BACKGROUND: Diagnosis and treatment of systemic lupus erythematosus (SLE) are often delayed in Latin America due to barriers at the patient, provider, and health care system levels. METHODS: This qualitative study, condu...BACKGROUND: Diagnosis and treatment of systemic lupus erythematosus (SLE) are often delayed in Latin America due to barriers at the patient, provider, and health care system levels. METHODS: This qualitative study, conducted in 16 countries, explored the experiences and recommendations of persons with SLE and rheumatologists to identify key needs and strategies to improve care. Semistructured interviews and focus groups were analyzed thematically. RESULTS: Six main themes emerged: (1) education and training, (2) access to specialized care, (3) health care system organization, (4) awareness, (5) patient organizations, and (6) research. Participants underscored the need to strengthen professional competencies, decentralize care, reduce administrative barriers, and raise awareness among decision-makers and society. CONCLUSIONS: The perspectives of persons with SLE and rheumatologists converge on the urgent need for coordinated, equitable, and patient- and caregiver-centered approaches to SLE care. Implementing these recommendations-through improved education, health care system reform, advocacy, and research-could substantially reduce diagnostic and treatment delays and improve outcomes for people living with SLE in Latin America.
Quintana R, Camacho C, Brigante A
… +12 more, Nieto R, Isnardi C, Juarez V, Buschiazzo E, Mimica Davet M, Massardo L, Acosta Colman I, Paatts Nicora A, Rebella M, Danza A, Silveira G, Pons-Estel G
BACKGROUND/OBJECTIVE: To explore experiences with diagnostic and treatment delays in systemic lupus erythematosus (SLE), with a focus on barriers and facilitators, as reported by rheumatologists and patients from 4 Latin...BACKGROUND/OBJECTIVE: To explore experiences with diagnostic and treatment delays in systemic lupus erythematosus (SLE), with a focus on barriers and facilitators, as reported by rheumatologists and patients from 4 Latin American Southern Cone countries (Argentina, Chile, Paraguay, and Uruguay). MATERIALS AND METHODS: A pragmatic qualitative approach was employed, consisting of in-depth interviews with patients and focus groups with rheumatologists and internists. The study was guided by 2 complementary conceptual frameworks: the World Health Organization's (WHO) right-to-health framework and Levesque's patient-centered access-to-care model. A convenience sampling strategy was used. Qualitative data were thematically analyzed using ATLAS.ti. RESULTS: A total of 34 patients, most with longstanding disease, and predominant cutaneous, articular, and renal involvement, and 33 physicians from both public and private health care sectors participated in the study. The analysis identified 6 key dimensions influencing timely access to care: accessibility (including beliefs and costs), disease presentation (with nonspecific or mild forms leading to a delay in diagnosis), availability of resources (specialists, diagnostic tools, treatments), acceptability (attitudes of health care providers), quality of care, and affordability. In addition to these barriers, several facilitating factors were identified. These included the presence of trained health care professionals, the availability of treatments through specific national programs, and individual-level resources such as patient education and financial means. CONCLUSION: Although each country presents distinct health care characteristics, common systemic challenges, such as fragmentation, geographic disparities, and inconsistent institutional support, were evident. This study provides critical insights into the complex interplay of structural and individual-level factors influencing access to care for patients with lupus and highlights key areas for future policy and health care interventions.
