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This study aims to determine the level of adherence to treatment in ankylosing spondylitis (AS) patients and to identify possible factors associated to lack of adherence. We included consecutive AS patients (NY modified criteria). Sociodemographic and clinical data were collected. Patients answered auto-reported questionnaires: Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Quality of Life, and Center for Epidemiological Studies Depression scale. Patients with rheumatoid arthritis (RA) (ACR'87 criteria) were assessed as the control group. The adherence of the studied groups to medical treatment and exercises was measured by means of two questionnaires: Compliance Questionnaire on Rheumatology (CQR) and Exercise Attitude Questionnaire-18 (EAQ-18). The study included 59 patients with AS and 53 patients with RA. Of the AS patients, 43 (72.9 %) were male, median age 47 years (interquartile range (IQR) 33-57) and median disease duration of 120 months (IQR 33-57). Of the RA patients, 37 (69.8 %) were female, had a median age of 56 years (IQR 43.5-60) and a median disease duration of 156 months (IQR 96-288). There were no significant differences in the results of the adherence questionnaires between both groups, with a total median of 68.42 for the CQR in both groups and of 40.7 in AS vs. 42.6 in RA for the EAQ. When dichotomizing patients as adherent and non-adherent, taking as good adherence a cut value in the CQR and EAQ higher than 60, adherence to pharmacological treatment was significantly higher in RA vs. AS (92.5 vs. 74.6 %, p = 0.01) and there were no differences in the EAQ. On the uni- and multivariate analysis, lack of adherence to treatment was not associated to sex, age, disease duration, education, health insurance, depressive status, and disease activity parameters in neither group of patients. AS have an acceptable adherence to pharmacological treatment, although it is lower than RA patients; nonetheless, both groups show a lack of adherence to exercise. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To assess patients’ preferences for rheumatoid-arthritis treatments with biologic agents using a discrete-choice experiment. Methods: A discrete-choice experiment was conducted with adult rheumatoid-arthritis patients who had never been treated with biological agents from two university hospitals—public and private—in Buenos Aires, Argentina. We evaluated preferences for seven treatment attributes (with two to three levels each): effectiveness, mode of administration, frequency of administration, local and systemic adverse events, severe infections, and out-of-pocket costs.A probit regression model was used to analyze the relative importance of rheumatoid-arthritis treatment attributes. We estimated attributes’ relative importance and their 95% confidence intervals. Results: Survey responses from 240 patients with rheumatoid arthritis receiving conventional disease-modifying antirheumatic drugs were included in the study. All tested biological agents’ attributes significantly affected the choice of treatment. Attributes’ relative importance in decreasing order was the following (mean, confidence interval 95%): cost, 0.81 (0.69–0.92); systemic adverse events, 0.66 (0.57–0.76); frequency of administration, 0.61 (0.52–0.71); efficacy, 0.42 (0.32–0.51); route of administration, 0.41 (0.30–0.52); local adverse events, 0.40 (0.31–0.49); and serious infections, 0.29 (0.22–0.37). Conclusions: Different treatment attributes had a significant and different influence in rheumatoid-arthritis patients’ choice of biological agents. This type of study can not only inform about patients’ preferences but also about the trade-offs among different possible treatments or process-related attributes. [Copyright &y& Elsevier]

This study aimed to develop a simplified version of the Ankylosing Spondylitis Disease Activity Score (ASDAS). The study included consecutive patients with ankylosing spondylitis according to modified New York and/or Assessment in Ankylosing Spondylitis 2009 criteria. Sociodemographic data and characteristics of the disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Ankylosing Spondylitis Quality of Life (ASQoL)) and erythrocyte sedimentation rate (ESR) were collected. ASDAS simplified version (SASDAS) was calculated as the simple linear sum of the five components of ASDAS which include: patient global assessment using visual analogue scale, back pain (BASDAI question no. 2), peripheral pain and swelling (BASDAI question no. 3), morning stiffness (BASDAI question no. 6), and ESR in millimeters per hour, divided by 10 so as to make it equivalent to the other scale's components. Eighty-six patients were included: 69 (80.2 %) were men with a median age of 46 years and median disease duration of 19 years. SASDAS showed an excellent correlation with the ASDAS ( r = 0.93). SASDAS also showed a good correlation with night pain ( r = 0.60), global pain ( r = 0.69), ASQoL ( r = 0.70), BASFI ( r = 0.75), and BASDAI ( r = 0.96). Using ASDAS cut-off values previously suggested, the corresponding cut-off values for SASDAS were as follows: from 0 to 7.8 (inactive disease), from 7.9 to 13.8 (moderate disease activity), from 13.9 to 27.6 (high disease activity), and above 27.6 (very high disease activity) with optimum sensitivity and specificity. SASDAS showed an excellent correlation with conventional clinical measures of disease activity, and it can be easily calculated and is simple to use in daily clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Rheumatoid arthritis (RA) poses significant healthcare challenges in Latin America (LA) due to its high prevalence and unique healthcare dynamics. Despite global advancements, LA faces specific hurdles in effectively managing RA., Areas Covered: This review examines RA epidemiology, treatment strategies, and clinical challenges in LA. RA prevalence varies, with higher rates among indigenous populations. While conventional disease-modifying antirheumatic drugs (csDMARDs) are recommended as first-line therapy, access remains inconsistent. Biologics and targeted synthetic DMARDs are available, but biosimilars have limited accessibility, with drug prices varying significantly. Key barriers include supply interruptions, diagnosis delays, and high non-adherence rates driven by socioeconomic factors. A severe shortage of rheumatologists, particularly in rural areas, affects patient care. Cardiovascular events, comorbidities, and endemic infections further complicate RA management., Expert Opinion: Although RA care in LA has improved through better use of csDMARDs and advanced treatments, major challenges persist, such as a shortage of specialists, limited medical education, and fragmented healthcare systems. Expanding training programs, enhancing telemedicine, and ensuring drug supply continuity are essential. Strengthening clinical research, improving access to affordable treatments, and developing comprehensive, region-specific strategies are crucial to closing the gap between LA and more developed regions in RA care..

Background/objective: To assess safety/efficacy of tofacitinib and tumor necrosis factor inhibitors (TNFi) in patients from Latin America (LATAM) in ORAL Surveillance., Methods: In ORAL Surveillance, 4362 patients with rheumatoid arthritis aged ≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg twice daily or TNFi. This post hoc analysis stratified patients by geographical location (LATAM, n = 1202; non-LATAM, n = 3160). Incidence rates (IRs; patients with first event/100 patient-years) and hazard ratios for adverse events of special interest were reported. Efficacy outcomes included Clinical Disease Activity Index and American College of Rheumatology 20/50/70 responses., Results: Risk factors associated with cardiovascular disease and malignancies were less prevalent in the LATAM cohort compared with the non-LATAM cohort. IRs for patients receiving tofacitinib (combined doses) versus TNFi were 0.54 versus 0.28 (LATAM) and 1.14 versus 0.92 (non-LATAM) for major adverse cardiovascular events; 0.58 versus 0.27 (LATAM) and 1.33 versus 0.95 (non-LATAM) for malignancies excluding nonmelanoma skin cancer; and 0.69 versus 0.35 (LATAM) and 0.63 versus 0.33 (non-LATAM) for all-cause death. IRs for nonmelanoma skin cancer and venous thromboembolism were also numerically higher with tofacitinib versus TNFi and in the non-LATAM cohort versus LATAM. Efficacy was similar across treatment groups within each cohort., Conclusions: Adverse events of special interest were generally less frequent in LATAM versus non-LATAM patients, reflecting differences in baseline characteristics, and higher with tofacitinib versus TNFi in both cohorts, consistent with the overall findings of ORAL Surveillance. Our findings emphasize the importance of assessing individual risk factors to guide benefit/risk assessment and treatment decisions., Clinical Trial Registration Number: NCT02092467., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Psoriatic arthritis (PsA) is chronic disease that compromises multiple domains and might be associated with progressive joint damage, increased mortality, functional limitation, and considerably impaired quality of life. Our objective was to generate evidence-based recommendations on the management of PsA in Pan American League of Associations for Rheumatology (PANLAR) countries., Methods: We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to adapt the 2019 recommendations of the European Alliance of Associations for Rheumatology. A working group consisting of rheumatologists from various countries in Latin America identified relevant topics for the treatment of PsA in the region. The methodology team updated the evidence and synthesized the information used to generate the final recommendations. These were then discussed and defined by a panel of 31 rheumatologists from 15 countries., Results: Theses guidelines report 15 recommendations addressing therapeutic targets, use of antiinflammatory agents and corticosteroids, treatment with disease-modifying antirheumatic drugs (conventional synthetic, biologic, and targeted synthetic), therapeutic failure, optimization of biologic therapy, nonpharmacological interventions, assessment tools, and follow-up of patients with PsA., Conclusion: Here we present a set of recommendations to guide decision making in the treatment of PsA in Latin America, based on the best evidence available, considering resources, medical expertise, and the patient's values and preferences. The successful implementation of these recommendations should be based on clinical practice conditions, healthcare settings in each country, and a tailored evaluation of patients., (Copyright © 2024 by the Journal of Rheumatology.)

