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1.
J Rheumatol ; 49(11): 1221-1228, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35840154

RESUMO

OBJECTIVE: To evaluate fatigue frequency and severity among patients with psoriatic arthritis (PsA) and assess the effect of fatigue severity on patient-reported outcome measures (PROMs) assessing quality of life, function, and work productivity. METHODS: Data were derived from the Adelphi Disease Specific Programme, a cross-sectional survey conducted in 2018 in the United States and Europe. Patients had physician-confirmed PsA. Fatigue was collected as a binary variable and through its severity (0-10 scale, using the 12-item Psoriatic Arthritis Impact of Disease fatigue question) from patients; physicians also reported patient fatigue (yes/no). Other PROMs included the 5-level EuroQol 5-dimension questionnaire (EQ-5D-5L) for health-related quality of life (HRQOL), Health Assessment Questionnaire-Disability Index, and Work Productivity and Activity Impairment Questionnaire. Multivariate linear regression was used to evaluate the association between fatigue severity and other PROMs. RESULTS: Among the 831 included patients (mean age 47.5 yrs, mean disease duration 5.3 yrs, 46.9% female, 48.1% receiving a biologic), fatigue was reported by 78.3% of patients. Patients with greater fatigue severity had greater disease duration, PsA severity, pain levels, body surface area affected by psoriasis, and swollen and tender joint counts (all P < 0.05). In multivariate analyses, patients with greater fatigue severity experienced worse physical functioning, HRQOL, and work productivity (all P < 0.001). Presence of fatigue was underreported by physicians (reported in only 32% of patients who self-reported fatigue). CONCLUSION: Prevalence of patient-reported fatigue was high among patients with PsA and underrecognized by physicians. Fatigue severity was associated with altered physical functioning, work productivity, and HRQOL.


Assuntos
Artrite Psoriásica , Eficiência , Fadiga , Qualidade de Vida , Inquéritos e Questionários , Trabalho , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Artrite Psoriásica/complicações , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/epidemiologia , Artrite Psoriásica/fisiopatologia , Estudos Transversais , Fadiga/complicações , Fadiga/epidemiologia , Índice de Gravidade de Doença , Medidas de Resultados Relatados pelo Paciente , Trabalho/psicologia , Estados Unidos/epidemiologia , Europa (Continente)/epidemiologia , Dor/complicações , Dor/epidemiologia , Autorrelato
2.
Rheumatol Int ; 42(2): 251-260, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35031846

RESUMO

To identify the association between traditional cardiovascular risk factors, diseases related factors, body composition and adipokines with high cardiovascular risk (HCVR) in psoriatic arthritis and non-psoriatic spondyloarthritis. This was a cross-sectional study involving age and BMI matched adults with psoriatic arthritis (PsA) (n = 56) and non-psoriatic spondyloarthritis (nPsA-SpA) (n = 58). Body composition using whole-body dual energy X-ray absorptiometry, adipokines and disease characteristics along with cardiovascular risk scoring QRISK3 and carotid intimal medial thickness (CIMT) was collected. Individuals with a QRISK3 ≥ 10% or CIMT of ≥ 75 percentile of the general population were categorised as HCVR. Predictors of HCVR were determined by logistic regression. HCVR was detected in 39 (34.2%) of the patients. After adjusting for all the factors, sarcopenia (aOR-15.83; 95% CI 1.16-215.48; p = 0.038) and presence of any traditional CV comorbidity (aOR: 18.97; 95% CI 1.63-221.29; p = 0.019) were associated with HCVR. nPsA-SpA had a 97% lesser chance of having HCVR as compared to PsA. The ROC curve analysis for the multiple logistic regression model which estimated the AUC as 0.787 (95% CI 0.701-0.874) and a P value < 0.001. Adipokine levels correlated well with body composition, but not with HCVR. PsA has a higher CV risk and the mechanisms for the same are poorly understood. Sarcopenia is an important determinant of HCVR and may be due to ectopic adipose tissue deposition in skeletal muscles. Focused physical therapy to prevent sarcopenia, optimum treatment of traditional CV risk factors and adequate disease control may help in preventing atherosclerosis in SpA.


