in SpA patients and in a higher proportion of patients with nr-axSpA. However, this change in prescribing profile, apparently, has not caused an over-treatment, as patients do not seem to have a lower disease burden than prior to the issue of the criteria.
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March 2019

Axial involvement according to ASAS criteria in an observational psoriatic arthritis cohort.

Acta Reumatol Port 2017 Apr-Jun;42(2):176-182

The definition of axial involvement in psoriatic arthritis (PsA) is still under debate. Currently, the axial spondyloarthritis (SpA) criteria defined by Assessment of Spondyloarthritis International Society (ASAS) may be the most adequate.(1) The aims of present study were to assess axial involvement according to ASAS criteria in an observational PsA cohort and define the clinical characteristics more associated with this kind of involvement. Our study included consecutive patients who had a visit in a tertiary Rheumatology centre. All patients included fulfill ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria for PsA and all of them had a recent radiographic assessment of sacroiliitis. Clinical and laboratorial data were taken into account to classify patients as fulfilling or not ASAS criteria for axial SpA. Clinical and demographic data were analyzed about their association with presence of ASAS criteria of axial SpA in an univariable logistic regression analysis. Variables with a p-value <0.05 were re-tested in a multivariable logistic regression. Those variables that maintained statistical significance were tested alone in another multivariable model. Analyses were performed with IBM SPSS Statistics (version 20.0). Regarding the 233 patients included, only 42 patients (19.4%) fulfilled ASAS criteria for axial SpA. However, 22 patients had asymptomatic radiographic sacroiliitis according to modified New York criteria. The prevalence of asymptomatic sacroiliitis was 15.7% between patients without axial symptoms. In multivariable analysis, inflammatory back pain (IBP) [OR=25.111; 95% confidence interval (CI) = 8.770, 71.900, p-value <0.001], presence of HLA-B27 [OR=9.072; 95% CI=2.756, 29.860; p-value <0.001] and male gender [OR=3.767; 95% CI=1.264, 11.232; p-value = 0.017] were associated to axial involvement according to ASAS criteria. Axial SpA ASAS criteria are useful to identify axial involvement in PsA patients. This type of involvement is more common in males, in the presence of HLA-B27 and IBP. Axial disease should be systematically assessed in clinical practice, mainly in patients presenting with this clinical features.
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October 2018

The value of repeat biopsy in lupus nephritis flares.

Medicine (Baltimore) 2017 Jun;96(24):e7099

Department of Rheumatology Department of Pathology Department of Internal Medicine Department of Nephrology, Unitat Funcional de Malalties Autoinmunes Sistèmiques (UFMAS), Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain.

Whether a repeat renal biopsy is helpful during lupus nephritis (LN) flares remains debatable. In order to analyze the clinical utility of repeat renal biopsy in this complex situation, we retrospectively reviewed our series of 54 LN patients who had one or more repeat biopsies performed only on clinical indications. Additionally, we reviewed 686 well-documented similar cases previously reported (PubMed 1990-2015).The analysis of all patients reviewed showed that histological transformations are common during a LN flare, ranging from 40% to 76% of cases. However, the prevalence of transformations and the clinical value of repeat biopsy vary when they are analyzed according to proliferative or nonproliferative lesions.The great majority of patients with class II (78% in our series and 77.5% in the literature review) progressed to a higher grade of nephritis (classes III, IV, or V), resulting in worse renal prognosis. The frequency of pathological conversion in class V is lower (33% and 43%, respectively) but equally clinically relevant, since almost all cases switched to a proliferative class. Therefore, repeat biopsy is highly advisable in patients with nonproliferative LN at baseline biopsy, because these patients have a reasonable likelihood of switch to a proliferative LN that may require more aggressive immunosuppression.In contrast, the majority of patients (82% and 73%) with proliferative classes in the reference biopsy (III, IV or mixed III/IV + V), remained into proliferative classes on repeat biopsy. Although rebiopsy in this group does not seem as necessary, it is still advisable since it will allow us to identify the 18% to 20% of patients that switch to a nonproliferative class. In addition, consistent with the reported clinical experience, repeat biopsy might also be helpful to identify selected cases with clear progression of proliferative lesions despite the initial treatment, for whom it is advisable to intensify inmunosuppression. Thus, our experience and the literature data support that repeat biopsy also brings more advantges than threats in this group.The results of the repeat biopsy led to a change in the immunosuppresive treatment in more than half of the patients on average, intensifying it in the majority of the cases, but also reducing it in 5% to 30%.
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http://dx.doi.org/10.1097/MD.0000000000007099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478313PMC
June 2017

Development of a checklist for patients with axial spondyloarthritis and psoriatic arthritis in daily practice: ONLY TOOLS project.

