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1.
Ann Rheum Dis ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33832966

RESUMO

BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. OBJECTIVES: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain. METHODS: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously. RESULTS: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9). CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33788913

RESUMO

OBJECTIVE: The Flare Assessment in Rheumatoid Arthritis (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between 2 consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare. METHODS: The Tocilizumab SubCutAneous (TOSCA) study evaluated the efficacy and safety of subcutaneous Tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12, and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve. RESULTS: 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: rho = 0.41 at W12 (p<0.0001) and 0.51 at W24 (p<0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81. CONCLUSION: FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.

3.
Lancet Rheumatol ; 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33786454

RESUMO

Background: Various observations have suggested that the course of COVID-19 might be less favourable in patients with inflammatory rheumatic and musculoskeletal diseases receiving rituximab compared with those not receiving rituximab. We aimed to investigate whether treatment with rituximab is associated with severe COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases. Methods: In this cohort study, we analysed data from the French RMD COVID-19 cohort, which included patients aged 18 years or older with inflammatory rheumatic and musculoskeletal diseases and highly suspected or confirmed COVID-19. The primary endpoint was the severity of COVID-19 in patients treated with rituximab (rituximab group) compared with patients who did not receive rituximab (no rituximab group). Severe disease was defined as that requiring admission to an intensive care unit or leading to death. Secondary objectives were to analyse deaths and duration of hospital stay. The inverse probability of treatment weighting propensity score method was used to adjust for potential confounding factors (age, sex, arterial hypertension, diabetes, smoking status, body-mass index, interstitial lung disease, cardiovascular diseases, cancer, corticosteroid use, chronic renal failure, and the underlying disease [rheumatoid arthritis vs others]). Odds ratios and hazard ratios and their 95% CIs were calculated as effect size, by dividing the two population mean differences by their SD. This study is registered with ClinicalTrials.gov, NCT04353609. Findings: Between April 15, 2020, and Nov 20, 2020, data were collected for 1090 patients (mean age 55·2 years [SD 16·4]); 734 (67%) were female and 356 (33%) were male. Of the 1090 patients, 137 (13%) developed severe COVID-19 and 89 (8%) died. After adjusting for potential confounding factors, severe disease was observed more frequently (effect size 3·26, 95% CI 1·66-6·40, p=0·0006) and the duration of hospital stay was markedly longer (0·62, 0·46-0·85, p=0·0024) in the 63 patients in the rituximab group than in the 1027 patients in the no rituximab group. 13 (21%) of 63 patients in the rituximab group died compared with 76 (7%) of 1027 patients in the no rituximab group, but the adjusted risk of death was not significantly increased in the rituximab group (effect size 1·32, 95% CI 0·55-3·19, p=0·53). Interpretation: Rituximab therapy is associated with more severe COVID-19. Rituximab will have to be prescribed with particular caution in patients with inflammatory rheumatic and musculoskeletal diseases. Funding: None.

4.
Joint Bone Spine ; 88(4): 105171, 2021 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-33689840

RESUMO

OBJECTIVE: Despite its prevalence, there are few worldwide hand osteoarthritis (HOA) cohorts. The main objective of DIGItal COhort Design (DIGICOD) cohort is to investigate prognostic clinical, biological, genetic and imaging factors of clinical worsening after 6years follow-up. METHODS: DIGICOD is a hospital-based prospective cohort including patients>35years-old with symptomatic HOA fulfilling: (i) ACR criteria for HOA with≥2 symptomatic joints among proximal/distal interphalangeal joints or 1st interphalangeal joint with Kellgren-Lawrence (KL)≥2; or (ii) symptomatic thumb base OA with KL≥2. Main exclusion criteria were inflammatory arthritis and crystal arthropathies. Annual clinical evaluations were scheduled with imaging (X-rays of the hands and of other OA symptomatic joints) and biological sampling every 3years. Hand radiographs are scored using KL and anatomical Verbruggen-Veys scores. Follow-up visits are ongoing. Cohort methodology and baseline characteristics are presented. RESULTS: Between April 2013 and June 2017, from the 436 HOA included patients, 426 have been analysed of whom 357 (84%) are women. Mean age±standard deviation was 66.7±7.3years and mean disease duration was 12.6±9.6years. Metabolic syndrome affected 151 (36.5%) patients. Mean Visual Analog Scale (VAS) hand pain (0-100mm) was 44.4±26.7mm at activity. Mean FIHOA (0-100) was 19.9±18.6. Elevated serum CRP level (≥5mg/L) involved 10% patients. Mean KL score (0-128) was 46.7±18 and the mean number of joint with KL≥2 was 15.1±6.3. Erosive HOA (defined as≥1 Erosive or Remodeling phase joint according to Verbruggen-Veys score) involved 195/426 (45.8%) patients and the median number (interquartile range) of erosive joints in erosive patients was 3.0 (1.0-5.0). CONCLUSION: DIGICOD is a unique prospective HOA cohort with a long-term 6years standardized assessment and has included severe radiologically HOA patients with a high prevalence of erosive disease.

