Sexual dysfunction and self-perceived sexual health in patients with rheumatoid arthritis and systemic lupus erythematosus: results from a cross-sectional survey.

Sexual dysfunction (SD) has been associated with worse quality of life and higher disease activity in patients with rheumatic diseases, yet it is still not regularly addressed during routine rheumatologic evaluations. This study aimed to determine the prevalence of sexual dysfunction in patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) and evaluate their perception of their sexual health. We performed a retrospective study in an outpatient rheumatology clinic to evaluate patients over 18 years old with a diagnosis of RA or SLE through the Spanish version of the Arizona Sexual Experiences Scale (ASEX) and the Sexual Health Perception Survey (SHEPS), a questionnaire of 6 items designed in our clinic. Additionally, we applied the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F version 4) and the Hospital Anxiety and Depression Scale (HADS). A total of 567 patients were evaluated with SHEPS, most of whom were women with a median age of 50 years (IQR: 34) and a median disease duration of 5 years (IQR: 9). Through the ASEX, we found that 67% of the patients with RA and 60% of the patients with SLE experienced SD. Patients reported the level of sex drive, arousal, and the ability to achieve orgasms as the areas with the most difficulties. Most patients did not know their disease could affect their sexuality and had never addressed these issues with their rheumatologists, but almost all of them were willing to. Our findings highlight the importance of addressing sexual health issues regularly during rheumatologic evaluations.

Impact of intimate partner violence on quality of life and disease activity in women with systemic lupus erythematosus.

OBJECTIVE: Stress and trauma are psychosocial factors with an impact on the course of systemic lupus erythematosus (SLE). The influence of violence on SLE has not been entirely explored, even though women (including patients with rheumatic diseases) are a vulnerable population to any form of violence. This study aims to assess the prevalence and impact of intimate partner violence (IPV) on health-related quality of life in women with SLE. METHODS: An observational, cross-sectional, and analytical study was conducted at a rheumatology clinic of a university hospital from September 2022 and September 2023. We evaluated the presence of IPV in 85 women with SLE with the Hurt, Insulted, Threatened with Harm and Screamed at (HITS) questionnaire and the Index of Spouse Abuse (ISA), and quality of life with LupusQoL. RESULTS: The prevalence by HITS score of past-year IPV was 24.4% and of lifetime IPV was 36.5%. Past-year non-physical violence was present in 17.1% of patients by ISA, and 27.1% were victims in their lifetime. While in physical violence, 7.3% were victims in the previous year and 21.2% in their lifetime. The total quality of life and the emotional domain by LupusQoL were diminished in victims of past-year IPV, compared to those who weren't exposed (p = .018 and p = .036, respectively). Past-year HITS score correlated with the Physician Global Assessment (PGA) (rho = 0.301, p = .006), while lifetime HITS score correlated with PGA (rho = 0.329, p = .002) and SLEDAI-2K (rho = 0.277, p = .010). CONCLUSION: We found that one in four women suffered IPV in the previous year, and those who were exposed had diminished quality of life. Also, the severity of the abuse correlated with disease activity. Our findings emphasize the importance of comprehensive care for patients with SLE.

Quality indicators and satisfaction with care in patients with systemic lupus erythematosus.

Grading the quality of care in patients with systemic lupus erythematosus and determining its relationship with care satisfaction may recognize gaps that could lead to better clinical practice. Eighteen quality indicators (QIs) were recently developed and validated for patients with SLE based on the 2019 EULAR management recommendations. Few studies have analyzed the relationship between quality of care and care satisfaction in patients with lupus. This was a cross-sectional study. We included patients at least 18 years old who met the EULAR/ACR 2019 classification criteria for SLE. We interviewed patients and retrieved data from medical records to assess their compliance with a set of 18 EULAR-based QIs. We calculated each QI fulfillment as the proportion of fulfilled QI divided by the number of eligible patients for each indicator. Care satisfaction was evaluated with the satisfaction domain of LupusPRO version 1.7. Spearman correlation coefficient was used to determine the relationship between quality of care and care satisfaction. Seventy patients with a median age of 33 (IQR 23-48) were included, 90% were women. Overall adherence was 62.29%. The median care satisfaction was 100. Global adherence to the 18-QIs and the care satisfaction score revealed no correlation (r = 0.064, p = 0.599). Higher QI fulfillment was found in the group with remission versus the moderate-high activity group (p = 0.008). In our study, SLE patients in remission had higher fulfillment of quality indicators. We found no correlation between the quality of care and satisfaction with care.

