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1.
Reumatol Clin (Engl Ed) ; 20(3): 162-165, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38443229

RESUMO

Gluteal pain is a frequent cause of medical attention in the daily clinical practice. It can be caused by multiple pathologies, being ischiofemoral impingement syndrome among those included in its differential diagnosis. Encompassed within the deep gluteal syndromes, this entity occurs as a consequence of the entrapment of the neuromuscular structures between the lesser femoral trochanter and the ischial tuberosity, causing pain in the root of the lower limb, with irradiation towards the thigh or the gluteal region and poor tolerance to deambulation and sedestation. The magnetic resonance imaging of the hip is fundamental for its diagnosis, and its management consists on medical treatment at onset. Despite not being a frequent diagnosis in the clinical practice in Rheumatology, keeping it in mind helps improving its prognosis by establishing an early and adequate treatment.


Assuntos
Ísquio , Dor Musculoesquelética , Humanos , Ísquio/diagnóstico por imagem , Ísquio/patologia , Imageamento por Ressonância Magnética/métodos , Fêmur/diagnóstico por imagem , Fêmur/patologia , Extremidade Inferior
3.
Front Med (Lausanne) ; 10: 1294247, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38053615

RESUMO

Introduction: Psoriatic 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. Methods: A 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. Results: A 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). Conclusion: Secukinumab 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.

4.
Clin Rheumatol ; 42(12): 3341-3350, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37688766

RESUMO

OBJECTIVE: The objective of this observational, descriptive, cross-sectional, multicentre study was to assess the perceived quality and grade of satisfaction expressed by patients with chronic arthropathies regarding the use of musculoskeletal (MSK) ultrasonography by rheumatologists as an integrated clinical care tool. METHODS: All Spanish rheumatology departments with MSK ultrasonography incorporated in their healthcare services were invited to participate in the study. A Spanish-language survey was offered to fill out anonymously to all consecutive patients with chronic arthropathies under follow-up in the rheumatology outpatient clinics who attended their centre for a period of 3 months. The survey consisted of three sections. The first section contained patients' demographics, disease data, frequency of performing rheumatological ultrasound and information about who performed their ultrasound assessments. The second section consisted of 14 questions about patient's experience and opinion on different aspects of the management, performance and perceived usefulness of performing ultrasound, to be answered on a Likert scale 1-5. The third section of the survey was addressed to the rheumatologist ultrasonographers. RESULTS: Nine hundred and four patients from 16 university hospital rheumatology departments completed the survey. All questions reached an overall favourable response ≥ 80%. Patients who reported usual ultrasound examinations in their rheumatology care and those in which it was their attending rheumatologist who performed the ultrasound assessments responded more favourably. CONCLUSION: Our encouraging patient-centred results may be useful in facilitating the implementation of rheumatological ultrasound in rheumatology care worldwide. Key Points • This is the largest multicentre survey carried out in patients with chronic joint diseases designed to assess their experience and perceived benefits with the use of ultrasonography performed by rheumatologists in daily practice. • Musculoskeletal ultrasound incorporated into rheumatology care was very well accepted and valued by most patients. • The patients perceived that ultrasonography helps not only their rheumatologist but also themselves to better understand their condition. • The patients believed that ultrasonography helps them accept and comply with the proposed treatment.


Assuntos
Artropatias , Doenças Reumáticas , Reumatologia , Humanos , Reumatologia/métodos , Estudos Transversais , Ultrassonografia/métodos , Doenças Reumáticas/diagnóstico por imagem
6.
Rheumatol Int ; 43(12): 2319-2326, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37650922

