Patients with Axial Spondyloarthritis are Great Consumers of Healthcare Resources, Especially Young and Women: Results from the Spanish Atlas.

INTRODUCTION: This study aimed to assess high healthcare utilization over 1 year in patients with axial spondyloarthritis (axSpA) and factors associated with increased healthcare utilization. METHODS: A total of 530 unselected patients with axSpA from the Atlas of Axial Spondyloarthritis in Spain-who had used at least one healthcare resource-were included in the present study. Total health care utilization was obtained from the total number of healthcare visits, medical tests, hospital admissions and emergency visits, during the 12 months prior to the survey. Linear regression was used to analyse possible factors associated with higher healthcare utilization. RESULTS: A total of 530 patients with axSpA participated in this study: mean age was 45.3 years and 51.1% were female. In the previous 12 months, 77.9% (n = 530) used at least one healthcare resource, with the median healthcare utilization at 25. In the multiple linear regression, the only categorical factor associated with higher healthcare utilization was female gender (ß = 12.854), while the continuous factors associated with higher healthcare utilization were higher disease activity (ß = 3.378), longer diagnostic delay (ß = 0.959), younger age (ß = - 0.737) and greater functional limitation (ß = 0.576). CONCLUSION: Half of patients with axSpA used 25 or more healthcare resources during 1 year. Higher healthcare utilization was associated with younger age, female gender, greater disease activity, higher functional limitation and longer diagnostic delay. Optimal monitoring of patients with axSpA may help to reduce their healthcare utilization.

Understanding the Disease Burden of Unemployed Patients With Axial Spondyloarthritis: Results From the Spanish Atlas 2017.

OBJECTIVE: To evaluate differences in sociodemographic factors and patient-reported outcomes (PROs) between unemployed and employed patients with axial spondyloarthritis (axSpA), and to explore work-related issues (WRIs). METHODS: Data from an online survey of 680 unselected patients of the Atlas of Axial Spondyloarthritis in Spain 2017 were analyzed. Active workforce participants were divided into employed and unemployed groups according to International Labour Organization definitions. Sociodemographic characteristics, PROs (Bath Ankylosing Spondylitis Disease Activity Index [0-10], Spinal Stiffness Index [3-12], Functional Limitation Index [0-54], and psychological distress through the 12-item General Health Questionnaire [0-12]) were assessed. Logistic regression analysis was used to evaluate the association with unemployment status. RESULTS: Four hundred fifteen (63.6%) patients with axSpA were categorized in the active population, of which 325 (78.3%) were employed and 90 (21.7%) unemployed. Of the unemployed patients, 62.8% (n = 54) declared that their joblessness was due to axSpA. Of the employed patients, 170 (54.3%) reported WRIs in the year prior to the survey, the most frequent being difficulty fulfilling working hours (44.1%), missing work for doctor appointments (42.9%), and taking sick leave (37.1%). Being unemployed was associated with lower educational level (OR = 2.92), disease activity (OR = 1.37), spinal stiffness (OR = 1.21), functional limitation (OR = 1.05), worse mental health (OR = 1.15), anxiety (OR = 2.02), and depression (OR = 2.69) in the univariable models; and with lower educational level (OR = 2.76) and worse mental health (OR = 1.15) in the multivariable analysis. CONCLUSION: Results show significant differences between employed and unemployed patients with axSpA. Employed patients with axSpA endure many problems at work related to their condition, whereas unemployed patients present worse disease outcomes associated with greater psychological distress.

A Benchmarking Study Evaluating Axial Spondyloarthritis Burden in Spain and Other European Countries. Results from the Spanish Atlas and the European Map of Axial Spondyloarthritis (EMAS) Studies.

