Food allergy (FA) is a potentially life-threatening chronic condition that is becoming an increasing public health problem worldwide. This systematic review (SR) was carried out to inform the development of clinical recommendations on the treatment of IgE-mediated FA with biologics and/or IT for the update of the EAACI guidelines. A SR of randomized-controlled trials or quasi-controlled trials was carried out. Studies were identified via comprehensive search strategies in Medline, Embase, and Cochrane Library, up to April 2022. POPULATION: Human adults, children, and adolescents with IgE-mediated FA. INTERVENTION: IT and/or biologics. COMPARATOR: Placebo or standard-of-care (allergen avoidance). OUTCOME: Efficacy (desensitization, sustained unresponsiveness (SU), remission), quality of life, and safety (systemic and local adverse reactions (AR)). The Cochrane RoB tool was used to assess the risk of bias. It was reported according to PRISMA and registered in PROSPERO CRD4202229828. After screening, 121 studies were included (111 for IT and 10 for biologics). Most studies had a high risk of bias and showed high heterogeneity in design and results. Metanalysis showed a positive effect of biologics and IT in terms of relative risk (RR) for achieving tolerance to the culprit food compared to avoidance or placebo. Omalizumab for any FA showed a RR of 2.17 [95% confidence interval: 1.22, 3.85]. For peanut allergy, oral IT (OIT) had a RR of 11.94 [1.76, 80.84] versus avoidance or placebo, sublingual IT (SLIT) had a RR of 3.00 [1.04, 8.66], and epicutaneous IT (EPIT) of 2.16 [1.56, 3.00]. OIT had a RR of 5.88 [2.27, 15.18] for cow's milk allergy, and of 3.43 [2.24, 5.27] for egg allergy. There was insufficient data on SLIT or EPIT for the treatment of egg and milk allergies. Most ARs reported were mild. For OIT the most common AR involved the gastrointestinal system and for EPIT, AR's most commonly affected the skin. There was limited data on severe or life-threatening ARs. There was limited evidence for long term efficacy and quality of life. In conclusion, biologics and IT, alone or in combination, are effective in achieving desensitization while on active treatment but more evidence is needed on long-term tolerance as current evidence is not of high quality. Adverse events while on therapy are generally mild to moderate but a long-term comprehensive safety profile is missing. There is a critical need to optimize and standardize desensitization protocols and outcome measures to facilitate our understanding of the efficacy and safety as well as to allow for comparison between interventions.
BACKGROUND AND OBJECTIVE: Systemic sclerosis (SSc) is a highly heterogeneous disease whose treatment is based mainly on immunosuppressants, antifibrotics, and vasodilators. Intravenous immunoglobulin (IVIG) have proved effective in other autoimmune diseases. The objective of this study is to evaluate the efficacy and safety of IVIG in SSc. METHODS: The systematic review was conducted according to the PRISMA Statement. Medline, Embase and Cochrane Library databases were searched until March 2024. We assessed the quality of included studies using the Cochrane Risk of Bias 2.0 tool (RoB 2) for randomised clinical trials and the Cochrane Risk in non-randomized studies (ROBINS-I) tool for observational studies. RESULTS: From 1242 studies identified, 15 studies were included, of which 14 were observational studies. In total, 361 patients with SSc were included, and 295 received treatment with IVIG. Most of the studies used a dose of 2 g/kg IVIG. Ten studies, including the clinical trial, showed high risk of bias, and five had a critical risk. Skin involvement was assessed using modified Rodnan skin score, in 11 studies and the authors reported cutaneous efficacy in 9 of them. The 6 studies that assessed muscle involvement reported an improvement. Six studies reported data on gastrointestinal efficacy. Other domains such as lung and joint involvement and steroid-sparing effect were evaluated. The most frequent adverse events were mild, including headache, abdominal pain, fever, and skin rash. CONCLUSION: Treatment with IVIG in SSc patients could be helpful and safe in patients with cutaneous, muscular, or digestive manifestations.