BACKGROUND/OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous clinical manifestations and high morbidity and mortality. Understanding delays in SLE care requires considering...BACKGROUND/OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous clinical manifestations and high morbidity and mortality. Understanding delays in SLE care requires considering both patient experiences and health care system factors. Based on the narratives of Mexican patients and rheumatologists from diverse regions and health care settings, this study examines delays in SLE care in their country. The analysis focuses on health care system components, and their associated barriers and facilitators. METHODS: Pragmatic qualitative study using semistructured interviews with patients and focus groups with rheumatologists. Participants were selected to reflect gender, clinical, and ethnic diversity. Data were analyzed using thematic and narrative approaches, classifying factors as barriers, facilitators, or mitigators, and reconstructing timelines of diagnostic and treatment delays. RESULTS: A total of 49 patients and 50 rheumatologists participated. Five main themes emerged: availability, accessibility, acceptability, quality of care, and disease-associated characteristics. Barriers included a shortage of specialists, centralized services, financial constraints, limited diagnostic resources, cultural and ethical gaps, and poor coordination across care levels. Facilitators and mitigators included access to full or partial health care coverage, private care, patient advocacy, and disease visibility. Timelines revealed critical points of delay, often influenced by structural and system-level deficiencies rather than individual patient behavior. CONCLUSION: Delays in SLE care in Mexico are multifactorial, primarily driven by health care system limitations. Addressing these delays requires integrated strategies that enhance access, quality, cultural competence, and ethical patient-centered care, alongside structural interventions to reduce inequities in the health care system.
Ospina-Caicedo A, Fuentes-Silva Y, Escobar-Jimenez K
… +31 more, Payan-Castillejos R, Ugarte-Gil M, Díaz-Cuiza PE, Guevara-Pacheco S, Stekman I, de Lara AM, Del Cisne Quezada-López I, Castro-Franco EA, Ballesteros JG, Maldonado I, Vázquez G, Martinez-Gomez SY, Del Carmen Ochoa M, Acosta C, Izquierdo JH, Sarabia-Chavez EV, Beleño-Epieyu NL, Camacho C, Ortega-Latan L, Espinosa-Escobar C, Colmenares-Roa T, Medina-Bornachera D, Orduz-Uribe K, Serna-Paz A, Vélez-Martínez J, Parra-Martínez M, Villacís-Tamayo R, Revollo SL, Gómez-Alconz JP, Quintana R, Del Pilar Peláez-Ballestas I
ABSTRACT: Systemic lupus erythematosus (SLE) is difficult to diagnose and treat due to its heterogeneity. In the Andean/Bolivarian Region (comprising Bolivia, Colombia, Ecuador, Peru, and Venezuela), fragmented health ca...ABSTRACT: Systemic lupus erythematosus (SLE) is difficult to diagnose and treat due to its heterogeneity. In the Andean/Bolivarian Region (comprising Bolivia, Colombia, Ecuador, Peru, and Venezuela), fragmented health care systems, limited access to specialists, and social inequities further exacerbate these challenges. OBJECTIVE: To examine the barriers and facilitators contributing to delays in the diagnosis and treatment of SLE from the perspectives of patients and rheumatologists. METHODS: Qualitative study conducted between January 2024 and April 2025, comprising interviews with 59 patients and focus groups with 76 rheumatologists across five countries. Data were thematically analyzed using the World Health Organization (WHO) right-to-health framework (availability, accessibility, acceptability, quality) and emerging themes. RESULTS: Seven major themes influence delay. Availability: shortages of rheumatologists, laboratory tests, and medications. Accessibility: stigma, geographic, cultural, and socioeconomic barriers, as well as self-medication. Acceptability: gender bias and lack of provider sensitivity. Quality: inadequate training in primary care, poor coordination, fragmented care, and excessive bureaucracy. Disease characteristics: heterogeneity and severity. Migration: cross-border mobility facilitated access to medications but introduced new barriers. Finally, health inequity is an overarching theme that explains delay. Facilitators included rheumatology training, multidisciplinary care, and public health coverage. CONCLUSIONS: Delays in SLE care reflect limitations within the health system, social stigma, and inequities. Strengthening primary care training, streamlining administrative processes, and fostering patient-centered, multidisciplinary approaches are critical. In addition, regional and transnational health policies are needed to guarantee timely and equitable access to diagnosis and treatment of SLE.