Introduction: The aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status., Methods: Data were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12 months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates., Results: A total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD., Conclusions: The percentage of patients with pMDD/pGAD reduced from baseline over 1 year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article., Trial Registration: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB)., (© 2023. The Author(s).)

Objective: To investigate the association among rheumatoid arthritis (RA), saliva production, and periodontal status., Methods: An observational study was carried out on 103 subjects with RA and 103 without RA matched by sex and age. Rheumatologic evaluation included serological and clinical variables. A full mouth periodontal examination was performed according to the American Academy of Periodontology (1999). Resting and stimulated whole salivary flows were determined after spiting during 5 min., Results: RA was associated with a higher prevalence of severe periodontitis (12% vs. 4%), with a marked reduction in resting and stimulated saliva production, and with a higher prevalence of resting (19% vs. 0%) and also stimulated hyposalivation (54% vs. 10%), compared with the control group. The differences in mean resting and stimulated salivary flows between RA and control groups persisted after the exclusion of people with hyposalivation. Saliva production was not associated with the presence or the severity of periodontal disease, or with the rheumatic clinical characteristics of the patients., Conclusions: More than 50% of people with RA have some degree of reduction in their salivary flows, an affection not associated with the periodontal status or rheumatic activity, which are the expression of the two related inflammatory diseases. The influence of autonomic dysfunction on hyposalivation can be considered. While periodontitis would be a disease-associated comorbidity of RA, poor saliva production should be included among the extra-articular manifestations. Key Points • Rheumatoid arthritis patients are more prone to suffer from periodontitis and/or hyposalivation. • Periodontal disease is more prevalent in people with rheumatoid arthritis and also an association was found between the severities of both pathologies. • More than 50% of people with RA would have some degree of reduction in their salivary flows, an affection not associated with the periodontal status or rheumatic activity. • Reduced saliva production in rheumatoid arthritis patients should be included among the extra-articular manifestations., (© 2023. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).)

Objective: The objective of this study was to assess the SARS-CoV-2-specific humoral and T cell response after a two-dose regimen of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA)., Methods: In this observational study, patients with RA who are ≥18 years of age and vaccinated for SARS-CoV-2 according to the Argentine National Health Ministry's vaccination strategy were included. Anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies (ELISA-COVIDAR test), neutralizing activity (cytotoxicity in VERO cells), and specific T cell response (IFN-γ ELISpot Assay) were assessed after the first and second dose., Results: A total of 120 patients with RA were included. Mostly, homologous regimens were used, including Gam-COVID-Vac (27.5%), ChAdOx1 (24.2%), and BBIBP-CorV (22.5%). The most frequent combination was Gam-COVID-Vac/mRNA-1273 (21.7%). After the second dose, 81.7% presented with anti-SARS-CoV-2 antibodies, 70.0% presented with neutralizing activity, and 65.3% presented with specific T cell response. The use of BBIBP-CorV and treatment with abatacept (ABA) and rituximab (RTX) were associated with undetectable antibodies and no neutralizing activity after two doses. BBIBP-CorV was also associated with the absence of T cell response. The total incidence of adverse events was 357.1 events per 1,000 doses, significantly lower with BBIBP-CorV (166.7 events per 1,000 doses, P < 0.02)., Conclusion: In this RA cohort vaccinated with homologous and heterologous regimens against COVID-19, 2 out of 10 patients did not develop anti-SARS-CoV-2 IgG, 70% presented with neutralizing activity, and 65% presented with specific T cell response. The use of BBIBP-CorV was associated with deficient humoral and cellular response, whereas treatment with ABA and RTX resulted in an impaired anti-SARS-CoV-2 IgG formation and neutralizing activity., (© 2023 American College of Rheumatology.)

Axial spondyloarthritis (axSpA) comprises a spectrum of chronic inflammatory manifestations affecting the axial skeleton and represents a challenge for diagnosis and treatment. Our objective was to generate a set of evidence-based recommendations for the management of axSpA for physicians, health professionals, rheumatologists and policy decision makers in Pan American League of Associations for Rheumatology (PANLAR) countries. Grading of Recommendations, Assessment, Development and Evaluation-ADOLOPMENT methodology was used to adapt existing recommendations after performing an independent systematic search and synthesis of the literature to update the evidence. A working group consisting of rheumatologists, epidemiologists and patient representatives from countries within the Americas prioritized 13 topics relevant to the context of these countries for the management of axSpA. This Evidence-Based Guideline article reports 13 recommendations addressing therapeutic targets, the use of NSAIDs and glucocorticoids, treatment with DMARDs (including conventional synthetic, biologic and targeted synthetic DMARDs), therapeutic failure, optimization of the use of biologic DMARDs, the use of drugs for extra-musculoskeletal manifestations of axSpA, non-pharmacological interventions and the follow-up of patients with axSpA., (© 2023. Springer Nature Limited.)

Background: Our aim was to compare the efficacy of rituximab, tocilizumab, and abatacept in individuals with rheumatoid arthritis (RA) refractory to treatments with MTX or TNFi agents., Methods: We searched 6 databases until January 2023 for phase 2-4 RCTs evaluating patients with RA refractory to MTX or TNFi therapy treated with rituximab, abatacept, and tocilizumab (intervention arm) compared to controls. Study data were independently assessed by two investigators. The primary outcome was considered as achieving ACR70 response., Results: The meta-analysis included 19 RCTs, with 7,835 patients and a mean study duration of 1.2 years. Hazard ratios for achieving an ACR70 response at six months were not different among the bDMARDs, however, we found high heterogeneity. Three factors showing a critical imbalance among the bDMARD classes were identified: baseline HAQ score, study duration, and frequency of TNFi treatment in control arm. Multivariate meta-regression adjusted to these three factors were conducted for the relative risk (RR) for ACR70. Thus, heterogeneity was attenuated (I2 = 24%) and the explanatory power of the model increased (R2 = 85%). In this model, rituximab did not modify the chance of achieving an ACR70 response compared to abatacept (RR = 1.773, 95%CI 0.113-10.21, p = 0.765). In contrast, abatacept was associated with RR = 2.217 (95%CI 1.554-3.161, p < 0.001) for ACR70 compared to tocilizumab., Conclusion: We found high heterogeneity among studies comparing rituximab, abatacept, and tocilizumab. On multivariate metaregressions, if the conditions of the RCTs were similar, we estimate that abatacept could increase the chance of reaching an ACR70 response by 2.2-fold compared to tocilizumab., (© 2023. The Author(s).)

Background: AVERT-2 (a phase IIIb, two-stage study) evaluated abatacept + methotrexate versus methotrexate alone, in methotrexate-naive, anti-citrullinated protein antibody-positive patients with early (≤ 6 months), active RA. This subanalysis investigated whether individual patients who achieved the week 24 Simplified Disease Activity Index (SDAI) remission primary endpoint could sustain remission to 1 year and then maintain it following changes in therapy., Methods: During the 56-week induction period (IP), patients were randomized to weekly subcutaneous abatacept 125 mg + methotrexate or abatacept placebo + methotrexate. Patients completing the IP who achieved SDAI remission (≤ 3.3) at weeks 40 and 52 entered a 48-week de-escalation (DE) period. Patients treated with abatacept + methotrexate were re-randomized to continue weekly abatacept + methotrexate, or de-escalate and then withdraw abatacept (after 24 weeks), or receive abatacept monotherapy. Proportions of patients achieving sustained SDAI and Boolean remission, and Disease Activity Score in 28 joints using C-reactive protein (DAS28 [CRP]) < 2.6, were assessed. For patients achieving early sustained SDAI remission at weeks 24/40/52, flow between disease activity categories and individual trajectories was evaluated; flow was also evaluated for later remitters (weeks 40/52 but not week 24)., Results: Among patients treated with abatacept + methotrexate (n/N = 451/752) at IP week 24, 22% achieved SDAI remission, 17% achieved Boolean remission, and 42% achieved DAS28 (CRP) < 2.6; of these, 56%, 58%, and 74%, respectively, sustained a response throughout IP weeks 40/52. Among patients with a sustained response at IP weeks 24/40/52, 82% (14/17) on weekly abatacept + methotrexate, 81% (13/16) on abatacept monotherapy, 63% (12/19) who de-escalated/withdrew abatacept, and 65% (11/17) on abatacept placebo + methotrexate were in SDAI remission at end of the DE period; rates were higher than for later remitters in all arms except abatacept placebo + methotrexate., Conclusions: A high proportion of individual patients achieving clinical endpoints at IP week 24 with abatacept + methotrexate sustained their responses through week 52. Of patients achieving early and sustained SDAI remission through 52 weeks, numerically more maintained remission during the DE period if weekly abatacept treatment continued., Trial Registration: NCT02504268 (ClinicalTrials.gov), registered July 21, 2015., (© 2023. Crown.)