AIM: To compare the burden of disease in Spanish patients with axial spondyloarthritis (axSpA) vs other European countries (OEC). METHODS: Data from 2846 unselected patients from the European Map of Axial Spondyloarthritis (EMAS) and the Atlas of Axial Spondyloarthritis in Spain (Atlas) were collected through online surveys. Comparative analysis was carried out between Spanish patients (2016) and patients from 12 OEC ( 2017-2018). Socio-demographic characteristics, life habits, and patient-reported outcomes (Bath Ankylosing Spondylitis Disease Activity Index 0-10, spinal stiffness 3-12, functional limitation 0-54, the 12-Item General Health Questionnaire [GHQ-12] for psychological distress 0-12) were compared. Chi-square and Mann-Whitney tests were used for qualitative and quantitative variables respectively. RESULTS: 680 (23.9%) Spanish axSpA patients were compared to 2166 axSpA patients (76.1%) from OEC. Compared to Spain, the OEC group had a higher percentage of females (64.1% vs 52.5%; P < .001) and university-educated participants (51.7% vs 36.9%; P < .001). Spanish patients showed a greater diagnostic delay (8.5 ± 7.7 vs 7.2 ± 8.6 years; P < .001), visits to orthopedic specialists before diagnosis (56.9% vs 25.3%; P < .001), human leukocyte antigen-B27 carriership (77.1% vs 70.1%; P = .003), disease activity (5.7 ± 2.0 vs 5.4 ± 2.0; P = .024), and higher unemployment rates (21.7% vs 9.2%; P < .001). Despite lower rates of diagnosed anxiety and depression, Spanish patients were at higher risk of psychological distress according to the GHQ-12 (5.7 ± 4.5 vs 4.8 ± 4.0; P < .001). CONCLUSION: Compared to European axSpA patients, Spanish patients experience a longer diagnostic delay and greater psychological distress. Being wrongly referred to orthopedic specialists and facing a more precarious labor scenario appear as possible causal factors, highlighting the need to increase the number of rheumatologists, the training of healthcare professionals, and improving axSpA patients' working conditions.

Delphi-based recommendations for the management of cardiovascular comorbidities in patients with psoriatic arthritis and moderate-to-severe psoriasis.

The aim of this study was to generate practical recommendations to assist rheumatologists and dermatologists in the management of cardiovascular (CV) comorbidities in patients with moderate-to-severe psoriasis (MS-PSO) and psoriatic arthritis (PsA). A two-round Delphi study was conducted. A panel of experts rated their agreement with a set of statements (n = 52) on a nine-point Likert scale (1 = totally disagree; 9 = totally agree). Statements were classified as inappropriate (median 1-3), irrelevant (median 4-6) or appropriate (median 7-9). Consensus was established when at least two-thirds of the panel responded with a score within any one range. A total of 25 experts, 60% rheumatologists and 40% dermatologists, participated in two consultation rounds. There was overall unanimity on the appropriateness of an initial assessment for CV risk factors in all patients with MS-PSO and PsA. Most panelists (88.0%) also supported the evaluation of patients' psychological and physical status. Additionally, most panelists (72.2%) agreed on a novel sequential approach for the management of CV comorbidities. This sequence starts with the assessment of hypertension, diabetes and dyslipidemia along with the identification of depression and anxiety disorders. Once these factors are under control, smoking cessation programs might be initiated. Finally, if patients have not met weight loss goals with lifestyle modifications, they should receive specialized treatment for obesity. This study has drawn up a set of practical recommendations that will facilitate the management of CV comorbidities in patients with MS-PSO and PsA.

Recommendations for the prescription of physical exercise for patients with spondyloarthritis. / Recomendaciones para la prescripción de ejercicio físico en pacientes con espondiloartritis.

OBJECTIVE: To develop expert-based recommendations on physical activity and exercise for patients with spondyloarthritis (SpA). METHODS: Two discussion groups, one of physical therapists, rehabilitation physicians, and professionals of physical activity and sports, and another of rheumatologists interested in SpA, were held to discuss the results of a survey of rheumatologists on exercise and two focus groups with patients on barriers to exercise. Preliminary recommendations were drafted. These were submitted to the opinion of the experts in both groups according to a two round Delphi methodology. RESULTS: Twenty one recommendations covering general aspects of exercise, adaptation to patient, how to deliver messages, pain management, and type of exercise and monitoring were issued. The level of agreement varied slightly between expert groups but it was high overall. Items with poor agreement were removed from the consensus. CONCLUSIONS: We present recommendations on when and how to prescribe and monitor exercise in patients with SpA based on the opinion of experts in exercise and in SpA. We must now test whether these recommendations are useful for clinical practice and have an effect on patients with SpA seen by rheumatologists.