Introduction: Tumor-induced osteomalacia (TIO), is a rare acquired paraneoplastic syndrome characterized by defective bone mineralization, caused by the overproduction of fibroblast growth factor 23 (FGF23) by a tumor. Material and methods: We conducted a systematic review to identify all case reports of TIO, focusing on those associated with mesenchymal tumors. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) consensus, and we included patients with a diagnosis of TIO and histological confirmation of phosphaturic mesenchymal tumors or resolution of the condition after treatment of the tumor. Bibliographical searches were carried out until December 2023 in the Cochrane Library, Medline and Embase, as well as congress abstracts online. Results: We identified 769 articles with 1979 cases reported. Most patients were adults, with a higher incidence on men. Disease duration before diagnosis is a mean of 4.8 years. Most tumors were histologically classified as PMT. Lower limbs were the predominant location. Hypophosphatemia was present in 99.8 % of patients. The FGF23 was elevated at diagnosis in 95.5 %. Resection of the tumor was the treatment of choice in most of patients. After resection, there was a clinical improvement in 97.6 % of cases, and serum phosphorus and FGF23 levels returned to normal ranges in 91.5 % and 81.4 % of the patients, respectively. Conclusion: TIO is usually misdiagnosed with rheumatological or musculoskeletal disorders. The diagnosis should be suspected in patients with hypophosphatemic osteomalacia, and the measurement of serum FGF23 can be useful for diagnosis and management.
BACKGROUND: Nailfold Videocapillaroscopy (NVC) is a valuable tool in the differential diagnosis of Raynaud's phenomenon (RP), present in certain Rheumatic diseases (RD). Knowing that many people have cardiovascular risk factors (CVRF), the main objective was to demonstrate that CVRF and carotid plaques produce NVC alterations. METHODS: Cross-sectional unicentric study carried out from 2020 to 2023. Four groups were formed: subjects with RD and RP, participants with RD without RP, subjects with RP without RD and finally participants without RP or RD (study group). Each subject exhibiting CVRF presented only a single risk factor. The variables collected were: sociodemographic, CVRF (diabetes, tobacco, alcohol (ALC), obesity (OBE), dyslipidemia and arterial hypertension (AH)), diseases, RP, treatments, tortuosities and NVC alterations (ramified capillaries, enlarged capillaries, giant capillaries, haemorrhages and density loss) and carotid ultrasound (CU). RESULTS: 402 subjects were included (76 % women, mean age 51 ± 16 years), 67 % had CVRF, 50 % RP and 38 % RD. Tortuosities were present in 100 % of CVRF participants. A statistically significant association was found between the presence of CVRF and all the NVC alterations: ramified capillaries (OR = 95.6), enlarged capillaries (OR = 59.2), giant capillaries (OR = 8.32), haemorrhages (OR = 17.6) and density loss (OR = 14.4). In particular, an association was found between giant capillaries with AH (p = 0,008) and OBE (p ã0,001), and haemorrhages and density loss with ALC and OBE (p < 0,001). On the other hand, 40 subjects presented CU plaques (9.9 %), associated with enlarged capillaries (OR = 8.08), haemorrhages (OR = 4.04) and ramified capillaries (OR = 3.01). The pathological intima-media thickness was also associated with haemorrhages (OR = 3.14). CONCLUSIONS: There is a clear association between CVRF and ultrasound atherosclerotic findings in carotid with NVC alterations. These findings are of special interest for a correct NVC interpretation and to avoid false positives in the diagnosis of primary and secondary RP.
OBJECTIVE: To develop an improved score for prediction of severe infection in patients with systemic lupus erythematosus (SLE), namely, the SLE Severe Infection Score-Revised (SLESIS-R) and to validate it in a large multicentre lupus cohort. METHODS: We used data from the prospective phase of RELESSER (RELESSER-PROS), the SLE register of the Spanish Society of Rheumatology. A multivariable logistic model was constructed taking into account the variables already forming the SLESIS score, plus all other potential predictors identified in a literature review. Performance was analysed using the C-statistic and the area under the receiver operating characteristic curve (AUROC). Internal validation was carried out using a 100-sample bootstrapping procedure. ORs were transformed into score items, and the AUROC was used to determine performance. RESULTS: A total of 1459 patients who had completed 1 year of follow-up were included in the development cohort (mean age, 49±13 years; 90% women). Twenty-five (1.7%) had experienced ≥1 severe infection. According to the adjusted multivariate model, severe infection could be predicted from four variables: age (years) ≥60, previous SLE-related hospitalisation, previous serious infection and glucocorticoid dose. A score was built from the best model, taking values from 0 to 17. The AUROC was 0.861 (0.777-0.946). The cut-off chosen was ≥6, which exhibited an accuracy of 85.9% and a positive likelihood ratio of 5.48. CONCLUSIONS: SLESIS-R is an accurate and feasible instrument for predicting infections in patients with SLE. SLESIS-R could help to make informed decisions on the use of immunosuppressants and the implementation of preventive measures.