Objective: To compare achievement of Disease Activity Index in Psoriatic Arthritis (DAPSA) remission (REM)/low disease activity (LDA) with very low disease activity (VLDA)/minimal disease activity (MDA) targets in tofacitinib-treated patients with psoriatic arthritis (PsA)., Methods: In this post hoc analysis, data were pooled from two phase 3 studies (6 months' [NCT01882439] and 12 months' [NCT01877668] duration) of patients with PsA receiving tofacitinib 5 or 10 mg twice daily. Cut-offs for DAPSA targets: ≤4 for clinical REM and >4-≤14 for LDA. VLDA and MDA were defined as meeting 7 or ≥5, respectively, of 7 criteria. An ordered logistic regression model was performed to evaluate associations between baseline characteristics and achievement of DAPSA targets as well as VLDA/MDA at month 3. Agreement between achieving DAPSA and VLDA/MDA targets at months 1-6 was assessed via kappa tests. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) scores (month 6), modified Total Sharp Score (mTSS) and proportion of radiographic non-progressors (mTSS ≤0.5) at month 12 (NCT01877668 only) were compared across DAPSA and VLDA/MDA targets., Results: Increased disease activity at baseline was associated with reduced likelihood of achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA at month 3. There was moderate agreement (kappa values 0.41-0.60) between DAPSA-REM and VLDA, and DAPSA-LDA and MDA, from months 1 to 6, although over half of patients achieving DAPSA-REM and over two thirds of patients achieving DAPSA-LDA, respectively, were not captured by VLDA and MDA. Achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA was associated with improved HAQ-DI and SF-36 PCS scores at month 6, and slightly reduced radiographic progression at month 12., Conclusion: This analysis of data from tofacitinib-treated patients with PsA demonstrated moderate agreement between the DAPSA and VLDA/MDA composite instruments. In agreement with previous studies, VLDA and MDA may be more difficult to achieve than DAPSA-REM and DAPSA-LDA, respectively. However, the clinical and prognostic relevance of this finding should be determined. These data support DAPSA and VLDA/MDA as useful tools for evaluating disease activity and treatment response in PsA., Clinicaltrials: GOV: NCT01882439; NCT01877668., Competing Interests: Declaration of Competing Interest EES has received grants/contracts from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Genzyme, Janssen, Novartis and Pfizer Inc (to institution); has received consulting fees from AbbVie, Eli Lilly and Janssen; and has received other remuneration from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis and Pfizer Inc. GC has received grants/contracts from Pfizer Inc (to institution); has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Pfizer Inc and Sandoz; and has received other remuneration from AbbVie, Amgen, Bristol-Myers Squibb, Janssen and Pfizer Inc. PN has received consulting fees and other remuneration from AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead/Galapagos, Janssen, Novartis, Pfizer Inc and UCB. JSS has received grants/contracts from AbbVie, Astro, AstraZeneca, Eli Lilly, Janssen, Merck Sharpe & Dohme, Pfizer Inc and Roche (to institution); and has received consulting fees and other remuneration from AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO Pharma, Janssen, Merck Sharpe & Dohme, Novartis-Sandoz, Pfizer Inc, R-Pharm, Roche, Samsung, Sanofi and UCB. PJM has received grants/contracts from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun and UCB; has received consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Sun and UCB; and has received other remuneration from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. ERS has received grants or contracts from AbbVie and Janssen; and has received consulting fees and other remuneration from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sandoz and UCB. CH, RM and DPdeL are employees and stockholders of Pfizer Inc. AES was an employee of Syneos Health, who were paid contractors to Pfizer Inc in the development of this manuscript., (Copyright © 2022. Published by Elsevier Inc.)

Objective: The aim of this study was to assess the immune response after a third dose of SARS-CoV-2 vaccine in patients with rheumatoid arthritis (RA) with undetectable antibody titers after the primary regimen of 2 doses., Methods: Patients with RA with no seroconversion after 2 doses of SARS-CoV-2 vaccine and who received a third dose of either an mRNA or vector-based vaccine were included. Anti-SARS-CoV-2 IgG antibodies, neutralizing activity, and T cell responses were assessed after the third dose., Results: A total of 21 nonresponder patients were included. At the time of vaccination, 29% were receiving glucocorticoids and 85% biologic disease-modifying antirheumatic drugs (including 6 taking abatacept [ABA] and 4 taking rituximab [RTX]). The majority (95%) received the BNT162b2 vaccine and only one of them received the ChAdOx1 nCoV-19 vaccine. After the third dose, 91% of the patients presented detectable anti-SARS-CoV-2 IgG and 76% showed neutralizing activity. Compared to other treatments, ABA and RTX were associated with the absence of neutralizing activity in 4 out of 5 (80%) patients and lower titers of neutralizing antibodies (median 3, IQR 0-20 vs 8, IQR 4-128; P = 0.20). Specific T cell response was detected in 41% of all patients after the second dose, increasing to 71% after the third dose. The use of ABA was associated with a lower frequency of T cell response (33% vs 87%, P = 0.03)., Conclusion: In this RA cohort, 91% of patients who failed to seroconvert after 2 doses of SARS-CoV-2 vaccine presented detectable anti-SARS-CoV-2 IgG after a third dose. The use of ABA was associated with a lower frequency of specific T cell response., (Copyright © 2022 by the Journal of Rheumatology.)

Objectives: To characterise infections in patients with rheumatoid arthritis (RA) in ORAL Surveillance., Methods: In this open-label, randomised controlled trial, patients with RA aged≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg two times per day or a tumour necrosis factor inhibitor (TNFi). Incidence rates (IRs; patients with first events/100 patient-years) and hazard ratios (HRs) were calculated for infections, overall and by age (50-<65 years; ≥65 years). Probabilities of infections were obtained (Kaplan-Meier estimates). Cox modelling identified infection risk factors., Results: IRs/HRs for all infections, serious infection events (SIEs) and non-serious infections (NSIs) were higher with tofacitinib (10>5 mg two times per day) versus TNFi. For SIEs, HR (95% CI) for tofacitinib 5 and 10 mg two times per day versus TNFi, respectively, were 1.17 (0.92 to 1.50) and 1.48 (1.17 to 1.87). Increased IRs/HRs for all infections and SIEs with tofacitinib 10 mg two times per day versus TNFi were more pronounced in patients aged≥65 vs 50-<65 years. SIE probability increased from month 18 and before month 6 with tofacitinib 5 and 10 mg two times per day versus TNFi, respectively. NSI probability increased before month 6 with both tofacitinib doses versus TNFi. Across treatments, the most predictive risk factors for SIEs were increasing age, baseline opioid use, history of chronic lung disease and time-dependent oral corticosteroid use, and, for NSIs, female sex, history of chronic lung disease/infections, past smoking and time-dependent Disease Activity Score in 28 joints, C-reactive protein., Conclusions: Infections were higher with tofacitinib versus TNFi. Findings may inform future treatment decisions., Trial Registration Number: NCT02092467., Competing Interests: Competing interests: A-RB has acted as a consultant for AbbVie, Akros, Alfasigma, Amgen, Biogen, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Roche and UCB, has received speaker fees or honoraria from AbbVie, Alfasigma, Amgen, Angelini, AstraZeneca, Berlin-Chemie, Bristol-Myers Squibb, MSD, Novartis, Pfizer, Roche, Sandoz, Teva, UCB and Zentiva, and has been a principal investigator in studies sponsored by Akros, AstraZeneca, Bristol-Myers Squibb, GSK, MSD, Novartis, Pfizer, Roche and UCB. GC has received grants and/or research support from AbbVie, Amgen, Eli Lilly, Gema Pharma, Genzyme, Novartis, Pfizer and Sanofi-Genzyme, and has acted as a consultant for AbbVie, Amgen, Eli Lilly, Gema Pharma, Genzyme, Novartis, Pfizer and Sanofi-Genzyme. VP-R is an employee of Instituto Nacional de Ciencias Médicas y Nutrición and is a principal investigator in studies sponsored by Bristol-Myers Squibb and Pfizer.DLB is a member of the advisory board for: AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Data Monitoring Committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; DLB/Brigham and Women's Hospital do not receive any income from this patent); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda. He served as a member of the Steering Committee for ORAL Surveillance, with funding from Pfizer paid to Brigham and Women’s Hospital. CAC, DG and ABS are employees and stockholders of Pfizer. A-SC is an employee of Pfizer. GS is an employee of Syneos Health, who were paid contractors to Pfizer in the development of this manuscript. JEP has received grants and/or research support from Bristol-Myers Squibb, Roche, Seattle Genetics and UCB, and has acted as a consultant for AbbVie, Actelion, Amgen, Bayer, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB. HS-K has acted as a consultant for, and been an advisor or review panel member for, AbbVie, Eli Lilly, Galapagos, MSD, Pfizer and UCB., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To compare the Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) against the Ankylosing Spondylitis Disease Activity Score (ASDAS) for measuring and categorizing disease activity using data from the EMBARK trial (ClinicalTrials.gov: NCT01258738), a randomized controlled trial of etanercept (ETN) for axial spondyloarthritis (axSpA)., Methods: Patients with early active axSpA received ETN 50 mg once weekly (n = 106) or placebo (PBO; n = 109) for 12 weeks in a double-blind manner; they then received open-label ETN for 92 weeks. For this analysis, ASDAS-C-reactive protein (CRP) and SASDAS-CRP were calculated at baseline, week 12, and week 24. The SASDAS was calculated by the linear addition of the ASDAS components without adjustment., Results: A very strong correlation, as determined by the Spearman correlation coefficient, was observed between the ASDAS and SASDAS for continuous variables at baseline and during treatment. For pooled categorical data at baseline, the SASDAS placed 69.9% of patients in the same disease categories as the ASDAS but overestimated for 17.8% of patients and underestimated for 12.2% of patients. A similar pattern was seen postbaseline. Cohen weighted [Formula: see text] statistics for all individual and pooled treatments and timepoints (0.54-0.73) reflected moderate to substantial agreement. The capacity to differentiate between treatments (ie, ETN and PBO/ETN) was higher with the ASDAS (effect size -0.74, 95% CI -1.03 to -0.46) compared with the SASDAS (effect size -0.51, 95% CI -0.79 to -0.23), but sensitivity to change was generally similar., Conclusion: A very strong correlation between the SASDAS and ASDAS was observed when considering continuous variables; however, moderate to substantial agreement was observed for categorical data, and the SASDAS classified a lower proportion of patients as being in the inactive and low disease activity categories., (Copyright © 2022 by the Journal of Rheumatology.)