6.
Clin Exp Rheumatol ; 38(6): 1056-1067, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33253107

RESUMO

OBJECTIVES: Despite availability of efficacious treatments, unmet needs still exist, preventing optimal and comprehensive management of rheumatoid arthritis (RA). Evolving the management of RA (eRA) is a European-wide educational initiative aiming to support improved patient care through practical and educational tools addressing specific unmet needs. METHODS: A multidisciplinary Steering Committee (17 members, 12 countries) identified unmet needs within the management of RA and prioritised those with the greatest impact on patient outcomes. Practical educational tools addressing priority needs were then developed for dissemination and implementation by the rheumatology community across Europe. RESULTS: Five areas of priority need were identified: increasing early recognition of RA and treatment initiation; treating RA to target; optimal, holistic approach to selection of treatment strategy, including shared decision-making; improving identification and management of comorbidities; and non-pharmacological patient management. A suite of 14 eRA tools included educational slides, best-practice guidance, self­assessment questionnaires, clinical checklists, a multidisciplinary team training exercise, an interactive patient infographic, and case scenarios. By April 2020, rheumatology professionals in 17 countries had been actively engaged in the eRA programme; in 11 countries, eRA tools were selected by national leaders in rheumatology and translated for local dissemination. A web platform, with country-specific pages, was developed to support access to the translated tools (https://www.evolvingthemanagementofra.com/). CONCLUSIONS: The eRA programme supports comprehensive management of RA across Europe through development and dissemination of practical educational tools. The eRA tools address priority needs and are available free of charge to the rheumatology community.

7.
Artigo em Inglês | MEDLINE | ID: mdl-33232465

RESUMO

OBJECTIVES: To evaluate the characteristics of patients (pts) with PsA treated by ustekinumab (UST) or secukinumab (SEK) and to compare real-world persistence of UST and SEK in PsA. METHODS: In this retrospective, national, multicentre cohort study, pts with PsA (CASPAR criteria or diagnosis confirmed by the rheumatologist) initiating UST or SEK with a follow-up ≥6 months were included from January 2011 to April 2019. The persistence between SEK and UST was assessed after considering the potential confounding factors by using pre-specified propensity-score methods. Causes of discontinuation and tolerance were also collected. RESULTS: A total of 406 pts were included: 245 with UST and 161 with SEK. The persistence rate was lower in the UST group compared with the SEK group [median persistence 9.4 vs 14.7 months; 26.4% vs 38.0% at 2 years; weighted hazard ratio (HR) = 1.42; 95% CI: 1.07, 1.92; P =0.015]. In subgroup analysis, the persistence rate of SEK associated with MTX was significantly higher than that of UST associated with MTX: HR = 2.20; 95% CI: 1.30, 3.51; P =0.001, in contrast to SEK vs UST monotherapy: HR = 1.06; 95% CI: 0.74, 1.53; P =0.75. Discontinuation due to inefficacy was reported in 91.7% (SEK) and 82.4% (UST) of pts. Discontinuation due to an adverse event was reported in 12.2% (SEK) and 7.7% (UST) of pts. CONCLUSION: In this first study comparing UST and SEK, the persistence of SEK was higher than that of UST in PsA. In subgroup analysis, this difference was only found in association with MTX.

8.
PLoS One ; 15(11): e0242306, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33216772

RESUMO

BACKGROUND: Since 1920, a decrease in serum cholesterol has been identified as a marker of severe pneumonia. We have assessed the performance of serum apolipoprotein-A1, the main transporter of HDL-cholesterol, to identify the early spread of coronavirus disease 2019 (Covid-19) in the general population and its diagnostic performance for the Covid-19. METHODS: We compared the daily mean serum apolipoprotein-A1 during the first 34 weeks of 2020 in a population that is routinely followed for a risk of liver fibrosis risk in the USA (212,297 serum) and in France (20,652 serum) in relation to a local increase in confirmed cases, and in comparison to the same period in 2019 (266,976 and 28,452 serum, respectively). We prospectively assessed the sensitivity of this marker in an observational study of 136 consecutive hospitalized cases and retrospectively evaluated its specificity in 7,481 controls representing the general population. RESULTS: The mean serum apolipoprotein-A1 levels in the survey populations began decreasing in January 2020, compared to the same period in 2019. This decrease was highly correlated with the daily increase in confirmed Covid-19 cases in the following 34 weeks, both in France and USA, including the June and mid-July recovery periods in France. Apolipoprotein-A1 at the 1.25 g/L cutoff had a sensitivity of 90.6% (95%CI84.2-95.1) and a specificity of 96.1% (95.7-96.6%) for the diagnosis of Covid-19. The area under the characteristics curve was 0.978 (0.957-0.988), and outperformed haptoglobin and liver function tests. The adjusted risk ratio of apolipoprotein-A1 for survival without transfer to intensive care unit was 5.61 (95%CI 1.02-31.0; P = 0.04). CONCLUSION: Apolipoprotein-A1 could be a sentinel of the pandemic in existing routine surveillance of the general population. NCT01927133, CER-2020-14.