Impact of obesity and overweight on C-reactive protein concentrations and disease activity in rheumatoid arthritis: A systematic review and meta-analysis.

AIM: This study aims to assess the association of obesity and CRP concentrations in adult patients with rheumatoid arthritis (RA), and its influence on measures of disease activity. METHODS: A comprehensive search was performed using Scopus, Web of Science, MEDLINE, and EMBASE, from the time of their inception to November 2021. Observational studies that evaluated the association between CRP concentrations and obesity or overweight in patients with RA were considered eligible. Correlation coefficients were pooled using the inverse variance method, while effect sizes were pre-calculated for adjusted standardized regression coefficients (ß). RESULTS: A total of 10 studies, which comprised 4024 patients, were included in this systematic review. Individually, most studies report a significant association between CRP concentrations and a higher body mass index or other adiposity measures, but the statistical significance was not sustained when pooling their data together. Through the estimates provided in the present review, it is noted that CRP tends to be more elevated in female patients with RA that have a higher BMI. However, this association is not present in men. CONCLUSION: CRP tends to be elevated in female patients with RA that have a higher BMI. Further research is required to assess this possible sex-related difference and to aid shared decision-making in order to avoid over-treatment and increased burden in patients with obesity and RA. PROSPERO registration number: CRD42022314580.

Cardiovascular health worsening in patients with autoimmune rheumatological diseases during the COVID-19 pandemic.

Rheumatic autoimmune diseases are associated with a myriad of comorbidities. Of particular importance due to their morbimortality are cardiovascular diseases. COVID-19 greatly impacted the world population in many different areas. Patients with rheumatic diseases had to face changes in their healthcare, in addition to unemployment, a decrease in physical activity, social isolation, and lack of access to certain medications. This review summarizes the impact of COVID-19 pandemic on cardiovascular risk factors, comorbidities, and unhealthy behaviors in patients with rheumatic inflammatory autoimmune diseases, particularly focused on rheumatoid arthritis and systemic lupus erythematosus. Searches were carried out in MEDLINE/PubMed and Scopus from August to December 2022. Four reviewers screened the title and abstract of retrieved records. Potentially eligible reports were then reviewed in full text. Differences were reconciled by either consensus or discussion with an external reviewer. During the COVID-19 pandemic, patients with rheumatic diseases showed an increase in the prevalence of mental health disorders (43.2-57.7%), reduced physical activity (56.8%), and a worsening in eating behaviors. Alcohol intake increased (18.2%), especially in early phases of the pandemic. Smoking prevalence decreased (28.2%). Dyslipidemia and hypertension showed no changes. The pandemic and lockdown affected rheumatic patients not only in disease-related characteristics but in the prevalence of their cardiovascular comorbidities and risk factors. Lifestyle changes, such as healthy eating, physical activity, and optimal management of their rheumatic diseases and comorbidities, are essential to manage the long-lasting consequences of the COVID-19 outbreak. Key Points • During the COVID-19 pandemic, anxiety, depression, sedentarism, obesity, and a worsening in eating behaviors increased. •Patients with rheumatic diseases and comorbidities have worse clinical outcomes and a higher cardiovascular disease burden than those without them. •Comparative studies are necessary to precisely elucidate the pandemic's impact on the prevalence of cardiovascular disease, risk factors, and comorbidities in patients with rheumatoid arthritis and systemic lupus erythematosus.

Design of a Rheumatology Transition Clinic for a Resource-Constrained Setting.