Recommendations by the Spanish Society of Rheumatology on the Use of Biological Therapies in Axial Spondyloarthritis. / Recomendaciones de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en espondiloartritis axial.

OBJECTIVE: Recent data published on biological therapy in axial spondyloarthritis (axSpA) since the last publication of the recommendations of the Spanish Society of Rheumatology (SER) has led to the generation of a review of these recommendations based on the best possible evidence. These recommendations should be a reference for rheumatologists and those involved in the treatment of patients with axSpA. METHODS: Recommendations were drawn up following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Centre for Evidence Based Medicine at Oxford. The level of agreement was established through the Delphi technique. RESULTS: In this review, we did an update of the evaluation of disease activity and treatment objectives. We included the new drugs with approved therapeutic indication for axSpA. We reviewed both the predictive factors of the therapeutic response and progression of radiographic damage. Finally, we drafted some recommendations for the treatment of patients refractory to anti-tumor necrosis factor, as well as for the possible optimization of biological therapy. The document also includes a table of recommendations and a treatment algorithm. CONCLUSIONS: We present an update of the SER recommendations for the use of biological therapy in patients with axSpA.

Points to Consider in the Foundation of Multidisciplinary Units for Psoriatic Arthritis: A Delphi Study and a Systematic Review of the Literature.

INTRODUCTION: In numerous clinical practice guidelines, emphasis is placed on the need for coordinated care of psoriatic arthritis (PsA) between rheumatologists and the objective was to develop experience-based points to consider facilitating the implementation of multidisciplinary units (Dermatology/Rheumatology) for the management of patients with PsA. METHODS: A scientific committee of rheumatology and dermatology experts in the management of PsA, and with experience in joint care, discussed the critical aspects of multidisciplinary PsA Units. The discussion became the basis for a Delphi survey in two rounds submitted to a panel of 24 specialists in rheumatology and dermatology not involved in PsA units. The statements and practices that reached a consensus were summarized and further elaborated. RESULTS: After two Delphi rounds, agreement was reached for 49 of the 50 proposed statements. These included a justification of the units, objectives, and utilities, as well as operational aspects of the units, such as the minimal and ideal premises, referral criteria, and necessary resources. The statements were compiled in 11 points to consider. CONCLUSIONS: This consensus offers some points to consider, including premises and recommendations, for the development of specialized Units in the management of PsA based on expert opinion. We trust these guidelines may facilitate their implementation in the future. FUNDING: Pfizer.

Barriers and Facilitators for the Practice of Physical Exercise in Patients With Spondyloarthritis: Qualitative Study of Focus Groups (EJES-3D). / Barreras y facilitadores para la práctica del ejercicio físico en pacientes con espondiloartritis: estudio cualitativo de grupos focales (EJES-3D).

OBJECTIVES: To explore barriers to exercise of patients with spondyloarthritis (SpA) and to propose facilitators. METHODS: Analysis of the speech of focus groups. It included the identification the elements that shape the studied reality, description of the relationship between them and synthesis through: 1) Thematic segmentation, 2) Categorization according to situations, relationships, opinions, feelings or others, 3) Coding of the various categories and 4) Interpretation of results. RESULTS: Two focus groups of one hour each with 11 patients recruited from associations and social networks in Madrid and surrounding provinces took place (64% men, 72% between 40 and 60 years, 57% with disease duration longer than 10 years, 80% performed some type of exercise or physical activity). The following were identified: 1) barriers to exercise, among which the following pointed out: disinformation, fear, pain, distrust, and prior negative experiences with exercise; 2) facilitators to exercise: the complementary to barriers plus regularity and social and professional support; 3) items that could influence in either way, negative or positively; and 4) four phases of coping with exercise or physical activity in SpA. CONCLUSION: Apart from recognizing the existence of some modifiable personal factors, patients generally demand: more knowledge and education on exercise, including the pros and cons in the context of their disease, and coherence of messages received, together with better monitors that accompany them in their coping with disease and exercise.

Prevalence and clinical features of psoriatic arthritis in psoriasis patients in Spain. Limitations of PASE as a screening tool.