RESUMO

Lupus nephritis is a major cause of morbidity in patients with systemic lupus erythematosus. Responsiveness to treatment is crucial to avoid chronic kidney disease. New molecules have been developed in recent years to improve renal survival rates. Biological therapies as coadjutant to conventional induction treatment have been tested in randomized clinical trials with heterogeneous results. Like many others biologic therapies, Abatacept has not shown a clear benefit in the context of clinical trials. We present two cases of lupus nephritis patients in whom addition of abatacept resulted in complete remission of the renal disease. The first case described a 49-year-old male with class IV lupus nephritis with nephrotic range proteinuria and high immunological activity refractory to conventional treatment with cyclophosphamide and corticosteroids and multitarget therapy with tacrolimus, mycophenolate mofetil and prednisone. Several biological therapies (rituximab, belimumab and tocilizumab) were unsuccessfully tried, so that abatacept was added to his background multitarget therapy showing complete clinical response. The second case described a 52-year-old female with class IV lupus nephritis treated initially with conventional treatment with partial response. In successive renal flares with nephrotic proteinuria, she showed intolerance to rituximab and refractoriness to voclosporin. Finally, abatacept was added to her background therapy with MMF and PDN showing complete and maintained remission of the disease. In no case the use of abatacept was associated with serious adverse events. Based on our experience, abatacept should be considered as a safe rescue therapy in patients with refractory lupus nephritis and proteinuria with nephrotic range. In addition to this case, we reviewed the use of abatacept in lupus nephritis in the literature.

7.
Front Immunol ; 14: 1080047, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37638008

RESUMO

Introduction: The knowledge of the aetiology of Behçet disease (BD), an immune-mediated vasculitis, is limited. HLA-B, mainly HLA-B51, and HLA-A molecules are associated with disease, but the ultimate cause of this association remains obscure. There is evidence that NK cells participate in the etiopathology of BD. NK cells have activator and inhibitor surface receptors, like the KIR and the NKG2 families. Classical HLA-class I molecules (A, B and C) are keys in the activity control of the NK because they are KIR ligands. Most NKG2 receptors bind HLA-E, which presents only nonapeptides derived from the signal peptide of other class-I molecules. Objective: This study investigates the contribution of the pair HLA-E and ligand, nonapeptide derived from the 3-11 sequence of the signal peptides of class I classical molecules, to the susceptibility to BD. Methods: We analyzed the frequency of the HLA-derivated nonapeptide forms in 466 BD patients and 444 controls and an HLA-E functional dimorphism in a subgroup of patients and controls. Results: In B51 negative patients, the frequency of VMAPRTLLL was lower (70.4% versus 80.0% in controls; P=0.006, Pc=0.04, OR=0.60, 95%CI 0.41-0.86), and the frequency of VMAPRTLVL was higher (81.6% versus 71.4% in controls; P=0.004, Pc=0.03, OR=1.78, 95%CI 1.20-2.63). In homozygosity, VMAPRTLLL is protective, and VMAPRTLVL confers risk. The heterozygous condition is neutral. There were no significant differences in the distribution of the HLA-E dimorphism. Discussion: Our results explain the association of BD with diverse HLA-A molecules, reinforce the hypothesis of the involvement of the NK cells in the disease and do not suggest a significant contribution of the HLA-E polymorphism to disease susceptibility.


Assuntos
Síndrome de Behçet , Arterite de Células Gigantes , Granulomatose com Poliangiite , Humanos , Síndrome de Behçet/genética , Antígenos HLA-A
9.
Front Med (Lausanne) ; 10: 1156557, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37250652

RESUMO

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.

10.
Reumatol. clín. (Barc.) ; 19(5): 249-254, May. 2023. tab
Artigo em Espanhol | IBECS | ID: ibc-219777

RESUMO

Introducción: La artritis psoriásica (APs) es un trastorno inflamatorio crónico que afecta principalmente a las articulaciones y las entesis. Además, se asocia con el síndrome depresivo (SD), la enfermedad cardiovascular, la hipertensión (HTA), la diabetes mellitus (DM), la obesidad y la psoriasis (Pso). Existen pocos estudios dirigidos a analizar la asociación de la afectación del aparato locomotor con las alteraciones de la calidad sexual (CS). Métodos. Se propuso un estudio observacional transversal en pacientes diagnosticados de APs, a los que aplicaron cuestionarios validados autoaplicados para determinar alteraciones de la CS: MGH-SFQ y CSFQ-14, que valoran los cuatro dominios de la función sexual; Qualisex y DLQI diseñados para patología articular y dermatológica respectivamente, que exploran aspectos sexuales. El objetivo fue describir la existencia de alteraciones sexuales de pacientes con APs, analizar la asociación entre las características sociodemográficas, comorbilidades (Pso, SD, factores de riesgo cardiovascular) y los tratamientos de los pacientes sobre la CS y describir diferencias de CS en función del género. Resultados: Se valoraron 72 pacientes y se observó que las variables de los pacientes con APs que se asociaron con mayor fuerza con puntuaciones más bajas en CS fueron ser mujer y la edad en el CSFQ-14 y MGH-SFQ; el nivel de ingresos, el tratamiento con AINE, la dislipemia (DL) y la depresión se asociaron a peores resultados en algunos dominios de la esfera sexual. Conclusiones: Los pacientes con APs presentaban una CS deteriorada, especialmente mujeres, de mayor edad, bajo nivel de ingresos y DL. Los tratamientos antiinflamatorios se asociaron con mejor CS. Globalmente, la enfermedad crónica y la carga psicológica de padecerla se comportaron como factores predisponentes de disfunción sexual.(AU)


