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2.
Arthritis Rheumatol ; 2021 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-33538097

RESUMO

AIM: To investigate whether TNF inhibitors (TNFi) impact spinal radiographic progression in patients with axial spondyloarthritis (axSpA) and whether this is coupled to their effect on inflammation. METHODS: Patients with axSpA fulfilling the modified New York criteria were included in this prospective cohort (ALBERTA FORCAST). Spine radiographs, done every 2 years up to 10 years, were scored by 2 central readers, using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The indirect effect of TNFi on mSASSS was evaluated with generalized estimating equations by testing the interaction between TNFi and ASDAS at the start of each 2-year interval (t). If significant, the association between ASDAS at t and mSASSS at the end of the interval (t+1) was assessed in: i. patients treated with TNFi in all visits; ii. some visits and iii. never treated. In addition, the association between TNFi at t and mSASSS at t+1 (adjusting for ASDAS at t) was also tested (direct effect). RESULTS: In total, 314 patients were included. A gradient was seen for the effect of ASDAS at t on mSASSS at t+1 (interaction p-value 0.10), with a higher progression in patients never treated with TNFi [ß (95% CI): 0.41 (0.13; 0.68)] compared to those continuously treated [0.16 (0.00;0.31)] (indirect effect). However, TNFi also directly slowed progression as treated patients had on average 0.85 mSASSS-units less on t+1 compared to those not treated [-0.85 (-1.35; -0.35)]. CONCLUSION: TNFi reduce spinal radiographic progression in patients with radiographic axSpA which might be partially uncoupled from their effects on ASDAS inflammation.

5.
RMD Open ; 6(2)2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32868452

RESUMO

OBJECTIVES: To compare the construct validity of three presenteeism instruments, using health and economic outcomes as external references, among working persons reporting musculoskeletal complaints. METHODS: Data from the prospective Study on Transitions in Employment, Ability and Motivation were used. Presenteeism measurement comprised a global rating of work-ability, and two instruments indicating at-work productivity, and was assessed yearly over 6 years of follow-up. Longitudinal associations between measures of health and subsequent presenteeism, and between presenteeism and subsequent days of sick leave were assessed using generalised estimating equation models. The effect of groups of contextual factors (socio-demographic, lifestyle, personal and work-related factors) was investigated by assessing the change in explained variability. RESULTS: In total, 4523 persons were analysed. The association between physical health and work-ability was stronger than both at-work productivity measures; 10 points increase in physical health (0-100, higher is better) was associated with 0.79 points (95% CI 0.75 to 0.84) better work-ability (0-10, higher is better) in the subsequent year. Besides, work-ability best predicted sick leave; one point higher work-ability was associated with 4 days less sick leave (95% CI -5.09 to -3.63) the subsequent year. Personal factors improved model fit for models on health and work-ability, but conflicting results were seen for both at-work productivity instruments. CONCLUSION: Work-ability showed higher construct validity against health and economic outcomes as compared to at-work productivity, which shows that work-ability is different to productivity (losses). Personal factors are especially relevant when interpreting the relation between health and work-ability or self-reported quantity of work.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32976683

RESUMO

OBJECTIVE: To compare the sensitivity to change of different imaging scoring methods in patients with early axial spondyloarthritis (axSpA). METHODS: Patients from the DESIR cohort fulfilling the ASAS axSpA criteria were included. Radiographs and MRI of the sacroiliac joints (SIJ) and spine were obtained at baseline, 1, 2 and 5 years. Each image was scored by 2 or 3 readers in 3 separate 'reading-waves'. The rate of change of outcomes measuring spinal and SIJ inflammation (e.g. SPARCC score) and structural damage on MRI (e.g. ≥3 fatty lesions) and radiographs (e.g. mNY grading) was assessed using multilevel generalized estimating equations (GEE) models (taking all readers and waves into account). To allow comparisons across outcomes, rates were standardized (difference between the individual's value and the population mean divided by the standard deviation). RESULTS: In total, 345 patients were included. Inflammation on MRI-SIJ (standardized rate range: -0.278; -0.441) was more sensitive to change compared to spinal inflammation (range: -0.030; -0.055). Structural damage in the SIJ showed a higher standardized rate of change on MRI-SIJ (range: 0.015-0.274) compared to X-SIJ (range: 0.043-0.126). MRI-SIJ damage defined by ≥3 fatty lesions showed the highest sensitivity to change (0.274). Spinal structural damage slowly progressed over time with no meaningful difference between radiographic (range: 0.037-0.043) and MRI structural outcomes (range: 0.008-0.027). CONCLUSION: Structural damage assessed in pelvic radiographs has low sensitivity to change, while fatty lesions detected on MRI-SIJ are a promising alternative. In contrast, MRI-spine is not better than X-spine in detecting structural changes in early axSpA patients.

