OBJECTIVES:A systematic literature review (SLR) of publications from 2000 to 2022 identified terminology for calcium pyrophosphate crystal deposition (CPPD) and revealed substantial heterogeneity and poor adherence to recommendations. This study aimed to standardise CPPD terminology by developing an international consensus on labels and definitions. METHODS:Members of the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) were invited by email to participate in a 3-round Delphi exercise. A steering committee identified key components of CPPD aetiology, pathophysiology, and clinical presentation among elements appearing in >10% of SLR papers, adding or removing items when scientifically justified. Participants selected preferred labels for each element. Respondents to the first round were invited to subsequent rounds. This paper reports the resulting G-CAN CPPD nomenclature. RESULTS:Consensus was reached for 'calcium pyrophosphate (CPP) crystal' and 'calcium pyrophosphate crystal deposition (CPPD)' to describe the deposition process. The unified term 'calcium pyrophosphate crystal deposition on imaging' was adopted across imaging modalities, whereas 'chondrocalcinosis' was redefined as conventional radiographic cartilage calcification consistent with CPPD. Four clinical manifestations were identified: 'acute CPP crystal arthritis' (with 'flare' for acute episodes), 'chronic CPP crystal arthritis', 'crowned dens syndrome', and 'osteoarthritis with CPPD'; the term 'pseudogout' received no support. The condition is now classified as 'asymptomatic CPPD' or 'CPPD disease' for symptomatic presentations. CONCLUSIONS:This G-CAN nomenclature is the first systematic effort to align CPPD terminology with contemporary biological and imaging evidence. By resolving longstanding ambiguities-particularly regarding 'chondrocalcinosis'-it provides a framework for consistent research definitions, clinical trial homogeneity, and improved patient care.
OBJECTIVES:To characterize the clinical profile of patients with anti-synthetase syndrome (ASyS) presenting with dermatomyositis (DM)-type skin lesions (ASyS-DM-skin) and compare them with patients with ASyS without DM-type skin lesions (ASyS-nonDM-skin) and patients with DM. METHODS:We performed a cross-sectional study of baseline data from the Spanish registry of patients with IIM (Myo-Spain). Patients with ASyS (classified as ASyS-DM-skin or ASyS-nonDM-skin) and DM were included. We compared characteristics between groups using univariable analysis. Two multivariable logistic regression models were evaluated: (1) factors associated with DM-type skin lesions among ASyS patients; and (2) factors associated with an ASyS diagnosis among patients with DM-type skin lesions. RESULTS:We included 194 patients with ASyS (61 [31.4%] ASyS-DM-skin) and 116 with DM. In the multivariable model restricted to patients with ASyS, DM-type skin lesions were positively associated with periungual capillary alterations (OR 2.49, 95% CI 1.10-5.65), and negatively associated with age at diagnosis (OR 0.97, 95% CI 0.94-0.99) and arthralgia (OR 0.39, 95% CI 0.15-1.00). Among patients with DM-type skin lesions, ASyS diagnosis was positively associated with Raynaud's phenomenon (OR 6.84, 95% CI 1.04-44.81), mechanic's hands (OR 12.60, 95% CI 1.55-102.7), and interstitial lung disease (OR 27.83, 95% CI 4.55-170.5), and negatively associated with heliotrope rash or Gottron sign/papules (OR 0.10, 95% CI 0.01-0.73) and muscle weakness at diagnosis (OR 0.11, 95% CI 0.01-0.83). Malignancy was less frequent in ASyS-DM-skin than in DM. CONCLUSION:ASyS-DM-skin patients displayed a distinct clinical phenotype, characterized by DM-type cutaneous involvement while retaining ASyS features, particularly interstitial lung disease, Raynaud's phenomenon, and mechanic's hands.