de Aguiar MF, Martins-Martinho J, Carones A
… +33 more, Bacchiega ABS, Duarte AC, Águeda AF, Elias CSO, Cortesão C, Soares C, Macieira C, Teixeira CEG, Peixoto D, Vinha DP, Nogueira E, Simil F, Guimarães F, Martins FR, Ferreira G, Assunção H, Rulff HTA, Lopes JP, da Costa JO, de Medeiros JB, Porto LSS, de Sousa LFA, Ochtrop MLG, Gonçalves MJ, Diz-Lopes M, Vieira M, Khmelinskii N, Torres RP, Neaime SAC, Silvestre-Teixeira V, Sachetto Z, de Souza AWS, Ponte C
BACKGROUND/OBJECTIVE: Ascites is a rare but potentially severe manifestation of systemic lupus erythematosus (SLE). We investigated the clinical characteristics and treatment outcomes, including recurrence of ascites, in...BACKGROUND/OBJECTIVE: Ascites is a rare but potentially severe manifestation of systemic lupus erythematosus (SLE). We investigated the clinical characteristics and treatment outcomes, including recurrence of ascites, in patients with SLE. METHODS: We conducted a historical cohort study of patients with SLE who presented with ascites via computed tomography and diagnostic paracentesis. Patients were categorized into 3 etiologic groups: SLE-related ascites, liver cirrhosis (LC)-related ascites, and ascites due to other causes. Clinical features and treatment responses were compared between the SLE-related and LC-related groups. RESULTS: Among the 72 patients with SLE and ascites, 44 (61.1%) had SLE-related ascites, and 16 (22.2%) had LC-related ascites. The median age in the SLE-related group was 39.0 years (interquartile range, 26.5 to 52.5), and 74.4% were female. Compared with the LC-related group, SLE-related ascites was associated with lower serum albumin (1.0 vs. 2.4 g/dL; p =0.04) and lower white blood cell counts in ascitic fluid (125 vs. 530 cells/μL; p =0.03). Glucocorticoids were administered to 97.7% of patients in the SLE-related group, with a higher short-term treatment response rate (88.6% vs. 25.0%; p <0.01). During a median follow-up of 5.7 years, recurrence occurred in 54.5% of patients with SLE-related ascites. Low baseline serum albumin ( p =0.047) and elevated baseline C-reactive protein (CRP) ( p =0.001) were identified as significant predictors of ascites recurrence. CONCLUSIONS: SLE-related ascites is characterized by marked hypoalbuminemia. Low serum albumin and elevated CRP levels are predictors of recurrence, highlighting the need for close monitoring and tailored management in high-risk patients.
Merayo-Chalico J, Mulia-Soto AS, Espinosa-León M
… +5 more, Abitia-Borboa CA, Barrera-Vargas A, Pimentel-Quiroz VR, García-Maturano JS, Hinojosa-Azaola A
BACKGROUND/OBJECTIVE: Systemic vasculitides are inflammatory diseases affecting multiple organs and impacting patients' quality of life, including sexual health-an aspect often overlooked in clinical care. This study aim...BACKGROUND/OBJECTIVE: Systemic vasculitides are inflammatory diseases affecting multiple organs and impacting patients' quality of life, including sexual health-an aspect often overlooked in clinical care. This study aimed to identify factors associated with SD in patients with systemic vasculitis. PATIENTS AND METHODS: A cross-sectional study was conducted from October 2023 to February 2025 at 3 centers in Mexico and Peru. Adults (≥18 y) with systemic vasculitis who were sexually active in the prior 6 months were included. Data collected included demographics, comorbidities, disease characteristics, treatment, physician (PhGA) and patient global assessments (PtGA), disease activity (BVAS v3 or EULAR definitions), damage (VDI), and sexual function (CSFQ-14). RESULTS: One hundred patients were included (57% females), mean age 47 (±13.5) years, median disease duration 83 months (IQI: 48 to 140). The most common types of vasculitides were granulomatosis with polyangiitis (47%) and microscopic polyangiitis (21%). SD was identified in 44% of patients, more frequent in women (70% vs 46%; p = 0.016) and older patients (51.8 vs 43.4 y; p = 0.002). Those with SD had lower hemoglobin (13.3 vs 14.2 g/dL; p = 0.002) and worse global assessments (PhGA: 5 vs 1 mm; p = 0.04; PtGA: 21 vs 10 mm; p = 0.006). CSFQ-14 score correlated negatively with PtGA and positively with hemoglobin. Female sex (OR: 3.55, 95% CI: 1.16-10.8; p = 0.026) and age (OR: 1.06, 95% CI: 1.015-1.115; p = 0.01) remained independently associated with SD. CONCLUSIONS: Sexual dysfunction appears to be common in systemic vasculitis, particularly among older women. Sexual health should be considered and discussed when clinically relevant.