OBJECTIVES: To describe the design process of a medical care program for adolescents with pediatric onset rheumatic diseases (PRD) during the transition from pediatric to adult care in a resource-constrained hospital. METHODS: The model of attention was developed in three steps: 1) the selection of a multidisciplinary team, 2) the evaluation of the state of readiness of patients and caregivers for the transition, and 3) the design of a strategy of attention according to local needs. The results of the first two steps were used in order to develop the strategy of attention. RESULTS: The transition process was structured in three stages: pretransition (at pediatric rheumatology clinic), Transition Clinic for Adolescents with Rheumatic Diseases (TCARD, the main intervention), and post-transition (at adult rheumatology clinic). Each stage was divided, in turn, into a variable number of phases (8 in total), which included activities and goals that patients and caregivers were to accomplish during the process. A multidisciplinary approach was planned by pediatric and adult rheumatologists, nutritionists, physiatrists, psychiatrist, psychologist, nurse, and social worker. During TCARD, counseling, education, nutritional, physical, and mental health interventions were considered. CONCLUSIONS: The proposed transition model for patients with rheumatic diseases can be a useful tool in developing countries.

Association of soluble cell adhesion molecules and lipid levels in rheumatoid arthritis patients.

OBJECTIVES: To evaluate the relationship between soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intracellular adhesion molecule-1 (sICAM-1), and lipid levels in rheumatoid arthritis (RA) patients with and without carotid plaque (CP). METHODS: Cross-sectional study nested of a RA cohort. RA patients without a previous cardiovascular event or statins' therapy, aged 40-75 years were recruited at an outpatient cardio-rheumatology clinic. Carotid ultrasound was performed in all study subjects. RA patients with CP were included and matched to RA patients without CP by age, gender, and traditional cardiovascular risk factors. Blood samples were drawn at the time of recruitment to measure sVCAM-1, sICAM-1, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and lipid levels. Correlations between cell adhesion molecules, disease activity indexes, ESR and CRP with lipid levels were assessed with Spearman's correlation coefficient (rs). RESULTS: We included 71 RA patients, 37 with CP and 34 without CP. RA (n = 71) patients had a moderate negative correlation of sVCAM-1 with total cholesterol (TC) (rs = - 0.366, p = 0.002) and low-density lipoprotein (LDL) (rs = - 0.316, p = 0.007), and a small negative correlation with high-density lipoprotein (rs = - 0.250, p = 0.036). ESR showed a small negative correlation with LDL (rs = - 0.247, p = 0.038). Patients with CP had a moderate negative correlation between sVCAM and TC (rs = - 0.405, p = 0.013). Patients without CP showed a moderate negative correlation between sVCAM with TC (rs = - 0.364, p = 0.034) and LDL (rs = - 0.352, p = 0.041), and sICAM with VLDL (rs = - 0.343, p = 0.047). CONCLUSIONS: RA patients showed an inverse association of sVCAM-1 and lipid levels. More studies are needed to define the precise role of sVCAM-1 in the lipid paradox of RA.

Subclinical systolic dysfunction by speckle tracking echocardiography in patients with systemic lupus erythematosus.

BACKGROUND: We aimed to compare the prevalence of subclinical left ventricular systolic dysfunction in Hispanic systemic lupus erythematosus (SLE) patients versus healthy controls. MATERIAL AND METHODS: This cross-sectional study included 46 SLE patients who fulfilled the 2019 European League Against Rheumatism and American College of Rheumatology (EULAR/ACR) classification criteria for SLE and with age ≥ 18 years. For comparison, we included a control group with 46 non-SLE subjects matched by age (±5 years) and gender. A transthoracic echocardiogram was performed on every participant. The echocardiographic measurements evaluated were left ventricular ejection fraction (LVEF), relative wall thickness (RWT), and tricuspid annular plane systolic excursion (TAPSE). Left ventricular-Global Longitudinal Strain (GLS) was evaluated, and a value higher than -18% was classified as subclinical left ventricular systolic dysfunction. Comparisons between groups were made using the Chi-square test or Fisher's exact test for qualitative variables, and Student's t-test or the Mann-Whitney's U test for quantitative variables. A p-value <.05 was considered significant. RESULTS: We found a significant difference in the presence of subclinical left ventricular systolic dysfunction between SLE-patients and controls (37.0% vs 8.7%, p = .001). We also found that SLE patients had a lower left ventricular GLS (-18.90% vs -20.51%, p = .011), TAPSE (21.63 mm vs 23.60 mm, p = .009), and LVEF (57.17% vs 62.47%, p = <.001) than controls. Systemic lupus erythematosus diagnosis was independently associated with the presence of subclinical left ventricular systolic dysfunction with an OR of 6.068 (CI 95% 1.675-21.987) (p = .006). Subclinical systolic dysfunction was more common in men (29.4% vs 3.4%, p = .020), patients with obesity (17.6% vs 0%, p = .045), or hypertension (47.1% vs 6.9%, p = .001). CONCLUSION: Systemic lupus erythematosus Hispanic patients had a higher prevalence of subclinical left ventricular systolic dysfunction, and worse left ventricular GLS, LVEF, and TAPSE values than matched healthy controls. Additionally, we found that male gender, obesity, and hypertension are associated with the presence of subclinical left ventricular systolic dysfunction in SLE patients. The inclusion of speckle tracking echocardiography as part of the cardiovascular evaluation of SLE patients may help identify high cardiovascular risk patients.