Introduction The EULAR points to consider (PtC) for reducing non-adherence need implementation.Objectives To design, implement and evaluate a strategy based on the PtC to improve treatment adherence in rheumatoid arthritis (RA).Methods A multidisciplinary panel cocreated an intervention that was subsequently tested in a cluster trial, where centres were randomised to access the developed intervention or follow the standard of care (SOC). 6-month initiation and implementation adherence were measured in consecutive patients with <2 years of RA. The results were discussed among the centres assigned to the intervention to explore barriers and facilitators to implementation.Results The intervention was a two-sided website. The items on the patient site mainly addressed disease and treatment education, self-management and peer support. The healthcare professional site has tutorials on communication to improve trust and adherence, plus shared decision-making aids. It was tested in 141 RA patients (67 control and 74 intervention). Both groups increased adherence at 6 months, mainly in the control group (48% to 67% vs 42% to 47% in the intervention group). Implementation had been very low in relation to barriers identified as lack of time, inadequate focus (exclusively for nurses) and consideration of the current SOC as adequate.Conclusion Despite designing an intervention based on the best evidence, the results were inconclusive; the lack of a detected effect could be explained by the limited implementation, which was insufficient for the complexity of the changes required (change of culture).Trial register number ClinicalTrials.gov ID NCT05425485.
To evaluate the main outcomes of disease activity and their association with other measures of activity, damage, and quality of life in patients with idiopathic inflammatory myopathy (IIM) according to time since diagnosis and positivity to antisynthetase autoantibodies (ASAs). Cross-sectional multicenter study within the Spanish Myo-Spain registry. Cases were classified as incident (≤ 12 months since diagnosis) and prevalent. The main outcomes of disease activity were the Myositis Disease Activity Assessment visual analogue scale (MYOACT), the Manual Muscle Test 8 (MMT-8), physician global activity (PhGA), and extramuscular activity. Other measures of activity, damage, and quality of life included patient global disease activity, MYOACT muscular, creatine phosphokinase, Health Assessment Questionnaire, physician and patient global damage, global damage of the Myositis Damage Index, and the 12-item Short-Form Health Survey (SF-12). We analyzed associations using a multivariate generalized linear model and a simple linear regression model. A total of 554 patients with different diagnostic subgroups of IIM were included (136 incident and 418 prevalent cases), with 215 ASA-positive patients (58 incident and 157 prevalent cases). All measures of disease activity were higher in the incident cases (p < 0.05), except for MYOACT muscular and creatine phosphokinase, for which no differences were recorded in ASA-positive patients. No differences were found between incident and prevalent cases for measures of damage. Values for the physical component of the SF-12 were higher in the prevalent cases (p < 0.05). The multivariate model was initially significant overall for the main activity outcomes. Positivity to ASAs was positively and negatively associated with the MYOACT index and MMT-8, respectively (p < 0.05), although no association was recorded with PhGA and extramuscular activity. Prevalent cases were negatively associated with the main outcomes of activity, except with MMT-8, for which the association was positive (p < 0.05). The main activity outcomes validated in polymyositis and dermatomyositis could also be used in other subtypes of IIM, such as antisynthetase syndrome. Recent diagnosis is associated with greater disease activity, as assessed based on these activity outcomes. PhGA and extramuscular activity are not modified by ASA positivity, thus supporting their preferred use for assessing treatment response in IIM with ASAs.
IntroductionSystemic lupus erythematosus (SLE) is a chronic autoimmune disease with ocular involvement in up to 30% of cases. Due to its type I collagen composition, the cornea is particularly susceptible to thinning due to immune-complex deposition. A reduced central corneal thickness (CCT) is clinically relevant in glaucoma, where a thinner CCT increases glaucoma risk and in refractive surgery planning. Previous studies on CCT in SLE are limited due to methodological heterogeneity, technology use, inclusion criteria, and sample size, resulting in conflicting findings. This study aims to evaluate and compare the mean CCT values between patients with SLE and healthy controls.Materials and methodsThis cross-sectional study assessed mean CCT in 71 participants, 36 patients with SLE and 35 age- and sex-matched healthy controls, recruited from ophthalmology consultations. Participants with other risk factors for corneal thinning were excluded. A pilot study estimated a sample size of 34 participants per group. After confirming concordance using the Kappa index, one randomly selected eye per participant was included. CCT was measured using Zeiss HD Cirrus 5,000 optical coherence tomography. Correlation analysis was conducted using Spearman’s Rho coefficient, while a Loess regression was performed to visualize both linear and non-linear trends. Multivariate linear regression assessed the relationship between CCT, SLE, and other variables.ResultsPatients in the SLE group exhibited significantly thicker CCT than controls (536.44 ± 39.91 μm vs. 517.57 ± 29.62 μm, p = 0.014). Intraocular pressure (IOP) was similar between groups (14.31 ± 3.12 mmHg vs. 14.54 ± 2.36 mmHg, p = 0.898). CCT positively correlated with the length of hydroxychloroquine (HCQ) use (R: 0.357; p = 0.041), showing a trend toward an increase with prolonged usage, peaking approximately 100 months. Multivariate regression confirmed the association between SLE and higher CCT, potentially due to HCQ use.DiscussionWe established an association between CCT and the presence of SLE, with SLE patients exhibiting significantly higher CCT values, potentially due to hydroxychloroquine use. These findings have important implications for IOP assessment, glaucoma risk evaluation, and refractive surgery planning in SLE patients and those undergoing treatment with HCQ. Further prospective studies are warranted to validate these observations and explore the underlying mechanisms.
