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1.
Drug Saf ; 2020 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-32006348

RESUMO

INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). OBJECTIVE: Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments. METHODS: The tofacitinib "dose-comparison cohort" included months 0-12 of two phase III studies (tofacitinib 5 [n = 238] and 10 [n = 236] mg twice daily [BID]); the "all-tofacitinib comparison cohort" (n = 783) included two phase III and one ongoing long-term extension study (data cutoff May 2016). An "observational comparison cohort" (n = 5799) comprised patients initiating a conventional synthetic disease-modifying antirheumatic drug (DMARD), biologic DMARD, or apremilast in the US Truven MarketScan database from 2010 to 2015. IRs for serious infections (SIEs; requiring hospitalization), herpes zoster (HZ), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, and major adverse cardiovascular events (MACE) across cohorts were qualitatively compared. RESULTS: IRs (patients with events/100 patient-years) for SIEs were similar between the tofacitinib dose-comparison cohort (5 mg BID: 1.3; 10 mg BID: 2.0) and the observational comparison cohort (1.1-7.9; treatment dependent). The tofacitinib dose-comparison cohort had a higher rate of HZ (5 mg BID: 2.0; 10 mg BID: 2.7) than did the observational comparison cohort (0.8-2.0). IRs for NMSC were generally lower in the all-tofacitinib comparison cohort (0.5) than in the observational comparison cohort (0.4-6.0). IRs for MACE, malignancies excluding NMSC, and NMSC were similar between cohorts. CONCLUSION: In patients with PsA, tofacitinib had a safety profile similar to that of other systemic therapies in real-world settings, except for the risk of HZ, a known risk of tofacitinib. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.

2.
Clin Rheumatol ; 2020 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-31955325

RESUMO

AIMS: To (1) determine the reliability and validity of the Bristol Rheumatoid Arthritis Fatigue scale (BRAF-NRS) in patients with psoriatic arthritis (PsA) and (2) examine possible clinical associations of worse fatigue in PsA. METHODS: Study phase 1: BRAF-NRS scale validation cohort. A consecutive cohort of 70 PsA patients was recruited to complete the 3-item BRAF-NRS and the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaires, alongside disease activity assessment. All patients also completed the BRAF-NRS questionnaire, 1 day later. Study phase 2: Identifying the potential clinical associations of fatigue by using BRAF-NRS (n = 283). A second cohort of 283 PsA patients underwent detailed skin and rheumatologic assessments including disease activity measures. Comorbidities were measured using the Charlson comorbidity index (CCI). Factors predicting worse fatigue as measured by BRAF-NRS were determined using regression analysis. RESULTS: In phase 1, 67 out of 70 patients from the first cohort had complete assessments. The internal consistency of BRAF-NRS as measured by Cronbach's alpha was 0.92. Test-retest reliability as measured by the intra-class correlation coefficient was 0.97. There was excellent correlation between the BRAF-NRS and FACIT-F score(r = - 0.83) (p = <0.001, 95% CI - 0.74 to - 0.91). In phase 2, using data from the second cohort of 283 PsA patients, possible clinical associations of worse fatigue were examined. On multiple linear regression analyses, the model predicted significant association of worse fatigue scores with low education status (p = 0.03), number of deformed joints (p = 0.01), not achieving minimal disease activity state (p < 0.001), higher CCI scores, and worse health assessment questionnaire score (p < 0.001). CONCLUSIONS: BRAF-NRS is a reliable, reproducible, and valid instrument for measuring fatigue in PsA. Fatigue in PsA is associated with low education status and overall more severe disease.Key Points• Fatigue is increasingly recognized as an important measure to examine among patients with PsA, but the available valid fatigue scores in PsA are relatively long and time-consuming especially when other core domains also need to be measured• BRAF-NRS is a short, easily readable, only 3-item tool to measure fatigue, and this is the first study which has examined its performance among the patients with PsA. Our results show that it is a reliable, reproducible, and valid (construct validity) instrument for measuring fatigue in PsA• This study also clearly showed a significant positive relationship between fatigue and comorbidities, and it was also found that comorbidities play the largest role in the multivariate model.