Introduction: Psoriatic arthritis (PsA) is a chronic inflammatory disorder that primarily affects the joints and entheses. In addition, it is associated with depressive syndrome (DS), cardiovascular disease, hypertension (HT), diabetes mellitus (DM), obesity and psoriasis (Pso). There are few studies aimed to analyze the association of the involvement of the musculoskeletal system with sexual function (SF). Methods: A cross-sectional observational study was proposed in patients diagnosed with PsA, to whom self-administered validated questionnaires were applied to determine alterations in SF: MGH-SFQ and CSFQ-14, which assess the 4 domains of sexual function; Qualisex and DLQI designed for joint and dermatological pathology respectively, which explore sexual aspects. The objective was to describe the existence of altered sexual function in patients with PsA; analyze the association between sociodemographic characteristics, comorbidities (Pso, DS, cardiovascular risk factors) and the treatments of patients on SF; and describe differences of SF according to gender. Results: 72 patients were evaluated. It was observed that the variables of patients with PsA that were associated with lower scores in SF were gender and age in the CSFQ-14 and MGH-SFQ; annual incomes, treatment with NSAIDs, DL and depression were associated with worse results in some domains of the sexual sphere. Conclusions: Patients with PsA had impaired SF, especially women, elder patiens, those with low annual incomes, DL and emotional disorders. Anti-inflammatory treatments were associated with better SF. Globally, the chronic disease and the psychological burden behaved as factors associated with sexual dysfunction.(AU)


Assuntos
Humanos , Masculino , Feminino , Disfunções Sexuais Fisiológicas , Psoríase , Artrite Psoriásica , Sexualidade , Comorbidade , Reumatologia , Estudos Transversais
11.
Reumatol Clin (Engl Ed) ; 19(5): 249-254, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37087380

RESUMO

INTRODUCTION: Psoriatic arthritis (PsA) is a chronic inflammatory disorder that primarily affects the joints and entheses. In addition, it is associated with depressive syndrome (DS), cardiovascular disease, hypertension (HT), diabetes mellitus (DM), obesity and psoriasis (Pso). There are few studies aimed to analyze the association of the involvement of the musculoskeletal system with sexual function (SF). METHODS: A cross-sectional observational study was proposed in patients diagnosed with PsA, to whom self-administered validated questionnaires were applied to determine alterations in SF: MGH-SFQ and CSFQ-14, which assess the 4 domains of sexual function; Qualisex and DLQI designed for joint and dermatological pathology respectively, which explore sexual aspects. The objective was to describe the existence of altered sexual function in patients with PsA; analyze the association between sociodemographic characteristics, comorbidities (Pso, DS, cardiovascular risk factors) and the treatments of patients on SF; and describe differences of SF according to gender. RESULTS: 72 patients were evaluated. It was observed that the variables of patients with PsA that were associated with lower scores in SF were gender and age in the CSFQ-14 and MGH-SFQ; annual incomes, treatment with NSAIDs, DL and depression were associated with worse results in some domains of the sexual sphere. CONCLUSIONS: Patients with PsA had impaired SF, especially women, elder patiens, those with low annual incomes, DL and emotional disorders. Anti-inflammatory treatments were associated with better SF. Globally, the chronic disease and the psychological burden behaved as factors associated with sexual dysfunction.