Antecedentes: Los tratamientos tópicos e intralesionales (IL) pueden ser considerados como tratamientos de primera línea en pacientes con hidradenitis supurativa (HS), sin embargo, la evidencia apoyando su uso es limitada. El objetivo de nuestra revisión es evaluar la eficacia y la seguridad de los tratamientos tópicos e IL en pacientes con HS.Material y métodos: Diseñamos una revisión sistemática de la literatura siguiendo el método PICO(T). Incluimos todo tipo de estudios (tipo de estudio [T]) que incluyeran individuos con HS de cualquier sexo, edad, y etnicidad (Población [P]), que recibieran cualquier tratamiento tópico o IL para la HS (Intervención[I]) que compararan con placebo, otros tratamientos o no tratamiento (comparador [C]) y reportaran resultados de eficacia y/o seguridad (Outcomes [O]). 2 resultados fueron definidos: calidad de vida y número de pacientes con al menos 1 efecto adverso. La búsqueda se llevó a cabo en las bases de datos Cochrane Library, MEDLINE and EMBASE; la selección de estudios se realizó de acuerdo con los criterios predefinidos. El riesgo de sesgo se determinó en cada estudioResultados: Se obtuvieron 11363 referencias de las cuales 31 cumplieron los criterios de inclusión. Estos estudios incluyeron 1143 pacientes con HS, 62% fueron mujeres. 10 estudios evaluaron la terapia fotodinámica (TFD), 8 glucocorticoides, 6 resorcinol, 2 antibióticos tópicos y 5 otras intervenciones. La mayoría de los artículos fueron series de casos (n=25), con solo 5 ensayos clínicos aleatorizados (ECA) y un estudio de cohortes. ECAs demostraron mejoría de la actividad de la enfermedad con clindamicina tópica y con toxina botulínica (BTX) frente a placebo y TFD con azul de metileno (AM) niosomal frente a AM libre; sin embargo, el acetónido de triamcinolona IL no fue superior al placebo. El riesgo de sesgo fue bajo en 3 y alto en 2 ECAs.Conclusión: La calidad de la evidencia que apoya el uso de tratamientos tópicos o IL es baja, pero apoya el uso de clindamicina tópica, TFD y BTX. Se requieren ECAs adecuadamente diseñados con resultados estandarizados y poblaciones homogéneas de pacientes y lesiones para apoyar la toma de decisiones en la práctica clínica.