Assuntos
Artrite Psoriásica/fisiopatologia , Doenças Cardiovasculares/etiologia , Espondilartrite/fisiopatologia , Adipocinas/sangue , Adulto , Artrite Psoriásica/complicações , Índice de Massa Corporal , Espessura Intima-Media Carotídea , Estudos Transversais , Feminino , Fatores de Risco de Doenças Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Espondilartrite/complicações
3.
Ann Rheum Dis ; 81(3): 359-369, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34819273

RESUMO

OBJECTIVE: To evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi). METHODS: Adults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi due to IR (lack of efficacy or intolerance) were randomised (2:1) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44. Patients receiving placebo crossed over to guselkumab at week 24. The primary (ACR20) and key secondary (change in HAQ-DI, ACR50, change in SF-36 PCS and PASI100) endpoints, at week 24, underwent fixed-sequence testing (two-sided α=0.05). Adverse events (AEs) were assessed through week 56. RESULTS: Among 285 participants (female (52%), one (88%) or two (12%) prior TNFi), 88% of 189 guselkumab and 86% of 96 placebo→guselkumab patients completed study agent through week 44. A statistically significantly higher proportion of patients receiving guselkumab (44.4%) than placebo (19.8%) achieved ACR20 (%difference (95% CI): 24.6 (14.1 to 35.2); multiplicity-adjusted p<0.001) at week 24. Guselkumab was superior to placebo for each key secondary endpoint (multiplicity-adjusted p<0.01). ACR20 response (non-responder imputation) in the guselkumab group was 58% at week 48; >80% of week 24 responders maintained response at week 48. Through week 24, serious AEs/serious infections occurred in 3.7%/0.5% of 189 guselkumab-randomised and 3.1%/0% of 96 placebo-randomised patients; the guselkumab safety profile was similar through week 56, with no deaths or opportunistic infections. CONCLUSION: Guselkumab significantly improved joint and skin manifestations and physical function in patients with TNFi-IR PsA. A favourable benefit-risk profile was demonstrated through 1 year. TRIAL REGISTRATION NUMBER: NCT03796858.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Idoso , Artrite Psoriásica/fisiopatologia , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Articulações/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Pele/efeitos dos fármacos , Resultado do Tratamento
4.
Int J Rheum Dis ; 25(1): 47-55, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34821039

RESUMO

BACKGROUND: This study was planned to evaluate the strength, proprioception, skill, coordination, and functional condition of the hand in individuals with psoriatic arthritis and to correlate disease activity with these parameters. METHODS: Fifty-six individuals (psoriatic arthritis group, n = 36; control group, n = 20) were included in the study. Evaluations were performed of disease activity with Disease Activity Score 28; grip strength with a dynamometer and pinch strength with pinch gauge dynamometers; joint position sensation with a goniometer; finger skills with a mobile application; and coordination and skill of both hands with the Purdue Pegboard test. The Michigan Hand Outcomes Questionnaire (MHQ) was used for hand functional evaluation. RESULTS: There was a significant difference between the grip and pinch strength of the psoriatic arthritis group and the control group (P < 0.05). There was no significant difference between the joint position sense measurements and the mobile application scores between the groups (P > 0.05). Purdue Pegboard scores showed a significant difference only in both hands and assembly subsections (P < 0.05). With Disease Activity Score 28, significant correlations were found between grip and pinch strength, mobile application scores, Purdue Pegboard all subsections, and left-hand joint position sense average error amount, and between MHQ and grip and pinch strength. CONCLUSIONS: This study is the first to show that psoriatic arthritis has a negative effect especially on hand strength; grip strength decreases as disease severity increases and, skill, coordination, and functionality of hand deteriorate.