7.
RMD Open ; 6(2)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32934010

RESUMO

BACKGROUND: Multidisciplinary collaboration is defined as a collective work involving multiple disciplines and is common in clinical care and research. Our aim was to describe current clinical and research collaboration among young specialists and to identify unmet needs in this area. METHODS: An online survey was disseminated by email and social media to members of the EMerging EUlar NETwork, the Young Nephrologists' Platform, the Paediatric Rheumatology European Society Emerging Rheumatologists and Researchers and the European Academy of Allergy and Clinical Immunology Junior Members. RESULTS: Of 303 respondents from 36 countries, 61% were female, 21% were aged below 30 years and 67% were aged 31-40 years. Young rheumatologists were the most represented (39%), followed by young nephrologists (24%), young paediatricians (20%), young allergologists (11%) then young internists (3%) and 3% other specialities. Collaborations were reported frequently by phone and email, also by various combined clinics while common local multidisciplinary meetings were uncommon. 96% would like to develop clinical research collaborations and 69% basic research collaborations. The majority of young specialists would be interested in online (84%) and/or 1-2 days (85%) common courses including case discussion (81%) and training workshops (85%), as well as webinars recorded with several specialists on a specific disease (96%). CONCLUSIONS: This collaborative initiative highlighted wishes from young specialists for developing (1) regular local multidisciplinary meetings to discuss complex patients, (2) clinical research collaboration with combined grants and (3) multidisciplinary online projects such as common courses, webinars and apps.

8.
Artigo em Inglês | MEDLINE | ID: mdl-32937029

RESUMO

OBJECTIVE: To test the impact of inflammation on MRI-structural changes occurring in the sacroiliac joints (SIJ) and the spine. METHODS: Patients with early axSpA from the DESIR cohort were included. MRIs of the SIJ (MRI-SIJ) and spine (MRI-spine), obtained at baseline, 2 and 5 years, were scored by 3 central readers. Inflammation and structural damage on MRI-SIJ/MRI-spine were defined by the agreement of ≥2 of 3 readers (binary outcomes), and by the average of 3 readers (continuous outcomes). The effect of inflammation (MRI-SIJ/MRI-spine) on damage (MRI-SIJ/MRI-spine, respectively) was evaluated in two models: i. Baseline prediction model: effect of baseline inflammation on damage assessed at 5-year; and ii. Longitudinal model: effect of inflammation on structural damage assessed during 5 years. RESULTS: 202 patients were included. Both the presence of bone marrow edema (BME) on MRI-SIJ and on MRI-spine at baseline were predictive of 5-year damage (≥3 fatty lesions) on MRI-SIJ [OR=4.2 (95% CI: 2.4; 7.3)] and MRI-spine [OR=10.7 (95% CI: 2.4; 49.0)], respectively, when adjusted for CRP. The association was also confirmed in longitudinal models (when adjusted for ASDAS) both in the SIJ [OR=5.1 (95% CI: 2.7; 9.6)] and spine [OR=15.6 (95% CI: 4.8; 50.3)]. Analysis of other structural outcomes (i.e. erosions) on MRI-SIJ yielded similar results. In the spine, a significant association was found for fatty lesions but not for erosions and bone spurs, which occurred infrequently over time. CONCLUSION: We found a predictive and longitudinal association between MRI-inflammation and several types of MRI-structural damage in patients with early axSpA which adds to the proof for a causal relationship.