BACKGROUND AND OBJECTIVE:Topical and intralesional (IL) treatments may be considered the first-line therapy in patients with hidradenitis suppurativa (HS); however, the evidence supporting their use is limited. The aim of our review is to evaluate the efficacy and safety profile of topical and IL treatments in patients with HS.MATERIALS AND METHODS:We designed a systematic review of the current medical literature available following the PICO(T) method. And including all types of studies (Study type [T]) of individuals with HS of any sex, age, and ethnicity (Population [P]) who received any topical or IL treatment for HS (Intervention [I]) compared to placebo, other treatments, or no treatment at all (Comparator [C]), and reported efficacy and/or safety outcomes (Outcomes [O]). Two outcomes were defined: quality of life and the no. of patients with, at least, one adverse event. The search was conducted in the Cochrane Library, MEDLINE, and EMBASE databases; study selection was performed based on pre-defined criteria. The risk of bias was determined in each study.RESULTS:We obtained a total of 11,363 references, 31 of which met the inclusion criteria. These studies included 1143 patients with HS, 62% of whom were women. A total of 10, 8, 6, 2, and 5 studies, respectively, evaluated the use of photodynamic therapy (PDT), glucocorticoids, resorcinol, topical antibiotics, and other interventions. Most articles were case series (n=25), with only five randomized clinical trials (RCTs) and one cohort study. RCTs showed improvement in disease activity with topical clindamycin and botulinum toxin (BTX) vs placebo, and PDT with methylene blue (MB) niosomal vs free MB; however, intralesional triamcinolone acetonide was not superior to placebo. The risk of bias was low in three RCTs and high in two RCTs.CONCLUSION:The quality of evidence supporting the use of topical, or IL treatments is low. However, it supports the use of topical clindamycin, PDT, and BTX. Well-designed RCTs with standardized outcomes and homogeneous populations of patients and lesions are needed to support decision-making in the routine clinical practice.
Crystallization of monosodium urate monohydrate (MSU) leads to painful gouty arthritis. Despite extensive research it is still unknown how this pathological biomineralization occurs, which hampers its prevention. Here we show how inflammatory MSU crystals form after a non-inflammatory amorphous precursor (AMSU) that nucleates heterogeneously on collagen fibrils from damaged articular cartilage of gout patients. This non-classical crystallization route imprints a nanogranular structure to biogenic acicular MSU crystals, which have smaller unit cell volume, lower microstrain, and higher crystallinity than synthetic MSU. These distinctive biosignatures are consistent with the template-promoted crystallization of biotic MSU crystals after AMSU at low supersaturation, and their slow growth over long periods of time (possibly years) in hyperuricemic gout patients. Our results help to better understand gout pathophysiology, underline the role of cartilage damage in promoting MSU crystallization, and suggest that there is a time-window to treat potential gouty patients before a critical amount of MSU has slowly formed as to trigger a gout flare.
Background: The recently published EULAR-UEMS standards for the training of European rheumatologists[1] define 28 individual competences that should be acquired during training. EULAR Education offers a large number of training courses and opportunities, however a mapping of these opportunities to a European set of training standards has not been performed so far. This may allow identification of gaps in the educational offer that can guide development of future courses and learning material. Objectives: To map the current EULAR educational offer to the competences in the EULAR-UEMS standards for training. Methods: Within the Standards Working Group of the EULAR Education Committee, the educational offer provided by EULAR was identified through the School of Rheumatology website (https://esor.eular.org/). Descriptions of each educational initiative were retrieved and reviewed. As per the EULAR website, initiatives were categorized into five groups: 1) online courses, 2) live courses, 3) free learning material, 4) webinars and 5) grants and bursaries. Each initiative was mapped to the 28 competences in the EULAR-UEMS standards. For each competence, an educational initiative was classified as Main Focus (when the initiative's main focus was the specific competence), Partial Focus (when the initiative´s main focus was not the specific competence, but the competence was partially included) or Not Included (when that competence was not significantly included in the initiative). Following individual retrieval, discussion and consensus among the group was reached. Results: The mapped EULAR educational offer included 9 online courses with over 120 modules, 10 live courses, webinars from the Education or Research series and two scientific grants (long and short-term scientific training grants for young fellows). Within the free learning material, eight initiatives were included, plus all recommendations and other EULAR task force deliverables. Tables 1 and 2 visually depict the mapping for rheumatology-specific and generic competences respectively. Within rheumatology-specific competences (domains 1-4), all were covered by several educational products. However, some were covered only by a few initiatives (Competence (C) 4.C.3 "Manage RMDs in the context of multimorbidity") or received a partial focus (C 3.1 "Recognise and manage time-sensitive conditions"). Additionally, for C 1.B.1 "Perform aspiration and injections of joints and periarticular structures" we could only identify materials related to US-guided injections and C 4.C.1 "Manage RMDs in different age groups" was limited to the paediatric age. Most generic competences (domains 5-7) were covered by fewer initiatives. We didn't retrieve specific training material in four generic competences, three within Domain 5 (the physician-patient relationship) – C 5.A.1 "Establish professional relationships with patients and their families", C 5.A.2 "Practice according to the applicable laws, regulations, ethical principles and recommendations while respecting patients' individual goals and preferences" and C 5.B.1 "Effectively communicate with patients and their families" – and one in Domain 6 (the interdisciplinary and multidisciplinary team) – C 6.2 "Demonstrate capacity and responsibility as future leader of a rheumatology team". The only competence covered in a substantial number of initiatives was C 7.A.2 "Be able to critically appraise and understand the implications of research findings". Conclusion: The EULAR educational offer includes a multitude of materials relevant to most, but not all, of the 28 individual competences from the EULAR-UEMS Standards. Identified gaps included communication and leadership as well as multimorbidity and time-sensitive conditions. Further work will help guide future EULAR educational endeavours. REFERENCES: [1] Alunno et al. Ann Rheum Dis 2023;82:1107-1113. Table 1. Mapping of EULAR's educational initiatives to the EULAR-UEMS standards for training of European rheumatologists (domains 1-4) Table 2. Mapping of EULAR's educational initiatives to the EULAR-UEMS standards for training of European rheumatologists (domains 5-7) Acknowledgements: NIL. Disclosure of Interests: None declared.