Assuntos
Artrite Psoriásica/fisiopatologia , Força da Mão , Mãos/fisiopatologia , Adulto , Idoso , Estudos de Casos e Controles , Estudos Transversais , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Propriocepção , Índice de Gravidade de Doença , Inquéritos e Questionários
5.
Isr Med Assoc J ; 23(7): 412-415, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34251122

RESUMO

BACKGROUND: Psoriatic arthritis (PsA) is an inflammatory rheumatic disease characterized by different phenotypes in terms of joint involvement. The so-called oligoarticular pattern involves fewer than five active joints at a different time points. The evaluation of disease activity in this subset of patients is an unmet need due to the lack of specific indices able to capture modifications over time. OBJECTIVES: To evaluate the ability of musculoskeletal ultrasound to monitor the response to apremilast treatment in oligoarticular PsA patients. METHODS: We evaluated 24 oligoarticular patients (19 women, 5 men; median age 56 years, interquartile range (IQR) 19; median disease duration 5 years, IQR 5.75). All patients were assessed at baseline (T0), and after 6 (T1), 12 (T2), and 24 (T3) weeks. Clinical assessment included evaluation of 66 swollen joints and patient global health assessment. All the patients underwent ultrasound assessment of the clinically involved joints. Synovial effusion/hypertrophy and power Doppler were scored with a semi-quantitative scale (0-3). The total inflammatory score was the sum of the scores. RESULTS: We found a reduction in the ultrasound inflammatory score at all time points, with a significant improvement at 6 and 12 weeks of treatment compared with baseline: T0 median 8.5 (IQR 5.0); T1 3.5 (3.0); T2 2.0 (3.5); P = 0.01. We observed a significant reduction of patient global health assessment after 24 weeks (T0 median 50 (32.5); T3 40 (57.5); P = 0.01). CONCLUSIONS: Musculoskeletal ultrasound could be useful in the assessment of treatment response in PsA patients with oligoarticular subset.


Assuntos
Artrite Psoriásica , Monitoramento de Medicamentos/métodos , Membrana Sinovial , Talidomida/análogos & derivados , Ultrassonografia/métodos , Anti-Inflamatórios não Esteroides/administração & dosagem , Artrite Psoriásica/diagnóstico por imagem , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/fisiopatologia , Feminino , Humanos , Inflamação/diagnóstico , Masculino , Pessoa de Meia-Idade , Escores de Disfunção Orgânica , Tamanho do Órgão , Gravidade do Paciente , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Líquido Sinovial/diagnóstico por imagem , Membrana Sinovial/diagnóstico por imagem , Membrana Sinovial/imunologia , Membrana Sinovial/patologia , Talidomida/administração & dosagem
6.
Ann Rheum Dis ; 80(12): 1553-1558, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34215648

RESUMO

OBJECTIVE: To investigate whether ultrasonography (US), as an objective imaging modality, can optimise the evaluation of disease activity in psoriatic arthritis (PsA) patients with concomitant fibromyalgia syndrome (FMS). METHODS: The study population included 156 consecutive PsA patients who were recruited prospectively and fulfilled the ClASsification criteria for Psoriatic ARthritis criteria. The patients underwent complete clinical evaluation including assessment of fulfilment of the 2016 fibromyalgia classification criteria. All of the patients underwent US evaluation including 52 joints, 40 tendons and 14 entheses. The US score was based on the summation of a semiquantitative score (including synovitis, tenosynovitis and enthesitis). Scoring was performed by a sonographer blinded to the clinical data. Spearman's correlation coefficient and multivariate linear regression models were used to examine the association of FMS with clinical and the US scores. RESULTS: Forty-two patients (26.9%) with coexisting PsA and FMS were compared with 114 (73.1%) PsA patients without FMS. Patients with PsA and FMS had significantly increased scores for clinical composite indices, including non-Minimal Disease Activity, Composite Psoriatic Disease Activity Index (CPDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS) (p<0.001). In contrast, the total US score and its subcategories were similar for those with and without FMS. The total US score significantly correlated with CPDAI, DAPSA and PASDAS (p<0.001) in the PsA without FMS but not in the PsA with FMS group. FMS was significantly associated with higher clinical scores (p<0.001) but not with the US score (multivariable linear regression models). CONCLUSIONS: US has significantly greater value than composite clinical scores in the assessment of disease activity in PsA patients with FMS.


