The emerging role of Rituximab in the treatment of large granular lymphocytic leukemia associated with rheumatoid arthritis: a single center experience.

Large Granular Lymphocytic (LGL) leukemia is a rare lymphoproliferative disorder with a peculiar association with Rheumatoid Arthritis (RA). The most common feature is neutropenia and patients can have splenomegaly, resembling Felty's Syndrome. These diseases have similar clinical and laboratory abnormalities, but the diagnosis of T-cell LGL (T-LGL) leukemia requires evidence of clonality. Even though T-LGL leukemia is indolent in most cases, inadequate treatment when it is indicated can lead to significant morbidity and mortality, mainly associated with recurrent infections. We present two clinical cases that emphasize the emerging role of Rituximab as an effective therapeutic option in patients with T-LGL and RA.

Can we predict the risk factors for switching due to ineffectiveness in the first year of therapy with bDMARD in patients with rheumatoid arthritis?

INTRODUCTION: Biological disease-modifying antirheumatic drugs (bDMARD) have improved the clinical course and quality of life of patients with rheumatoid arthritis (RA). However, some patients failed to respond or have an insufficient response to bDMARD early in the course of the treatment. OBJECTIVES: To determine the percentage of RA patients who need to switch due to ineffectiveness in the first year of treatment and to identify specific baseline features as possible predictors of switch due to ineffectiveness in the first year of treatment. MATERIALS AND METHODS: An observational retrospective study was conducted with patients with RA that started their first bDMARD. Demographic data, disease characteristics, disease activity data scores, laboratory parameters and treatment at baseline were collected. The proportion of patients who failed to respond and who switched to another bDMARD in the first year of treatment was calculated. RESULTS: A total of 437 (364 females, 83.3%) patients with RA were included. The majority of these patients started an anti-TNF-α agent (n=315, 72.1%). Forty-eight (11.0%) patients failed to respond to the bDMARD in the first year of treatment. There were significantly more current or former smokers (p=0.030), with a history of depression (p=0.003) and positive for RF at baseline (p=0.014) in the switch group. In the multivariate analysis, anti-TNF-α agents use (OR 8.3, 95% CI 2.4-28.8, p=0.001), tobacco exposure (OR 2.3, 95% CI 1.1-4.8, p=0.02) and history of depression (OR 3.1, 95% CI 1.3-7.7) seem to predict the need to switch in the first year of treatment due to ineffectiveness. DISCUSSION AND CONCLUSION: In our study, tobacco exposure and depression appear to be modifiable risk factors associated with early switching due to ineffectiveness. Addressing these factors in daily clinical practice is crucial to enhance the overall response to therapy and improve the well-being of patients.

Can microvascular damage predict disease severity in patients with systemic sclerosis?

INTRODUCTION: Systemic sclerosis (SSc) is characterized by progressive fibrosis of the skin and internal organs, microvascular damage and cellular and humoral immunity abnormalities. Microvascular damage can be easily detected through nailfold videocapillaroscopy (NVC). MATERIALS AND METHODS: A retrospective study of patients with SSc and a NVC performed within the first 6 months after diagnosis was conducted. Visceral involvement in the first 3 years of the disease and NVC findings were collected. The severity of microvascular damage was classified into four categories, according to the worsening of the NVC patterns. The severity of organ involvement was assessed by the disease severity scale of Medsger for each organ and as a global measure of disease severity, the simple summation was used. RESULTS: A total of 86 patients with SSc were included. A moderate correlation was found between the severity of microvascular damage and the global measure of disease severity (r=0.55, p<0.001), the severity of peripheral vascular involvement (r=0.43, p<0.001) and the severity of skin involvement (r=0.34, p=0.001). The presence of a late scleroderma pattern in NVC were predictive in univariate analysis of digital ulcers (OR 6.03, 95% CI 1.52-23.86, p=0.01), muscular involvement (OR 13.09, 95% CI 1.09-156.78, p=0.04), calcinosis (OR 27.22, 95% CI 5.56-133.33, p<0.001) and worse global disease severity score (OR 1.67, 95% CI 1.17-2.38, p=0.005). Multivariate analysis adjusted for disease duration and gender confirmed late pattern as an independent predictor of calcinosis (OR 42.89, 95% CI 5.53-332.85, p<0.001). DISCUSSION AND CONCLUSION: In this study, the worsening of NVC pattern in SSc was associated with the overall disease severity, the severity of peripheral vascular involvement and extension of skin involvement. This study highlights the importance of NVC as a prognostic tool and a possible predictor of systemic visceral involvement.