Objectives: To evaluate the adherence to treatment with Tofacitinib in patients with Rheumatoid Arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to Tofacitinib and to compare the performance of both questionnaires., Material and Methods: A cross-sectional study was carried out. We included patients ≥18 years old, with RA (ACR/EULAR criteria 2010) under treatment with Tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5., Statistical Analysis: Descriptive statistics. t-Test or Mann Whitney to compare the continuous variables, Chi 2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression., Results: We included 52 patients, 82.7% women, with a median (m) age of 57.7 years, disease duration m 16 years, 63.5% had comorbidities. Of the patients, 86.5% were treated with Tofacitinib (5 mg BID) and 48% received Tofacitinib as monotherapy. The median time of Tofacitinib treatment was 13 months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5% and 84.6% had an adherence ≥ 80%. The variables significantly associated with adherence ≥ 80% were the presence of comorbidities (p = .014) and older age (p = .033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment., Conclusions: Treatment adherence to Tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low., (Copyright © 2020 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Background/objective: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Interstitial lung disease (ILD) is an extra-articular manifestation of RA. We investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD., Methods: This post hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 2 phase (P)1, 10 P2, 6 P3, 1 P3b/4, and 2 long-term extension studies. Interstitial lung disease events were adjudicated as "probable" (supportive clinical evidence) or "possible" (no supportive clinical evidence) compatible adverse events. Incidence rates (patients with events per 100 patient-years) were calculated for ILD events., Results: Of 7061 patients (patient-years of exposure = 23,393.7), 42 (0.6%) had an ILD event; median time to ILD event was 1144 days. Incidence rates for ILD with both tofacitinib doses were 0.18 per 100 patient-years. Incidence rates generally remained stable over time. There were 17 of 42 serious adverse events (40.5%) of ILD; for all ILD events (serious and nonserious), 35 of 42 events (83.3%) were mild to moderate in severity. A multivariable Cox regression analysis identified age 65 years or older (hazard ratio 2.43 [95% confidence interval, 1.13-5.21]), current smokers (2.89 [1.33-6.26]), and Disease Activity Score in 28 joints-erythrocyte sedimentation rate score (1.30 [1.04-1.61]) as significant risk factors for ILD events., Conclusions: Across P1/2/3/4/long-term extension studies, incidence rates for ILD events were 0.18 following tofacitinib treatment, and ILD events were associated with known risk factors for ILD in RA., Competing Interests: This study was sponsored by Pfizer Inc. G.C. has received research grants from Novartis and Pfizer Inc. and is a speaker, advisor and/or consultant to AbbVie, Bristol-Myers Squibb, Eli Lilly, Genzyme, Janssen, Novartis, Pfizer Inc., and Roche. E.M. has received research grants from Eli Lilly, Pfizer Inc., and Roche and is a member of the speakers' bureaus for AbbVie, Bristol-Myers Squibb, Eli Lilly, Pfizer Inc., Roche, and Sanofi. M.H.C. has received research grants from Gilead, Pfizer Inc., and Roche; and is a consultant and member of the speakers' bureaus for Eli Lilly and Pfizer Inc. A.F. has received research grants from Boehringer Ingelheim and Corbus and is a consultant to Boehringer Ingelheim and Roche. A.F. is a former employee of the University of Colorado and is currently employed by Bristol-Myers Squibb. P.R. is a consultant to Pfizer Inc. S.C. is a consultant to AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Novartis, and Pfizer Inc. J.L.R., A.V.T., T.G., K.K., L.W., and D.P.L., are employees and shareholders of Pfizer Inc. S.S. is a former employee of Pfizer Inc., Capelle aan den IJssel, the Netherlands. J.K.P., H.M., and O.C. declare no conflict of interest., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: The aim of this study was to determine the prevalence of depression among rheumatoid arthritis (RA) Argentinean patients and its association with sociodemographic and clinical factors., Methods: We performed a cross-sectional study of consecutive adults with RA. Sociodemographic data, comorbidities, RA disease activity, and current treatment were assessed. The following instruments were used to evaluate quality of life (EQ-5D-3 L [EURO Quality 5-dimension 3 lines], QOL-RA [Quality of Life-Rheumatoid Arthritis]), functional capacity (HAQ-A [Health Assessment Questionnaire-Argentinean version]), and depression (PHQ-9 [Patient Health Questionnaire 9]; scores 5-9: mild, 10-14: moderate, 15-19: moderate-severe, and ≥20: severe depression, a cutoff value ≥10 is diagnostic of major depression)., Results: Two hundred fifty-eight patients were included, with a median disease duration of 9 years (interquartile range, 3.6-16.7 years). The m PHQ-9 score was 6 (interquartile range, 2-12.3 years). The prevalence of major depression was 33.8%. The frequency of mild, moderate, moderate/severe, and severe depression was 66 (25.6%), 42 (16.3%), 27 (10.5%), and 18 (7%), respectively. Patients with major depression had worse functional capacity (HAQ-A: mean ± SD, 1.6 ± 0.8 vs. 0.7 ± 0.7; p < 0.0001), poorer quality of life (QOL-RA: mean ± SD, 5.4 ± 1.8 vs. 7.3 ± 1.6; p < 0.0001), greater pain (visual analog scale: mean ± SD, 56.2 ± 27.5 mm vs. 33.4 ± 25.7 mm; p < 0.0001), higher disease activity (Disease Activity Score in 28 joints: mean ± SD, 4.3 ± 1.4 vs. 3.3 ± 1.3; p < 0.0001), higher frequency of comorbidities (67% vs. 33%; p = 0.017), and lower frequency of physical activity (22% vs. 35%; p = 0.032). In the multivariate analysis, patients with moderate and severe depression had worse functional capacity (odds ratio, 2.1; 95% confidence interval, 1.6-4.3; p < 0.0001) and quality of life (odds ratio, 0.7; 95% confidence interval, 0.5-0.8; p < 0.0001), independently of disease activity., Conclusions: A third of RA patients in this Argentinean cohort had major depression. In those patients, depression was associated with worst functional capacity and quality of life., Competing Interests: The authors declare no conflict of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Enerceptan (EtaBS) has been developed as a proposed biosimilar of etanercept., Methods: This randomized, multicenter, evaluator-blinded, noninferiority study conducted in Argentina included adults with active, moderate, and severe rheumatoid arthritis with inadequate response to methotrexate. Subjects were randomly assigned to 32 weeks treatment with EtaBS (n = 99) or etanercept (n = 51) at a weekly 50-mg dose administered subcutaneously. Patients were categorized according to prior use of biologic disease-modifying antirheumatic drugs and concomitant use of steroids. The primary efficacy endpoint was ACR20 response rate at week 32. Safety, immunogenicity, and steady-state concentration of both drugs were evaluated. The noninferiority margin for ACR20 was estimated at 12%., Results: In the per-protocol population, 85 subjects (92.4%) treated with EtaBS and 44 subjects (93.6%) treated with etanercept achieved ACR20 (difference, -1.2%; 95% confidence interval, -10.1% to 7.6%). Frequent adverse drug reactions occurred in 34.3% and 38% of subjects treated with EtaBS and etanercept, respectively. The most common reaction was upper respiratory tract infection. Six and 3 serious adverse events occurred in 4 and 3 subjects treated with EtaBS and etanercept, respectively. Injection site reactions occurred in 67.7% and 66.0% of subjects treated with EtaBS and etanercept, respectively. Two subjects treated with EtaBS and 1 subject treated with etanercept developed antibodies by week 32., Conclusions: Efficacy outcomes for EtaBS were noninferior to original etanercept in patients with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate. Safety and immunogenicity results were comparable between the two. This study is a major step toward improving access to biologics in Latin America., Competing Interests: I.S. received honoraria as clinical investigator from Novartis, Merck, GlaxoSmithKline, Janssen, Bristol Myers Squibb, AbbVie, Roche, Eli Lilly, Sanofi, AstraZeneca, Servier, and Gema Biotech SAU, and fees as speaker and advisor from Janssen, Bristol Myers Squibb, Eli Lilly, Genzyme, and Gema Biotech SAU. E.M. is a speaker and advisor at Sanofi, Gema Biotech SAU, AbbVie, Pfizer, Amgen, GlaxoSmithKline, Sandoz, Eli Lilly, Roche, Bristol Myers Squibb, and AstraZeneca. G.C. has received grants and/or personal fees from AbbVie, Amgen, Bristol Myers Squibb, Gema Biotech SAU, Janssen, and Pfizer. D.S. has received research grants from Roche, Sanofi-Genzyme, Bristol Myers Squibb, Galápagos, Janssen, Eli Lilly, GlaxoSmithKline, UCB, and Gema Biotech SAU; fees for conference from Roche, Bristol Myers Squibb, and AbbVie; and fees as rheumatology consultant from Bristol Myers Squibb and Roche. M.Á.C. has received personal fees from Gema Biotech SAU. E.K. has received honoraria form BRIX SDL, LATECBA SA, AbbVie Argentina, Bristol Myers Squibb, and Gema Biotech SAU. E.S. has received honoraria as a central radiological assessor from Gema Biotech SAU. E.G. has received honoraria from Biosidus SA and Gema Biotech SAU. L.C. and N.L. are connected with Gema Biotech SAU. M.A.L., R.P.H., A.S., P.T., H.V., J.V.Z., and A.F. have no conflicts of interest to declare., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objetive: The aim of this study was to investigate whether peripheral arthritis together with disease activity independently contribute to functional impairment over time in patients with axSpA and to evaluate if there are contextual factors modifying this relationship., Material and Methods: Patients with axial spondyloarthritis from the ESPAXIA cohort were followed-up annually over a mean of 3.7 years. Physical function was assessed by the self-reported questionnaire BASFI, disease activity by ASDAS and peripheral arthritis was also recorded. Generalized estimating equations (GEE) were used to investigate longitudinal association between peripheral arthritis, ASDAS and BASFI as the outcome. Autoregressive models (adjusted for BASFI 1 year earlier) were run to allow for a truly longitudinal interpretation. Interactions between each of ASDAS and peripheral arthritis with contextual factors (age, gender, educational level, smoking, job type) were tested., Results: 185 patients (77 % male, mean (SD) age 42 (13) years old and mean disease duration (SD) of 9.4 (9.6) years) were included. ASDAS and peripheral arthritis independently contributed to explaning BASFI over time. Contextual factors did not modify either of the relationships. A true longitudinal relation was proven with the autoregressive GEE model, showing that, adjusted for age, gender, spinal mobility and use of NSAIDs, an increase of one ASDAS unit led to a BASFI 0.48 units higher (ß 0.48 [95%CI 0.39, 0.57]), and the presence of peripheral arthritis, to a BASFI 0.44 units higher (ß 0.44 [95%CI 0.08, 0.8])., Conclusion: Peripheral arthritis and higher disease activity independently lead to more functional impairment in axSpA over time. Contextual factors do not modify these relationships., Competing Interests: Declaration of Competing Interest The authors have declared no conflict of interest related to this work., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune systemic disease that preferentially affects small and large joints with a progressive course and can become deforming and disabling. In recent years, much progress has been made in the evaluation of inflammation and disease activity, however, there are other factors that have a high impact on the quality of life of these patients, such as depression, anxiety, fatigue, sleep disorders, suicidal behavior, fibromyalgia, sexual activity, sarcopenia, frailty, cachexia and obesity that are not always evaluated by rheumatologists. This review shows that the evaluation and timely detection of these aspects in patients with RA could interfere with the prognosis and improve their quality of life., Competing Interests: Dr Gustavo Citera report grants, personal fees from Pfizer, during the conduct of the study; grants, personal fees from Pfizer, outside the submitted work. The authors report no other conflicts of interests in this work., (© 2021 Espinoza et al.)