BACKGROUND: Diagnosing and initiating treatment of psoriatric arthritis (PsA) as early as possible is essential to prevent irreversible joint destruction and poor clinical outcomes. Dermatologists are uniquely placed to identify early symptoms of PsA in psoriasis patients but levels of under- and late-diagnosis remain high. OBJECTIVE: To evaluate the prevalence and clinical features of PsA in Spanish psoriatic patients attended by dermatologists and then referred to rheumatologic units for PsA diagnosis confirmation. METHODS: a multicenter, non-interventional, cross-sectional trial conducted at 40 hospitals in Spain. Patients were initially screened for PsA by a dermatologist based on clinical evaluation and results from the Psoriatic Arthritis Screening and Evaluation (PASE) Questionnaire. All patients were then evaluated by a blinded rheumatologist for the presence of PsA using Moll and Wright criteria and Classification Criteria for Psoriatic Arthritis (CASPAR). RESULTS: Of 375 psoriatic patients enrolled at dermatology units, 28.6% patients scored ≥44 in PASE, whereas 32.3% patients screened positive for suspicion of PsA (clinical evaluation and/or PASE). Correlation of suspicion of PsA by dermatologists and PASE score was 0.368 (Pearson correlation coefficient). Following rheumatologic assessment, prevalence of PsA was 22.9% (86/375 patients) according to Moll and Wright and CASPAR criteria. The correlation of diagnosis of PsA between dermatologists and rheumatologists was 0.410 (Kappa Index). CONCLUSIONS: Prevalence of PsA in our study was within the range reported in other studies. Our analyses found only a moderate correlation in the diagnosis of PsA between dermatologists and rheumatologists. The screening questionnaire, PASE, showed a moderate predictive value for the diagnosis of PsA.

Development and validation of a new instrument to measure health-related quality of life in patients with psoriatic arthritis: the VITACORA-19.

OBJECTIVE: To develop/validate an instrument to measure health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA), for use in clinical studies. METHODS: An item pool of 35 items was generated following standardized procedures. Item reduction was performed using clinimetric and psychometric approaches after administration to 66 patients with PsA. The resulting instrument, the VITACORA-19, consists of 19 items. Its validity content, internal consistency, test-retest reliability, known groups/convergent validity, and sensitivity to change were tested in a longitudinal and multicenter study conducted in 10 hospitals in Spain, with 323 patients who also completed the EuroQol 5-dimensional questionnaire (EQ-5D) and a health status transition item. There were 3 study groups: group A (n = 209, patients with PsA), group B (n = 71, patients with arthritis without psoriatic aspect, patients with arthrosis, and patients with dermatitis), and group C (n = 43, healthy controls). RESULTS: The questionnaire was considered easy/very easy to answer by 94.7% of the patients with PsA. The factorial analysis clearly identified only 1 factor. Cronbach's alpha coefficient and interclass correlation coefficients exceeded 0.90. Statistically significant differences (p < 0.001) were observed between groups: subjects from group C had better HRQoL, followed by group B, and finally group A had the worst HRQoL. The VITACORA-19 scores showed significant correlations (p < 0.001) to PsA disease activity, EQ-5D, and perceived health state, scoring the patients with better health state higher. The minimum important difference was established as an 8-point change in the global score. CONCLUSION: The Spanish-developed VITACORA-19, designed to measure HRQoL in patients with PsA, has good validity, reliability, and sensitivity to change.

Association of biomarkers of inflammation, cartilage and bone turnover with gender, disease activity, radiological damage and sacroiliitis by magnetic resonance imaging in patients with early spondyloarthritis.