Lupus Erythematosus, Systemic , Humans , Female , Adult , Middle Aged , Male , Lupus Erythematosus, Systemic/complications , Prospective Studies , Immunosuppressive Agents , Logistic Models
OBJECTIVES: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions. METHODS: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions. RESULTS: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers. CONCLUSION: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.
Antirheumatic Agents , Medication Adherence , Rheumatic Diseases , Rheumatology , Humans , Rheumatic Diseases/drug therapy , Antirheumatic Agents/therapeutic use , Delphi Technique , Clinical Trials as Topic , Outcome Assessment, Health Care
Background: Fibromyalgia (FM) is a chronic disease characterized by widespread pain. Although much is known about this disease, research has focused on diagnosis and treatment, leaving aside factors related to patient's experience and the relationship with healthcare system. Objectives: The aim was to analyze the available evidence on the experience of FM patients from the first symptoms to diagnosis, treatment, and follow-up. Methods: A scoping review was carried out. Medline and the Cochrane Library were searched for original studies or reviews dealing with FM and focusing on patient journey. Results were organized using a deductive classification of themes. Results: Fifty-four articles were included in the qualitative synthesis. Five themes were identified: the patient journey, the challenge for the health systems, a complex doctorpatient relationship, the importance of the diagnosis, and the difficulty of standardizing the treatment. Conclusions: This scoping review confirms the negative impact of FM on the patient, their social environment, and health systems. It is necessary to minimize the difficulties encountered throughout the diagnosis and follow-up of patients with FM.(AU)
Antecedentes: La fibromialgia (FM) es una enfermedad crónica caracterizada por dolor generalizado. Aunque se sabe mucho de esta enfermedad, la investigación se ha centrado en el diagnóstico y el tratamiento, sin valorar la experiencia del paciente y la relación con el sistema. Objetivos: El objetivo fue analizar la evidencia sobre la experiencia de los pacientes con FM desde el inicio de los síntomas hasta el diagnóstico, el tratamiento y el seguimiento. Métodos: Se realizó una revisión de alcance. Se buscaron en Medline y en Cochrane Library estudios o revisiones sobre la FM y patient journey. Los resultados se clasificaron mediante deductiva de temas. Resultados: Se incluyeron 54 artículos en la síntesis cualitativa. Se identificaron cinco temas: el viaje del paciente, el reto para los sistemas sanitarios, la compleja relación médico-paciente, la importancia del diagnóstico, y la dificultad de estandarizar el tratamiento. Conclusiones: Esta revisión confirma el impacto negativo de la FM en pacientes, su entorno social y sistemas sanitarios. Es necesario minimizar las dificultades durante el diagnóstico y seguimiento de pacientes con FM.(AU)
Humans , Male , Female , Fibromyalgia/diagnosis , Fibromyalgia/drug therapy , Rheumatology , Rheumatic Diseases
BACKGROUND: Fibromyalgia (FM) is a chronic disease characterized by widespread pain. Although much is known about this disease, research has focused on diagnosis and treatment, leaving aside factors related to patient's experience and the relationship with healthcare system. OBJECTIVES: The aim was to analyze the available evidence on the experience of FM patients from the first symptoms to diagnosis, treatment, and follow-up. METHODS: A scoping review was carried out. Medline and the Cochrane Library were searched for original studies or reviews dealing with FM and focusing on "patient journey". Results were organized using a deductive classification of themes. RESULTS: Fifty-four articles were included in the qualitative synthesis. Five themes were identified: the patient journey, the challenge for the health systems, a complex doctor-patient relationship, the importance of the diagnosis, and the difficulty of standardizing the treatment. CONCLUSIONS: This scoping review confirms the negative impact of FM on the patient, their social environment, and health systems. It is necessary to minimize the difficulties encountered throughout the diagnosis and follow-up of patients with FM.