BACKGROUND: Osteoporosis is common in dialysis patients, yet treatment options are limited due to safety concerns in advanced kidney disease. Denosumab, with non-renal clearance, has been increasingly used, but its cardi...BACKGROUND: Osteoporosis is common in dialysis patients, yet treatment options are limited due to safety concerns in advanced kidney disease. Denosumab, with non-renal clearance, has been increasingly used, but its cardiovascular safety remains uncertain. METHODS: We conducted a retrospective cohort study using the TriNetX Global Collaborative Network, encompassing data from 139 health care organizations. Adults older than or equal to 50 years with osteoporosis and end-stage renal disease on dialysis treated with either denosumab or oral bisphosphonates were included. Propensity score matching (1:1) balanced demographics, comorbidities, medications, and laboratory variables. The primary outcome was major adverse cardiovascular events (MACE: myocardial infarction, stroke, and heart failure). Secondary outcomes included hypocalcemia, fractures, and all-cause mortality. Cox proportional hazards models estimated hazard ratios (HRs). RESULTS: After matching, 2112 patients (1056 per group) were analyzed (mean age: 73.9 y, 63.1% female). Denosumab was associated with increased risk of MACE (32.3% vs. 24.1%; HR: 1.690, 95% CI: 1.301-2.194; p <0.001), acute myocardial infarction, heart failure, and hypocalcemia (HR: 2.247, 95% CI: 1.650-3.061; p <0.001). Fracture incidence and all-cause mortality were not significantly different between groups. Sensitivity analyses and subgroup evaluations confirmed the robustness of these findings. CONCLUSIONS: In dialysis-dependent patients with osteoporosis, denosumab may be associated with increased cardiovascular and electrolyte-related risks compared with bisphosphonates, without clear evidence of superior fracture protection. These findings highlight the need for careful risk-benefit assessment when prescribing denosumab and underscore the importance of future prospective studies to clarify its safety and efficacy in this high-risk population.
OBJECTIVE: Self-reported allergies to penicillin and other beta-lactam antibiotics pose a public health challenge due to their association with broad-spectrum antibiotic overuse, increased health care costs and worse cli...OBJECTIVE: Self-reported allergies to penicillin and other beta-lactam antibiotics pose a public health challenge due to their association with broad-spectrum antibiotic overuse, increased health care costs and worse clinical outcomes. Of the general population, 10% to 25% are labeled as beta-lactam allergic, but fewer than 1% have beta-lactam antibiotic allergies as confirmed by testing. Patients with systemic autoimmune rheumatologic diseases (SARDs) may be more likely to be labeled, but little is known about beta-lactam allergy in this population. This scoping review characterizes (1) reported prevalence, (2) possible shared etiopathogenesis, (3) de-labeling strategies, and (4) clinical implications of beta-lactam allergy in SARDs. METHODS: This scoping review was guided by the Arksey and O'Malley 6-stage framework. A comprehensive search was conducted in MEDLINE, CINAHL, Embase, Web of Science, and Scopus. Articles containing original information on beta-lactam allergy status in patients with SARDs were included. Results were reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). RESULTS: Of 9447 records identified, 20 met the inclusion criteria. In 16 studies reporting prevalence, beta-lactam antibiotic allergy labels were seen in 4.5% to 37% of patients. In the 2 studies evaluating de-labeling, only 0.5% to 4.4% had confirmed allergies. Immune dysregulation and frequent antibiotic exposure were cited as contributors to mislabeling. No studies directly evaluated clinical outcomes in relation to allergy status. CONCLUSION: This scoping review identifies key gaps and opportunities for improving beta-lactam allergy evaluation in rheumatology patients. Further research is needed to define effective, safe de-labeling strategies tailored to patients with SARDs.