Measurement properties of the Portuguese version of the rheumatoid arthritis patient-reported experience measure (CQRA-PREM): a cross-sectional single center study.

AIMS: to test the measurement properties of the Portuguese version of the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) for patients with rheumatoid arthritis (RA). METHODS: This cross-sectional clinical field study recruited adult patients with RA during rheumatology appointments of a Portuguese rheumatology center. Patients completed the Portuguese version of CQRA-PREM, composed of 7 domains and 24 questions. Sociodemographic characteristics, symptoms/disease duration, current treatment, Pain-Visual Analog Scale (VAS), Patient Global Assessment (PGA)-VAS and Health Assessment Questionnaire (HAQ) were also collected from the patient. Disease Activity Score for 28 joints with C-reactive Protein (DAS28-CRP) was recorded by the rheumatologist. The assessment of CQRA-PREM measurement properties followed the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) recommendations. RESULTS: A total of 61 patients with RA were included. The domains in which patients showed better experience were the "Needs and preferences", followed by "Coordination and Communication". The domain "Information, education and self-care" was an identified area of improvement for providing patient-centered care. Ceiling effects were found in four domains of the CQRA-PREM. Internal consistency of all domains was considered good (α>0.7). Homogeneity was considered good for each question in all domains analyzed (0.30≤rp≤0.70). The divergent validity of the PREM was good, revealing that the domains were not correlated (Pain-VAS, HAQ, DAS28-CRP) or only weakly (PGA-VAS) correlated with clinical outcomes. CONCLUSIONS: The CQRA-PREM showed acceptable measurement properties and is a useful tool for evaluating quality of healthcare provided in daily practice, as perceived by RA patients in Portugal.

Comparing DAPSA, DAPSA28, and DAS28-CRP in Patients With Psoriatic Arthritis Initiating a First Tumor Necrosis Factor Inhibitor Across Nine European Countries.

OBJECTIVE: Because 66/68 joint counts are not always performed in routine care, we aimed to determine which of the modified 28-joint disease activity index for psoriatic arthritis (DAPSA28) or 28-joint disease activity score with C-reactive protein (DAS28-CRP) should be preferred for monitoring disease activity in psoriatic arthritis (PsA) when the original DAPSA (66/68 joints) is not available. METHODS: Prospectively collected real-world data of European bionaive patients with PsA initiating a first tumor necrosis factor inhibitor were pooled. Remission and response status were evaluated at 6 months by remission (DAPSA ≤ 4, DAPSA28 ≤ 4, and DAS28-CRP < 2.6), response (75% improvement for DAPSA and DAPSA28), and combined EULAR good/moderate responses for DAS28-CRP. Logistic regression analyses on multiple imputed data were used to identify baseline predictors. RESULTS: Remission and response cohorts included 3,159 and 1,866 patients, respectively. The 6-month proportions achieving remission/response were DAPSA (27%/44%), DAPSA28 (28%/44%), and DAS28-CRP (59%/80%). Of 14 possible baseline predictors, 11 predicted both DAPSA and DAPSA28 remission (8 of which also predicted their response, indicated by "*"): longer disease duration*, male sex*, and higher CRP* were positive, whereas older age*, higher body mass index*, patient fatigue*, and global, physician global, health assessment questionnaire score*, and tender and swollen* joint counts were negative predictors. Eight and five of these predicted DAS28-CRP remission and response, respectively. CONCLUSION: In patients with PsA, DAPSA28 should be preferred over DAS28-CRP as a substitute for DAPSA when 66/68 joint counts are not available because of the large overlap in remission and response status and in predictors between DAPSA and DAPSA28.