Assuntos
Apolipoproteína A-I/sangue , Infecções por Coronavirus/sangue , Pneumonia Viral/sangue , Adulto , Idoso , Betacoronavirus , Biomarcadores/sangue , Infecções por Coronavirus/epidemiologia , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/epidemiologia , Estudos Retrospectivos , Estados Unidos
10.
RMD Open ; 6(3)2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33148784

RESUMO

Health resource use and identification of related costs are two essential steps in health economics assessment. The elicited costs will be balanced with health outcome improvement and enable the comparison of different diagnostic procedures or therapeutic strategies from a health economic point of view. The cost typology can be disentangled in three main components, that is, direct cost related to health resource use, indirect costs related to productivity loss and sometimes intangible costs (costs related to pain and suffering). These costs can be elicited from different perspectives depending on the general aim of the assessment: payer, societal perspective or patient perspective. Practically, the first step corresponds to the quantification of health resource use, that is, number of consultations, biological or imaging workups, hospitalisation, dispensed medication units or days on sick leave. It can be done by specific self-questionnaires or by access to insurance health databases. The second step is then to value each health resource use item, based on available public databases-either produced by insurance entities or statistics institute-providing the unit costs for each item. Importantly, substantial variability does exist in the costing exercise, requiring accepting a certain uncertainty around cost estimates. This can be taken into account by sensitivity analyses, which capture in what extent measurement error can impact cost assessment, depending on different hypotheses or assumptions. One essential element of health economic assessment is the identification of costs incurred by or associated with a specific health condition for a study on the economic burden of a disease-cost-of-illness study-or with a given diagnostic or therapeutic intervention in the context of health technology assessment in which these costs are compared with the alternative reference strategy-cost-effectiveness study.

13.
Ann Rheum Dis ; 2020 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-33055078

RESUMO

OBJECTIVE: To evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis. METHODS: This was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0-100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients' and physicians' global assessment and function scores. RESULTS: Of 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was -7.9 (SD 19.4) and -9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group. CONCLUSION: Tocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

14.
J Rheumatol ; 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32934129

RESUMO

OBJECTIVE: Axial spondyloarthritis (axSpA) may have an impact on work. The Ankylosing Spondylitis Work Instability Scale (AS-WIS) assesses difficulties at work. The objective of this study was to evaluate the predictive value of the AS WIS on work impact. METHODS: Prospective cohort study with two timepoints (at baseline and after 1.5 years) including patients with axSpA and a paid professional activity. Patients completed the AS-WIS at baseline and work instability was scored as moderate/high if ≥11 (0-20 scale). At follow up, adverse work outcomes (AWO) were defined as short-term sick leave or severe AWO (long-term sick leave, disability, unemployment). Univariable and multivariable logistic regression analyses were performed to explain AWO. RESULTS: Of 101 patients, mean age 45 (standard deviation (SD) 9) years, 52% male, disease duration was 14 (SD 8) years. The BASDAI and the BASFI were respectively 34 (SD 21) and 23 (SD 23), 69 (68%) received a TNF-inhibitor. At baseline, 46 (46%) patients had moderate/high AS-WIS. At 1.5 years of follow-up, 37 patients (36%) had AWO: 25 patients (25%) a short-term sick leave, and 12 patients (12%, 7/100 patient years) a severe AWO. Independent baseline factors associated with AWO were a moderate/high AS-WIS score (odds ratio 2.71 [95% confidence interval 1.04-7.22]) and shorter disease duration (0.94 [0.89-0.99]). CONCLUSION: In patients with axSpA, a moderate/high AS-WIS score was predictive of AWO in this population with well-controlled axSpA. This short questionnaire can be helpful to screen for future difficulties at work.