9.
Arthritis Res Ther ; 22(1): 195, 2020 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-32825839

RESUMO

BACKGROUND: To investigate whether the reason to discontinue the first TNF inhibitor (TNFi) affects the response to the second TNFi in axial spondyloarthritis (axSpA). METHODS: Patients with axSpA from the Rheumatic Diseases Portuguese Register (ReumaPt), who discontinued their first TNFi and started the second TNFi between June 2008 and May 2018, were included. Response was assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement (ASDAS-CII), major important improvement (ASDAS-MI), low disease activity (ASDAS-LDA), and inactive disease (ASDAS-ID). The reason for discontinuation of the first TNFi was defined, according to ASDAS-CII as primary failure (no response ≤ 6 months), secondary failure (response ≤ 6 months but lost thereafter), adverse events, and others. The association between the reason for discontinuation of the first TNFi and response to the second TNFi over time was assessed in multivariable generalized equation (GEE) models. RESULTS: In total, 193 patients were included. The reason for discontinuation of the first TNFi did not influence the response to the second TNFi, according to the ASDAS-CII. However, a difference was found with more stringent outcomes, e.g., there was a higher likelihood to achieve ASDAS-ID with the second TNFi for patients discontinuing the first TNFi due to secondary failure (OR 7.3 [95%CI 1.9; 27.7]), adverse events (OR 9.1 [2.5; 33.3]), or other reasons (OR 7.7 [1.6; 37.9]) compared to primary failure. CONCLUSION: Patients with axSpA with secondary failure to their first TNFi, compared to those with primary failure, have a better response to the second TNFi according to stringent outcomes.

10.
Acta Reumatol Port ; 45(1): 26-33, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32572012

RESUMO

OBJECTIVE: The Assessments of SpondyloArthritis international Society Health Index (ASAS HI), estimates the impact of Spondyloarthritis (SpA) on global functioning and health. This article assesses the construct validity, reliability and responsiveness of the Portuguese version of the ASAS HI. PATIENTS AND METHODS: Patients fulfilling ASAS classification criteria for axial (axSpA) or peripheral SpA (pSpA) were included. Construct validity was assessed through Spearman's correlation analysis with other health outcomes. Discriminant validity was tested comparing the ASAS HI across disease activity and functional states using the Kruskal-Wallis test. Internal consistency was assessed by Cronbach's α, and test-retest reliability by intraclass correlation coefficients (ICC). Responsiveness was evaluated by the standardized response mean (SRM) in patients with active disease who required therapy escalation. RESULTS: Among the 91 patients included, 67% were male, mean (SD) age 47.2 (12.9) years, 63 patients with axSpA and 28 patients with pSpA. The hypothesis defined a priori to test construct validity were confirmed. The ASAS HI showed ability to discriminate between patients with different disease activity and functional states (p<0.001). Internal consistency (Cronbach's α: 0.88) and test-retest reliability [ICC=0.76 (95%CI 0.09-0.91)] were good. Responsiveness was moderate (SRM=-0.53). The smallest detectable change was 3.0. CONCLUSIONS: The Portuguese version of the ASAS HI is a comprehensible questionnaire that is valid, reliable and responsive. It can be used to assess the impact of SpA and its treatment on functioning and health, in clinical practice and for research purposes.

11.
RMD Open ; 6(1)2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32584783

RESUMO

OBJECTIVE: This study aims to (1) assess the perceived need for a postdoctoral (post-doc) mentoring programme in rheumatology, (2) describe the characteristics and organisational aspects of a pilot mentoring programme implemented by the EMerging European League Against Rheumatism NETwork (EMEUNET) and (3) report mentors' and mentees' evaluation of the pilot programme. METHODS: An online survey was conducted among young researchers in rheumatology to evaluate the need and preferred characteristics of a post-doc mentoring initiative. Informed by the survey, a pilot programme was designed and launched. The pilot programme was evaluated with 3-month, 6-moth and 12-month surveys and interviews with mentees and a 12-month survey among mentors, after completion. RESULTS: From 275 responses (43 countries, 86% from Europe) collected, analyses were restricted to the target population (total population=158; post-docs (n=103 (65%)) and PhD students (n=55 (35%))). There was a clear need (99% positive responses) for a post-doc mentoring programme. Discussions about current and new projects, and how to lead projects were ranked as priorities in post-doc mentoring. The most desired mentor attribute was generosity and interest in helping (86%), followed by research experience (68%) and having a well-established network (66%). The pilot programme included four mentees (through competitive application) allocated to three mentors. Evaluation surveys and interviews revealed that the programme organisation and content were well appreciated by mentees and mentors. CONCLUSIONS: The EMEUNET post-doc mentoring programme addresses unmet need for mentoring, is viable and appreciated by mentors and mentees. The programme structure and content are transferable to other fields where there is need for academic career mentoring.