Fibromyalgia , Humans , Fibromyalgia/diagnosis , Fibromyalgia/therapy , Physician-Patient Relations , Pain , Chronic Disease
Objetivos: Explorar la experiencia de las personas con fibromialgia (FM) en países latinoamericanos con objeto de identificar problemas en la atención sanitaria y otros ámbitos potencialmente solucionables. Métodos: Estudio cualitativo con enfoque fenomenológico y de análisis de contenido a través de grupos focales y metodología de viaje del paciente (Ux del inglés User Experience). Se llevaron a cabo 9 grupos focales virtuales con pacientes con FM y profesionales sanitarios en Argentina, México y Colombia reclutados a partir de informantes clave y redes sociales. Resultados: Participaron 43 personas (33 clínicos y 10 pacientes). Los agentes que interaccionan con el paciente en la enfermedad se encuentran en 3 esferas: la de la atención sanitaria, la del apoyo y vida laboral y la del contexto socioeconómico. La línea del viaje presenta 2 grandes tramos, 2 bucles y una línea discontinua delgada. Los 2 grandes tramos representan los tiempos que van desde los primeros síntomas hasta la visita médica y desde el diagnóstico hasta el seguimiento. Los bucles incluyen: 1.°) sucesión de diagnósticos, tratamientos erróneos y derivaciones a especialistas y 2.°) nuevos síntomas cada cierto tiempo, visitas a especialistas y dudas diagnósticas. Pocos pacientes logran la fase final de autonomía. Conclusión: El viaje de una persona con FM en Latinoamérica está lleno de obstáculos. La meta deseada es que todos los agentes entiendan que el automanejo por parte del paciente con FM es una parte indispensable del éxito, y solo se puede lograr accediendo a recursos de forma precoz y guiado por profesionales.(AU)
Objectives: To explore the patient journey of people with fibromyalgia (FM) in Latin American countries in order to identify problems in health care and other areas that may be resolvable. Methods: Qualitative study with phenomenological and content analysis approach through focus groups and patient journey (Ux; User Experience) methodology. Nine virtual focus groups were conducted with FM patients and healthcare professionals in Argentina, Mexico and Colombia recruited from key informants and social networks. Results: Forty-three people participated (33 were clinicians and 10 were patients). The agents interacting with the patient in their disease journey are found in three spheres: healthcare (multiple medical specialists and other professionals), support and work life (including patient associations) and socioeconomic context. The line of the journey presents two large sections, two loops and a thin dashed line. The two major sections represent the time from first symptoms to medical visit (characterized by self-medication and denial) and the time from diagnosis to follow-up (characterized by high expectations and multiple contacts to make life changes that are not realized). The two loop phases include (1) succession of misdiagnoses and mistreatments and referrals to specialists and (2) new symptoms every so often, visits to specialists, diagnostic doubts, and impatience. Very few patients manage to reach the final phase of autonomy. Conclusion: The journey of a person with FM in Latin America is full of obstacles and loops. The desired goal is for all the agents involved to understand that self-management by the patient with FM is an essential part of success, and this can only be achieved with early access to resources and guidance from professionals.(AU)
Humans , Male , Female , Fibromyalgia/drug therapy , Chronic Pain/drug therapy , Patient Navigation , Health Status Disparities , Health Personnel , Qualitative Research , Rheumatology , Rheumatic Diseases , Argentina , Mexico , Colombia , Focus Groups
OBJECTIVES: To explore the patient journey of people with fibromyalgia (FM) in Latin American countries in order to identify problems in health care and other areas that may be resolvable. METHODS: Qualitative study with phenomenological and content analysis approach through focus groups and patient journey (Ux; User Experience) methodology. Nine virtual focus groups were conducted with FM patients and healthcare professionals in Argentina, Mexico and Colombia recruited from key informants and social networks. RESULTS: Forty-three people participated (33 were clinicians and 10 were patients). The agents interacting with the patient in their disease journey are found in three spheres: healthcare (multiple medical specialists and other professionals), support and work life (including patient associations) and socioeconomic context. The line of the journey presents two large sections, two loops and a thin dashed line. The two major sections represent the time from first symptoms to medical visit (characterized by self-medication and denial) and the time from diagnosis to follow-up (characterized by high expectations and multiple contacts to make life changes that are not realized). The two loop phases include (1) succession of misdiagnoses and mistreatments and referrals to specialists and (2) new symptoms every so often, visits to specialists, diagnostic doubts, and impatience. Very few patients manage to reach the final phase of autonomy. CONCLUSION: The journey of a person with FM in Latin America is full of obstacles and loops. The desired goal is for all the agents involved to understand that self- management by the patient with FM is an essential part of success, and this can only be achieved with early access to resources and guidance from professionals.