Molecular Profiling of Axial Spondyloarthritis Patients Reveals an Association between Innate and Adaptive Cell Populations and Therapeutic Response to Tumor Necrosis Factor Inhibitors.

This study aims at identifying molecular biomarkers differentiating responders and non-responders to treatment with Tumor Necrosis Factor inhibitors (TNFi) among patients with axial spondyloarthritis (axSpA). Whole blood mRNA and plasma proteins were measured in a cohort of biologic-naïve axSpA patients (n = 35), pre and post (14 weeks) TNFi treatment with adalimumab. Differential expression analysis was used to identify the most enriched pathways and in predictive models to distinguish responses to TNFi. A treatment-associated signature suggests a reduction in inflammatory activity. We found transcripts and proteins robustly differentially expressed between baseline and week 14 in responders. C-reactive protein (CRP) and Haptoglobin (HP) proteins showed strong and early decrease in the plasma of axSpA patients, while a cluster of apolipoproteins (APOD, APOA2, APOA1) showed increased expression at week 14. Responders to TNFi treatment present higher levels of markers of innate immunity at baseline, and lower levels of adaptive immunity markers, particularly B-cells. A logistic regression model incorporating ASDAS-CRP, gender, and AFF3, the top differentially expressed gene at baseline, enabled an accurate prediction of response to adalimumab in our cohort (AUC = 0.97). In conclusion, innate and adaptive immune cell type composition at baseline may be a major contributor to response to adalimumab in axSpA patients. A model including clinical and gene expression variables should also be considered.

Patient-reported outcomes in axial spondyloarthritis and psoriatic arthritis patients treated with secukinumab for 24 months in daily clinical practice.

OBJECTIVES: In patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) initiating secukinumab, we aimed to assess and compare the proportion of patients achieving 6-, 12- and 24-month patient-reported outcomes (PRO) remission and the 24-month retention rates. PATIENTS AND METHODS: Patients with axSpA or PsA from 16 European registries, who initiated secukinumab in routine care were included. PRO remission rates were defined as pain, fatigue, Patient Global Assessment (PGA) ≤2 (Numeric Rating Scale (NRS) 0-10) and Health Assessment Questionnaire (HAQ) ≤0.5, for both axSpA and PsA, and were calculated as crude values and adjusted for drug adherence (LUNDEX). Comparisons of axSpA and PsA remission rates were performed using logistic regression analyses (unadjusted and adjusted for multiple confounders). Kaplan-Meier plots with log-rank test and Cox regression analyses were conducted to assess and compare secukinumab retention rates. RESULTS: We included 3087 axSpA and 3246 PsA patients initiating secukinumab. Crude pain, fatigue, PGA and HAQ remission rates were higher in axSpA than in PsA patients, whereas LUNDEX-adjusted remission rates were similar. No differences were found between the patient groups after adjustment for confounders. The 24-month retention rates were similar in axSpA vs. PsA in fully adjusted analyses (HR [95 %CI] = 0.92 [0.84-1.02]). CONCLUSION: In this large European real-world study of axSpA and PsA patients treated with secukinumab, we demonstrate for the first time a comparable effectiveness in PRO remission and treatment retention rates between these two conditions when adjusted for confounders.

Neutrophile to lymphocyte and platelet to lymphocyte ratios predict clinical response to bDMARD in naïve spondylarthritis patients.