Silicone breast implants and connective tissue diseases: How does current evidence add to the no-association consensus? Systematic review and meta-analysis.

To evaluate the current state of the evidence regarding the association of silicone breast implantation with the onset of connective tissue diseases, constitutional symptoms, and rheumatic serological profile in adult women. A comprehensive search was carried out using MEDLINE, Embase, Web of Science and Scopus, from inception to September 2, 2020. Cohort studies assessing the clinical and serological profile of women with cosmetic breast implants were included. Meta-analyses were conducted using risk ratios. A total of 10 cohorts with overall moderate quality of evidence were included in this systematic review. Exposure to silicone breast implants was slightly associated with the development of rheumatoid arthritis [RR: 1.35; (95% CI 1.08 to 1.68); P = .008; I2 = 0%]. However, no significant differences were exhibited between the breast implant-exposed population and controls regarding the rest of the outcomes. In adult women, exposure to silicone breast implantation is not associated with the onset of constitutional symptoms and most connective tissue diseases. A marginal association with rheumatoid arthritis was exhibited, but the certainty of this result is jeopardized by the significant amount of self-reported data for this outcome. Further research is required to adequately explore the clinical significance of these results.

Statin indication according to the 2019 World Health Organization cardiovascular disease risk charts and carotid ultrasound in Mexican mestizo rheumatoid arthritis patients.

BACKGROUND: We aimed to assess the concordance of recommendation for initiating statin therapy according to the 2019 World Health Organization (WHO) cardiovascular disease (CVD) risk charts and to the presence of carotid plaque (CP) identified with carotid ultrasound in Mexican mestizo rheumatoid arthritis (RA) patients, and to determine the proportion of patients reclassified to a high cardiovascular risk after the carotid ultrasound was performed. METHODS: This was a cross-sectional study nested of a RA patients' cohort. A total of 157 Mexican mestizo RA patients were included. The cardiovascular evaluation was performed using the 2019 WHO CVD risk charts (laboratory-based model) for the Central Latin America region. A carotid ultrasound was performed in all patients. The indication to start statin therapy was considered if the patient was classified as high risk, moderate risk if > 40 years with total cholesterol (TC) > 200 mg/dl or LDL-C > 120 mg/dl, and low risk if > 40 years with TC > 300 mg/dl, according to the WHO CVD risk chart or if the patient had carotid plaque (CP). Cohen's kappa (k) coefficient was used to evaluate the concordance between statin therapy initiation. RESULTS: Initiation of statin therapy was considered in 49 (31.2%) patients according to the 2019 WHO CVD risk charts and 49 (31.2%) patients by the presence of CP. Cardiovascular risk reclassification by the presence of CP was observed in 29 (18.9%) patients. A slight agreement (k = 0.140) was observed when comparing statin therapy recommendations between 2019 WHO CVD risk charts and the presence of CP. CONCLUSION: The WHO CVD risk charts failed to identify a large proportion of patients with subclinical atherosclerosis detected by the carotid ultrasound and the concordance between both methods was poor. Therefore, carotid ultrasound should be considered in the cardiovascular evaluation of RA patients.

Anti-carbamylated protein antibodies positivity and disease activity in Hispanic patients with established rheumatoid arthritis: An observational study.