12.
Arthritis Rheumatol ; 72(11): 1855-1862, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32562362

RESUMO

OBJECTIVE: To investigate the relationship between smoking and imaging outcomes over 5 years in axial spondyloarthritis (SpA) and to assess whether socioeconomic factors influence these relationships. METHODS: Axial SpA patients from the Devenir des Spondylarthropathies Indifferérenciées Récentes cohort were included. The following 4 imaging outcomes were assessed by 3 central readers at baseline, 2 years, and 5 years: spine radiographs (using the modified Stoke Ankylosing Spondylitis Spine Score [mSASSS]), sacroiliac (SI) joint radiographs (using the modified New York criteria), magnetic resonance imaging (MRI) of the spine (using the Spondyloarthritis Research Consortium of Canada [SPARCC] score), and MRI of the SI joint (using the SPARCC score). The explanatory variable of interest was smoking status at baseline. Interactions between smoking and socioeconomic factors (i.e., job type [blue-collar or manual work versus white-collar or nonmanual work] and education [low versus high]) were first tested, and if significant, analyses were run using separate strata. Generalized estimating equations models were used, with adjustments for confounders. RESULTS: In total, 406 axial SpA patients were included (52% male, 40% smokers, and 18% blue collar). Smoking was independently associated with more MRI-detected SI joint inflammation at each visit over the 5 years, an effect that was seen only in patients with blue-collar professions (ß = 5.41 [95% confidence interval (95% CI) 1.35, 9.48]) and in patients with low education levels (ß = 2.65 [95% CI 0.42,4.88]), using separate models. Smoking was also significantly associated with spinal inflammation (ß = 1.69 [95% CI 0.45, 2.93]) and SI joint damage (ß = 0.57 [95% CI 0.18, 0.96]) across all patients, irrespective of socioeconomic factors and other potential confounders. CONCLUSION: Strong associations were found between smoking at baseline and MRI-detected SI joint inflammation at each visit over a time period of 5 years in axial SpA patients with a blue-collar job or low education level. These findings suggest a possible role for mechanical stress amplifying the effect of smoking on axial inflammation in axial SpA.

13.
Artigo em Inglês | MEDLINE | ID: mdl-32417911

RESUMO

OBJECTIVES: To evaluate the occurrence and progression of facet joint ankylosis in the whole spine using low-dose CT (ldCT) in radiographic axial spondyloarthritis (r-axSpA) and compare progression of facet joint ankylosis and syndesmophytes. METHODS: Patients with r-axSpA from the Sensitive Imaging in Ankylosing Spondylitis (SIAS) cohort underwent ldCT at baseline (n = 60) and 2 years (n = 53). Facet joints (right and left, levels C2-S1) were scored as ankylosed, not ankylosed or unable to assess. Joints that were frequently poorly visible (>15% missing), were excluded. Inter-reader reliability on the patient level was assessed with intraclass correlation coefficients (ICCs) and smallest detectable change (SDC). Ankylosis was assessed at joint level and patient level for both timepoints. Syndesmophytes were assessed with CT syndesmophyte score. RESULTS: Levels C5-T2 were difficult to assess and excluded from all further analyses. Facet joint ICCs were good to excellent for status scores (0.72-0.93) and poor to excellent for progression scores (0.10-0.91). Facet joint ankylosis was detected at every level but most frequently in the thoracic joints. In total, 48% of patients showed 2-year progression. Most progression occurred in the thoracic segment. Using SDCs as cutoff, 18% of patients had progression of facet joint ankylosis only, whereas 20% of patients had progression of syndesmophytes only. CONCLUSION: This is the first study evaluating facet joints in the whole spine by ldCT in r-axSpA. Facet joint ankylosis was detected most often in the thoracic spine. Assessing facet joints in addition to syndesmophytes detected substantially more patients with damage progression over two years.