Objective: We aim to study association between neutrophile to lymphocyte (NLR) and platelet to lymphocyte (PLR) ratios and disease activity, and their value to predict bDMARD response. Methods: A set of spondylarthritis (SpA) patients under bDMARD registered in the Reuma.pt registry was studied. Sociodemographic, clinical and laboratorial variables were assessed on bDMARD initiation, 6, 12, 18 and 24 months (M) thereafter. Univariable and multivariable generalized estimation equations models assessed associations with disease activity. The NLR and PLR predictive value was assessed using univariable and multivariable logistic regression models. Results: A total of 170 patients were included. Most were male (54.7%), with a predominantly axial phenotype (84.7%). Significant associations were observed between NLR [B=1.55, 95% confidence interval (CI) = (1.38; 1.74)] and PLR [(B=1.16, 95% CI = (1.09; 1.24)] with ASDAS-CRP (p < 0.001). Both baseline ratios predicted ∆ ASDAS-CRP ≥ 1.1 at 6 months [OR = 2.20, 95% CI = (1.21, 4.00) for NLR; OR = 1.02, 95% CI = (1.01, 1.04) for PLR, p < 0.01)]. PLR was a significant predictor of ∆ ASDAS-CRP ≥ 1.1 in all timepoints [OR (12 M) = 1.02, 95% CI = (1.00, 1.03), p < 0.05; OR (18M) = 1.02, 95% CI = (1.01, 1.03), p < 0.001; OR (24M) = 1.01, 95% CI = (1.01, 1.02), p < 0.01]. Conclusion: NLR and PLR were associated with disease activity during the follow up of these patients. They seem to be significant predictors of therapeutic response to bDMARD in naïve SpA patients.

Impact of Risk Factors on COVID-19 Outcomes in Unvaccinated People With Rheumatic Diseases: A Comparative Analysis of Pandemic Epochs Using the COVID-19 Global Rheumatology Alliance Registry.

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.

What is the association of depression with clinical response to therapy in patients with psoriatic arthritis treated with biologic disease-modifying antirheumatic drugs?

INTRODUCTION: Psoriatic arthritis (PsA) is a chronic, progressive inflammatory joint disease that is associated with higher prevalence of depression. There is limited literature about the impact of depression, particularly regarding the response to therapy. METHODS: A retrospective cohort study with PsA patients that started their first biologic disease-modifying antirheumatic drugs (bDMARD) was conducted. In the majority of cases, a cutoff score of ≥ 8 in Hospital Anxiety and Depression Scale (HADS) was used to define cases of depression. In cases where patients did not complete the questionnaire, a previous diagnosis made by a psychiatrist was used to establish the presence of depression. Response to therapy 12 months after the start of bDMARD was evaluated and the switch rate to another bDMARD due to inefficacy was assessed at month 12. RESULTS: A total of 129 patients (66 females, 51.2%; mean age of 47.7 ± 11.0 years and mean disease duration of 10.0 ± 7.7 years) with PsA were included. Thirty-two (24.8%) patients had depression. Patients with depression and peripheral involvement had a significantly lower ACR20/50/70 responses (p = 0.001, p = 0.002, and p = 0.001 respectively) after 12 months of therapy and a significantly worse EULAR response (p = 0.002). Furthermore, patients with depression and axial involvement had a significantly worse response based on ASDAS response criteria (p = 0.031). Switch due to ineffectiveness in the first 12 months was significantly higher in patients with depression (p = 0.002). CONCLUSION: Depression in PsA is a frequent yet often understudied comorbidity. The causal relationship between depression and PsA is difficult to decrypt and further research is needed. Recognition of depressive symptoms is crucial and a multidisciplinary approach should be provided to individuals with this comorbidity. Key Points • Depression in PsA is a frequent yet often understudied comorbidity. In our study, the prevalence of depression was 24.8%. • Depression in PsA seems to be associated to lower response to therapy and higher discontinuation rates of bDMARD. • Recognition of depressive symptoms is crucial and a multidisciplinary approach should be provided to individuals with this comorbidity.

Immune-mediated skin lesions related to biological disease-modifying antirheumatic drugs: a 22-year experience of a tertiary center.