OBJECTIVE: This study aimed to investigate the impact of clinical and psychological factors on the discordance between patient and physician global assessments (PGA and PhGA) in patients with psoriatic arthritis (PsA). M...OBJECTIVE: This study aimed to investigate the impact of clinical and psychological factors on the discordance between patient and physician global assessments (PGA and PhGA) in patients with psoriatic arthritis (PsA). METHODS: This cross-sectional study included 160 patients with PsA who met the CASPAR criteria. Discordance was defined as a difference of ≥2 mm or ≥3 mm on a 10-mm visual analog scale (VAS); both thresholds were used in the analyses. Predictors of discordance were identified using logistic regression, and the mediation of pain was tested through structural equation modeling. RESULTS: The majority of the study population consisted of women (72.5%), with a mean age of 47.8 years (SD, 11.9). Discordance was observed in 54.4% (≥2 mm) and 33.8% (≥3 mm) of patients. Discordance was more common among female patients and patients not in employment and was associated with higher pain, tender joint count, fatigue, morning stiffness, fibromyalgia, anxiety, and functional disability. For the ≥3 mm threshold, female sex (OR: 3.38), lower education (OR: 3.27), and pain VAS ≥4 mm (OR: 8.90) were independent factors. For the ≥2 mm threshold, pain VAS ≥4 mm, and HAQ-DI remained independently associated with discordance. Pain explained nearly half the variance in PGA and PhGA scores and fully mediated the effects of anxiety and fibromyalgia on discordance. CONCLUSION: Discordance in PsA is influenced by clinical and psychological factors, particularly female sex, lower education, pain, and disability. Pain mediates the effects of anxiety and fibromyalgia, underscoring the value of patient-centered care.
BACKGROUND: Timely diagnosis, treatment, and delays in systemic lupus erythematosus (SLE) remain underexplored in the Central America and Caribbean (CAC) region. The objective was to describe and analyze patient-level an...BACKGROUND: Timely diagnosis, treatment, and delays in systemic lupus erythematosus (SLE) remain underexplored in the Central America and Caribbean (CAC) region. The objective was to describe and analyze patient-level and health care system-level barriers and facilitators associated with diagnostic and therapeutic delays in SLE, based on experiences of patients and rheumatologists from 6 countries in the CAC region. METHODS: A qualitative study was conducted in Cuba, the Dominican Republic, Guatemala, Honduras, Nicaragua, and Panama. Patients and rheumatologists were purposively recruited. Data were collected through in-depth interviews and focus groups. Thematic analysis was conducted. RESULTS: A total of 46 patients and 40 rheumatologists participated. Barriers and facilitators were grouped into 4 themes. Patient-related and context-related delays reflected disease interpretation and health-seeking behaviors: mild or nonspecific manifestations and self-medication delayed care, whereas visible symptoms and a family history of autoimmunity facilitated timely consultation. Health care system-related delay encompassed 3 themes: (a) accessibility-financial precarity, geographic barriers, and medication costs delayed care, though social support and universal coverage (Cuba) facilitated treatment; (2) technical and cultural competence-insufficient provider training and misdiagnoses hindered timely care, while trustful rheumatologist-patient relationships improved adherence; (3) health resources-shortages of specialists, diagnostic tests, and medications were major obstacles. CONCLUSIONS: Delays in SLE care in CAC are predominantly driven by systemic rather than patient-level factors. Strengthening health system capacity, expanding rheumatology services, and fostering culturally sensitive care are essential to reducing inequities and improving outcomes.