14.
RMD Open ; 6(1)2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32396521

RESUMO

OBJECTIVE: To study changes on MRI of the spine and sacroiliac joint (SIJ) in early axial spondyloarthritis (axSpA) over time. METHODS: In the Devenir des Spondyloarthropathies Indifférenciées Récentes cohort, MRI-spine and MRI-SIJ at baseline and 2 and 5 years were scored by central readers for bone marrow oedema (BME), fatty lesions, erosions, sclerosis, ankylosis and spinal bone spurs. The average mean number of lesions was reported or the agreement of ≥2 out of 3 readers for binary outcomes. Net progression was calculated by subtracting the patients that 'improved' from those that 'worsened' divided by the total number of patients. RESULTS: Over 5 years, in 155 patients with axSpA (mean age 33.5 (SD 8.9) years, symptom duration 1.4 (0.8) years, 63% human leucocyte antigen+, 14% modified New York+), BME on MRI-SIJ decreased by a mean Spondyloarthritis Research Consortium of Canada score of 1.4 (SD 6.5) (p=0.009). The largest BME decrease was observed in patients using biological disease-modifying antirheumatic drugs at 5 years. Spinal BME increased by 0.3 (4.6) (p=0.41). Fatty lesions and/or erosions on MRI-SIJ increased by a mean of 1.0 (SD 2.6) (p<0.001). Spinal fatty lesions and/or erosions increased by 0.2 (SD 0.5) (p<0.001). Compared with baseline, at 5 years, 7.3% less patients had BME on MRI-SIJ according to the Assessment of Spondyloarthritis International Society definition, while 6.6% more patients had ≥5 fatty lesions and/or erosions. At 5 years, 0.7% less patients had ≥5 spinal BME lesions and 0.7% less patients had ≥5 spinal fatty lesions. CONCLUSION: Over 5 years, BME on MRI-SIJ decreased and spinal BME remained similar, but numerically, little progression of structural lesions on MRI of the SIJ and spine was seen.

16.
RMD Open ; 6(1)2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-32144137

RESUMO

OBJECTIVES: To compare definitions of high disease activity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in selecting patients for treatment with biologic disease-modifying antirheumatic drugs (bDMARDs). METHODS: Patients from Rheumatic Diseases Portuguese Register (Reuma.pt) with a clinical diagnosis of axial spondyloarthritis (axSpA) were included. Four subgroups (cross-tabulation between ASDAS (≥2.1) and BASDAI (≥4) definitions of high disease activity) were compared regarding baseline characteristics and response to bDMARDs at 3 and 6 months estimated in multivariable regression models. RESULTS: Of the 594 patients included, the majority (82%) had both BASDAI≥4 and ASDAS ≥2.1. The frequency of ASDAS ≥2.1, if BASDAI<4 was much larger than the opposite (ie, ASDAS <2.1, if BASDAI≥4): 62% vs 0.8%. Compared to patients fulfilling both definitions, those with ASDAS ≥2.1 only were more likely to be male (77% vs 51%), human leucocyte antigen B27 positive (79% vs 65%) and have a higher C reactive protein (2.9 (SD 3.5) vs 2.1 (2.9)). Among bDMARD-treated patients (n=359), responses across subgroups were globally overlapping, except for the most 'stringent' outcomes. Patients captured only by ASDAS responded better compared to patients fulfilling both definitions (eg, ASDAS inactive disease at 3 months: 61% vs 25% and at 6 months: 42% vs 25%). CONCLUSION: The ASDAS definition of high disease activity is more inclusive than the BASDAI definition in selecting patients with axSpA for bDMARD treatment. The additionally 'captured' patients respond better and have higher likelihood of predictors thereof. These results support using ASDAS≥2.1 as a criterion for treatment decisions.