Objective To examine the disease, demographic, and imaging features associated with different inflammatory phenotypes of calcium pyrophosphate deposition (CPPD) disease i.e., recurrent acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and crowned dens syndrome (CDS). Methods Data from an international cohort assembled from 25 sites in 7 countries for the development and validation of the 2023 ACR/EULAR CPPD classification criteria, that met the criteria were included. Three cross‐sectional studies were conducted to determine the phenotypic characteristics of recurrent acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and CDS. Multivariable logistic regression analysis was used to calculate the adjusted odds ratios (aOR) and 95% confidence intervals (CIs) to examine the association between potential risk factors and the inflammatory phenotype. Results Among the 618 people included ((56% female), mean age (standard deviation (S.D.)) 74.0 (11.9) years), 602 (97.4%) had experienced acute CPP crystal arthritis, 332 (53.7%) had recurrent acute arthritis, 158 (25.6%) had persistent inflammatory arthritis, and 45 (7.3%), had had CDS. Recurrent acute CPP crystal arthritis associated with longer disease duration (aOR 2.88 (95%CI 2.00;4.14)). Chronic CPP crystal inflammatory arthritis was associated with ). acute wrist arthritis (aOR(95%CI) 2.92(1.81‐4.73)), metacarpophalangeal (aOR(95% CI) 1.87(1.17‐2.97)) and scapho‐trapezio‐trapezoid (STT) joint osteoarthritis (aOR(95% CI) 1.83(1.15‐2.91)), and negatively associated with either metabolic or familial risk for CPPD (aOR(95% CI) 0.60(0.37‐0.96). CDS was associated with male sex (aOR(95% CI) 2.35(1.21‐4.59)), STT joint osteoarthritis (aOR(95% CI) 2.71(1.22‐6.05)), and more joints affected with chondrocalcinosis (aOR(95% CI) 1.46(1.15‐1.85)). Conclusions CPPD disease encompasses acute and chronic inflammatory phenotypes, each with specific clinical and imaging features which need to be considered in the diagnostic workup.