3.
Clin Rheumatol ; 39(1): 167-175, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31522318

RESUMO

OBJECTIVES: Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) have been associated with generalized and localized bone loss. We conducted a comprehensive study using imaging (dual-energy X-ray absorptiometry, DXA) and laboratory biomarkers in order to determine bone health and to study the effects of anti-tumor necrosis factor (TNF) biologics in RA and AS. PATIENTS AND METHODS: Thirty-six RA and 17 AS patients undergoing 1-year etanercept (ETN) or certolizumab-pegol (CZP) therapy were studied. Bone density was assessed by DXA at baseline and after 12 months. Serum C-reactive protein (CRP), calcium, phosphate, parathyroid hormone (PTH), vitamin D3, osteocalcin, procollagen type I N-propeptide (P1NP), C-terminal telopeptide (ßCTX), osteoprotegerin, sclerostin (SOST), Dickkopf-1 (DKK-1), soluble receptor activator nuclear kappa B ligand (sRANKL), and cathepsin K (cathK) levels were determined at baseline and after 6 and 12 months. RESULTS: TNF-α inhibition was clinically effective. Anti-TNF-α halted further bone loss over 1 year. In general, anti-TNF therapy significantly increased P1NP, SOST levels, and the P1NP/ßCTX ratios, while decreased DKK-1 and CathK production at different time points in most patient subsets. In the full cohort and in RA, baseline and/or 12-month bone mineral density (BMD) at multiple sites exerted inverse relationships with CRP and ßCTX, and positive correlation with SOST. In AS, L2-4 BMD after 1-year biologic therapy inversely correlated with baseline ßCTX, while femoral neck BMD rather showed inverse correlations with CRP. CONCLUSIONS: Anti-TNF therapy slowed down generalized bone loss, in association with clinical improvements, in both diseases. TNF blockade may enhance bone formation and suppress joint destruction. Anti-TNF therapy may act inversely on DKK-1 and SOST. Independent predictors of BMD were SOST and ßCTX in RA, whilst CRP in AS.Key Points• One-year anti-TNF therapy halted generalized bone loss in association with clinical improvement in arthritides.• Anti-TNF therapy may inversely act on DKK-1 and SOST.• Independent predictors of BMD were SOST and ßCTX in RA, while CRP in AS.

4.
Ir J Med Sci ; 189(1): 237-243, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31129869

RESUMO

INTRODUCTION: Rheumatic disease (RD) patients when family planning must consider fertility, disease activity, and management from preconception to lactation. A clear understanding is necessary, especially for those receiving disease-modifying antirheumatic medications. Previous studies have highlighted unmet needs in the care of women with RDs with reproductive healthcare needs. This study describes the first published standardized reproductive care pathway for women with RDs and the outcomes of this approach. MATERIAL AND METHODS: We developed the care pathway with multidisciplinary input from rheumatologists, rheumatology nurse specialists, obstetricians, midwives, maternal medicine specialists, and pharmacists. We identified patients' emotional and healthcare needs, ensured access to expert advice, maintenance of good disease control, and positive reproductive outcomes. We prospectively followed the patients and report the results of the service. RESULTS: Ninety-eight women with median age (range) of 35 years (19-48) were assessed. The majority had an inflammatory arthritis. Seventy-six babies were born to 62 mothers. There were 12 miscarriages and one perinatal death. Breastfeeding rates at 6 weeks were low (28%). CONCLUSION: We describe the first published evidence-based integrated multidisciplinary reproductive care pathway for women with RDs and the results of this approach. Seventy percent of women successful in trying to conceive delivered a healthy baby, and 90% of patients were 'very satisfied' with the service.

5.
Rheumatol Ther ; 2019 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-31813119

RESUMO

Psoriatic disease (PsD) is a multisystem inflammatory disorder with a high prevalence of cardiovascular (CV) risk factors contributing to accelerated atherosclerosis and its sequelae. Imaging studies, notably with ultrasound, computed tomography, and positron emission tomography (PET) scanning have confirmed significant atherosclerotic change with plaque formation and vessel stenosis. Atherosclerosis is likely driven by a combination of traditional risk factors which occur more frequently in PsD and by systemic inflammation with associated pro-inflammatory cytokine production. While the mechanisms driving atherosclerosis in PsD are incompletely understood, it is now best practice to try to minimize the impact of CV risk factors by regular assessment, prevention, and treatment and also by ensuring that inflammatory musculoskeletal and cutaneous disease is adequately suppressed. Future studies need to focus on improving our understanding of the mechanisms driving atherosclerosis and, as a consequence, developing more rationale approaches to prevention and treatment.