17.
Semin Arthritis Rheum ; 50(6): 1394-1399, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32209237

RESUMO

OBJECTIVE: To assess if an integrated longitudinal analysis using all available imaging data affects the precision of estimates of change in patients with axial spondyloarthritis (axSpA), with completers analysis as reference standard. METHODS: Patients from the DESIR cohort fulfilling the ASAS axSpA criteria were included. Radiographs and MRIs of the sacroiliac joints and spine were obtained at baseline, 1, 2 and 5 years. Each image was scored by 2 or 3 readers in 3 'reading-waves' (or campaigns). Each outcome was analyzed: i. According to a 'combination algorithm' (e.g. '2 out of 3' for binary scores); and ii. Per reader. Change over time was analyzed with generalized estimating equations by 3 approaches: (a)'integrated-analysis' (all patients with ≥1 score from ≥1 reader from all waves); (b1)Completers-only analysis (patients with 5-year follow-up, using scores from individual readers); (b2)Completers analysis using a 'combination algorithm' (as (b1) but with combined scores). Approaches (b1) and (b2) were considered the 'reference'. RESULTS: In total, 413 patients were included. The 'integrated analysis' was more inclusive with similar levels of precision of the change estimates as compared to both completers analyses. In fact, for low-incident outcomes (e.g.% mNY-positive over 5-years), an increased incidence was 'captured', with more precision, by the 'integrated analysis' compared to the completers analysis with combined scores (% change/year (95%CI): 1.1 (0.7; 1.5) vs 1.2 (0.5; 1.8), respectively). CONCLUSION: An efficient and entirely assumption-free 'integrated analysis' does not jeopardize precision of the estimates of change in imaging parameters and may yield increased statistical power for detecting changes with low incidence.

18.
Ann Rheum Dis ; 79(6): 744-759, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32033937

RESUMO

OBJECTIVES: To inform the 2019 update of the European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA). METHODS: A systematic literature research (SLR) to investigate the efficacy of any disease-modifying antirheumatic drug (DMARD) (conventional synthetic (cs)DMARD, biological (b) and biosimilar DMARD, targeted synthetic (ts)DMARD) or glucocorticoid (GC) therapy in patients with RA was done by searching MEDLINE, Embase and the Cochrane Library for articles published between 2016 and 8 March 2019. RESULTS: 234 abstracts were selected for detailed assessment, with 136 finally included. They comprised the efficacy of bDMARDs versus placebo or other bDMARDs, efficacy of Janus kinase (JAK) inhibitors (JAKi) across different patient populations and head-to-head of different bDMARDs versus JAKi or other bDMARDs. Switching of bDMARDs to other bDMARDs or tsDMARDs, strategic trials and tapering studies of bDMARDs, csDMARDs and JAKi were assessed. The drugs evaluated included abatacept, adalimumab, ABT-122, baricitinib, certolizumab pegol, SBI-087, CNTO6785, decernotinib, etanercept, filgotinib, golimumab, GCs, GS-9876, guselkumab, hydroxychloroquine, infliximab, leflunomide, mavrilimumab, methotrexate, olokizumab, otilimab, peficitinib, rituximab, sarilumab, salazopyrine, secukinumab, sirukumab, tacrolimus, tocilizumab, tofacitinib, tregalizumab, upadacitinib, ustekinumab and vobarilizumab. The efficacy of many bDMARDs and tsDMARDs was shown. Switching to another tumour necrosis factor inhibitor (TNFi) or non-TNFi bDMARDs after TNFi treatment failure is efficacious. Tapering of DMARDs is possible in patients achieving long-standing stringent clinical remission; in patients with residual disease activity (including patients in LDA) the risk of flares is increased during the tapering. Biosimilars are non-inferior to their reference products. CONCLUSION: This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Substituição de Medicamentos , Quimioterapia Combinada , Glucocorticoides/uso terapêutico , Humanos , Inibidores de Janus Quinases/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicamentos Sintéticos/uso terapêutico , Fator de Necrose Tumoral alfa/antagonistas & inibidores
19.
Ann Rheum Dis ; 79(6): 760-770, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32033941