OBJECTIVE: Retrospective cohort study assessing real-world use patterns and test properties of labial salivary gland biopsy (LSGBx) for diagnosing Sjögren's disease (SjD). METHODS: We retrieved 89 LSGBx samples from our...OBJECTIVE: Retrospective cohort study assessing real-world use patterns and test properties of labial salivary gland biopsy (LSGBx) for diagnosing Sjögren's disease (SjD). METHODS: We retrieved 89 LSGBx samples from our dermatopathology archive and obtained 23 cadaveric LSGBx samples without known autoimmune diseases for control. SjD cases included 15 seropositive Sjögren's disease (spSjD), 34 seronegative Sjögren's disease (snSjD), and 40 not SjD. All slides were de-identified and presented in random order to a blinded dermatopathologist and oral pathologist to review and score all samples according to established criteria. Patient demographics and clinical information were obtained via chart review. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of LSGBx were calculated, and odds of a SjD diagnosis after a positive LSGBx was assessed with logistic regression. RESULTS: LSGBx supported SjD in 73.3% of spSjD, 73.5% of snSjD, and 55.0% of notSjD cases, and 21.7% of cadaveric specimens. Sensitivity for SjD (spSjD + snSjD) was 73.5%, specificity was 45.0%, PPV was 62.1%, and NPV was 58.1%. A positive LSGBx increased the odds of SjD (OR=2.27, 95% CI: 0.93-5.51). The odds were similar and non-significant for spSjD and snSjD. Cadaveric specimens had lower LSGBx positivity rates compared to notSjD cases (OR=0.24, 95% CI: 0.07-0.77). Objective measures of eye dryness (14/89 cases) or oral dryness (0/89) were infrequently assessed. CONCLUSION: The predictive value of LSGBx for SjD is limited. The lack of objective clinical data in this cohort suggests that LSGBx is often heavily weighted for diagnosis, but these data question that approach.
Álvarez MB, Hernandez-Garduno AG, Villarreal-Treviño AV
… +6 more, Ramírez-Nova V, Gastelum-Strozzi A, Peláez-Ballestas I, Rubio-Pérez N, García-Rodríguez F, Latin American Group for the Study of Lupus (GLADEL)
BACKGROUND/OBJECTIVE: The delay in managing patients with juvenile systemic lupus erythematosus (jSLE) is one of the most important determinants impacting outcomes. METHODS: We conducted a systematic review regarding the...BACKGROUND/OBJECTIVE: The delay in managing patients with juvenile systemic lupus erythematosus (jSLE) is one of the most important determinants impacting outcomes. METHODS: We conducted a systematic review regarding the delay in referral, diagnosis, and treatment of patients with jSLE, and the barriers and facilitators related to these processes. Electronic searches were conducted in Scopus, PubMed, and Web of Science for studies published up to March 4, 2025; additionally, reports were identified through a citation search. The project followed the PRISMA guidelines, and the critical appraisal was based on the Joanna Briggs Institute Checklist (JBI). Meta-analyses, using random effects models, were conducted to estimate the delay. RESULTS: The review included 24 papers from Europe, Asia, the Americas, and Africa. The median JBI quality score was 5 (IQR=4.75 to 6). Only one study presented a definition for the delay to diagnosis of jSLE. The estimated mean time from onset to diagnosis was 3.5 months (95% CI=2.73-4.27, I2 =93.4%, p <0.0001). Only 3 studies reported a referral delay. Two studies indicated that all patients received therapy at diagnosis. There was no difference in the time to diagnosis between countries from the Global North and the Global South. The most common barriers identified for timely diagnosis were male sex, low anti-nuclear antibody titers, low family income, and patients presenting mild clinical manifestations. CONCLUSIONS: Currently, no consensus exists on defining the delays in referral, diagnosis, or treatment for jSLE patients. Common barriers are related to both sociodemographic and clinical factors.