6.
Musculoskelet Sci Pract ; 45: 102077, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31731056

RESUMO

BACKGROUND: As many patients referred to orthopaedic and rheumatology services do not require medical or surgical interventions, advanced practice physiotherapists (APPs) have been introduced into hospital services to triage the care of these patients. Patient perspectives are critical to review the acceptance of this model of care and potential for expansion into primary care. This study aimed to explore the clinical journeys, and the experiences and perceptions of patients attending APP services. METHOD: Semi-structured interviews (n = 10) were conducted with patients across two hospital sites, with narrative data subjected to a thematic analysis. MSK journeys were mapped via medical chart and interview data, with surveys collecting demographics. RESULTS: Patient journeys involved multiple contact points and some duplication in MSK health services. Overall, experiences of the APP service were positive, with faster access into the hospital system and patients valued the interpersonal and professional skills of the APP. Having already attended a physiotherapist, some patients did have a preconception of what the APP could offer them. However, initial concerns were mitigated following the APP appointment, as the APP had extensive MSK knowledge. Hospitals remained the preferred location for MSK appointments due to availability of diagnostics and 'specialists', and close proximity of the doctor. CONCLUSION: Patients were positive about the new MSK APP service and benefits related to shorter wait times and seeing a specialist who listened and involved them in their management. However, a cultural shift regarding patient perceptions of the 'specialists' in hospitals and the role of a physiotherapist is required.

7.
ACR Open Rheumatol ; 1(4): 213-218, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31777797

RESUMO

Objective: Physiotherapist-led musculoskeletal triage clinics are an effective and efficient means of managing patients presenting with musculoskeletal disorders in primary and secondary care. Data regarding the activity and outcomes of physiotherapist-led triage in hospital-based outpatient rheumatology clinics are scarce. Thus, the aim of this study was to undertake a service evaluation of activity and outcomes of a physiotherapist-led rheumatology-based Musculoskeletal Assessment Clinic (MAC). The primary objective was to quantify the proportion of patients independently managed by the clinical specialist physiotherapists (CSPs). Methods: A retrospective service evaluation was undertaken of all patients who attended the Rheumatology MAC at St Vincent's University Hospital, Dublin (SVUH) between August 2012 and February 2014. The Clinical Audit Department of SVUH approved the study. Data were analyzed using descriptive statistics. Results: Five hundred and eight patients attended the MAC: 76% were female and the mean age was 55 years and ranged between 18-91. Seventy-five percent of patients were independently managed by the CSP without needing to see a consultant rheumatologist, whereas 17% were referred to the rheumatology team. Eighty-seven percent of patients referred to the rheumatology team had rheumatological intervention (eg, injection, medical management, or multidisciplinary rehabilitation). A substantially higher proportion of patients with regional musculoskeletal pain and degenerative conditions were independently managed by the CSP compared with those who had rheumatological/inflammatory conditions. Conclusion: The majority of patients who attended the MAC were independently managed by the physiotherapists, suggesting that physiotherapist-led triage may be a useful and efficient means of managing a proportion of patients referred for a specialist rheumatological consultation.

8.
J Rheumatol ; 2019 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-31523049

RESUMO

OBJECTIVE: Compelling evidence supports a treat-to-target (T2T) strategy for optimal outcomes in rheumatoid arthritis (RA). There is limited knowledge regarding the factors that impede implementation of T2T, particularly in a setting where adherence to T2T is protocol specified. We aimed to assess clinical factors that associate with failure to adhere to T2T. METHODS: RA patients from 10 countries starting or changing conventional synthetic disease-modifying anti-rheumatic (csDMARDs) drugs and/or starting tumor necrosis factor inhibitor (TNFi) were followed for 2 years (RA BIODAM cohort). Participating physicians were required per-protocol to adhere to the T2T strategy. Factors influencing adherence to T2T low disease activity (T2T-LDA; DAS≤2.4) were analyzed in two types of binomial generalized estimating equations (GEE) models: i. including only baseline features (baseline model); ii. Modelling variables that inherently vary over time as such (longitudinal model). RESULTS: A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. Failure of adherence to T2T-LDA was noted in 1765 (40.5%) visits. In the baseline multivariable model, high number of comorbidities (OR (95%CI): 1.10 (1.02; 1.19)), smoking (1.32 (1.08; 1.63)) and high number of tender joints (1.03 (1.02; 1.04)), were independently associated with failure to implement T2T, while ACPA/RF positivity (0.63 (0.50; 0.80)), was a significant facilitator of T2T. Results were similar in the longitudinal model. CONCLUSION: Lack of adherence to T2T in the RA BIODAM cohort was evident in a substantial proportion despite being a protocol requirement and this could be predicted by clinical features.