Assuntos
Artrite Psoriásica/diagnóstico por imagem , Fibromialgia/fisiopatologia , Ultrassonografia , Adulto , Idoso , Artrite Psoriásica/complicações , Artrite Psoriásica/fisiopatologia , Estudos de Casos e Controles , Entesopatia/diagnóstico por imagem , Entesopatia/fisiopatologia , Feminino , Fibromialgia/complicações , Humanos , Masculino , Pessoa de Meia-Idade , Sinovite/diagnóstico por imagem , Sinovite/fisiopatologia , Tenossinovite/diagnóstico por imagem , Tenossinovite/fisiopatologia
7.
Ann Rheum Dis ; 80(11): 1419-1428, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34162594

RESUMO

OBJECTIVES: To evaluate 6-month effectiveness of ustekinumab versus tumour necrosis factor inhibitor (TNFi), analysing predictors of low disease activity (LDA)/remission. METHODS: PsABio is a prospective, observational cohort study of patients with psoriatic arthritis (PsA) at 92 sites in eight European countries, who received first-line to third-line ustekinumab or a TNFi. Comparative achievement at 6 months of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) LDA/remission, and minimal disease activity (MDA)/very LDA using propensity score (PS)-adjusted multivariate logistic regression was assessed. RESULTS: In the final analysis set of 868 participants with 6-month follow-up data (ustekinumab, n=426; TNFi, n=442), with long-standing disease and a high mean cDAPSA score (31.0 vs 29.8, respectively), proportions of patients in ustekinumab/TNFi treatment groups achieving cDAPSA LDA at 6 months were 45.7%/50.7%. cDAPSA remission was achieved in 14.9%/19.2%, and MDA in 26.4%/30.8% of patients. PS-adjusted odds ratios (OR; 95% confidence interval (CI)) of reaching cDAPSA LDA and MDA were 0.73 (0.46 to 1.15) and 0.87 (0.61 to 1.25) with ustekinumab versus TNFi, indicating no significant difference. High baseline body mass index or high cDAPSA were associated with a lower chance (OR (95% CI)) of reaching cDAPSA LDA with TNFi (0.94 (0.89 to 0.99) and 0.64 (0.52 to 0.79), respectively). Predictive factors were similar to previously published evidence, with cDAPSA and 12-item Psoriatic Arthritis Impact of Disease scores and chronic widespread pain at baseline appearing as new risk factors for unfavourable outcome. Safety data were similar between groups. CONCLUSION: Treatment targets were reached similarly after 6 months of treatment with ustekinumab and TNFi.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Ustekinumab/uso terapêutico , Adulto , Artrite Psoriásica/fisiopatologia , Estudos de Coortes , Feminino , Humanos , Interleucina-12/antagonistas & inibidores , Interleucina-23/antagonistas & inibidores , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
8.
Exp Dermatol ; 30(12): 1834-1837, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34192381

RESUMO

Psoriasis and psoriatic arthritis (PsA) are interrelated inflammatory diseases. Psoriasis usually precedes PsA onset and represents a well-established risk factor for PsA development. Bone erosion is a hallmark of PsA, and the contribution of cutaneous psoriatic inflammation in this process has been demonstrated. However, little is still known on the pathogenetic mechanisms that link psoriatic skin to joint damage. Clinical features of psoriatic disease, including specific body site involvement, seem to be important risk predictors of PsA. The aim of this pilot research study was to investigate if psoriatic cutaneous inflammation, affecting these anatomical predictive sites for PsA, could be linked to osteoclast differentiation and activity. Our results showed that psoriasis skin localizations were positively related to the osteoclastogenic profile in psoriatic patients. These results provide new insights into the fascinating skin-joint axis concept.