Objectives: To evaluate the adherence to treatment with tofacitinib in patients with rheumatoid arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to tofacitinib and to compare the performance of both questionnaires., Material and Methods: A cross-sectional study was carried out. We included patients ≥18years old, with RA (ACR/EULAR criteria 2010) under treatment with tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5., Statistical Analysis: Descriptive statistics. T-test or Mann Whitney to compare the continuous variables, chi 2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression., Results: We included 52 patients, 82.7% women, with a median (m) age of 57.7years, disease duration m 16years, 63.5% had comorbidities. Of the patients, 86.5% were treated with tofacitinib (5mg BID) and 48% received tofacitinib as monotherapy. The median time of tofacitinib treatment was 13months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5%, and 84.6% had an adherence ≥80%. The variables significantly associated with adherence ≥80% were the presence of comorbidities (P=.014) and older age (P=.033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment., Conclusions: Treatment adherence to tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low., (Copyright © 2020 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Large epidemiologic and clinical estimates of spondyloarthritis (SpA) in Latin America are not available. In this narrative review, our goal was to descriptively summarize the prevalence and features of SpA in Latin America, based on available small studies. A review of peer-reviewed literature identified 41 relevant publications. Of these, 11 (mostly based on Mexican data) estimated the prevalence of SpA and its subtypes, which varied from 0.28 to 0.9% (SpA), 0.02 to 0.8% (ankylosing spondylitis), 0.2 to 0.9% (axial SpA), and 0.004 to 0.08% (psoriatic arthritis). Demographic and/or clinical characteristics were reported in 31 of the 41 publications, deriving data from 3 multinational studies, as well as individual studies from Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru, Uruguay, and Venezuela. Data relating to treatment, disease manifestations (articular and extra-articular), and comorbidities were summarized across the countries. Available data suggest that there is a variability in prevalence, manifestations, and comorbidities of SpA across Latin America. Basic epidemiologic and clinical data are required from several countries not currently represented. Data relating to current treatment approaches, patient outcomes, and socioeconomic impact within this large geographic region are also needed.

Background: The SpENAT, a Spanish version of the Educational Needs Assessment Tool, is a self-completed questionnaire that assesses educational needs (ENs) with the purpose of providing tailored and patient-centered information. It consists of 39 questions grouped into the 7 following domains: Pain management, Movement, Feelings, Arthritic process, Treatments, Self-help measures and Support system., Objectives: The objective of the study was to describe the ENs of rheumatoid arthritis (RA) patients using the SpENAT and to determine the main sources of information consulted by these patients., Material and Methods: Multicenter, observational, cross-sectional study. We included consecutive patients≥18 years with diagnosis of RA (ACR 87/ACR-EULAR 2010). Sociodemographic data, disease characteristics and clinimetric properties were recorded. All patients completed the SpENAT and were asked about the sources employed to obtain information about their disease., Statistical Analysis: Population characteristics were described. ENs were determined as percentages of the highest possible score for each domain. Needs for each domain according to sex, years of education, disease duration, use of biologicals and functional capacity were analyzed by means of ANOVA, and bivariate comparisons were made with Student's t-test and the Bonferroni correction. Correlation between domains was determined with the Spearman correlation coefficient. We compared patients' age by source of information with Student's t-test., Results: We included 496 patients from 20 centers across the country. More ENs were observed in the domains of Movement, Feelings and the Arthritic process. Patients with higher educational level (>7 years) reported more ENs in the Arthritic process and Self-help measure domains. A higher functional impairment (HAQ-A≥0.87) was associated with more ENs in every domain. Patients with high activity showed more ENs than those in remission in the domains of Pain management, Movement, Feelings, Treatments and Support system, as well as those with low activity in Self-help measures and Support system domains. All SpENAT domains showed positive correlations among each other (P<.0001), the most important being Pain management/Movement and Treatments/Arthritic process (r≥0.7). The source of information most frequently consulted was the rheumatologist (93.95%); those who made use of Internet were on average younger (P=.0004)., Conclusion: RA patients were very interested about knowing more about their disease. High functional impairment was associated with more ENs. Patients with high disease activity had higher EN levels in almost every domain. The rheumatologist was the main source of information for the patient with RA., (Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objective: Psoriatic arthritis (PsA) is a chronic, systemic inflammatory disease. This study assessed the cost-effectiveness of secukinumab, an interleukin-17A inhibitor, versus other biologics in PsA from the Argentinean social security perspective., Methods: A semi-Markov model evaluated subcutaneous (sc) treatment with secukinumab 150 mg and 300 mg against other sc treatments such as adalimumab, certolizumab pegol, etanercept, golimumab, ustekinumab, and intravenous treatment infliximab in biologic-naïve (with or without moderate to severe psoriasis) and biologic-experienced PsA patients over a lifetime horizon. Response to treatments was determined using the PsA Response Criteria (PsARC) at 12 weeks. Model inputs were derived from randomized controlled trials, network meta-analyses, published literature, and other Argentinean sources. Model outcomes included quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratios. Sensitivity analyses and alternative scenarios with a higher cost option were also conducted., Results: Among biologic-naïve PsA patients without psoriasis, secukinumab 150 mg provided the highest QALYs (7.18) versus all sc biologics at the lowest cost ($3 755 678 Argentine peso), thus dominating them. Among biologic-naïve PsA patients with psoriasis and biologic-experienced PsA patients, secukinumab 300 mg provided highest QALYs (6.99 and 7.53, respectively), dominated infliximab, and was cost-effective versus other sc biologics. Deterministic sensitivity analyses indicated sensitivity of results to variation in PsARC rates, drug acquisition costs, Health Assessment Questionnaire change, and utilities. A probabilistic sensitivity analysis showed maximum net monetary benefits with both secukinumab doses. Results from an alternative scenario analysis were similar to base-case analysis., Conclusions: For both biologic-naïve and experienced PsA patients, secukinumab is either a dominant or cost-effective treatment option compared with other biologics in Argentina., (Copyright © 2019 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Objective: Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population., Methods: Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations., Results: This analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years])., Conclusion: This analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.