INTRODUCTION: Immune-mediated skin lesions (IMSL) can be very disabling leading to treatment discontinuation. Although these lesions have rarely been previously described, the true incidence is unknown. OBJECTIVE: To explore the cumulative incidence, management and outcomes of IMSL related to bDMARD in a large cohort of patients with chronic inflammatory rheumatic diseases. To explore possible associations and risk factors for IMSL development. METHODS: A retrospective single-center study of patients with rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA) that had been treated with at least one bDMARD for at least 6 months was conducted. IMSL related to bDMARD characteristics and outcomes were collected. RESULTS: A total of 989 patients with RA, SpA and PsA were included. Twenty-seven patients (2.7%) presented IMSL potentially related to bDMARD, being psoriasis the most common IMSL (n=12, 44.4%), followed by drug-induced lupus erythematosus (n=6), alopecia areata (n=3) and leukocytoclastic vasculitis (n=2). IMSL led to withdrawal of bDMARD in 18 of the 27 patients (66.7%). Patients with IMSL had younger age at diagnosis (p=0.038), longer disease duration (p=0.018), longer duration of bDMARD treatment (p=0.008), and higher number of previous bDMARDs (p < 0.001) than patients without IMSL. In the group of patients with IMSL there was a significantly higher percentage of patients treated with adalimumab (p < 0.001). In multivariate regression model, the number of previous bDMARDs (OR 2.13, 95%CI 1.47-3.10, p < 0.001) and treatment with adalimumab (OR 4.60, 95%CI 1.96-10.80 , p < 0.001) were statistically significant predictive factors for IMSL development. CONCLUSION: In our study, IMSL related to bDMARDs had an estimated cumulative incidence of 2.7%. Younger age at diagnosis, longer disease duration, longer duration of bDMARD treatment, higher number of previous bDMARDs and treatment with adalimumab were independently associated with an increased risk of IMSL development.

Content validity of a patient-reported experience measure (CQRA-PREM) for patients with rheumatoid arthritis in Portugal.

TBackground: The evaluation of perceptions of patients with rheumatoid arthritis (RA) has a positive influence in their health outcomes and overall experience of care. The Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) was developed to provide the perceptions and the feedback of the patients with RA to the health professionals team. This PREM is already validated and in use in the United Kingdom (UK) and Netherlands. In Portugal, there is no validated PREM to evaluate the experience of patients with RA. OBJECTIVE: To translate, cultural adapt and validate the content of the CQRA-PREM for the Portuguese population. METHODS: A qualitative study using focus groups was conducted to evaluate CQRA-PREM content validity. The CQRA-PREM was first translated and cultural adapted to Portuguese by two researchers, and after back translation, a panel of experts agreed on the preliminary Portuguese version of CQRA-PREM. Patients with RA were recruited from a rheumatology center at a tertiary university hospital center to participate in focus group meetings. Before the focus group they filled in the preliminary version of CQRA-PREM, with its 7 domains and 24 items (Likert scale 1-5). RESULTS: Twelve participants (median 54 (45-58) years old; 92% female) were included in two focus groups. All domains of the questionnaire had medians of 3 or above. Seven major themes and six subthemes emerged. Participants considered the questionnaire as very clear and simple and with adequate questions. Patients pointed as extremely important being treated with dignity and respect and considered the awareness of the multidisciplinary team and the presentation of support programs and organizations as areas for improvement. CONCLUSION: The Portuguese version of the CQRA-PREM is acceptable and its content is valid in the perspective of patients with RA to assess the quality of care provided by the healthcare services.

Severe infections in Portuguese patients with rheumatoid arthritis under biologic treatment - a multicenter, nationwide study (SIPPRA-B Study).