Assuntos
Artrite Psoriásica/fisiopatologia , Osteoclastos/patologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
9.
Ann Rheum Dis ; 80(11): 1410-1418, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34083206

RESUMO

BACKGROUND: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during treatment with tumour necrosis factor inhibitors (TNFi) is extensively used in psoriatic arthritis (PsA), although the additive benefit remains unclear. We aimed to compare treatment outcomes in patients with PsA treated with TNFi and csDMARD comedication versus TNFi monotherapy. METHODS: Patients with PsA from 13 European countries who initiated a first TNFi in 2006-2017 were included. Country-specific comparisons of 1 year TNFi retention were performed by csDMARD comedication status, together with HRs for TNFi discontinuation (comedication vs monotherapy), adjusted for age, sex, calendar year, disease duration and Disease Activity Score with 28 joints (DAS28). Adjusted ORs of clinical remission (based on DAS28) at 12 months were calculated. Between-country heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Secondary analyses stratified according to TNFi subtype (adalimumab/infliximab/etanercept) and restricted to methotrexate as comedication were performed. RESULTS: In total, 15 332 patients were included (62% comedication, 38% monotherapy). TNFi retention varied across countries, with significant heterogeneity precluding a combined estimate. Comedication was associated with better remission rates, pooled OR 1.25 (1.12-1.41). Methotrexate comedication was associated with improved remission for adalimumab (OR 1.45 (1.23-1.72)) and infliximab (OR 1.55 (1.21-1.98)) and improved retention for infliximab. No effect of comedication was demonstrated for etanercept. CONCLUSION: This large observational study suggests that, as used in clinical practice, csDMARD and TNFi comedication are associated with improved remission rates, and specifically, comedication with methotrexate increases remission rates for both adalimumab and infliximab.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adalimumab/uso terapêutico , Adulto , Artrite Psoriásica/fisiopatologia , Quimioterapia Combinada , Etanercepte/uso terapêutico , Feminino , Humanos , Infliximab/uso terapêutico , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Indução de Remissão , Resultado do Tratamento
10.
Ann Rheum Dis ; 80(9): 1147-1157, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33985942

RESUMO

OBJECTIVES: To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA). METHODS: In this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs). RESULTS: 391/500 patients screened were randomised and treated. At W24, 71.4%-79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms. CONCLUSIONS: Tildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Adulto , Artrite Psoriásica/fisiopatologia , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Glucocorticoides/uso terapêutico , Humanos , Leflunomida/uso terapêutico , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Sulfassalazina/uso terapêutico
11.
Rheumatol Int ; 41(6): 1065-1077, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33885930

RESUMO

Psoriatic arthritis (PsA) is a chronic inflammatory disease characterized by involvement of skin, axial and peripheral skeleton. An altered balance between extracellular matrix (ECM) formation and breakdown is a key event in PsA, and changes in ECM protein metabolites may provide insight to tissue changes. Dietary fish oils (n-3 PUFA) might affect the inflammation driven tissue turnover. The aim was to evaluate ECM metabolites in patients with PsA compared to healthy individuals and investigate the effects of n-3 PUFA. The 24-week randomized, double-blind, placebo-controlled trial of PUFA included 142 patients with PsA. Fifty-seven healthy individuals were included for comparison. This study is a sub-study investigating biomarkers of tissue remodelling as secondary outcomes. Serum samples at baseline and 24 weeks and healthy individuals were obtained, while a panel of ECM metabolites reflecting bone and soft tissue turnover were measured by ELISAs: PRO-C1, PRO-C3, PRO-C4, C1M, C3M, C4M, CTX-I and Osteocalcin (OC). C1M, PRO-C3, PRO-C4 and C4M was found to be elevated in PsA patients compared to the healthy individuals (from 56 to 792%, all p < 0.0001), where no differences were found for OC, CTX-I, PRO-C1 and C3M. PRO-C3 was increased by 7% in patients receiving n-3 PUFA after 24 weeks compared to baseline levels (p = 0.002). None of the other biomarkers was changed with n-3 PUFA treatment. This indicates that tissue turnover is increased in PsA patients compared to healthy individuals, while n-3 PUFA treatment for 24 weeks did not have an effect on tissue turnover. Trial registration NCT01818804. Registered 27 March 2013-Completed 18 February 2016. https://clinicaltrials.gov/ct2/show/NCT01818804?term=NCT01818804&rank=1.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Proteínas da Matriz Extracelular/efeitos dos fármacos , Ácidos Graxos Ômega-3/farmacologia , Adulto , Artrite Psoriásica/fisiopatologia , Biomarcadores/metabolismo , Método Duplo-Cego , Proteínas da Matriz Extracelular/metabolismo , Ácidos Graxos Ômega-3/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
12.
Ann Rheum Dis ; 80(11): 1400-1409, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-33926921