Assuntos
Artrite Psoriásica , Psoríase , Humanos , Feminino , Idoso , Artrite Psoriásica/complicações , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/diagnóstico , Estudos Transversais , Psoríase/complicações , Comorbidade , Obesidade/complicações
12.
BMC Musculoskelet Disord ; 24(1): 316, 2023 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-37087414

RESUMO

BACKGROUND: In patients with axial spondyloarthritis, vertebral fracture risk is elevated and not always correlated with bone mineral density (BMD). Trabecular bone score (TBS) may offer some advantages in the assessment of vertebral fracture risk in these patients. The primary objective of this study was to compare TBS and BMD between axial spondyloarthritis patients depending on their vertebral fracture status. Secondary objectives were to estimate the prevalence of morphometric vertebral fractures, and to explore factors associated with fracture, as well as the interference of syndesmophytes on BMD and TBS. METHODS: A cross-sectional study was conducted. Data were collected on demographic and clinical characteristics, lab results, imaging findings and treatment. Statistical analysis was performed using SPSS v.13 statistical software. RESULTS: Eighty-four patients (60 men and 24 women; mean age of 59 years) were included. Nearly half (47.6%) of them had lumbar syndesmophytes. The rate of morphometric fracture was 11.9%. TBS showed a higher area under the curve (0.89) than total hip, femoral neck and lumbar BMD (0.80, 0.78, and 0.70 respectively) for classifying patients regarding their fracture status. Nonetheless, the differences did not reach statistical significance. Syndesmophytes affected lumbar spine BMD (p < 0.001), but not hip BMD or TBS. Fractures were associated with TBS, total hip BMD, erythrocyte sedimentation rate and C-reactive protein levels. CONCLUSIONS: We identified decreased TBS and total hip BMD, as well as increased erythrocyte sedimentation rate and C-reactive protein levels as factors associated with morphometric vertebral fractures. Unlike lumbar spine BMD, TBS is not affected by the presence of syndesmophytes.


Assuntos
Espondiloartrite Axial , Fraturas por Osteoporose , Fraturas da Coluna Vertebral , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Densidade Óssea , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/epidemiologia , Fraturas da Coluna Vertebral/etiologia , Absorciometria de Fóton , Osso Esponjoso/diagnóstico por imagem , Estudos Transversais , Proteína C-Reativa/metabolismo , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/lesões , Fraturas por Osteoporose/epidemiologia
13.
Rheumatology (Oxford) ; 62(SI): SI54-SI63, 2023 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-35731139

RESUMO

OBJECTIVES: The early trajectory of skin fibrosis provides insights into the disease course of systemic sclerosis (SSc) including mortality; however, little is known about late skin fibrosis. The aims of our study were to ascertain the prevalence and characteristics of late skin fibrosis in SSc. METHODS: We developed and tested three conceptual scenarios of late (>5 years after first non-RP feature) skin fibrosis including new worsening of skin disease, and failure to improve after worsening within 5-year window. We defined skin worsening as change in modified Rodnan skin score (mRSS) ≥5 units or ≥25%. Using strict inclusion criteria including complete mRSS, we identified 1,043 (out of 19 115) patients within the EUSTAR database for our analysis. We further restricted analysis within 887 (out of 1043) patients who had lcSSc or dcSSc at baseline. RESULTS: One-fifth of patients among the whole cohort (n = 208/1043, 19.9%) experienced mRSS worsening, including in patients with lcSSc or dcSSc at baseline (n = 193/887, 21.8%). This was largely due to new skin worsening after the 5-year window or failure to improve with worsening within the 5-year window. Patients with lower baseline mRSS and lcSSc were more likely to develop late skin fibrosis. Anti-Scl-70 was associated with progression from baseline lcSSc to dcSSc, and anticentromere was protective. CONCLUSIONS: Late skin fibrosis is not uncommon in SSc. We have identified different patterns relevant to clinical practice and trial design. Late skin fibrosis is a neglected manifestation of SSc and warrants further investigation including to determine clinical outcomes and optimal therapeutic strategy.