In psoriatic arthritis (PsA), genetic factors play a substantial role in disease susceptibility as well as in its expression. This study aims to determine the distribution of class I and class II HLA antigens in PsA patients and secondly to analyze the influence of genetic factors in the clinical expression of the disease. Consecutive PsA patients (CASPAR criteria) with less than 1 year of disease duration were included. Sociodemographic and clinical data were recorded. Blood samples were obtained, DNA was extracted by polymerase chain reaction (PCR), and class I (A, B, and C) and class II (DR) HLA antigens were determined by oligotyping. A control group of 100 nonrelated healthy controls from the general population served as control. p values were corrected (pc) according to the number of alleles tested. A total of 73 patients were included, 37 were females (50.7 %) with a median disease duration of 72 months (interquartile range (IQR) 24-149). Thirty-three patients (45.2 %) had a family history of psoriasis. When analyzing all the class I and class II HLA antigens, a significantly higher frequency of B38 (odds ratio (OR) 2.95, p = 0.03) and Cw6 (OR 2.78, p = 0.009) was found in PsA patients compared to the control group. On the contrary, the HLA-A11 (OR 0.14, p = 0.04) and B7 (OR 0.31, p = 0.03) were significantly more frequent among healthy controls. Furthermore, B18 was significantly more frequent in patients with early arthritis onset (less than 40 years): seven patients (22.6 %) with early onset compared to two patients (4.8 %) with late onset (p = 0.03). No association between HLA-B27 and spondylitis or HLA-DR4 with polyarticular involvement was observed. The HLA-B38 and Cw6 alleles are associated with a greater PsA susceptibility in Argentine population.

Unlabelled: The objective of the study was to evaluate work disability and its main associated factors in patients with early arthritis. Argentine Consortium for Early Arthritis (CONAART) is the first early arthritis cohort in Argentina. Patients with one or more swollen joints and less than 2 years of symptoms duration were followed up prospectively in 13 departments of rheumatology. Social, demographic, familiar, clinical, and laboratory data were recollected. At first year and every year, X-rays of hands and feet were performed and working status and pharmaco-economic data were recollected. Work status (employed, unemployed, retired) and type of work were assessed by direct interview using a predesigned questionnaire. Eight hundred forty-eight patients were included, rheumatoid arthritis (RA) = 483 (57 %)and undifferentiated arthritis (UA) = 365 (43 %), 694 (81.8 %) were women, median age was 46 years (interquartile range (IQR) 35-55.7) and median symptoms duration 7 months (IQR 3-12). Patients with RA had significantly higher disease activity, worse functional capacity and quality of life, and more severe radiological damage compared to UA patients. However work disability (unemployed patient) was comparable between groups (RA = 21 % versus UA = 18.6 % p = NS). In both groups, unemployed patients had higher disease activity score of 28 joints (DAS28), worse Health Assessment Questionnaire (HAQ) values, and less years of formal education (p value <0.005 in all comparisons). Radiological damage was greater in unemployed patients but this difference did not reach statistical significance. In multivariate analysis, disease activity was the main variable associated with unemployment in both groups. Joint involvement was the main cause of work disability in this cohort of patients with early arthritis, independently of the final diagnosis., Key Messages: 1. Work disability is higher in patients with inflammatory arthritis as compared to the general population. 2. Prevalence of work disability is comparable among patients with undifferentiated and rheumatoid arthritis. 3. Disease activity is the main disease variable associated with work disability.

The aim of this study is to determine the prevalence of psoriatic arthritis (PsA) according to CASPAR criteria, ASAS peripheral and axial SpA criteria, and New York criteria for AS. The first 100 patients consecutively attending a psoriasis dermatology clinic were assessed. Demographic and clinical data were collected; all patients were questioned and examined for joint manifestations. Rheumatoid factor and radiographies of hands, feet, cervical spine, and pelvis for sacroiliac joints were obtained. X-rays were read independently by two experienced observers in blind fashion. Patients with objective joint manifestations, both axial and peripheral, were evaluated for fulfillment of CASPAR, ASAS peripheral and axial, and New York criteria. Median age 48 years; 93 % of patients had psoriasis vulgaris and 56 % nail involvement. Seventeen patients had peripheral arthritis as follows: nine mono/oligoarticular and eight polyarthritis. Median arthritis duration was 8 years. Seventeen percent of patients fulfilled CASPAR and ASAS peripheral criteria, 6 % New York, and 5 % ASAS axial criteria. Patients who met CASPAR criteria showed a significantly higher psoriasis duration compared to those without arthritis (M 16 vs. 10 years, p = 0.02), and a higher frequency of nail involvement (88.2 vs. 49.4 %, p = 0.003). Five patients (29.4 %) fulfilled ASAS axial criteria; all of them had peripheral involvement as follows: mono/oligoarticular in three patients and polyarticular in two. Patients with peripheral and axial involvement presented a significantly higher frequency of erythrodermic psoriasis compared to the other patients (35.3 vs. 1.2 %, p = 0.0006 and 80 vs. 16.7 %, p = 0.02). Prevalence of PsA, for CASPAR and ASAS peripheral criteria, was of 17 %. Five percent of patients met ASAS axial criteria, while 6 % met New York criteria. Worth noting, few patients without signs or symptoms of arthritis had radiological changes, both axial and peripheral, precluding a proper classification.

Objectives: To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA)., Methods: AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX., Results: Of 646 patients randomised, 79.2% abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the abatacept group. Injection site reactions (ISRs) occurred less frequently with abatacept (4.1% vs 10.4%)., Conclusions: Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with abatacept.

The aim of this study is to determine the prevalence of psoriatic arthritis (PsA) according to Classification of Psoriatic Arthritis (CASPAR) criteria, Assessment of Spondyloarthritis International Society (ASAS) peripheral and axial SpA criteria, and New York criteria for AS. The first 100 patients consecutively attending a psoriasis dermatology clinic were assessed. Demographic and clinical data were collected; all patients were questioned and examined for joint manifestations. Rheumatoid factor and radiographies of hands, feet, cervical spine, and pelvis for sacroiliac joints were obtained. X-rays were read independently by two experienced observers in blind fashion. Patients with objective joint manifestations, both axial and peripheral, were evaluated for fulfillment of CASPAR, ASAS peripheral and axial, and New York criteria. Median age 48 years; 93 % of patients had psoriasis vulgaris and 56 % had nail involvement. Seventeen patients had peripheral arthritis as follows: nine mono/oligoarticular and eight polyarthritis. Median arthritis duration was of 8 years. Seventeen percent of patients fulfilled CASPAR and ASAS peripheral criteria, 6 % New York, and 5 % ASAS axial criteria. Patients who met CASPAR criteria showed a significantly higher psoriasis duration compared to those without arthritis (M 16 vs 10 years, p = 0.02), and a higher frequency of nail involvement (88.2 vs 49.4 %, p = 0.003). Five patients (29.4 %) fulfilled ASAS axial criteria; all of them had peripheral involvement as follows: mono/oligoarticular in three patients and polyarticular in two. Patients with peripheral and axial involvement presented a significantly higher frequency of erythrodermic psoriasis compared to the other patients (35.3 vs 1.2 %, p = 0.0006 and 80 vs 16.7 %, p = 0.02). Prevalence of PsA, for CASPAR and ASAS peripheral criteria, was of 17 %. Five percent of patients met ASAS axial criteria, while 6 % met New York criteria. Worth noting, few patients without signs or symptoms of arthritis had radiological changes, both axial and peripheral, precluding a proper classification.