RESUMO

OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA). METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication). RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched. CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.


Assuntos
Adalimumab/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Adulto , Idoso , Artrite Psoriásica/fisiopatologia , Artrite Reumatoide/fisiopatologia , Estudos de Coortes , Pesquisa Comparativa da Efetividade , Dinamarca , Substituição de Medicamentos , Feminino , Humanos , Modelos Logísticos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Sistema de Registros , Espondiloartropatias/tratamento farmacológico , Espondiloartropatias/fisiopatologia , Resultado do Tratamento
14.
Turk J Med Sci ; 51(4): 1601-1614, 2021 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-33581710

RESUMO

Psoriatic arthritis (PsA) is an underdiagnosed entity with a broad impact on the quality of life. Although the pathogenesis is largely unknown, autoimmune footprints of the inflammation in PsA have increasingly been recognized. Most of the genetic variation predisposing to PsA is mapped to the class I major histocompatibility complex (MHC) region and shared by a variety of autoimmune diseases. Polymorphisms in the genes IL12B, IL23R, IL13, TNIP1, TRAF3IP2, TYK2, and many others explain the non- HLA genetic risk with little known functional consequences. Entheseal and synovial cellular infiltrate with oligoclonal CD8+ T cells and occasional germinal centers, loss of regulatory T cell function, and specific autoantibodies such as anti-PsA peptide, anti-LL-37, and anti-ADAMTSL5 are the immunopathological findings suggestive of autoimmunity. These were supported by clinical observations of autoimmune multimorbidity and treatment response to calcineurin/mTOR and co-stimulation inhibition.


Assuntos
Artrite Psoriásica/genética , Artrite Psoriásica/fisiopatologia , Doenças Autoimunes/genética , Autoimunidade , Artrite Psoriásica/imunologia , Doenças Autoimunes/fisiopatologia , Predisposição Genética para Doença , Humanos , Qualidade de Vida
16.
Rheumatology (Oxford) ; 60(8): 3669-3678, 2021 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-33394051

RESUMO

OBJECTIVES: PsA is characterized by enthesitis, synovitis and osseous involvement in the peripheral and axial joints. Few studies have examined axial involvement in PsA using imaging techniques. Here we examined axial involvement in PsA patients using MRI. In addition, we determined the efficacy of 24 week adalimumab treatment in improving the MRI findings of spondylitis and sacroiliitis. METHODS: This was a prospective, open-label, single-arm study in patients with PsA. Adalimumab was administered to patients for a total of 24 weeks. MRI examinations were conducted at baseline and at week 24 of adalimumab treatment. RESULTS: Thirty-seven patients with PsA were included in this study. Spondylitis was observed in at least one site of the positive scan in 91% (n = 31) of patients with PsA. The number of arthritic sites in the cervical, thoracic and lumbar regions of the spine was 48, 67 and 53, respectively. All patients had MRI-determined sacroiliitis of grade ≥1 severity while 28 patients (82%) had grade ≥2 sacroiliitis in at least one sacroiliac region. Sacroiliac arthritis was statistically more severe on the right side than on the left side (P < 0.05). In 34 patients with PsA, the thoracic spine was the most common site of spondylitis. In addition, 24 week adalimumab treatment led to an improvement in the mean number of spondylitis sites and the mean grade of sacroiliitis. CONCLUSION: Treatment with adalimumab for 24 weeks resulted in improvement in spondylitis and sacroiliitis.