Deniz R, Altun O, Tansu Yavuz C
… +12 more, Karabulut Gök S, Deniz F, Yerişenoğlu Demir HK, Mirza Altintaş R, Uğur K, Boncukcuoğlu AE, Karaalioğlu B, Özgür DS, Akkuzu G, Yildirim F, Erzik C, Bes C
BACKGROUND/OBJECTIVE: Canakinumab (CAN), a monoclonal antibody targeting interleukin-1β, has demonstrated efficacy in various autoinflammatory diseases (AIDs), particularly in inadequate response to colchicine in familia...BACKGROUND/OBJECTIVE: Canakinumab (CAN), a monoclonal antibody targeting interleukin-1β, has demonstrated efficacy in various autoinflammatory diseases (AIDs), particularly in inadequate response to colchicine in familial Mediterranean fever (FMF). This study aimed to evaluate the indications, efficacy, and safety of CAN based on real-life experience from a tertiary rheumatology clinic. METHODS: This single-center study included 54 patients treated with CAN between May 2020 and September 2024. Patients were grouped as MEFV-positive FMF (n=42), MEFV-negative FMF (n=7), non-FMF autoinflammatory diseases (n=2), and adult-onset Still's disease (AOSD; n=3). Demographic and clinical data, treatment indications, response patterns, laboratory parameters, and adverse events were analyzed. RESULTS: CAN was initiated mainly due to adverse effects (40.5%) or inadequate response (42.8%) to anakinra and colchicine. The median duration of CAN therapy was 22 months. Among MEFV-positive FMF patients, 81% achieved a complete response and 19% partial response. CAN significantly reduced attack frequency and duration, and improved inflammatory markers (CRP, ESR, WBC, and neutrophil count). Proteinuria decreased in a statistically significant but clinically modest manner following CAN treatment. Only 1 patient experienced reversible cytopenia. Dose intervals were successfully prolonged in 54.8% of MEFV-positive patients without loss of efficacy. CONCLUSIONS: Canakinumab is an effective and well-tolerated IL-1β inhibitor in FMF and other AIDs, particularly in patients who are inadequately responsive or intolerant to colchicine and anakinra. Real-world experience supports its sustained efficacy and the feasibility of dose interval extension in selected cases.
Troum OM, Botson JK, Fang F
… +3 more, Mohammad AS, Verma S, LaMoreaux B
J Clin Rheumatol
· 2026 Jan · PMID 40984755
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BACKGROUND/OBJECTIVE: Pegloticase is indicated to lower serum urate (SU) in patients with uncontrolled gout refractory to urate-lowering therapy. Pegloticase is infused for 120 minutes every 2 weeks, which can create log...BACKGROUND/OBJECTIVE: Pegloticase is indicated to lower serum urate (SU) in patients with uncontrolled gout refractory to urate-lowering therapy. Pegloticase is infused for 120 minutes every 2 weeks, which can create logistical barriers. The phase 4, open-label AGILE trial (NCT04511702) assessed the safety and efficacy of shorter-duration pegloticase infusions in patients with uncontrolled gout. METHODS: AGILE examined 60-, 45-, and 30-minute intravenous pegloticase infusion durations co-administered with oral methotrexate. The desirable infusion duration was determined by enrolling patients sequentially into initial cohorts and assessing them over 24 weeks. The primary endpoint was infusion reaction (IR) incidence, including anaphylaxis. Key efficacy/safety endpoints included treatment response rate; pegloticase discontinuation due to IR; anaphylaxis, or SU-lowering response loss; and time to IR that led to discontinuation, anaphylaxis, or SU-lowering response loss. RESULTS: The 60-minute infusion cohort (n=116) was chosen and enrolled based on safety reviews. Overall, 6.0% of patients (7/116; 95% CI: 2.5%-12.0%) experienced IRs, including anaphylaxis in 1.7% (2/116) of patients. A treatment response was observed in 67.2% (78/116; 95% CI: 57.9%-75.7%) of patients (SU <6 mg/dL for ≥80% of the time during weeks 20-24). Pegloticase discontinuation due to IR, anaphylaxis, or loss of SU-lowering response occurred in 19.0% (22/116; 95% CI: 12.3%-27.3%) of patients. At least 1 adverse event occurred in 77.6% (90/116) of patients; 3.4% (4/116) of patients had serious adverse events. CONCLUSIONS: Safety, tolerability, and efficacy results of pegloticase infused for 60 minutes were comparable to traditional infusion durations (120 min), making shorter infusion times feasible.