OBJECTIVE:The study objective was to examine the disease, demographic, and imaging features associated with different inflammatory phenotypes of calcium pyrophosphate deposition (CPPD) disease, ie, recurrent acute calcium pyrophosphate (CPP) crystal arthritis, chronic CPP crystal inflammatory arthritis, and crowned dens syndrome (CDS). METHODS:Data from an international cohort (assembled from 25 sites in 7 countries for the development and validation of the 2023 CPPD classification criteria from the American College of Rheumatology/EULAR) that met the criteria were included. Three cross-sectional studies were conducted to determine the phenotypic characteristics of recurrent acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and CDS. Multivariable logistic regression analysis was used to calculate adjusted odds ratio (aOR) and 95% confidence interval (CI) to examine the association between potential risk factors and the inflammatory phenotype. RESULTS:Among the 618 people included (56% female; mean age [standard deviation] 74.0 [11.9] years), 602 (97.4%) had experienced acute CPP crystal arthritis, 332 (53.7%) had recurrent acute arthritis, 158 (25.6%) had persistent inflammatory arthritis, and 45 (7.3%) had had CDS. Recurrent acute CPP crystal arthritis associated with longer disease duration (aOR 2.88 [95% CI 2.00-4.14]). Chronic CPP crystal inflammatory arthritis was associated with acute wrist arthritis (aOR 2.92 [95% CI 1.81-4.73]), metacarpophalangeal joint osteoarthritis (aOR 1.87 [95% CI 1.17-2.97]), and scapho-trapezo-trapezoid (STT) joint osteoarthritis (aOR 1.83 [95% CI 1.15-2.91]), and it was negatively associated with either metabolic or familial risk for CPPD (aOR 0.60 [95% CI 0.37-0.96]). CDS was associated with male sex (aOR 2.35 [95% CI 1.21-4.59]), STT joint osteoarthritis (aOR 2.71 [95% CI 1.22-6.05]), and more joints affected with chondrocalcinosis (aOR 1.46 [95% CI 1.15-1.85]). CONCLUSION:CPPD disease encompasses acute and chronic inflammatory phenotypes, each with specific clinical and imaging features that need to be considered in the diagnostic workup.
Background Tocilizumab (TCZ) is the only biologic therapy approved for giant cell arteritis (GCA). Clinical trials with TCZ in GCA was performed with intravenous (iv) TCZ in a phase 2 trial [1], and with subcutaneous (sc) TCZ in the phase 3 GiACTA [2]. There is general agreement on the initial/maintenance dose, but duration of TCZ therapy is not well established. In GiACTA trial, after one year on TCZ, most patients had GCA relapse after withdrawal. Objectives To assess the predictive factors of relapse in GCA in a clinical practice scenario. Methods Multicentre observational study of 471 patients with GCA. The diagnosis of GCA was performed between 2016 and 2021 according to: a) ACR criteria, and/or b) temporal artery biopsy, and/or c) imaging techniques.Relapse was defined according to EULAR consensus definition [3].From the 471 patients, we selected the patients who had available the data on relapse during follow-up. Multivariable study was conducted to identify the best set of predictors for the appearance of a relapse. Results GCA relapses were observed in 63 of 405 (15%) patients for whom such data was available (Table 1). No significant differences were observed between the two groups in demographic, clinical and laboratory characteristics or in prednisone dose at initiation of TCZ. The set of variables associated with GCA relapses were prior use of synthetic conventional disease-modifying antirheumatic drugs (scDMARDs), use of iv.TCZ, shorter time on TCZ therapy and optimization of TCZ dose (Figure 1). Conclusion GCA relapse seems related mainly to TCZ schedule and was associated with iv TCZ, and a shorter treatment time and optimization. References [1]Villiger PM, et al. Lancet. 2016. PMID: 26952547[2]Stone JH, et al. N Engl J Med. 2017. PMID: 28745999[3]Hellmich B, et al. Ann Rheum Dis. 2020. PMID: 31270110 Acknowledgements: NIL. Disclosure of Interests Alba Herrero-Morant: None declared, J. Loricera Speakers bureau: Roche, Novartis, UCB Pharma, MSD, Celgene, and Grünenthal, Iván Ferraz-Amaro: None declared, Santos Castañeda: None declared, Clara Moriano: None declared, J. Narváez: None declared, Vicente Aldasoro: None declared, Olga Maiz: None declared, Rafael Melero: None declared, Ignacio Villa-Blanco: None declared, Paloma Vela-Casasempere: None declared, Susana Romero-Yuste: None declared, Jose Luis Callejas-Rubio: None declared, Eugenio de Miguel: None