9.
J Rheumatol ; 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31474600

RESUMO

OBJECTIVE: The OMERACT Soluble Biomarker Working Group initiated an international, multicenter, prospective study, The Rheumatoid Arthritis (RA) BIODAM cohort (NCT01476956), to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings. METHODS: RA patients from 38 sites in 10 countries starting or changing conventional synthetic diseasemodifying anti-rheumatic (csDMARDs) drugs and/or starting tumor necrosis factor inhibitor (TNFi) reserved. 5 were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp van der Heijde (vdHm-SHS) score. RESULTS: A total of 571 patients were recruited and 439 (76.9%) completed 2-year follow-up. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, DAS44 3.8, 77.7% rheumatoid factor (RF) or anti-citrullinated peptide antibody (ACPA) positive. Percentage of patients in DAS and ACR remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (>0.5) at 1- and 2-years was 38.3% and 59.8%, respectively. CONCLUSION: The RA-BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints.

10.
Ann Rheum Dis ; 78(11): 1472-1479, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31427438

RESUMO

OBJECTIVES: To describe and explore differences in formal regulations around sick leave and work disability (WD) for patients with rheumatoid arthritis (RA), as well as perceptions by rheumatologists and patients on the system's performance, across European countries. METHODS: We conducted three cross-sectional surveys in 50 European countries: one on work (re-)integration and social security (SS) system arrangements in case of sick leave and long-term WD due to RA (one rheumatologist per country), and two among approximately 15 rheumatologists and 15 patients per country on perceptions regarding SS arrangements on work participation. Differences in regulations and perceptions were compared across categories defined by gross domestic product (GDP), type of social welfare regime, European Union (EU) membership and country RA WD rates. RESULTS: Forty-four (88%) countries provided data on regulations, 33 (75%) on perceptions of rheumatologists (n=539) and 34 (77%) on perceptions of patients (n=719). While large variation was observed across all regulations across countries, no relationship was found between most of regulations or income compensation and GDP, type of SS system or rates of WD. Regarding perceptions, rheumatologists in high GDP and EU-member countries felt less confident in their role in the decision process towards WD (ß=-0.5 (95% CI -0.9 to -0.2) and ß=-0.5 (95% CI -1.0 to -0.1), respectively). The Scandinavian and Bismarckian system scored best on patients' and rheumatologists' perceptions of regulations and system performance. CONCLUSIONS: There is large heterogeneity in rules and regulations of SS systems across Europe in relation to WD of patients with RA, and it cannot be explained by existing welfare regimes, EU membership or country's wealth.

11.
J Rheumatol Suppl ; 95: 11-19, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31154399

RESUMO

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Collaborative Research Network (CRN) intends to launch and secure funding for 3 pilot projects related to psoriatic disease, psoriatic arthritis (PsA), and cutaneous psoriasis (PsC). The first pilot project, a PsA Biomarkers for Joint Damage (BioDAM) pilot, will seek to determine the independent predictive ability of serum biomarkers for joint damage in PsA. The second pilot project will aim to identify predictors of the development of PsA among patients with PsC. The third pilot project will aim to identify biomarkers that predict treatment response in PsA and PsC. These pilot projects will prompt the development of clinical protocols to operate across participating centers, lead to the development of standard operating procedures for the collection and transport of biosamples across international borders, and begin to establish administrative and managerial structures for the CRN. The CRN hopes that the successful completion and research outputs of these 3 pilot projects will demonstrate the CRN's value to prospective collaborators and sponsors and thereby secure sustainable longterm funding.