Fibromyalgia , Humans , Fibromyalgia/diagnosis , Fibromyalgia/therapy , Fibromyalgia/complications , Latin America , Mexico , Qualitative Research , Focus Groups
OBJECTIVE: Approximately one third of individuals worldwide have not received a COVID-19 vaccine. Although studies have investigated risk factors linked to severe COVID-19 among unvaccinated people with rheumatic diseases (RDs), we know less about whether these factors changed as the pandemic progressed. We aimed to identify risk factors associated with severe COVID-19 in unvaccinated individuals in different pandemic epochs corresponding to major variants of concern. METHODS: Patients with RDs and COVID-19 were entered into the COVID-19 Global Rheumatology Alliance Registry between March 2020 and June 2022. An ordinal logistic regression model (not hospitalized, hospitalized, and death) was used with date of COVID-19 diagnosis, age, sex, race and/or ethnicity, comorbidities, RD activity, medications, and the human development index (HDI) as covariates. The main analysis included all unvaccinated patients across COVID-19 pandemic epochs; subanalyses stratified patients according to RD types. RESULTS: Among 19,256 unvaccinated people with RDs and COVID-19, those who were older, male, had more comorbidities, used glucocorticoids, had higher disease activity, or lived in lower HDI regions had worse outcomes across epochs. For those with rheumatoid arthritis, sulfasalazine and B-cell-depleting therapy were associated with worse outcomes, and tumor necrosis factor inhibitors were associated with improved outcomes. In those with connective tissue disease or vasculitis, B-cell-depleting therapy was associated with worse outcomes. CONCLUSION: Risk factors for severe COVID-19 outcomes were similar throughout pandemic epochs in unvaccinated people with RDs. Ongoing efforts, including vaccination, are needed to reduce COVID-19 severity in this population, particularly in those with medical and social vulnerabilities identified in this study.
COVID-19 , Rheumatic Diseases , Rheumatology , Humans , Male , Pandemics , COVID-19 Vaccines/therapeutic use , COVID-19 Testing , COVID-19/epidemiology , Rheumatic Diseases/diagnosis , Rheumatic Diseases/drug therapy , Rheumatic Diseases/epidemiology , Risk Factors , Registries
OBJECTIVE: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework. METHODS: A three-round online Delphi exercise, including patient research partners (PRPs) and other community partners in healthcare, was conducted. Domains scored 7-9 (i.e., critically important to include) by ≥ 70 % of participants in both groups were included. Items were consolidated in a subsequent dedicated meeting. RESULTS: Nineteen domains scored ≥ 70 % consensus in both groups. The focus group refined these into a list of twelve domains. CONCLUSION: The achieved consensus will inform the next steps of developing the core domain set for LOS in RA.