OBJECTIVES: We aimed to determine the prevalence of anti-carbamylated protein (anti-CarP) antibodies in Mexican Hispanics with established rheumatoid arthritis (RA) and to assess their relationship with disease activity. METHODS: A cohort study was conducted in 278 patients with established RA during an 18-month follow-up. We measured IgG/IgM/IgA rheumatoid factor (RF), IgG anticitrullinated protein antibodies (ACPA) and IgG/IgM/IgA anti-CarP antibodies using enzyme-linked immunosorbent assay (ELISA). For disease activity, we performed the 28-joint disease activity score with erythrocyte sedimentation rate (DAS28-ESR). Repeated measures one-way ANOVA was used to test the association between anti-CarP IgG antibody status and longitudinal DAS28-ESR scores. Patients were evaluated at baseline and at 6, 12, and 18 months during follow-up. RESULTS: Anti-CarP IgG antibodies were positive in 47.8% of patients and, accounting for all isotypes, in 9.5% of patients with negative RF and ACPA. Triple antibody positivity was present in 42.6% of patients in our sample. Anti-CarP IgG antibody positivity did not show statistically significant differences in mean DAS28-ESR when compared to anti-CarP IgG antibody negative patients at baseline, 6, 12 or 18 months. CONCLUSION: Anti-CarP IgG antibodies are not associated to a higher disease activity in Hispanic patients with established RA. Our findings suggest that the clinical value of measuring anti-CarP antibodies in RA diminishes over time.

Autologous ATG-free hematopoietic stem cell transplantation for refractory autoimmune rheumatic diseases: a Latin American cohort.

Autologous hematopoietic stem cell transplantation (HSCT) has been recognized as treatment alternative for patients with severe, refractory autoimmune rheumatic diseases (ARDs). Usually, anti-thymocyte globulin (ATG)-containing conditioning regimens are employed; however, ATG is unavailable in some developing nations. We report our 15-year clinical experience autografting patients with ARDs with an ATG-free conditioning regimen and a brief assessment of patient-reported outcomes post-HSCT. All patients had active disease and were resistant to multiple lines of treatment. Event-free survival (EFS) was assessed using the Kaplan-Meier method. Eight patients underwent autologous HSCT. Diagnoses included juvenile idiopathic arthritis (n = 3), systemic lupus erythematosus (n = 2), systemic sclerosis (n = 2), and rheumatoid arthritis (n = 1). Median time from diagnosis to HSCT was 3 years (0.75-19). Hematological recovery was documented in all recipients, and 4 patients (50%) completed the procedure in a completely ambulatory setting. Five (62.5%) patients achieved complete response and 3 (37.5%) partial response. The median EFS was 7 months (95% CI, 4.97-9.02), and the 1-year EFS rate was 21.9% (95% CI, 18.25-25.76). Transplant-related mortality was 0%, and 1 recipient died 8 years post-HSCT due to chronic kidney disease. Six (75%) patients presented steroid dosage reduction post-HSCT, and 2 (25%) perceived improvement in functionality despite having relapsed. HSCT is a viable treatment alternative for selected patients with severe therapy-resistant ARDs, as an improvement in disease management and quality of life was documented. The need remains to elucidate the characteristics of the optimal HSCT candidate, as well as the adequate conditioning regimen when ATG is not available. Key Points • Despite advances in the treatment of autoimmune rheumatic diseases, some patients remain refractory. In this context, autologous hematopoietic stem cell transplantation (HSCT) rises as a viable alternative. • Of 8 HSCT recipients with autoimmune rheumatic diseases, 5 (62.5%) patients achieved complete response and 3 (37.5%) partial response, with a 1-year event-free survival of 21.9%. • Transplant-related mortality was 0%, with 4 (50%) patients autografted in a completely outpatient setting. • Even when relapse presented, patients reported an improvement in functionality and quality of life; also, a better response to DMARDs and a reduction in steroid dependency post-HSCT were documented.

Cardiovascular risk reclassification according to six cardiovascular risk algorithms and carotid ultrasound in psoriatic arthritis patients.