INTRODUCTION: Despite years of experience with biological disease modifying anti-rheumatic drugs (bDMARD) in rheumatoid arthritis (RA), little is known about differences in infectious risk among bDMARDs. The aim of this study was to assess the incidence and type of infections in RA patients on bDMARDs and to determine possible predictors. METHODS: A retrospective multicenter cohort study that included patients registered in the Rheumatic Diseases Portuguese Registry (Reuma.pt) with RA, and exposed to at least one bDMARD until April 2021. RA patients under bDMARD and with at least one episode of severe infection (SI), defined as infection that requires hospitalization, use of parenteral antibiotics or that resulted in death, were compared to patients with no report of SI. Demographic and clinical data at baseline and at the time of each SI were collected to establish comparisons between different groups of bDMARDs. Comparisons between different bDMARDs were assessed and logistic regression was performed to identify predictors of SI. RESULTS: We included 3394 patients, 2833 (83.5%) female, with a mean age at RA diagnosis of 45.5±13.7 years. SI was diagnosed in 142 of the 3394 patients evaluated (4.2%), totaling 151 episodes of SI. At baseline, patients with SI had a significantly higher proportion of prior orthopedic surgery, asthma, interstitial lung disease, chronic kidney disease and corticosteroid use, higher mean age and longer median disease duration at first bDMARD. Nine patients died (6.0%). Ninety-two SI (60.9%) occurred with the first bDMARD, the majority leading to discontinuation of the bDMARD within 6 months (n=75, 49.7%), while 65 (43.0%) restarted the same bDMARD and 11 (7.3%) switched to another bDMARD (6 of them to a different mechanism of action). In the multivariate analysis, we found that chronic kidney disease, asthma, infliximab, corticosteroid use, interstitial lung disease, previous orthopedic surgery, higher Health Assessment Questionnaire and DAS284V-ESR are independent predictors of SI. CONCLUSION: This study described the incidence and types of SI among Portuguese RA patients on biologics, identifying several predictors of SI, both globally and with different bDMARDs. Physicians should be aware of the real-word infectious risk in RA patients on bDMARDs when making treatment decisions.

The impact of antinuclear antibodies seroconversion induced by anti-tumor necrosis factor α agents on the clinical outcomes in rheumatic patients.

INTRODUCTION: Anti-tumor necrosis factor α (anti-TNFα) agents can potentially induce the anti-nuclear antibodies (ANA) development over time. Evidence of the real impact of these autoantibodies on clinical response to treatment in rheumatic patients is still scarce. OBJECTIVES: To explore the impact of ANA seroconversion induced by anti-TNFα therapy on clinical outcomes in biologic-naïve patients with Rheumatoid arthritis (RA), axial spondylarthritis (axSpA) and psoriatic arthritis (PsA). METHODS: An observational retrospective cohort study enrolling biologic-naïve patients with RA, axSpA and PsA who started their first anti-TNFα agent was conducted for 24 months(M). Sociodemographic data, laboratory findings, disease activity and physical function scores were collected at baseline, 12M and 24M. To examine the differences between the groups with and without ANA seroconversion, independent samples t-tests, Mann-Whitney U-tests and chi-square tests were performed. Linear and logistic regression models were used to assess the effects of ANA seroconversion on the clinical response to treatment. RESULTS: A total of 432 patients with RA (N=185), axSpA (N=171) and PsA (N=66) were included. ANA seroconversion rate at 24M was 34.6%, 64.3% and 63.6% for RA, axSpA and PsA, respectively. Regarding sociodemographic and clinical data in RA and PsA patients, no statistically significant differences between groups with and without ANA seroconversion were found. In axSpA patients, ANA seroconversion was more frequent in patients with higher body mass index (p=0.017) and significantly less frequent in patients treated with etanercept (p=0.01). Regarding disease activity, DAS28 for RA patients and ASDAS-CRP for axSpA patients were significantly higher in ANA seroconversion group at 12M (p=0.017 and p=0.009, respectively). For PsA patients, CDAI was significantly higher in ANA seroconversion group at 24M (p=0.043). Overall switching rate of biologic disease-modifying antirheumatic drugs (bDMARD) was significantly higher in the ANA seroconversion group over time (p=0.025). For RA patients, ANA seroconversion predicted DAS28 (ß=-0.21, 95%CI[-1.86;-0.18], p=0.017) at 12M. CONCLUSIONS: ANA seroconversion induced by anti-TNFα agents could interfere in clinical response of patients with rheumatic diseases. The presence of these autoantibodies can be considered as a potential predictor of poor treatment response and higher need for bDMARD switching over time.

Hypophosphatemic osteomalacia induced by intravenous iron therapy: a case report.