Assuntos
Adalimumab/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Adulto , Idoso , Artrite Psoriásica/diagnóstico por imagem , Artrite Psoriásica/fisiopatologia , Feminino , Humanos , Japão , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sacroileíte/diagnóstico por imagem , Sacroileíte/fisiopatologia , Espondilite/diagnóstico por imagem , Espondilite/fisiopatologia , Vértebras Torácicas/diagnóstico por imagem
17.
Arthritis Care Res (Hoboken) ; 73(4): 593-602, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-31961492

RESUMO

OBJECTIVE: We evaluated the psychometric properties of 3 patient-reported outcome measures to assess the physical function in psoriatic arthritis (PsA). METHODS: Data were available for the Health Assessment Questionnaire disability index (HAQ DI), the 12-item Short Form instrument physical component summary (SF-12 PCS), and the Psoriatic Arthritis Impact of Disease instrument functional capacity score (PsAID-FC). Data came from a longitudinal study in 14 countries of consecutive adults with definite PsA with ≥2 years of duration. The score distribution, construct validity, responsiveness, and thresholds of meaning of the patient-reported outcome measures were evaluated. RESULTS: At baseline, 414 subjects (52% male) were analyzed. The mean ± SD age was 52.4 ± 12.5 years and duration of illness was 10.9 ± 8.1 years. Ceiling effects were noted in 31% and 21% of patients for HAQ DI and PsAID-FC, respectively; floor effects were minimal. All 3 patient-reported outcome measures met a priori hypotheses for construct validity. After a median follow-up of 4.1 (interquartile range 2.7) months in 350 patients, 27%, 54%, and 18% of patients reported themselves improved, not changed, and worsened, respectively. Change scores were statistically different for groups for worsening versus no-change for all patient-reported outcome measures. PsAID-FC was more sensitive to change than the other 2 patient-reported outcome measures. Comparing groups with worsening condition to no-change, the standardized response mean square ratios were HAQ DI 29.9, SF-12 PCS 16.7, and PsAID-FC 40.1. CONCLUSION: HAQ DI, SF-12 PCS, and PsAID-FC are valid measures of physical function for PsA. PsAID-FC, a single question, performed similarly to the other patient-reported outcome measures and may be an additional option to measure PsA-specific physical function.


Assuntos
Artrite Psoriásica/diagnóstico , Indicadores Básicos de Saúde , Medidas de Resultados Relatados pelo Paciente , Adulto , Idoso , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/fisiopatologia , Feminino , Estado Funcional , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Psicometria , Reprodutibilidade dos Testes , Resultado do Tratamento
19.
Rheumatology (Oxford) ; 60(4): 1755-1762, 2021 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-33097960