Reumatol Clin (Engl Ed) 2018 May - Jun;14(3):155-159. Epub 2017 Mar 9.

Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, España.

Objective: To standardize clinical evaluation of patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) using a checklist.

Methods: Qualitative study that included: 1) nominal group (18 experts); 2) literature reviews of measures used in the assessment of patients with axial SpA or PsA; and 3) focus groups, one with rheumatologists and another with patients, organized to become familiar with their opinion on medical assistance. Taking this into account, the experts selected the measures to be included in the checklist based on their relevance, feasibility, and the outcome type.

Results: The checklist includes measures for the evaluation of personal history, physical examination, activity and function, laboratory tests, imaging studies and treatments. It also defines risk factors of radiographic progression, predictors of the response to biological therapies, and comprises measures of excellence.

Conclusions: This checklist for patients with axial SpA and PsA could help standardize daily clinical practice and improve clinical management and patient prognosis.
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http://dx.doi.org/10.1016/j.reuma.2016.12.003DOI Listing
May 2019

Description and Prevalence of Spondyloarthritis in Patients with Anterior Uveitis: The SENTINEL Interdisciplinary Collaborative Project.

Ophthalmology 2016 08 12;123(8):1632-1636. Epub 2016 Apr 12.

Uveitis Unit, University Hospital of León, León, Spain; Instituto de Biomedicina (IBIOMED), University of Leon, Spain.

Purpose: To describe and analyze the prevalence of spondyloarthritis (SpA) in patients with anterior uveitis (AU).

Design: Multicentric, observational, prospective study.

Participants: Consecutive patients with AU who were human leukocyte antigen (HLA)-B27 positive or HLA-B27 negative with more than 1 episode of AU separated by at least 3 months were selected. Patients with a previous diagnosis of SpA were excluded.

Methods: Included patients were evaluated by an ophthalmologist and a rheumatologist following a predefined visit schedule.

Main Outcome Measures: Sociodemographic and clinical variables including the diagnosis of SpA according to Assessment of SpondyloArthritis International Society (ASAS) criteria and an exhaustive ophthalmological examination (best-corrected visual acuity, intraocular pressure, biomicroscopic examination of the anterior and posterior segment of the eye, cataract evaluation, optical coherence tomography evaluating both the 1-mm central retina thickness and the optic nerve head and retinal nerve fiber layer, and visual field in a dark room with 1 eye patched) were collected. Baseline descriptive, bivariate, and concordance analyses were performed.

Results: We included 798 patients, mostly men (59%) with a mean age of 45 years; 60% were AU HLA-B27 positive, and 40% had recurrent negative AU HLA-B27. A total of 50.2% and 17.5% of patients presented axial and peripheral SpA according to ASAS criteria, respectively. Patients with AU who were HLA-B27 positive were more frequently diagnosed with axial (69.8% vs. 27.3%, P < 0.0001) and peripheral SpA (21.9% vs. 11.1%, P < 0.0001) than patients with recurrent negative AU HLA-B27. In general, we did not detect important differences between groups in the ophthalmologic variables.

Conclusions: A large percentage of patients with clinically significant AU have an undiagnosed SpA. This percentage is even higher if the HLA-B27 haplotype is positive.
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http://dx.doi.org/10.1016/j.ophtha.2016.03.010DOI Listing
August 2016

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

Trials 2015 Aug 20;16:370. Epub 2015 Aug 20.

Clinical Pharmacology Service, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain.

Background: Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice.

Methods/design: To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015.

Discussion: The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers.

Trial Registration: EudraCT 2011-005871-18 (21 December 2011).
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http://dx.doi.org/10.1186/s13063-015-0828-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4546086PMC
August 2015

Rituximab therapy for ankylosing spondylitis associated to demyelinating disease of the central nervous system.

Joint Bone Spine 2016 Jan 14;83(1):105-6. Epub 2015 Mar 14.

Department of Rheumatology, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain. Electronic address:

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http://dx.doi.org/10.1016/j.jbspin.2015.01.022DOI Listing
January 2016

Ankylosing spondylitis without axial progression: analysis of associated factors.

J Rheumatol 2014 Dec 1;41(12):2409-12. Epub 2014 Nov 1.