The objective was to compare the prevalence of subclinical atherosclerosis and cardiovascular risk (CVR) reclassification using six CVR algorithms and a carotid ultrasound in psoriatic arthritis (PsA) patients and controls. The method was cross-sectional study. A total of 81 patients aged 40-75 years, who fulfilled the 2006 CASPAR criteria and 81 controls matched by age, gender, and comorbidities were recruited. CVR was evaluated according to six CVR algorithms, including Framingham Risk Score (FRS)-lipids, FRS-body mass index (BMI), Atherosclerotic Cardiovascular Disease (ASCVD) Algorithm, Systematic Coronary Risk Evaluation (SCORE), QRISK3, and Reynolds Risk Score (RRS). A carotid ultrasound was performed to identify the presence of carotid plaque (CP) defined as a carotid intima media thickness ≥ 1.2 mm or a focal narrowing of the surrounding lumen ≥ 0.5mm. Patients with presence of CP, classified in the low-moderate risk by the CVR algorithms, were reclassified to a higher risk category. CP was more prevalent in PsA patients (44.4% vs 24.7%, p = 0.008), as was subclinical atherosclerosis (51.9% vs 33.3%, p = 0.017). When comparing the CVR reclassification to a higher risk category, a difference was found in the six CVR algorithms. The reclassification was more prevalent in PsA patients: 30.8% vs 12.3%, p = 0.004 with FRS-lipids; 28.4% vs 9.9%, p = 0.003 with FRS-BMI; 40.7% vs 19.8%, p = 0.003 with SCORE; 30.9% vs 16.0%, p = 0.026 with ASCVD algorithm; 37.0% vs 19.8%, p = 0.015 with RRS; and 33.3% vs 16.0%, p = 0.011 with QRISK3. The CVR algorithms underestimate the actual CVR of PsA patients. A carotid ultrasound should be considered as part of the CVR evaluation of PsA patients. KEY POINTS: • Subclinical atherosclerosis was more prevalent in psoriatic arthritis patients than controls. • Cardiovascular risk reclassification, through a carotid ultrasound, according to traditional cardiovascular risk algorithms was more common in psoriatic arthritis patients. • The cardiovascular risk algorithm that showed the lowest reclassification rate in psoriatic arthritis patients was the FRS-BMI. • All cardiovascular risk algorithms underestimate the actual risk of psoriatic arthritis patients, preventing the initiation of an adequate cardiovascular treatment.

Statin indication according to the 2019 World Health Organization cardiovascular disease risk charts and carotid ultrasound in Mexican mestizo rheumatoid arthritis patients

Abstract Background: We aimed to assess the concordance of recommendation for initiating statin therapy according to the 2019 World Health Organization (WHO) cardiovascular disease (CVD) risk charts and to the presence of carotid plaque (CP) identified with carotid ultrasound in Mexican mestizo rheumatoid arthritis (RA) patients, and to determine the proportion of patients reclassified to a high cardiovascular risk after the carotid ultrasound was performed. Methods: This was a cross-sectional study nested of a RA patients' cohort. A total of 157 Mexican mestizo RA patients were included. The cardiovascular evaluation was performed using the 2019 WHO CVD risk charts (laboratory-based model) for the Central Latin America region. A carotid ultrasound was performed in all patients. The indication to start statin therapy was considered if the patient was classified as high risk, moderate risk if > 40 years with total cholesterol (TC) > 200 mg/dl or LDL-C > 120 mg/dl, and low risk if > 40 years with TC > 300 mg/dl, according to the WHO CVD risk chart or if the patient had carotid plaque (CP). Cohen's kappa (k) coefficient was used to evaluate the concordance between statin therapy initiation. Results: Initiation of statin therapy was considered in 49 (31.2%) patients according to the 2019 WHO CVD risk charts and 49 (31.2%) patients by the presence of CP. Cardiovascular risk reclassification by the presence of CP was observed in 29 (18.9%) patients. A slight agreement (k = 0.140) was observed when comparing statin therapy recommendations between 2019 WHO CVD risk charts and the presence of CP. Conclusion: The WHO CVD risk charts failed to identify a large proportion of patients with subclinical atherosclerosis detected by the carotid ultrasound and the concordance between both methods was poor. Therefore, carotid ultra-sound should be considered in the cardiovascular evaluation of RA patients.