Arthritis, Rheumatoid , Rheumatology , Humans , Consensus , Longitudinal Studies , Outcome Assessment, Health Care
OBJECTIVE: To identify perceptions of gender bias in Spanish rheumatology and to quantify the involvement of both sexes in all areas of the specialty. METHODS: A survey was sent to all members of the SER on participation and perception of biases and of their own competencies, and actual data on participation in governing bodies, congresses, committees, and Spanish rheumatology departments in the last 5 years were reviewed. RESULTS: The survey was answered by 95 rheumatologists, 4.8% of SER members (14 men and 81 women), both groups being similar in terms of age, academic level, and position and work centre. No differences were detected in the distribution of work and non-work tasks between sexes, nor in invitations to positions of power in the last five years, nor in the perception of capacity to occupy the different positions of power, which was high for both sexes. Male respondents more frequently consider that activities such as participating in a scientific committee or giving a conference are not empowering. A third of both sexes consider that the SER should review its processes with a gender perspective but less than a third believe that this should be done by quotas. The reality of the last 5 years is that 1) there is a male to female ratio of 3:2 on SER boards of directors and in this period there has been no female president or treasurer; 2) in the scientific committees of the congresses men predominate (2:1) although slightly less in the local organizing committee; 3) there are more male speakers and moderators than women (very striking in satellite symposia, 4: 1); 4) 9 out of 10 editors-in-chief are men; 5) in academic positions there are 3 men for every 2 women, 9 to 1 in professorships or emeritus positions; although more women supervise residents; and 6) there are more women (60%) than men (40%) in Spanish rheumatology departments, although 75% of department chiefs are men. CONCLUSION: Although not perceived by either the men or the women, there are biases in the involvement of women in important and leadership positions in the specialty.
Rheumatology , Sexism , Humans , Male , Female , Surveys and Questionnaires , Leadership , Perception
Objetivo: Proponer una modificación consensuada del Health Assessment Questionnaire (HAQ) según los valores, idioma y cultura predominantes en la sociedad española actual. Métodos: En primer lugar, se realizó una revisión de alcance de la literatura y una encuesta a usuarios del HAQ para identificar las limitaciones de este cuestionario. En una segunda fase se celebró una reunión con profesionales expertos para discutir los resultados y diseñar propuestas de modificación. Resultados: La revisión de alcance permitió describir las principales versiones del HAQ, así como sus propiedades psicométricas. En la encuesta a usuarios del HAQ se valoraron el grado de comprensión, la utilidad, la actualidad y la universalidad de cada uno de los ítems y se admitieron sugerencias y opiniones sobre sus principales inconvenientes. Durante la reunión de discusión se propusieron modificaciones de los ítems en función de los resultados de la revisión de alcance y de la encuesta a usuarios. Además, se tuvieron en cuenta la dificultad de comprensión de los ítems, su dificultad para evaluar los movimientos previstos, el carácter redundante, su obsolescencia y el posible sesgo de género. Conclusiones: Se propone una actualización de la versión española del HAQ en base a la revisión de la literatura y a la opinión de expertos que pone de manifiesto el cambio de paradigma en los valores culturales y que pretende aumentar la validez de contenido y capacidad de discriminación de este cuestionario.(AU)
Objective: To propose a consensus modification of the HAQ according to the predominant values, language, and culture of the society. Methods: First, a scoping review of the literature and a survey of HAQ users were conducted to identify the problems of this questionnaire. In a second phase, a meeting was held with expert professionals to discuss the results and design proposals for modification. Results: The scoping review allowed us to describe the main versions of the HAQ, as well as their psychometric properties. The HAQ users survey assessed the degree of comprehension, usefulness, timeliness, and universality of each of the items, and suggestions and opinions on its main limitations were accepted. During the discussion meeting, modifications to the items were proposed based on the results of the scoping review and the users survey. In addition, the difficulty of understanding the items, their difficulty in assessing intended movements, redundancy, obsolescence, and possible gender bias were taken into account. Conclusions. An update of the Spanish version of the HAQ is proposed based on the literature review and expert opinion that highlights the paradigm shift in cultural values and aims to increase the content validity and discrimination capacity of this questionnaire.(AU)
Humans , Male , Female , Translating , Surveys and Questionnaires , Health Status