From the Services of Rheumatology; Anesthesiology, Hospital Clínico Universitario de Salamanca, Salamanca; Rheumatology, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba, Córdoba; Rheumatology, Hospital Universitario Central de Asturias, Oviedo; Rheumatology, Hospital Clinic de Barcelona; Rheumatology, Hospital de Bellvitge, L'Hospitalet de Llobregat; Rheumatology, Hospital Parc Taulí, Sabadell, Barcelona; Rheumatology, Hospital Fundación de Alcorcón; Rheumatology, Hospital Puerta de Hierro, Madrid, Spain.C. Montilla, MD, PhD; I. Calero-Paniagua, MD, Rheumatology; A. Díaz-Alvarez, MD, PhD, Anesthesiology, Hospital Clínico Universitario de Salamanca; E. Collantes-Estevez, MD, PhD; P. Font, MD, PhD, Rheumatology, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba; R. Almodovar, MD, PhD; P. Zarco, MD, PhD, Rheumatology, Hospital Fundación de Alcorcón; R. Queiro-Silva, MD, PhD, Rheumatology, Hospital Universitario Central de Asturias; J.D. Cañete, MD, PhD, Rheumatology, Hospital Clinic de Barcelona; X. Juanola, MD, PhD, Rheumatology, Hospital de Bellvitge, L'Hospitalet de Llobregat; J. Mulero, MD, PhD; E. de Miguel, MD, PhD, Rheumatology, Hospital Puerta de Hierro; J. Gratacós, MD, PhD, Rheumatology, Hospital Parc Taulí.

Objective: To evaluate clinical factors associated with the absence of radiographic progression in patients with spondylitis.

Methods: The cross-sectional study included 672 patients. All patients presented a disease evolution of more than 15 years. Patients were classified as with radiographic spinal involvement versus without radiographic spinal involvement. We included clinical variables potentially related to null radiological progression.

Results: Seventy-five patients had no radiographic involvement. These patients were predominantly female, had a lower erythrocyte sedimentation rate (ESR), and a lower C-reactive protein level. Multivariate analysis showed an association with the female sex and low ESR.

Conclusion: Clinical factors associated with this lack of progression were female sex and low ESR.
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http://dx.doi.org/10.3899/jrheum.140018DOI Listing
December 2014

Prevention of anti-tumor necrosis factor-associated tuberculosis: a 10-year longitudinal cohort study.

Clin Infect Dis 2015 Feb 13;60(3):349-56. Epub 2014 Oct 13.

Department of Infectious Diseases, Bellvitge University Hospital-Institut d'investigació biomèdica de Bellvitge (IDIBELL).

Background: The extent to which anti-tumor necrosis factor (TNF)-associated tuberculosis can be prevented is unclear, and there is no established guidance on the optimal screening strategy for latent tuberculosis (LTBI) in patients about to start anti-TNF therapy. We aimed to determine the effectiveness of a comprehensive program for the prevention of anti-TNF-associated tuberculosis, and to evaluate 3 LTBI screening strategies and the need for retesting patients with negative results at baseline.

Methods: In total, 726 patients were screened prior to anti-TNF therapy using 1 of 3 diagnostic strategies over 3 consecutive periods: first, a 2-step tuberculin skin test (TST); second, a 2-step TST plus QuantiFERON-TB Gold In-Tube test (QFT-GIT) (2-step TST/QFT); and third, a single-step TST plus QFT-GIT (TST/QFT). Infected patients were offered preventive therapy. We assessed differences in the incidence of tuberculosis between anti-TNF exposed and nonexposed patients, and between the 3 study periods.

Results: Tuberculosis developed during the first year in 2.85 per 1000 exposed patient-years (3/1052 patient-years) and 1.77 per 1000 nonexposed patient-years (1/566 patient-years). No cases occurred beyond the first year of treatment. LTBI diagnoses decreased with the single-step TST/QFT (26.5%) compared with the 2-step TST (42.5%; P < .001) and 2-step TST/QFT (38.5%; P = .02); the incidence of tuberculosis among exposed patients did not change significantly across the 3 periods (2.63/1000, 3.91/1000, and 2.4/1000 patient-years, respectively).

Conclusions: Although anti-TNF-associated tuberculosis can be reduced, some risk remains during the first year of therapy. Neither the 2-step TST nor systematic retesting after negative baseline testing is justified.
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http://dx.doi.org/10.1093/cid/ciu796DOI Listing
February 2015

ASDAS high disease activity versus BASDAI elevation in patients with ankylosing spondylitis as selection criterion for anti-TNF therapy.

Reumatol Clin 2014 Jul-Aug;10(4):204-9. Epub 2014 Mar 2.

Rheumatology Service, Reina Sofia University Hospital/IMIBIC and University of Córdoba, Spain.