Assuntos
Esclerodermia Difusa , Escleroderma Sistêmico , Dermatopatias , Humanos , Esclerodermia Difusa/complicações , Esclerodermia Difusa/patologia , Escleroderma Sistêmico/complicações , Escleroderma Sistêmico/epidemiologia , Escleroderma Sistêmico/patologia , Fibrose , Dermatopatias/patologia , Pele/patologia
14.
Reumatol. clín. (Barc.) ; 18(10): 567-573, dic. 2022. ilus, tab, graf
Artigo em Inglês | IBECS | ID: ibc-211891

RESUMO

Objective: To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting. Materials and methods: Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed. Results: Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%). Conclusions: In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.(AU)


Objetivo: Evaluar la efectividad y seguridad de la monoterapia con tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) sin tratamiento biológico en comparación con pacientes con exposición previa a biológico en un entorno real.Materiales y métodos: Ensayo clínico no controlado, estudio multicéntrico prospectivo de 32 semanas que incluyó pacientes con AR con actividad de la enfermedad moderada-grave que comenzaron con TCZ en monoterapia y que tuvieron una respuesta inadecuada previa o fueron intolerantes al metotrexato. La eficacia de acuerdo con la respuesta EULAR fue evaluada a las 24 semanas y la seguridad a las 32 semanas. Resultados: De los 93 pacientes seleccionados, 84 (90%) fueron elegibles para el análisis de efectividad. Los pacientes sin tratamiento biológico previo (n=46, 54,8%) eran más jóvenes (51,5 frente a 57,9 años), con una duración más corta de la enfermedad (6,4 frente a 13,3 años), pero presentaban comorbilidades similares en comparación con los pacientes con tratamiento previo. La remisión de DAS28 se logró en un mayor porcentaje en el grupo de pacientes con tratamiento biológico previo. Se registraron 89 eventos adversos en 50 pacientes, la mayoría de ellos no graves (86,3%). Conclusiones: En un entorno del mundo real, TCZ exhibe una eficacia y seguridad similares en monoterapia en pacientes con AR, independientemente de la exposición previa a otras terapias biológicas. Este estudio proporciona hallazgos adicionales y valiosos en el contexto del mundo real sobre el uso de TCZ en pacientes con AR.(UA)


Assuntos
Humanos , Masculino , Feminino , Artrite Reumatoide , Resultado do Tratamento , Anticorpos Monoclonais , Terapia Biológica , Metotrexato , Encaminhamento e Consulta , Reumatologia , Doenças Reumáticas
15.
Reumatol Clin (Engl Ed) ; 18(10): 567-573, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36435554

RESUMO

OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting. MATERIALS AND METHODS: Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed. RESULTS: Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%). CONCLUSIONS: In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Humanos , Antirreumáticos/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico
16.
RMD Open ; 8(2)2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36328401

RESUMO

OBJECTIVES: Tocilizumab showed trends for improving skin fibrosis and prevented progression of lung fibrosis in systemic sclerosis (SSc) in randomised controlled clinical trials. We aimed to assess safety and effectiveness of tocilizumab in a real-life setting using the European Scleroderma Trial and Research (EUSTAR) database. METHODS: Patients with SSc fulfilling the American College of Rheumatology (ACR)/EULAR 2013 classification criteria, with baseline and follow-up visits at 12±3 months, receiving tocilizumab or standard of care as the control group, were selected. Propensity score matching was applied. Primary endpoints were the modified Rodnan skin score (mRSS) and FVC at 12±3 months compared between the groups. Secondary endpoints were the percentage of progressive/regressive patients for skin and lung at 12±3 months. RESULTS: Ninety-three patients with SSc treated with tocilizumab and 3180 patients with SSc with standard of care fulfilled the inclusion criteria. Comparison between groups did not show significant differences, but favoured tocilizumab across all predefined primary and secondary endpoints: mRSS was lower in the tocilizumab group (difference -1.0, 95% CI -3.7 to 1.8, p=0.48). Similarly, FVC % predicted was higher in the tocilizumab group (difference 1.5 (-6.1 to 9.1), p=0.70). The percentage of progressive/regressive patients favoured tocilizumab over controls. These results were robust regarding the sensitivity analyses. Safety analysis confirmed previously reported adverse event profiles. CONCLUSION: Although this large, observational, controlled, real-life EUSTAR study did not show significant effectiveness of tocilizumab on skin and lung fibrosis, the consistency of direction of all predefined endpoints generates hypothesis for potential effectiveness in a broader SSc population.