OBJECTIVES: To investigate factors associated with severe COVID-19 in people with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). METHODS: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with PsO, PsA and axSpA were obtained from two international physician-reported registries. A three-point ordinal COVID-19 severity scale was defined: no hospitalisation, hospitalisation (and no death) and death. ORs were estimated using multivariable ordinal logistic regression. RESULTS: Of 5045 cases, 18.3% had PsO, 45.5% PsA and 36.3% axSpA. Most (83.6%) were not hospitalised, 14.6% were hospitalised and 1.8% died. Older age was non-linearly associated with COVID-19 severity. Male sex (OR 1.54, 95% CI 1.30 to 1.83), cardiovascular, respiratory, renal, metabolic and cancer comorbidities (ORs 1.25-2.89), moderate/high disease activity and/or glucocorticoid use (ORs 1.39-2.23, vs remission/low disease activity and no glucocorticoids) were associated with increased odds of severe COVID-19. Later pandemic time periods (ORs 0.42-0.52, vs until 15 June 2020), PsO (OR 0.49, 95% CI 0.37 to 0.65, vs PsA) and baseline exposure to TNFi, IL17i and IL-23i/IL-12+23i (OR 0.57, 95% CI 0.44 to 0.73; OR 0.62, 95% CI 0.45 to 0.87; OR 0.67, 95% CI 0.45 to 0.98; respectively; vs no disease-modifying antirheumatic drug) were associated with reduced odds of severe COVID-19. CONCLUSION: Older age, male sex, comorbidity burden, higher disease activity and glucocorticoid intake were associated with more severe COVID-19. Later pandemic time periods, PsO and exposure to TNFi, IL17i and IL-23i/IL-12+23i were associated with less severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with PsO, PsA and axSpA during COVID-19 waves or similar future respiratory pandemics.
Arthritis, Psoriatic , Axial Spondyloarthritis , COVID-19 , Physicians , Psoriasis , Rheumatology , Adult , Humans , Male , Arthritis, Psoriatic/drug therapy , Arthritis, Psoriatic/epidemiology , Arthritis, Psoriatic/complications , COVID-19/epidemiology , COVID-19/complications , Psoriasis/drug therapy , Psoriasis/epidemiology , Psoriasis/complications , Glucocorticoids , Interleukin-12 , Registries
To verify, via a survey, the experience and needs of patients receiving methotrexate (MTX), their general management and the quality of the information provided by the rheumatologist. We conducted a 51-item online survey between May and July 2020 addressed to persons diagnosed with an immune-mediated disease and treated with MTX (regardless of the route of administration). Recruitment was done via Twitter. We obtained 294 responses, of which 283 were complete and could be analysed. Almost 82% of the respondents were women, 80% resided in Spain, 75% were between 31 and 60 years old, and 57% were active workers. Diseases included psoriasis (41%), lupus, Sjögren's or vasculitides (33%), and rheumatoid arthritis (16%), among others. Eighty per cent had read the leaflet inserted in the package, of whom 62% found it helpful. Only 15% of the respondents reported having been offered additional written material, which was considered barely functional (33 out of 100). Most patients (88%) responded that they had not received advice on any reliable sources to consult on the internet, and those who received it considered it unhelpful (24 out of 100). Patients receiving MTX due to an autoimmune disease demand more and better-quality written or web-based information than what is currently offered at their clinics.
Antirheumatic Agents , Arthritis, Rheumatoid , Humans , Female , Adult , Middle Aged , Male , Methotrexate/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Arthritis, Rheumatoid/diagnosis , Surveys and Questionnaires , Rheumatologists , Treatment Outcome
OBJECTIVE: To determine the association between race/ethnicity and COVID-19 outcomes in individuals with systemic lupus erythematosus (SLE). METHODS: Individuals with SLE from the US with data entered into the COVID-19 Global Rheumatology Alliance registry between March 24, 2020 and August 27, 2021 were included. Variables included age, sex, race, and ethnicity (White, Black, Hispanic, other), comorbidities, disease activity, pandemic time period, glucocorticoid dose, antimalarials, and immunosuppressive drug use. The ordinal outcome categories were: not hospitalized, hospitalized with no oxygenation, hospitalized with any ventilation or oxygenation, and death. We constructed ordinal logistic regression models evaluating the relationship between race/ethnicity and COVID-19 severity, adjusting for possible confounders. RESULTS: We included 523 patients; 473 (90.4%) were female and the mean ± SD age was 46.6 ± 14.0 years. A total of 358 patients (74.6%) were not hospitalized; 40 patients (8.3%) were hospitalized without oxygen, 64 patients (13.3%) were hospitalized with any oxygenation, and 18 (3.8%) died. In a multivariable model, Black (odds ratio [OR] 2.73 [95% confidence interval (95% CI) 1.36-5.53]) and Hispanic (OR 2.76 [95% CI 1.34-5.69]) individuals had higher odds of more severe outcomes than White individuals. CONCLUSION: Black and Hispanic individuals with SLE experienced more severe COVID-19 outcomes, which is consistent with findings in the US general population. These results likely reflect socioeconomic and health disparities and suggest that more aggressive efforts are needed to prevent and treat infection in this population.