To assess the association between biomarkers of inflammation, cartilage and bone turnover with gender, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Spondylitis Disease Activity Score (ASDAS) and bone marrow oedema in resonance magnetic imaging (MRI) of sacroiliac joints (SIJs) and radiological damage in early spondyloarthritis (SpA). Cross-sectional study of 60 patients (56.7 % females; mean age, 32.4 years) with early SpA. Sociodemographic data, clinical features, serum matrix metalloproteinase 3 (MMP-3), high sensitivity C-reactive protein (hsCRP), C-terminal cross-linking telopeptides of type I collagen (CTX-I) and urinary deoxypyridinoline, ASDAS, BASDAI, BASFI, BASRI and MRI of the SIJs were collected. The mean (SD) disease duration was 12.4 (6.8 months). Twenty-two (68.7 %) of the 32 patients had active sacroiliitis by MRI. MMP-3 and CTX I correlated with swollen joint (r = 0.515, r = 0.386, p = 0.01). hsCRP correlated with ESR (r = 0.303, p = 0.05), with CRP (r = 0.455, p = 0.01) and with total BASRI (r = 0.95, p = 0.05). Biomarkers were unrelated with the rest of variables. Levels of MMP-3 (44.3 ± 52.4 vs 24.7 ± 33.4, p < 0.05) and CTX-I (0.53 ± 0.45 vs 0.24 ± 0.38; p < 0.05) were higher in men. Our study shows that CTX-I and MMP-3 are a marker of peripheral disease activity in early SpA. Male gender had higher levels of CTX-I and MMP-3, which may indicate higher disease activity. Higher hsCRP levels trended towards correlation with more baseline radiographic damage. Therefore, these biomarkers may help identify a subgroup of patients who will need closer monitoring and more intensive treatment.

Different clinical expression of patients with ankylosing spondylitis according to gender in relation to time since onset of disease. Data from REGISPONSER.

OBJECTIVE: To describe the differential characteristics by gender and time since disease onset in patients diagnosed with ankylosing spondylitis (AS) attending the Spanish rheumatology clinics, including those on the "Spanish Registry of spondyloarthritis" (REGISPONSER), as well as the diagnostic and therapeutic implications that this entails. PATIENTS AND METHODS: This is a transversal and observational study of 1514 patients with AS selected from 2367 spondyloarthritis cases included in REGISPONSER. For each patient, the demographics, epidemiology, geriatric, clinical, laboratory, radiological, and therapeutic aspects were were evaluated and comprehensively recorded under the aegis of REGISPONSER, constituting the Minimum Basic identifying data for the disease. Physical function was assessed by Bath Ankylosing Spondylitis Functional Index (BASFI). Clinical activity was evaluated using erythrocyte sedimentation rate, C reactive protein and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Each patient underwent pelvic anteroposterior, anteroposterior and lateral lumbar spine as well as lateral cervical spine x rays; they were scored according to the Bath Ankylosing Spondylitis Spine Radiographic Index, which measures structural damage. RESULTS: Of the 1514 patients screened, 1131 (74.7%) were men. We found significant differences in age at onset of symptoms as well as in the day of inclusion, between the two groups, being lower in men. We also obtained differences in the duration of the disease, which was lower in women. As for the existence of a history of AS among first-degree relatives, family forms were more common among women. The mean BASDAI score was also higher in women, regardless of time since onset of disease. In contrast, the improvement of pain with the use of NSAID's and radiological severity were higher in men, both reaching statistical significance. CONCLUSIONS: Among the Spanish AS patients, there are some differences in the clinical manifestations, even when the time since onset of disease was controlled; we also found radiological differences by gender; men showing more structural damage, while women were more active. These data suggest that the phenotype of AS differs between genders. This can influence the subsequent diagnostic approach and therapeutic decisions.

Genetic polymorphisms inside and outside the MHC improve prediction of AS radiographic severity in addition to clinical variables.

OBJECTIVE: The aim of this study was to analyse if single nucleotide polymorphisms (SNPs) inside and outside the MHC region might improve the prediction of radiographic severity in AS. METHODS: A cross-sectional multi-centre study was performed including 473 Spanish AS patients previously diagnosed with AS following the Modified New York Criteria and with at least 10 years of follow-up from the first symptoms of AS. Clinical variables and 384 SNPs were analysed to predict radiographic severity [BASRI-total (BASRI-t) corrected for the duration of AS since first symptoms] using multivariate forward logistic regression. Predictive power was measured by the area under the receiver operating characteristic curve (AUC), specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV). RESULTS: The model with the best fit measured radiographic severity as the BASRI-t 60th percentile and combined eight variables: male gender, older age at disease onset and six SNPs at ADRB1 (rs1801253), NELL1 (rs8176785) and MHC (rs1634747, rs9270986, rs7451962 and rs241453) genes. The model predictive power was defined by AUC = 0.76 (95% CI 0.71, 0.80), being significantly better than the model with only clinical variables, AUC = 0.68 (95% CI 0.63, 0.73), P = 0.0004. Internal split-sample analysis proved the validation of the model. Patient genotype for SNPs outside the MHC region, inside the MHC region and clinical variables account for 26, 38 and 36%, respectively, of the explained variability on radiographic severity prediction. CONCLUSION: Prediction of radiographic severity in AS based on clinical variables can be significantly improved by including SNPs both inside and outside the MHC region.