Objectives: This study analysed the frequency of anterior uveitis (AU) and its correlations in a large cohort of patients with spondyloarthritis (SpA)., Methods: A common protocol of investigation was prospectively applied to 2012 SpA patients in 85 centres from 10 Ibero-American countries. Clinical and demographic variables and disease indexes were investigated. Categorical variables were compared by χ2 and Fisher's exact test, and continuous variables were compared by ANOVA or Kruskal-Wallis test. A value of p<0.05 was considered significant., Results: AU was referred by 372 SpA patients (18.5%). AU was statistically associated with inflammatory low back pain (p<0.001), radiographic sacroiliitis (p<0.001), enthesopathies (p=0.004), urethritis/acute diarrhoea (p<0.001), balanitis (p=0.002), hip involvement (p=0.002), HLA-B27 (p=0.003), and higher C-reactive protein (p=0.001), whilst it was negatively associated with the number of painful (p=0.03) and swollen (p=0.005) peripheral joints, psoriatic arthritis (p<0.001), psoriasis (p<0.001), nail involvement (p<0.001), and dactilitis (p=0.062; trend). No association with gender, race, and indices (disease activity, functionality and quality of life) was observed. Logistic regression showed that ankylosing spondylitis (p=0.001) and HLA-B27 (p=0.083; trend) was significantly associated with AU, while extra-articular manifestations (predominantly psoriasis) were negatively associated (p=0.016)., Conclusions: Anterior uveitis is a frequent extra-articular manifestation in SpA patients, positively associated with axial involvement and HLA-B27 and negatively associated with peripheral involvement and psoriatic arthritis.

Objective: To identify susceptibility loci for rheumatoid arthritis (RA) in Latin American individuals with admixed European and Amerindian genetic ancestry., Methods: Genotyping was performed in 1,475 patients with RA and 1,213 control subjects, using a customized BeadArray containing 196,524 markers covering loci previously associated with various autoimmune diseases. Principal components analysis (EigenSoft package) and Structure software were used to identify outliers and define the population substructure. REAP software was used to define cryptic relatedness and duplicates, and genetic association analyses were conducted using Plink statistical software., Results: A strong genetic association between RA and the major histocompatibility complex region was observed, localized within BTNL2/DRA-DQB1- DQA2 (P = 7.6 × 10(-10) ), with 3 independent effects. We identified an association in the PLCH2-HES5-TNFRSF14-MMEL1 region of chromosome 1 (P = 9.77 × 10(-6) ), which was previously reported in Europeans, Asians, and Native Canadians. We identified one novel putative association in ENOX1 on chromosome 13 (P = 3.24 × 10(-7) ). Previously reported associations were observed in the current study, including PTPN22, SPRED2, STAT4, IRF5, CCL21, and IL2RA, although the significance was relatively moderate. Adjustment for Amerindian ancestry improved the association of a novel locus in chromosome 12 at C12orf30 (NAA25) (P = 3.9 × 10(-6) ). Associations with the HLA region, SPRED2, and PTPN22 improved in individuals positive for anti-cyclic citrullinated peptide antibodies., Conclusion: Our data define, for the first time, the contribution of Amerindian ancestry to the genetic architecture of RA in an admixed Latin American population by confirming the role of the HLA region and supporting the association with a locus in chromosome 1. In addition, we provide data for novel putative loci in chromosomes 12 and 13., (Copyright © 2013 by the American College of Rheumatology.)

Periprosthetic osteolysis (PO) is a frequent complication in patients with joint implants. There are no data regarding the prevalence of PO in patients with rheumatoid arthritis (RA), juvenile chronic arthritis (JCA), ankylosing spondylitis (AS), and osteoarthritis (OA)., Objectives: To evaluate the prevalence of PO in patients with RA, JCA, AS, and OA, who have undergone total hip replacement (THR), and to identify factors associated with its development., Methods: The study included patients diagnosed with RA (ACR 1987), AS (modified New York criteria), JCA (European 1977 criteria), and osteoarthritis (OA) (ACR 1990 criteria) with unilateral or bilateral THR. Demographic, clinical, and therapeutic data were collected. Panoramic pelvic plain radiographs were performed, to determine the presence of PO at acetabular and femoral levels. Images were read by two independent observers., Results: One hundred twenty-two hip prostheses were analyzed (74 cemented, 30 cementless, and 18 hybrids). The average time from prosthesis implantation to pelvic radiograph was comparable among groups. PO was observed in 72 hips (59%). In 55% of cases, PO was detected on the femoral component, with a lower prevalence in RA (53%) vs AS (64.7%) and JCA (76.5%). Acetabular PO was more frequent in JCA patients (58.8%), compared with RA (11.6%) and OA (28.5%) patients ( P = 0.0001 and P = 0.06, respectively). There was no significant association between the presence of PO and clinical, functional, or therapeutic features., Conclusion: The prevalence of PO was 59%, being more frequent at the femoral level. Larger studies must be carried out to determine the clinical significance of radiologic PO.

Introduction: Spondyloarthritis (SpA) includes a group of diseases that share immunogenetic, clinical and radiologic findings, with a particular involvement of the axial skeleton and the entheses., Methods: SpA patients attending ambulatory care in 11 rheumatology services located in 6 Argentine provinces were included in a prospective, observational multicentre cohort of SpA in Argentina (Iberoamerican Spondyloarthritis Registry [RESPONDIA]). Data collected were transmitted online and stored in the Spanish spondyloarthritis registry (REGISPONSER) Web site. Sociodemographic, clinical features and diagnosis, disease activity, functional status, quality of life, work status, radiographic changes and treatment data were collected by means of validated tools., Results: A total of 402 patients were included; 59% were male, with median age of 48.3 years and median disease duration of 8 years; 68.7% of patients belonged to middle and lower-middle social classes. Eighty-six patients were diagnosed with ankylosing spondylitis (AS), 242 with psoriatic arthritis, 25 with reactive arthritis, 10 with SpA associated with inflammatory bowel disease, 33 with undifferentiated SpA and 6 with juvenile AS. The median score was 2.6 for the Bath AS Functional Index, 3.8 for the Bath AS Disease Activity Index and 5 for the Bath AS Radiology Index. The lower social class patients achieved a worse Bath AS Functional Index than other social classes and a worse Bath AS Disease Activity Index, compared with upper-middle class., Conclusions: The sociodemographic distribution pattern observed in these SpA patients was similar to that expected in the general population of Argentina, with worse functional capacity and higher disease activity observed in the lower social classes.

Objective: Analyze disability determinants in a cohort of Argentine patients with rheumatoid arthritis (RA)., Material and Methods: Consecutive patients with RA, according to ACR'87 criteria, were recruited from 6 rheumatology centers. Demographic and socioeconomic data, family history, comorbid diseases, extra-articular manifestations and information about received treatments were provided. Disease activity was assessed using Disease Activity Score 28 (DAS 28) and the Health Assessment Questionnaire (HAQ)-A was used for the functional capacity. Hand and feet radiographs were assessed using Sharp-van der Heijde score., Results: A total of 640 patients with RA were included, of which 85.2% were females. Mean age was 53 years (interquartile range [IQR], 44-62) and mean disease duration was 8 years (IQR, 4-14). DAS 28 mean was 2.72 (IQR, 1.7-3.7) and HAQ-A mean was 0.62 (IQR, 0.13-1.25). Multiple linear regression showed that the main variables associated with disability were DAS 28, radiologic damage and age. Main predictors of functional disability in the multiple logistic regression using severe HAQ (>2) as dependent variable were DAS 28 (OR, 2; P < 0.0001); age (OR, 1; P = 0.008); and structural damage (OR, 1; P = 0.001)., Conclusions: In this population, the disease activity was the variable that showed the highest impact on the physical function. Radiologic damage affected HAQ as the disease progressed.

Objective: To evaluate work status and its determinants among ankylosing spondylitis (AS) patients in our country., Materials and Methods: We carried out a case-control study, including AS patients older than 16-year-old. Demographic, socioeconomic, and employment data were collected. Individuals from the general population matched by age, sex, and socioeconomic level served as the control group. Functional capacity was evaluated by bath ankylosing spondylitis functional index (BASFI) and health assessment questionnaire (HAQ-S) and disease activity by bath ankylosing spondylitis disease activity index (BASDAI). All patients completed quality of life (ASQol), depression (CES-D), and fatigue (FSS)-validated questionnaires., Results: Sixty-four patients with AS (57 men) and 93 controls (83 men) were included. The frequency of retirement due to age was comparable in both groups, however, a significantly larger number of patients with AS were retired due to disability: 6 (9.4%) versus 0 (P = 0.004). Patients with AS had a significantly greater number of comorbidities than controls (78.7% vs. 31.5%, P = 1 x 10(-8)). Sixteen patients (26.2%) were unemployed compared with 4 controls (4.5%) (P = 0.001). Permanence at work was significantly lower in patients (median age 58, SD 54-61 years) versus controls (median age 66, SD 63-68 years) (log Rank P = 0.001). There were less full-time workers (71% vs. 87%, P = 0.03) and higher number of sick leave days (6.56 +/- 13 vs. 2.13 +/- 4.5, P = 0.01) in AS patients than controls. Unemployed patients had significantly worst quality of life, disease activity, and depression scores than employed patients. In the multivariate analysis, the primary variable associated to unemployment was depression [Odds Ratio (OR): 20, 95% confidence interval (CI), 1.69-258, P = 0.001] followed by disease activity (OR: 1.05, 95% CI, 1-1.1, P = 0.04) and age (OR: 1.1, 95% CI, 1.02-1.21, P = 0.01) as secondary variables., Conclusions: The frequency of work disability among our patients with AS was significantly higher than in age, sex, and socioeconomic matched population. The main variable associated with work disability and unemployment was depression. Whether this factor is contributing to or is a result of disability is not known.