Assuntos
Artrite Psoriásica/diagnóstico , Psoríase/diagnóstico , Artrite Psoriásica/sangue , Biomarcadores/sangue , Dermatologia , Humanos , Projetos Piloto , Psoríase/sangue , Reumatologia
12.
J Rheumatol Suppl ; 95: 33-37, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31154402

RESUMO

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group reported at the 2018 GRAPPA annual meeting on the outcome of the OMERACT 2018 Conference in Terrigal, Australia. The working group presented the endorsement of the 66/68 joint count for the assessment of peripheral arthritis and the provisional endorsement of the PsA Impact of Disease 12 questionnaire for the assessment of PsA-specific health-related quality of life in PsA randomized controlled trials and observational studies. In this report, the group presents its plan to seek OMERACT endorsement for outcome measures that address the domains of MSK disease activity for enthesitis and dactylitis, physical function, fatigue, and structural damage following the OMERACT Filter 2.1 methodology.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Ensaios Clínicos como Assunto , Psoríase/tratamento farmacológico , Qualidade de Vida , Artrite Psoriásica/diagnóstico , Dermatologia , Nível de Saúde , Humanos , Psoríase/diagnóstico , Reumatologia , Resultado do Tratamento
13.
J Rheumatol Suppl ; 95: 54-57, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31154406

RESUMO

At the 2018 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members received updates on several ongoing efforts. Among them were updates on GRAPPA's patient research partners; educational initiatives; research efforts, including the trainee symposium, pilot research grants, and Collaborative Research Network; treatment recommendations; and additional efforts related to advancing the understanding of disease aspects.


Assuntos
Artrite Psoriásica/terapia , Dermatologia , Psoríase/terapia , Reumatologia , Humanos , Pesquisa
14.
Ann Rheum Dis ; 78(8): 1107-1113, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31005900

RESUMO

OBJECTIVES: The International League of Associations for Rheumatology classification criteria define systemic juvenile idiopathic arthritis (SJIA) by the presence of fever, rash and chronic arthritis. Recent initiatives to revise current criteria recognise that a lack of arthritis complicates making the diagnosis early, while later a subgroup of patients develops aggressive joint disease. The proposed biphasic model of SJIA also implies a 'window of opportunity' to abrogate the development of chronic arthritis. We aimed to identify novel SJIA biomarkers during different disease phases. METHODS: Children with active SJIA were subgrouped clinically as systemic autoinflammatory disease with fever (SJIA syst ) or polyarticular disease (SJIA poly ). A discovery cohort of n=10 patients per SJIA group, plus n=10 with infection, was subjected to unbiased label-free liquid chromatography mass spectrometry (LC-MS/MS) and immunoassay screens. In a separate verification cohort (SJIA syst , n=45; SJIA poly , n=29; infection, n=32), candidate biomarkers were measured by multiple reaction monitoring MS (MRM-MS) and targeted immunoassays. RESULTS: Signatures differentiating the two phenotypes of SJIA could be identified. LC-MS/MS in the discovery cohort differentiated SJIA syst from SJIA poly well, but less effectively from infection. Targeted MRM verified the discovery data and, combined with targeted immunoassays, correctly identified 91% (SJIA syst vs SJIA poly ) and 77% (SJIA syst vs infection) of all cases. CONCLUSIONS: Molecular signatures differentiating two phenotypes of SJIA were identified suggesting shifts in underlying immunological processes in this biphasic disease. Biomarker signatures separating SJIA in its initial autoinflammatory phase from the main differential diagnosis (ie, infection) could aid early-stage diagnostic decisions, while markers of a phenotype switch could inform treat-to-target strategies.

15.
J Rheumatol ; 46(9): 1089-1096, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30824647

RESUMO

OBJECTIVE: To evaluate the effect of baseline risk factors on radiographic progression in patients with active psoriatic arthritis (PsA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and were treated with tofacitinib or adalimumab (ADA). METHODS: Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. OPAL Broaden was a 12-month, double-blind phase III trial. Patients received tofacitinib 5 mg twice daily (BID; n = 107), tofacitinib 10 mg BID (n = 104), or ADA 40 mg once every 2 weeks (n = 106), all with 1 background csDMARD. Radiographs (baseline and Month 12) were scored using the van der Heijde-modified total Sharp score (mTSS) for PsA. Radiographic nonprogression was defined as an increase from baseline in mTSS ≤ 0.5, ≤ 0, or ≤ 0.66. Changes from baseline in mTSS and nonprogression (≤ 0.5 increase from baseline in mTSS) were analyzed by baseline C-reactive protein (CRP) > 2.87 or ≤ 2.87 mg/l. Baseline predictors of radiographic progression were analyzed. RESULTS: At Month 12, > 90% of patients receiving tofacitinib or ADA met all radiographic nonprogression criteria. Mean changes from baseline through Month 12 in mTSS, erosion, and joint space narrowing scores were close to 0. Changes in radiographic outcomes were minimal, irrespective of baseline CRP levels > 2.87 or ≤ 2.87 mg/l, with a small numerical difference observed for tofacitinib 5 mg BID. A significant relationship was observed between baseline CRP level and increases from baseline in mTSS > 0.5 at Month 12. CONCLUSION: Elevated CRP levels at baseline were associated with greater structural progression. Changes in radiographic outcomes were minimal regardless of CRP levels. [Clinical trial registration number (www.ClinicalTrials.gov): NCT01877668].