[Diagnosis and treatment of Chlamydia-induced reactive arthritis]. / Diagnóstico y tratamiento de la artritis relacionada con la infección por Clamidia.

Urogenital chlamydia infections are the most prevalent of all sexually transmitted diseases although the number of chlamydia-induced reactive arthritis cases are generally below the estimated incidence of the disease. This may be related with the high rate of asymptomatic chlamydial infections and the lack of adequate diagnostic criteria. Polymerase chain reaction (PCR), a new system for detection of Chlamydia, is one of the most useful techniques for the diagnosis of this disease. Biologic therapy produces theoretical doubts regarding its indication and there is little information related with chlamydia induced reactive arthritis treatment efficacy. Although the usefulness of long antibiotic treatment is not clear, the use of combination antibiotics opens new therapeutic strategies for chlamydia induced reactive arthritis.

Phenotypic differences between familial versus sporadic ankylosing spondylitis: a cross-sectional Spanish registry of spondyloarthropathies (REGISPONSER).

OBJECTIVES: To analyse potential differences in disease phenotype between patients with familial ankylosing spondylitis (AS) and sporadic AS. METHODS: A cross-sectional study was conducted on all patients with definite AS registered at the internet database REGISPONSER. Sociodemographic data, clinical features, spinal mobility measurements, the Bath AS disease activity index (BASDAI), functional index (BASFI) and radiology index (BASRI), laboratory data (ESR, CRP, HLA-B27), overall patient assessment of the disease (VAS), and treatments used were obtained. Familial AS was considered when the patient was confirmed to have first-degree relatives with spondyloarthropathy. The Chi-square test and Mann-Whitney U-test were used for the statistical analysis. RESULTS: A total of 1316 AS patients (990 males, 326 females; mean age 48.2 ± 12.6 years), with mean age at symptom onset 26.1 ± 8.5 years, were evaluated. The prevalence of familial AS was 20% (n=263). Familial and sporadic AS groups presented differences (p<0.05) in the following parameters: female (34.6% vs. 22%), mean age at symptom onset (25.0±9.2 years vs. 27.3 ± 10.0 years), disease duration (23 ± 13 years vs. 21 ± 12 years), uveitis (27.5% vs. 19.3%), presence of HLA-B27+ (93% vs. 83%), VAS for overall patient assessment (5.0 cm vs. 4.4 cm), BASDAI (4.4 cm vs. 4.0 cm) and response to NSAID (82% vs. 74%). CONCLUSIONS: Patients with familial AS were younger at symptom onset and had poorer VAS for overall patient assessment and BASDAI than the other group. There was a higher prevalence of females, uveitis, positive HLA-B27, hip prostheses and a better response to NSAID in the familial AS group.

[Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients]. / Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas.

OBJECTIVE: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. RESULTS: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. CONCLUSIONS: We present the SER recommendations related to biologic therapy risk management.

[Consensus Statement of the Spanish Society of Rheumatology on the management of biologic therapies in spondyloarthritis except for psoriatic arthritis]. / Documento SER de consenso sobre el uso de terapias biológicas en la espondilitis anquilosante y otras espondiloartritis, excepto la artritis psoriásica.

OBJECTIVE: Due to the amount and variability in quality regarding the use of biologic therapy (BT) in patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA) patients, the Spanish Society of Rheumatology has promoted the generation of recommendations based on the best evidence available. These recommendations should be a reference for rheumatologists and those involved in the treatment of patients with spondyloarthritis (SpA), except for psoriatic arthritis (PsA), who are using, or about to use BT. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. RESULTS: We have produced recommendations on the use of BT currently available for SpA (but not PsA) in our country. These recommendations include disease assessment, treatment objectives, therapeutic scheme and switching. CONCLUSIONS: We present an update on the SER recommendations for the use of BT in patients with SpA, except for PsA.