Cutaneous manifestations of antiphospholipid syndrome.

Antiphospholipid syndrome (APS) is an acquired thrombophilic disorder in which autoantibodies are produced against a variety of phospholipids and phospholipid-binding proteins. The purpose of this article is to review cutaneous findings in patients with APS diagnosis. An overview regarding prevalence, description, pathogenesis and histopathology, are described for cutaneous manifestations of APS.

Does current evidence on disease-modifying antirheumatic drugs for psoriatic arthritis reinforce an effect on radiographic progression? Results from a systematic review and meta-analysis.

This study aims to estimate the effect of synthetic and biologic disease-modifying antirheumatic drugs (DMARDs) on radiographic progression and quality of life in adult patients with psoriatic arthritis. A comprehensive search was performed using MEDLINE, Embase, Web of Science, Scopus, and Cochrane Central Register of Controlled Trials (CCRCT). Clinical trials comparing DMARDs with placebo for ≥ 12 weeks were included. The meta-analysis was conducted with a random-effects model using mean differences (MD). A total of 16 trials with overall moderate quality of evidence were included. Exposure to a biologic agent reduced radiographic progression at 24 weeks of treatment (MD: - 0.66; [95% CI - 0.97 to - 0.34]; P < .00001; I2 = 100%). The reduction of the baseline score was more than two times higher for TNF blockers compared with IL-17 and IL-12/IL-23 inhibitors (MD: - 0.94 vs - 0.41). Improvement in health-related quality of life scores was observed in biologic-treated populations (MD: - 0.21; [95% CI - 0.25 to - 0.18]; P < .00001; I2 = 97%). No sufficient data were available regarding conventional synthetic agents. Our data analyses suggest a better control of radiological damage with bDMARDs, as compared to placebo, after 24 weeks of treatment. However, the accuracy of these results in real life are jeopardized by the exceedingly high level of heterogeneity exhibited within and across included studies, and the true intervention effect cannot be determined with confidence. Further research is required to assess long-term outcomes and to control heterogeneity in the evaluation of treatments for psoriatic arthritis. PROSPERO registration number: CRD42019122223. Key Points • Radiographic progression is not the primary outcome for most efficacy studies in psoriatic arthritis; hence, baseline data are substantially diverse in major clinical trials. • The best available evidence on this particular outcome is currently at a moderate risk of bias. • Existing reports of the effect of DMARDs on structural damage must be taken with caution. • Further research is required to assess long-term outcomes and to control heterogeneity between studies.

Efficacy and safety of weekly vitamin D3 in patients with fibromyalgia: 12-week, double-blind, randomized, controlled placebo trial.

INTRODUCTION: FM is a chronic musculoskeletal disorder characterized by the presence of generalized pain. There are contradictory results regarding the prevalence and supplementation effect of vitamin D deficiency on FM patients. We aim to determine the safety and efficacy of a 12-week vitamin D supplementation on FM patients. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial. We included female participants of 18 years old or older, who met 1990 or 2010 ACR criteria for fibromyalgia. The Spanish validated FIQ and the VAS of pain were applied at baseline. The participants were then randomized to receive placebo or 50,000 IU of Vitamin D3 PO, weekly for 12 weeks. RESULTS: We included 80 patients. There was no statistical difference in the initial and final FIQ between both groups. The FIQ delta also did not prove to be different at the end of the study. The increase in vitamin D levels in the intervention group was corroborated. Regarding serious adverse effects, none was reported in both groups. There was no statistical difference in minor adverse events. CONCLUSION: In this double-blind placebo-controlled randomized study conducted to measure the efficacy and safety of vitamin D exclusively in patients with FM, we found that there is no evidence of a trend in favor of vitamin D treatment, since we did not observe improvement in the VAS of pain or FIQ. TRIAL REGISTRY: Clinical Trials.gov number: NCT03369379 Key Points • There are conflicting results in vitamin D to treat fibromyalgia. • In this double-blind, randomized controlled trial, we did not find a difference in the VAS nor FIQ with vitamin D supplementation. • The increase in vitamin D levels in the intervention group was corroborated.