OBJECTIVE: Osteomalacia is an uncommon, overlooked and debilitating metabolic bone disease with numerous aetiologies. Herein, we report an atypical cause of osteomalacia - intravenous iron therapy. METHODS: Description of a case report of hypophophatemic osteomalacia induced by ferric carboxymaltose infusions. RESULTS: A 70-year-old male with Rendu-Osler-Weber syndrome requiring repeated infusions of ferric carboxymaltose was admitted for disabling lower limb pain associated with persistent hypophosphatemia (1.6mg/dL) and increased urinary fractional excretion of phosphate (43%, UP04=118.3mg/dL), serum fibroblast growth factor 23 (324UA/mL), intact parathyroid hormone (110pg/mL) and bone alkaline phosphatase (40.1mcg/L). X-ray and CT of the feet showed severe diffuse bone demineralization. Feet MRI displayed a subchondral fracture of the cuneiform-navicular joints. Spine X-ray revealed dorsolumbar vertebral flattening. Somatostatin receptor PET scan excluded an occult tumor. Bone biopsy with histomorphometry confirmed the presence of osteomalacia. After excluding other causes, a diagnosis of hypophosphatemic osteomalacia induced by frequent ferric carboxymaltose infusions was made. The iron formulation was replaced by saccharated ferric oxide infusions and progressive titration of calcitriol up to 1.5mg/day and oral disodium phosphate up to 5740mg/day was started. After 6 months, there was a clear clinical and analytical improvement. CONCLUSION: Osteomalacia may be a consequence of prolonged hypophosphatemia induced by recurrent ferric infusions, which is an uncommon and neglected bone adverse event of this therapy. Phosphate levels and bone symptoms should be monitored during repetitive iron infusions, maintaining a high level of suspicion for osteomalacia as it is important to identify and treat it in a timely manner, minimizing its severe morbidity.

FRAX 10-year fracture risk in rheumatoid arthritis assessed with and without bone mineral density - are we treating our patients under bDMARDs?

OBJECTIVE: This study aimed to identify the rheumatoid arthritis (RA) patients under biological therapy who have FRAX® scores classified as high fracture risk and to evaluate if they are receiving treatment for osteoporosis (OP). The authors also investigated the intra-individual agreement between FRAX® fracture risk calculated with and without bone mineral density (BMD). METHODS: A single-center retrospective cohort study was performed in a total of 303 patients with RA under biologics. Demographic and clinical data were collected using Rheumatic Diseases Portuguese Register (Reuma.pt), complemented with data from the hospital clinical records. FRAX scores with and without BMD were calculated. The Kendall's Tau coefficient was used to assess the agreement between FRAX risk categories. Correlations were evaluated by the Spearman test. Comparisons of distributions from independent variables used the Mann-Whitney test. RESULTS: When FRAX® score was calculated without BMD (n=303), 25% patients were categorized as high fracture risk. Among them, only 54% were receiving OP treatment. FRAX® assessment with BMD (n=231) identified 33% patients with high fracture risk, 52% in treatment for OP. Thirty patients (21%) previously classified as low fracture risk using FRAX® without BMD were recategorized as high risk (𝜏=0.570, p.

Portuguese adaptation and validation of a patient-reported experience measure for patients with rheumatoid arthritis: A protocol study.

Background: There is a growing attention to patient-reported experience measures in assessing the quality of care in patient-centered care models. A specific patient-reported experience measure for patients with rheumatoid arthritis (RA) has been developed in the United Kingdom-Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure. This patient-reported experience measure might be feasible to be used in Portugal, yet an adaptation and validation process is needed. Therefore, the aims of this study will be to translate and cross-culturally adapt the Portuguese version of the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure, evaluate its content and face validity through a qualitative approach, and evaluate its psychometric properties through a clinical field testing. Methods: This study is based on a multimethod approach combining qualitative and quantitative approaches. This study will include patients with RA from a single rheumatology center. Three sequential phases are planned: Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure translation and cultural adaptation, Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure content and face validity assessed through 2 focus groups with at least 10 patients, and the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure field testing through a cross-sectional study with 50 patients. Conclusions: By involving patients with RA in the validation and implementation of the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure, we expect to demonstrate the usefulness of this specific patient-reported experience measure to improve health care provided to patients with RA.