Background: The presence of eosinophilia in peripheral blood has been considered by some authors as an indicator of bad prognosis in patients with rheumatoid arthritis (RA); however, the methodology and the number of patients included in those studies were not appropriate., Objective: To determine the prevalence and possible causes of eosinophilia in patients with RA, and its relationship with a more severe disease., Material and Methods: Patients with RA (American College of Rheumatology '87) were included, demographic, clinical, and laboratory data were collected. The presence of eosinophilia was defined as an eosinophil absolute count above 350/mm. Disease activity, health assessment questionnaire, and hand x-rays were performed in all patients. A coproparasitologic test and serology for Toxocara by enzyme-linked immunosorbent assay (ELISA) were determined in patients with eosinophilia., Results: One hundred nine patients were included, 95 women (87.2%), mean age 50.6 +/- 13 years, mean disease duration 10.8 +/- 7.6 years. Eight patients (7.33%) showed eosinophilia. When demographic and clinical characteristics of patients with or without eosinophilia were compared, the former showed a higher erythrocyte sedimentation rate levels and significantly more frequency of dry mouth, anal pruritus, and paresthesia. The remaining clinical variables, as well as radiologic structural damage were comparable. Parasites in feces (Ascaris lumbricoides and Enterobius vermicularis) were found in 2 patients with eosinophilia. Seven patients with eosinophilia (87.5%) versus 4 (19%) without eosinophilia showed positive serology for Toxocara (P = 0.001)., Conclusion: The frequency of eosinophilia in our population of patients with RA was 7.33%. It was not an indicator of severity of the disease and in all cases evidence for secondary causes (parasitosis) was found.

Objective: Audiovestibular disorders have been described in several autoimmune diseases but have not been studied in patients with ankylosing spondylitis (AS). The aim of this study was to evaluate the audiovestibular function in patients with AS., Methods: We prospectively evaluated 22 consecutive patients with AS. Clinical, radiologic, and immunogenetic features were analyzed. All patients underwent a complete ear, nose, and throat physical examination and audiologic evaluation that included pure-tone audiometry thresholds at octave frequencies of 250 to 8000 Hz, impedance audiometry (tympanogram, static compliance, acoustic reflexes, and reflex decay), and speech audiometry. Thirty-one healthy volunteers and 26 patients with rheumatoid arthritis (RA) were included as controls., Results: Patients with AS had a median age of 45.5 years (interquartile range [IQR] 38-54) and a median disease duration of 20 years (IQR 12.5-26.2). Otosclerosis was observed in 2 patients with AS (9.1%), 3 patients with RA (11.5%), but not in any healthy controls (P = not significant). Sensorineural hearing loss (SNHL) was observed in 13 patients with AS (59%), 17 patients with RA (65.4%), and 13 healthy controls (41.9%) without statistically significant differences. Because age can influence audiometric results, patients and controls were divided into 4 age groups. A higher frequency of SNHL was observed in patients with AS from 45 to 59 years compared with healthy controls and patients with RA (87% versus 20%, P = 0.03, versus 70%, P = not significant, respectively)., Conclusion: Middle-aged patients with AS had a significantly higher frequency of SNHL compared with controls. SNHL should be considered as a possible complication of AS as well as of RA and other autoimmune diseases. Possible toxic effect of nonsteroidal antiinflammatory drugs should also be considered in such patients.

Background: Osteoarthritis (OA) of the knee is a common cause of chronic disability in patients with quadriceps muscle weakness. Beneficial effects have been proposed for functional electrostimulation (FES) and exercise at the muscle level., Objectives: The objective of the study was to begin to compare the effects of both therapeutic modalities on quadriceps muscle strength, pain, and functional capacity in patients with OA of the knee and to prove whether the combination of these modalities provides greater benefits than the use of each therapeutic modality alone., Methods: This pilot study included 37 patients with OA of the knee who were assessed at baseline and at 8 weeks, accounting for the following variables: body mass index, knee pain (measured using a VAS), WOMAC, quadriceps strength (measured using a dynamometer) and 6-minute walk test. Patients were randomized into 3 groups: (A) 8 patients who received FES 3 times per week; (B) 10 patients recruited into a twice-a-week physical training program; and (C) 8 patients under combined therapy; 29.7% of patients were lost to follow-up due to noncompliance with the treatment plan, leaving a total of 26 patients at 8 weeks., Results: Pain and WOMAC improved in all 3 groups; strength improved significantly in the exercise-only group; the FES + exercise combination improved strength significantly when compared with the individual therapeutic procedures., Conclusions: FES merits a larger placebo-controlled study as it may prove to be useful patients with OA of the knee; the combination with exercise was helpful in improving muscle strength. This technique may be considered in patients who are unable to carry out physical activity due to health problems or in those who are not interested in physical activity.

The specificity and sensitivity of anti-cyclic citrullinated peptide antibodies (anti-CCP) was examined in Latin-American patients with rheumatoid arthritis (RA). The variables considered included: 1) relation with the activity of disease, 2) extra-articular manifestations (EAM), 3) synthesis of cytokines (IL-4, IL-10, IL-12, TNF-alpha, and IFN-gamma) and IgM and IgA rheumatoid factor (RF), and 4) the association with HLA-DRB1 polymorphism. Seventy-nine RA patients were assessed (69 with established RA, and 10 with recent-onset RA not receiving any treatment), 56 with ankylosing spondylitis (AS), 25 with systemic lupus erythematosus (SLE), 50 with primary Sjögren's syndrome (pSS), and 10 healthy individuals. Of the 69 patients with established RA, 36 were reexamined 2 years later. The activity of the RA was measured by criteria adopted by the American College of Rheumatology. Anti-CCP2, RF and cytokines levels were determined by ELISA. HLA genotypes were established by first, PCR sequence amplification using sequence-specific primers and then, complete sequencing of the product. Anti-CCP antibodies were observed in 96% of patients with RA during the first evaluation and in 86% at the second evaluation (p = 0.12). No significant change in antibody titre was observed between the two evaluations (131 +/- 58.7 and 130.6 +/- 67.1 IU, respectively). The overall sensitivity and specificity was 94% and 92%, respectively; however, at titres > 60 IU, the values were 84% and 95%, respectively. The anti-CCP likelihood ratio positive test was 12 and the likelihood ratio negative test was 0.06. The positive predictive value was 87%, and the negative predictive value was 96%. Anti-CCP antibodies were observed in 12% of SLE and pSS patients, in 2% of AS patients, and in 10% of healthy controls. In RA patients, these antibodies were not associated with the activity of disease, EAM or HLA-DRB1 alleles; no significant correlation was observed between antibody titre and cytokines level. Although anti-CCP antibodies have potential as a diagnostic tool for RA, they are not useful for monitoring clinical activity or predicting the clinical course of disease. Antibody synthesis is HLA-DRB1 independent and not correlated with Th1/Th2 cytokines.

Background: The Health Assessment Questionnaire (HAQ) is one of the most frequently used instruments to assess functional capacity in activities of daily living., Objective: The objective of our study was to determine the reproducibility and validity of an Argentinean version of the HAQ disability index (HAQ-DI) in patients with rheumatoid arthritis (RA)., Methods: Consecutive adult patients with RA from 3 different provinces in Argentina were included. The original English version of the HAQ-DI was translated and adapted into Spanish by 3 rheumatologists and the final version back translated into English by a bilingual person. The reproducibility of the questionnaire was assessed in 30 patients who came for a second visit 3 to 5 days later. The cross-sectional construct validity was assessed by comparing the HAQ with classic parameters of disease activity (number of swollen and tender joints, patient and physician visual analog scale for pain and activity as well as functional class, erythrocyte sedimentation rate, and C-reactive protein., Results: Two hundred patients with RA were included. The reproducibility was r = 0.97 (P = 1 x 10-5); intraitem correlation analysis did not show any redundancy. Correlation between HAQ-A and parameters of disease activity were all significant. A stepwise multiple regression analysis showed that the main variables associated with HAQ-A scores were visual analog scale for pain and duration of morning stiffness. A weak although significant negative correlation was found between the HAQ-A and economic level (r = -0.21, P = 0.03). The median time to complete the questionnaire was 5 minutes and there were no problems with any questions., Conclusion: This version of the HAQ-DI would allow for more availability so that Spanish-speaking countries can select the version most suitable to their sociocultural environment.