Objective: To investigate which of the 2 ankylosing spondylitis (AS) disease activity instruments identifies better those patients with characteristics that have been associated with positive response to anti-TNF therapy.

Methods: Data from patients with AS in the REGISPONSER registry were analyzed. Patients were categorized by disease activity using 3 different selection criteria: elevated Bath Ankylosing Spondylitis Disease Activity Index criteria (BASDAI≥4), high Ankylosing Spondylitis Disease Activity Score (ASDAS≥2.1), or very high ASDAS (ASDAS≥3.5). To determine which criterion selects for patients most likely to respond to anti-TNF therapy, the groups of patients selected with each criterion were compared on five disease characteristics that are associated with good response to anti-TNF therapy: lower age, lower function score, less enthesitis, higher C-reactive protein (CRP), and HLA-B27-positive status.

Results: 50.9%, 66.3%, and 24.9% of 1156 patients had elevated BASDAI, high ASDAS, or very high ASDAS, respectively. Compared to patients selected with elevated BASDAI, more patients selected with high ASDAS had characteristics associated with good response to anti-TNF therapy. Patients with very high ASDAS had higher CRP and were younger, but more frequently had enthesitis and had higher function scores when compared to those with elevated BASDAI.

Conclusions: Selection of AS patients with the ASDAS instrument results in patient sub-populations with different characteristics than those selected with the BASDAI instrument. Since some of these characteristics have been associated with response to anti-TNF therapy, further study should establish if the choice of selection instrument improves the outcome of therapy in the selected populations.
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http://dx.doi.org/10.1016/j.reuma.2013.12.006DOI Listing
April 2016

Standards of care for patients with spondyloarthritis.

Rheumatol Int 2014 Feb 4;34(2):165-70. Epub 2014 Jan 4.

Rheumatology Unit, Hospital Virgen del Puerto, Plasencia, Spain.

To define and give priory to standards of care in patients with spondyloarthritis (SpA). A systematic literature review on SpA standards of care and a specific search in relevant and related sources was performed. An expert panel was established who developed the standards of care and graded their priority (high, mild, low, or no priority) following qualitative methodology and Delphi process. An electronic survey was sent to a representative sample of 167 rheumatologists all around the country, who also gave priority to the standards of care (same scale). A descriptive analysis is presented. The systematic literature review retrieved no article specifically related to SpA patients. A total of 38 standards of care were obtained-12 related to structure, 20 to process, and 6 to result. Access to care, treatment, and safety standards of care were given a high priority by most of rheumatologists. Standards not directly connected to daily practice were not given such priority, as standards which included a time framework. The standards generated for the performance evaluation (including patient and professionals satisfaction) were not considered especially important in general. This set of standards of care should help improve the quality of care in SpA patients.
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http://dx.doi.org/10.1007/s00296-013-2934-6DOI Listing
February 2014

Scoring with the Berlin MRI method for assessment of spinal inflammatory activity in patients with ankylosing spondylitis: a calibration exercise among rheumatologists.

Clin Exp Rheumatol 2013 Nov-Dec;31(6):883-8. Epub 2013 Dec 20.

Institute for Musculoskeletal Health, Madrid, Spain.

Objectives: To test the reliability of the Berlin MRI scoring method and the effect of a calibration exercise on the score's reliability among untrained readers in MRI examinations of patients with established ankylosing spondylitis (AS).

Methods: Eleven rheumatologists read blinded images of 20 AS patients before and after a two-day workshop on the Berlin MRI scoring method. Reliability (intra- and inter-reader) and concordance with the expert (all measured by intraclass correlation coefficient (ICC)) were compared before and after 2 weeks of the training. Feasibility in terms of time and difficulty was also measured.

Results: The mean Berlin score increased from (mean ± standard deviation) 5.04 ± 6.41 before to 6.40±7.08 after the calibration exercise (p<0.01). Inter-reader ICC decreased from 0.83 (95% CI: 0.75-0.93) to 0.78 (95% CI: 0.66-0.90), and intra-reader ICC from 0.89 (95% CI: 0.84-0.94) to 0.87 (95% CI: 0.82-0.92). Agreement with an experienced reader improved after the calibration exercise, with ICC = 0.59 (95% CI 0.45-0.76) before vs. ICC = 0.65 (95% CI 0.50-0.80) after training.

Conclusions: The Berlin method is a reliable scoring method for assessment of spinal inflammatory activity by using MRI in patients with AS, even in the hands of inexperienced readers. A calibration exercise can improve feasibility and sensitivity of the scoring method.
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March 2014
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