16.
J Rheumatol ; 46(8): 996-1005, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30770518

RESUMO

OBJECTIVE: The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting's approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS). METHODS: Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS. RESULTS: OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a "green" endorsement, whereas among the group of other stakeholders, 88% voted for a "green" endorsement. CONCLUSION: The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.

17.
Ir J Med Sci ; 188(1): 169-172, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29748892

RESUMO

BACKGROUND: Rheumatoid arthritis (RA) is a chronic immune-mediated inflammatory disease which can cause significant disability, morbidity, mortality, and impaired fertility. It commonly affects women of childbearing age. Managing rheumatoid arthritis (RA) in the perinatal period poses challenges. There is concern about the teratogenic effects of many traditional disease-modifying anti-rheumatic drugs (DMARDs) and an ever-growing list of new therapeutic options with limited data in pregnancy and breastfeeding. AIMS: We aimed to create a standardized approach to pharmacological management of RA patients seen in our newly established Rheumatology and Reproductive Health Service. METHODS: We reviewed relevant publications on the use of anti-rheumatic drugs in pregnancy. These include recent guidelines from The British Society for Rheumatology (BSR) and British Health Professionals in Rheumatology (BHPR) and the European League Against Rheumatism (EULAR). RESULTS: After considering relevant publications, we developed a Saint Vincent's University Hospital/National Maternity Hospital consensus protocol for evidence-based medication in pregnancy in RA. CONCLUSIONS: RA tends to improve during pregnancy and flare postpartum. Several anti-rheumatic medication options during pregnancy and breastfeeding are now available including anti-tumor necrosis factor (anti-TNF) agents. Good disease control at all stages of reproduction is important to ensure best outcome for both mother and baby.


Assuntos
Antirreumáticos/farmacologia , Artrite Reumatoide/tratamento farmacológico , Complicações na Gravidez/tratamento farmacológico , Aleitamento Materno , Contraindicações de Medicamentos , Feminino , Humanos , Lactação/efeitos dos fármacos , Guias de Prática Clínica como Assunto , Gravidez
19.
J Rheumatol ; 46(3): 266-273, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30385708

RESUMO

OBJECTIVE: Systemic inflammationˆ is assessed through measurement of acute-phase reactants such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). With few exceptions, most randomized controlled trials (RCT) have assessed acute-phase reactants (CRP and ESR) as part of the American College of Rheumatology (ACR) 20 response criteria. As part of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) working group, we performed a systematic review of the literature to assess the performance of inflammatory biomarkers in psoriatic arthritis (PsA). METHODS: A systematic search of PubMed and Embase was performed. The search included peer-reviewed articles and scientific meeting abstracts about RCT and longitudinal observational studies that assessed systemic inflammation using acute-phase reactants in PsA. Studies were assessed following the components of the OMERACT filter including construct validity, responsiveness, and predictive validity. RESULTS: There were 2764 articles retrieved, and 71 articles were included for this systematic review. Twenty-eight articles reported CRP and/or ESR separately, and the remaining articles reported CRP and/or ESR as part of the ACR response criteria. Studies assessing OMERACT responsiveness provided conflicting reports. Inflammatory biomarkers had construct validity for more active disease. Evidence suggests that an elevation of ESR predicts cardiovascular outcomes. CONCLUSION: Data regarding assessment of systemic inflammation using acute-phase reactants (CRP and ESR) are limited. There is only weak evidence to support normalization of these biomarkers in predicting good clinical outcomes/remission criteria. The predictive value for cardiovascular outcomes was generally good. Further studies to assess systemic inflammation in PsA using acute-phase reactants and other laboratory biomarkers are needed.

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