declared, E. Galíndez-Agirregoikoa Speakers bureau: Celgene, AbbVie, Pfizer, Roche, Lilly, MSD, Janssen, and Bristol, Francisca Sivera: None declared, Carlos Fernández-López: None declared, Carles Galisteo: None declared, Julio Sanchez-Martin: None declared, Monica Calderón-Goercke: None declared, Lara Sanchez-Bilbao: None declared, J. Luis Hernández: None declared, Ricardo Blanco Speakers bureau: Abbvie, Pfizer, Roche, Lilly, Bristol-Myers, Janssen, Galapagos and MSD, Consultant of: Abbvie, Pfizer, Roche, Lilly, Bristol-Myers, Janssen and MSD, Grant/research support from: Abbvie, MSD, Novartis and Roche.Figure 1Forest plot of the multivariable analysis.Table 1Main features of the patients with GCA according to relapses.No relapsing GCA (n=342)Relapsing GCA (n= 63)pAge at GCA diagnosis (mean±SD)72±970±90.12Women/Men (% de women)246/96 (72)47/16 (75)0.57PhenotypecGCA152 (44)31 (48)0.63ecGCA62 (18)12 (18)0.95mixGCA128 (37)22 (34)0.58Cardiovascular risk factorsHigh blood pressure, n (%)212 (63)37 (60)0.65Dyslipidemia, n (%)193 (57)33 (53)0.57Diabetes, n (%)63 (19)12 (19)0.89Previous or current smoking history, n (%)33 (10)9 (14)0.28Ischemic manifestationsHeadache, n (%)189 (55)36 (58)0.70Jaw claudication, n (%)84 (26)11 (19)0.25Visual manifestations, n (%)56 (16)13 (20)0.48Systemic manifestationsFever, n (%)39 (11)12 (19)0.11Constitutional syndrome, n (%)139 (41)27 (42)0.83PmR, n (%)210 (62)43 (68)0.32LaboratoryESR, mm/1a hora, median [IQR]36 [14-56]14 [6-42]0.85CRP (mg/dL), median [IQR]1.6 [0.3-3.0]0.8 [0.4-2.9]0.21Previous treatmentscDMARDs, n (%)171 (50)53 (82)<0.001bDMARDs, n (%)4 (1)4 (6)<0.001Prednisone dose (mg/day), median [IQR]20 [10-40]20 [10-30]0.86TCZIV/SC, (%IV)171/171 (50)45/18 (69)0.004Mono/combo, (%mono)263/79 (77)43/20 (66)0.066Optimization, n (%)123 (39)38 (62)<0.001Months receiving TCZ27 [18-43]4 [2-12]<0.001Abbreviations: bDMARDs: biologic disease-modifying antirheumatic drugs,GCA, CRP: C-reactive protein, giant cell arteritis, ESR: erythrocyte sedimentation rate, IQR: interquartile range [25th-75th], JAKINIB: Janus kinase inhibitors, scDMARDs: synthetic conventional disease-modifying antirheumatic drugs, SD: standard deviation
IntroductionPsoriatic arthritis (PsA) is a complex and heterogeneous inflammatory disease. Secukinumab, a biologic disease-modifying antirheumatic drug (bDMARD), has extensive clinical evidence of efficacy and safety in the treatment of PsA but data in clinical practice are still limited. This study aims to provide real-world evidence on secukinumab use, effectiveness, and persistence in PsA.MethodsA retrospective, multicenter study was conducted on patients diagnosed with PsA and treated with secukinumab up to June 2021 at 12 centers in the Valencian Community (Spain). Data on DAS28-CRP, DAPSA, Tender and Swollen Joint Counts (TJC, SJC), enthesitis, dactylitis, skin and nail involvement, pain, patient and physician global assessment (ptGA, phGA) using 100-mm visual analog scale (VAS), and persistence for up to 24 months were collected.ResultsA total of 178 patients were included (49% men; mean [standard deviation, SD] age: 51.4 [10.5] years; 39% obese). Secukinumab was used as a first-, second-, or ≥ third-line bDMARD in 37, 21, and 42% of patients, respectively. The percentage of patients achieving at least low disease activity (DAS28-CRP ≤ 3.2) increased from 25% at baseline to 66% at month 6 (M6) and was maintained (75%) up to M24. Mean (SD) DAS28-CRP baseline values (3.9 [1.2]) decreased to 2.9 (1.1) (p < 0.001) at M6 and remained low through M24 (2.6 [1.1]) (p < 0.001). Secukinumab also improved peripheral arthritis increasing the percentage of patients with TJC = 0 (20% baseline; 57% M24) and SJC = 0 (37% baseline; 80% M24). Treatment reduced the percentage of patients with enthesitis (25% baseline; 6% M24), dactylitis (20% baseline; 4% M24), and skin (70% baseline; 17% M24), and nail (32% baseline; 2% M24) involvement. Additionally, we observed improvements in the mean pain VAS (−26.4 mm M24), ptGA (−26.2 mm M24), and phGA (−24.8 mm M24). Secukinumab showed an overall 24-month persistence rate of 67% (95% confidence interval [CI]: 60–74%). Patients receiving first-line secukinumab showed the highest 24-month persistence rate (83, 95% CI: 73–92; p = 0.024).ConclusionSecukinumab showed long-term effectiveness across the six key PsA domains thus reducing disease activity and pain, which are major treatment goals. This was accompanied by high persistence rates, especially in bDMARD naive patients.