COVID-19 , Lupus Erythematosus, Systemic , Rheumatology , Adult , Female , Humans , Male , Middle Aged , Ethnicity , Hispanic or Latino , Lupus Erythematosus, Systemic/diagnosis , Lupus Erythematosus, Systemic/drug therapy , Lupus Erythematosus, Systemic/epidemiology , United States/epidemiology , White , Black or African American
OBJECTIVE: To propose a consensus modification of the HAQ according to the predominant values, language, and culture of the society. METHODS: First, a scoping review of the literature and a survey of HAQ users were conducted to identify the problems of this questionnaire. In a second phase, a meeting was held with expert professionals to discuss the results and design proposals for modification. RESULTS: The scoping review allowed us to describe the main versions of the HAQ, as well as their psychometric properties. The HAQ users survey assessed the degree of comprehension, usefulness, timeliness, and universality of each of the items, and suggestions and opinions on its main limitations were accepted. During the discussion meeting, modifications to the items were proposed based on the results of the scoping review and the users survey. In addition, the difficulty of understanding the items, their difficulty in assessing intended movements, redundancy, obsolescence, and possible gender bias were taken into account. CONCLUSIONS: An update of the Spanish version of the HAQ is proposed based on the literature review and expert opinion that highlights the paradigm shift in cultural values and aims to increase the content validity and discrimination capacity of this questionnaire.
Language , Sexism , Humans , Male , Female , Reproducibility of Results , Surveys and Questionnaires , Psychometrics
OBJECTIVE: To systematically review the measurement properties of outcome instruments used in large-vessel vasculitis (LVV). METHODS: MEDLINE, Embase, Cochrane, and Scopus databases were searched for studies published from inception to July 14, 2020, that addressed measurement properties of instruments used in giant cell arteritis (GCA) and Takayasu arteritis (TA). The measurement properties of the instruments identified were collected following the Outcome Measures in Rheumatology (OMERACT) and Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) frameworks. Instruments were grouped according to the following domains measured: disease activity/damage, organ function, and health-related quality of life (HRQOL)/health status. RESULTS: From 3534 articles identified, 13 met the predefined criteria. These studies addressed 12 instruments: 4 specific to TA, 2 designed for all types of systemic vasculitis, and 6 non-disease-specific instruments. No instruments specific to GCA were identified. Regarding TA, the Indian Takayasu Clinical Activity Score (ITAS) showed very good consistency, adequate reliability, but doubtful validity for disease activity. The Disease Extent Index-Takayasu (DEI-Tak) showed adequate construct validity but doubtful discriminating validity for disease activity/damage. Instruments, including the Vasculitis Damage Index and the Birmingham Vasculitis Activity Score, were poorly assessed for disease activity/damage. In total, 6 non-vasculitis-specific patient-reported outcome (PRO) instruments showed inadequate validity in GCA/TA. CONCLUSION: The measurement properties of 12 outcome instruments for LVV covering the OMERACT domains of disease activity/damage, organ function, and HRQOL were assessed. The ITAS and the DEI-Tak were the instruments with the most adequate measurement properties for disease activity/damage in TA. Disease activity/damage instruments specific to GCA, as well as validated PROs for both GCA and TA, are lacking.
Giant Cell Arteritis , Takayasu Arteritis , Humans , Quality of Life , Reproducibility of Results , Giant Cell Arteritis/diagnosis , Outcome Assessment, Health Care