RESUMO

OBJECTIVES: To perform a systematic literature review (SLR) concerning the safety of synthetic (s) and biological (b) disease-modifying anti rheumatic dugs (DMARDs) to inform the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis (RA). METHODS: An SLR of observational studies comparing safety outcomes of any DMARD with another intervention for the management of RA. A comparator group was required for inclusion. For treatments still without registry data (eg, sarilumab and the Janus kinase (JAK) inhibitors baricitinib, upadacitinib), randomised controlled trials (RCTs) and long-term extensions (LTEs) were used. Risk of bias (RoB) was assessed according to standard procedures. RESULTS: Forty-two observational studies fulfilled the inclusion criteria, addressing safety outcomes with bDMARDs and sDMARDs. Nine studies showed no difference in the risk of serious infections across bDMARDs and two studies (high RoB) showed an increased risk with bDMARDs compared with conventional synthetic (cs) DMARDs (adjusted incidence rate ratio 3.1-3.9). The risk of Herpes zoster infection was similar across bDMARDs, but one study showed an increased risk with tofacitinib compared with abatacept (adjusted HR (aHR) 2.0). Five studies showed no increased risk of cancer for bDMARDs compared with csDMARDs. An increased risk of lower intestinal perforation was found for tocilizumab compared with csDMARDs (aHR 4.5) and tumour necrosis factor inhibitor (TNFi) (aHR 2.6-4.0). Sixty manuscripts reported safety data from RCTs/LTEs. Overall, no unexpected safety outcomes were found, except for the possibly increased risk of venous thromboembolism (VTE) with JAK inhibitors. CONCLUSION: Data obtained by this SLR confirm the known safety profile of bDMARDs. The risk of VTE in RA, especially in patients on JAK inhibitors, needs further evaluation.


Assuntos
Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Infecções/induzido quimicamente , Perfuração Intestinal/induzido quimicamente , Produtos Biológicos/efeitos adversos , Doenças Cardiovasculares/induzido quimicamente , Herpes Zoster/induzido quimicamente , Humanos , Neoplasias/induzido quimicamente , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicamentos Sintéticos/efeitos adversos , Tromboembolia Venosa/induzido quimicamente
20.
Ann Rheum Dis ; 79(4): 453-459, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32094157

RESUMO

OBJECTIVES: To investigate whether following a treat-to-target (T2T)-strategy in daily clinical practice leads to more patients with rheumatoid arthritis (RA) meeting the remission target. METHODS: RA patients from 10 countries starting/changing conventional synthetic or biological disease-modifying anti-rheumatic drugs were assessed for disease activity every 3 months for 2 years (RA BIODAM (BIOmarkers of joint DAMage) cohort). Per visit was decided whether a patient was treated according to a T2T-strategy with 44-joint disease activity score (DAS44) remission (DAS44 <1.6) as the target. Sustained T2T was defined as T2T followed in ≥2 consecutive visits. The main outcome was the achievement of DAS44 remission at the subsequent 3-month visit. Other outcomes were remission according to 28-joint disease activity score-erythrocyte sedimentation rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definitions. The association between T2T and remission was tested in generalised estimating equations models. RESULTS: In total 4356 visits of 571 patients (mean (SD) age: 56 (13) years, 78% female) were included. Appropriate application of T2T was found in 59% of the visits. T2T (vs no T2T) did not yield a higher likelihood of DAS44 remission 3 months later (OR (95% CI): 1.03 (0.92 to 1.16)), but sustained T2T resulted in an increased likelihood of achieving DAS44 remission (OR: 1.19 (1.03 to 1.39)). Similar results were seen with DAS28-ESR remission. For more stringent definitions (CDAI, SDAI and ACR/EULAR Boolean remission), T2T was consistently positively associated with remission (OR range: 1.16 to 1.29), and sustained T2T had a more pronounced effect on remission (OR range: 1.49 to 1.52). CONCLUSION: In daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher rates of remission.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Planejamento de Assistência ao Paciente , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Idoso , Artrite Reumatoide/imunologia , Artrite Reumatoide/fisiopatologia , Sedimentação Sanguínea , Proteína C-Reativa/imunologia , Tomada de Decisão Clínica , Estudos de Coortes , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Fator Reumatoide/imunologia
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