BackgroundPostgraduate rheumatology training programmes are already established at a national level in most European countries. However, previous work has highlighted a substantial level of heterogeneity in the organisation and, in part, content of programmes. ObjectiveTo define competences and standards of knowledge, skills and professional behaviours required for the training of rheumatologists. MethodsA European Alliance of Associations for Rheumatology (EULAR) task force (TF) of 23 experts, including two members of the European Union of Medical Specialists (UEMS) section of rheumatology, was convened. The mapping phase consisted of the retrieval of key documents on specialty training in rheumatology and other related specialties across a broad set of international sources. The content of these documents was extracted and represented the foundation for the document draft that underwent several rounds of online discussion within the TF, and afterwards was also distributed to a broad group of stakeholders for collecting feedback. The list of generated competences was voted on during the TF meetings, while the level of agreement (LoA) with each statement was established by anonymous online voting. ResultsA total of 132 international training curricula were retrieved and extracted. In addition to the TF members, 253 stakeholders commented and voted on the competences through an online anonymous survey. The TF developed (1) an overarching framework indicating the areas that should be addressed during training, (2) 7 domains defining broad areas that rheumatology trainees should master by the end of the training programme, (3) 8 core themes defining the nuances of each domain and (4) 28 competences that trainees should acquire to cover each of the areas outlined in the overarching framework. A high LoA was achieved for all competences. ConclusionThese points to consider for EULAR-UEMS standards for the training of European rheumatologists are now defined. Their dissemination and use can hopefully contribute to harmonising training across European countries.
Background Secukinumab is a biologic disease-modifying antirheumatic drug (bDMARD) that has demonstrated efficacy in the treatment of axial spondyloarthritis (axSpA, i.e., ankylosing spondylitis and non-radiographic axSpA) across various clinical trials. However, data of secukinumab in clinical practice is still limited. Here, we aimed to provide real-world data on secukinumab use, effectiveness, and persistence in axSpA. Patients and methods Retrospective, multicenter study of patients with a diagnosis of axSpA treated with secukinumab at 12 centers up to June 2021 in the Valencian Community (Spain). Information was gathered on BASDAI measurement, pain, patient and physician global assessment (ptGA, phGA) using a 100-mm visual analog scale (VAS), persistence and other secondary variables by treatment line (first, second, and ≥ third) for up to 24 months. Results 221 patients were included (69% men; mean age [standard deviation, SD]: 46.7 [12.1] years old). Secukinumab was used as a first-line bDMARD in 38% of patients, as a second-line in 34% and as a ≥ hird-line in 28%. The percentage of patients achieving low disease activity (BASDAI<4) increased from 9% at baseline to 48% at month 6 and was maintained (49%) up to month 24. The greatest improvement in BASDAI was observed in naïve patients (month 6: −2.6; month 24: −3.7), followed by second-line (month 6: −1.9; month 24: −3.1) and ≥ third-line (month 6: −1.3; month 24: −2.3) patients. Reductions in mean pain VAS (−23.3; −31.9), ptGA (−25.1; −31.9) and phGA (−25.1; −31) were also observed at 6 and 24 months. Secukinumab showed an overall 12-months persistence rate of 70% (95% confidence interval [CI]: 63–77%) and a 24-months persistence rate of 58% (95% CI, 51–66%). Patients receiving first-line secukinumab had the highest 24-months persistence rate ( p = 0.05). Conclusion Secukinumab improved disease activity in axSpA patients, especially in naive, and second-line patients, which was accompanied by high persistence rates up to 24 months.