Assuntos
Fibrose Pulmonar , Escleroderma Sistêmico , Humanos , Estados Unidos , Fibrose Pulmonar/etiologia , Fibrose Pulmonar/complicações , Pontuação de Propensão , Escleroderma Sistêmico/complicações , Escleroderma Sistêmico/tratamento farmacológico , Anticorpos Monoclonais Humanizados/efeitos adversos
17.
Reumatol Clin (Engl Ed) ; 17(8): 437-439, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34625145

RESUMO

OBJECTIVE: To describe a multicentre case series of new onset or worsening of psoriasis in patients treated with biological drugs. MATERIAL AND METHODS: Descriptive study. We reviewed the clinical history of patients with chronic inflammatory disease (CID) treated with biological drugs, who developed new onset or worsening of psoriasis during the follow-up period. RESULTS: Twenty-six cases of paradoxical psoriasis (PP) were recorded. Ninety-three percent of the patients were treated with anti-TNFα and adalimumab was responsible for 50% of the cases. Only 5 patients had a personal history of psoriasis. The biological drug was discontinued in 13 patients. Lesion recurrence was more frequent when another anti-TNFα was reintroduced. CONCLUSIONS: The PP is a reversible adverse effect that can be observed in patients exposed to biological drugs, mainly anti-TNFα.


Assuntos
Produtos Biológicos , Psoríase , Adalimumab/efeitos adversos , Produtos Biológicos/efeitos adversos , Terapia Biológica/efeitos adversos , Humanos , Infliximab/efeitos adversos , Psoríase/induzido quimicamente
18.
Reumatol. clín. (Barc.) ; 17(8): 437-439, Oct. 2021. ilus
Artigo em Espanhol | IBECS | ID: ibc-213341

RESUMO

Objetivo: Describir una serie multicéntrica de casos de inducción o empeoramiento de psoriasis en pacientes tratados con fármacos biológicos. Material y métodos: Estudio descriptivo. Se revisó la historia clínica de pacientes con enfermedad inflamatoria crónica (EIC) en tratamiento con fármacos biológicos, y que presentaron durante el período de seguimiento, psoriasis de nueva aparición o empeoramiento de la misma. Resultados: Se registraron 26 casos de psoriasis paradójica (PP). El 93% de los pacientes estaban en tratamiento con un anti-TNFα, siendo el adalimumab el responsable del 50% de los casos. Solo 5 pacientes presentaban antecedentes personales de psoriasis. En 13 pacientes fue necesario retirar el fármaco biológico y la recidiva de las lesiones fue más frecuente en los pacientes en los que se reintrodujo otro anti-TNFα. Conclusiones: La PP es un efecto adverso reversible que se puede observar en pacientes expuestos a fármacos biológicos, principalmente a anti-TNFα.(AU)


Objective: To describe a multicentre case series of new onset or worsening of psoriasis in patients treated with biological drugs. Material and methods: Descriptive study. We reviewed the clinical history of patients with chronic inflammatory disease (CID) treated with biological drugs, who developed new onset or worsening of psoriasis during the follow-up period. Results: Twenty-six cases of paradoxical psoriasis (PP) were recorded. Ninety-three percent of the patients were treated with anti-TNFα and adalimumab was responsible for 50% of the cases. Only 5 patients had a personal history of psoriasis. The biological drug was discontinued in 13 patients. Lesion recurrence was more frequent when another anti-TNFα was reintroduced. Conclusions: The PP is a reversible adverse effect that can be observed in patients exposed to biological drugs, mainly anti-TNFα.(AU)


Assuntos
Humanos , Masculino , Feminino , Psoríase , Produtos Biológicos/efeitos adversos , Produtos Biológicos/toxicidade , Adalimumab , Dermatopatias , Reumatologia
19.
J Rheumatol ; 48(10): 1552-1558, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33795330