RESUMO

OBJECTIVES: Our aim is to understand clinical characteristics, real-life treatment strategies, outcomes of early PsA patients and determine the differences between the inception and established PsA cohorts. METHODS: PsArt-ID (Psoriatic Arthritis- International Database) is a multicentre registry. From that registry, patients with a diagnosis of PsA up to 6 months were classified as the inception cohort (n==388). Two periods were identified for the established cohort: Patients with PsA diagnosis within 5-10 years (n = 328), ≥10 years (n = 326). Demographic, clinical characteristics, treatment strategies, outcomes were determined for the inception cohort and compared with the established cohorts. RESULTS: The mean (s.d.) age of the inception cohort was 44.7 (13.3) and 167/388 (43.0%) of the patients were male. Polyarticular and mono-oligoarticular presentations were comparable in the inception and established cohorts. Axial involvement rate was higher in the cohort of patients with PsA ≥10 years compared with the inception cohort (34.8% vs 27.7%). As well as dactylitis and nail involvement (P = 0.004, P = 0.001 respectively). Both enthesitis, deformity rates were lower in the inception cohort. Overall, 13% of patients in the inception group had a deformity. MTX was the most commonly prescribed treatment for all cohorts with 10.7% of the early PsA patients were given anti-TNF agents after 16 months. CONCLUSION: The real-life experience in PsA patients showed no significant differences in the disease pattern rates except for the axial involvement. The dactylitis, nail involvement rates had increased significantly after 10 years from the diagnosis and the enthesitis, deformity had an increasing trend over time.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/fisiopatologia , Adulto , Antirreumáticos/uso terapêutico , Estudos de Coortes , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Articulações dos Dedos/fisiopatologia , Glucocorticoides/uso terapêutico , Humanos , Deformidades Articulares Adquiridas/fisiopatologia , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Doenças da Unha/tratamento farmacológico , Doenças da Unha/fisiopatologia , Medidas de Resultados Relatados pelo Paciente , Sistema de Registros , Sulfassalazina/uso terapêutico , Inibidores do Fator de Necrose Tumoral/uso terapêutico
20.
Ann Rheum Dis ; 80(1): 103-108, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33115761

RESUMO

OBJECTIVES: To assess axial involvement on MRI in early peripheral spondyloarthritis (pSpA) and to evaluate whether axial inflammation predicts relapse on treatment withdrawal. METHODS: Fifty-six patients with early, active, newly diagnosed pSpA underwent MRI of the sacroiliac joints (SIJs) and spine prior to golimumab initiation. At sustained clinical remission of pSpA, treatment was withdrawn and a second MRI was performed. Bone marrow oedema (BME) was scored by three readers according to the Spondyloarthritis Research Consortium of Canada (SPARCC) method. Scores were compared with an axial spondyloarthritis cohort (Belgian Arthritis and Spondylitis cohort). Structural lesions were assessed using a similar method. Furthermore, fulfilment of the Assessment of Spondyloarthritis International Society (ASAS) definition of a positive MRI for sacroiliitis was assessed. Spinal images were evaluated for BME and structural lesions using the Canada-Denmark MRI spine scoring system by two readers. RESULTS: Thirty-six per cent showed SIJ BME at baseline, all fulfilling the ASAS definition of sacroiliitis. No association with back pain was found. Twenty-one per cent displayed SIJ structural lesions. Spinal BME was limited: the median inflammation scores were low and no patients had ≥5 inflammatory corner lesions. On clinical remission, a significant decrease in SIJ SPARCC scores was detected. On clinical remission, no significant differences in SIJ SPARCC scores were noted between patients relapsing and those maintaining remission after treatment discontinuation. CONCLUSION: In patients with early pSpA, a surprisingly high prevalence of sacroiliitis on MRI was observed; SPARCC scores decreased significantly on tumour necrosis factor inhibition. Residual inflammation on MRI was not predictive of relapse of peripheral manifestations. No relevant inflammatory spinal involvement was detected. Collectively, our findings suggest a higher inflammatory burden in patients with early pSpA than anticipated.


Assuntos
Artrite Psoriásica/diagnóstico por imagem , Medula Óssea/diagnóstico por imagem , Edema/diagnóstico por imagem , Sacroileíte/diagnóstico por imagem , Adulto , Anticorpos Monoclonais/uso terapêutico , Artrite Psoriásica/complicações , Artrite Psoriásica/tratamento farmacológico , Artrite Psoriásica/fisiopatologia , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Articulação Sacroilíaca/diagnóstico por imagem , Sacroileíte/complicações , Sacroileíte/fisiopatologia , Espondiloartropatias/diagnóstico por imagem , Espondiloartropatias/tratamento farmacológico , Espondiloartropatias/fisiopatologia , Inibidores do Fator de Necrose Tumoral/uso terapêutico
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