RESUMO

OBJECTIVE: Tofacitinib (TOF) is the first Janus kinase (JAK) inhibitor approved for psoriatic arthritis (PsA). It has shown efficacy in patients refractory to anti-tumor necrosis factor-α in randomized controlled trials (RCTs). Our aim was to assess efficacy and safety of TOF in clinical practice. METHODS: This was an observational, open-label multicenter study of PsA patients treated with TOF due to inefficacy or adverse events of previous therapies. Outcome variables were efficacy, corticosteroid dose-sparing effect, retention rate, and safety. A comparative study of clinical features between our cohort of patients and those from the OPAL Beyond trial was performed. RESULTS: There were 87 patients (28 women/59 men), with a mean age of 52.8 ± 11.4 years. All patients were refractory to biologic disease-modifying antirheumatic drugs (DMARDs) and/or to conventional synthetic DMARDs plus apremilast. TOF was started at 5 mg twice daily after a mean follow-up of 12.3 ± 9.3 years from PsA diagnosis. At first month, Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) decreased from median 4.8 (IQR 4.1-5.4) to 3.7 (IQR 2.8-4.7, P < 0.01), Disease Activity Index for Psoriatic Arthritis from median 28 (IQR 18.4-34.1) to 15.5 (IQR 10.1-25.7, P < 0.01), and C-reactive protein from median 1.9 (IQR 0.3-5.0) to 0.5 (IQR 0.1-2.2) mg/dL (P < 0.01). Also, TOF led to a significant reduction in prednisone dose. Mild adverse effects were reported in 21 patients (24.13%), mainly gastrointestinal symptoms. TOF retention rate at Month 6 was 77% (95% CI 65.2-86.3). Patients in clinical practice were older with longer disease duration and received biologic agents more commonly than those in the OPAL Beyond trial. CONCLUSION: Data from clinical practice confirm that TOF seems to be effective, rapid, and relatively safe in refractory PsA despite clinical differences with patients in RCTs.


Assuntos
Artrite Psoriásica , Pirimidinas/uso terapêutico , Pirróis/uso terapêutico , Adulto , Artrite Psoriásica/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Piperidinas , Resultado do Tratamento
20.
Rheumatology (Oxford) ; 61(1): 213-222, 2021 12 24.
Artigo em Inglês | MEDLINE | ID: mdl-33769468

RESUMO

OBJECTIVES: The study aim was to evaluate the estimated glomerular filtration rate (eGFR), its association with clinical disease and its predictive ability with respect to mortality in SSc patients from the European Scleroderma Trials and Research Group (EUSTAR) database. METHODS: SSc patients from the EUSTAR database who had items required for the calculation of eGFR at a baseline visit and a second follow-up visit available were included. A cut-off eGFR value of 60 ml/min was chosen for all SSc patients, and 30 ml/min for those with scleroderma renal crisis (SRC). Cox regression and competing risk analysis were performed to evaluate the use of eGFR as a predictive factor of mortality. RESULTS: A total of 3650 SSc patients were included in this study. The median serum level of creatinine and the mean of eGFR were 0.8 mg/dl (interquartile range = 0.6-0.9) and 86.6 ± 23.7 ml/min, respectively. The eGFR was significantly lower in patients with pulmonary hypertension. Overall survival (OS) was significantly reduced in SSc patients with eGFR < 60 ml/min compared with patients with eGFR ≥ 60 ml/min [OS at 5 years 0.763 (95% CI: 0.700, 0.814) vs 0.903 (95% CI: 0.883, 0.919; P < 0.001)]. In multivariable analysis, OS was associated with male gender (P < 0.01), systolic pulmonary arterial pressure (sPAP) (P < 0.001) and eGFR (P < 0.001). The cumulative incidence of deaths due to SSc was associated with increased sPAP (P < 0.001) and reduced eGFR (P < 0.05). The OS at 5 years of 53 SRC patients was not significantly different between SSc patients with eGFR > 30 ml/min and those with eGFR <30 ml/min. CONCLUSION: eGFR represents a predictive risk factor for overall survival in SSc. The eGFR, however, does not represent a risk factor for death in SRC.


Assuntos
Taxa de Filtração Glomerular , Escleroderma Sistêmico/mortalidade , Adulto , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Risco , Taxa de Sobrevida
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