15.
Clin Exp Rheumatol ; 2020 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-32896246

RESUMO

OBJECTIVES: GO-PRACTICE aimed to evaluate the persistence, clinical response and safety of golimumab in adult patients with chronic inflammatory rheumatic disease. METHODS: Prospective observational study with 24 months of follow-up, involving 134 rheumatologists from public or private health establishments in France. The primary outcome was the persistence of golimumab 24 months after initial prescription. Cumulative persistence probabilities were determined from Kaplan-Meier estimates. Secondary outcomes included an evaluation of disease activity and golimumab safety profile. RESULTS: Of 754 consecutively recruited patients, 170 had rheumatoid arthritis (RA) (54.3 years, 74.1% female, 64.7% biologics-naïve), 106 had psoriatic arthritis (PsA) (48.1 years, 70% female, 66.0% biologics-naïve) and 478 had axial spondyloarthritis (axSpA) (42.8 years, 54.6% female, 60.9% biologics-naïve). Golimumab persistence at 2 years was 56.5%, 45.1% and 52.6%, respectively, in RA, PsA and axSpA groups. Persistence was higher in biologics-naïve (58.3%) than in biologics pre-treated patients (42.7%, p<0.01). For 362 patients continuing golimumab at 2 years, disease activity improved significantly from baseline to 2 years: mean 28-joint disease activity score for RA and PsA was lowered by 2.06 and 1.89 points, and mean ankylosing spondylitis disease activity score was lowered by 3.11 points (p<0.0001) for axSpA. Patient appreciation of disease activity also improved; 8.9% of discontinuations were due to intolerance. CONCLUSIONS: Golimumab persistence was satisfactory at 2 years and accompanied by improvements in clinical effectiveness in 362 patients continuing golimumab at 2 years. Golimumab was well tolerated and its safety profile was consistent with those reported in previous studies.

16.
Joint Bone Spine ; : 105060, 2020 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-32755722

RESUMO

OBJECTIVE: To assess the time to initiation of biologic disease-modifying anti-rheumatic drugs (bDMARDs) in ESPOIR, the French cohort of patients with rheumatoid arthritis (RA), and factors associated with the timing of bDMARD initiation. METHODS: In total, 658 patients with early RA satisfying the 2010 ACR/EULAR criteria were included between 2003 and 2005 and followed annually for 10 years (end of follow up: 2013-2015). The timing of bDMARD introduction and predictors of use were analysed by the Kaplan-Meier method based on Cox proportional-hazard models. RESULTS: Overall, 178 patients (31.0%, 95% confidence interval [27.0-34.7]) initiated a bDMARD during the 10-year follow-up, with a mean delay of 43.6 months. The penetration rate was higher during the first 2 years of follow-up (6% between the first and second year, approximately 3.3% each year between the second and seventh year, and<2.0% after the eighth year). The first-used bDMARD was etanercept for 72 patients and adalimumab for 71. On multivariate analysis, Disease Activity Score in 28 joints, radiologic progression and positivity for anti-citrullinated protein antibodies were significantly associated with rapid initiation of a bDMARD (P<0.0001), whereas older age at first joint pain was inversely associated (P<0.0001). CONCLUSIONS: Although access to bDMARDs is widespread in France, less than one third of patients with early RA in the ESPOIR cohort initiated a bDMARD over the 10-year follow-up. Poor prognostic factors for RA were associated with more rapid initiation, as expected.

17.
Rheumatol Int ; 40(12): 2085-2095, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32862307

RESUMO

To develop and validate a self-administered questionnaire to identify in people with Inflammatory arthritis (IA) Facilitators And Barriers to Physical activity (PA): the IFAB questionnaire. The development of the questionnaire included a systematic review of barriers and facilitators to PA to identify key themes, face validity assessment by 11 experts, and cognitive debriefing with 14 patients. The psychometric properties of the questionnaire were assessed by convergent validity (Spearman correlation) against the modified Health Assessment Questionnaire (mHAQ), the Fear-Avoidance Beliefs Questionnaire subscale for PA and the Tampa Scale for Kinesiophobia, internal consistency (Cronbach α) in 63 IA patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA). Reliability and feasibility were assessed in 32 IA patients. The questionnaire comprises 10 items: 4 assessing either barriers or facilitators, 3 assessing barriers, and 3 assessing facilitators. The items are related to psychological status (N = 6), social support (N = 2), disease (N = 1), environmental factors (N = 1). The validation study included 63 patients: 26 RA, 24 axSpA, 13 PsA; with mean age 52.8 (standard deviation 16.5) years, mean disease duration 12.5 (12.3) years, and 53% of women. The questionnaire was correlated (rho = 0.24) with mHAQ. Internal consistency (Cronbach α 0.69) and reliability (interclass coefficient 0.79 [95% confidence interval 0.59; 0.88]) were satisfactory, as was feasibility (missing data 12%, mean completion time < 5 min). The questionnaire allows the assessment of barriers and facilitators to PA in patients with IA. This questionnaire may guide targeted interventions to increase levels of PA in these patients.

18.
Autoimmun Rev ; 19(8): 102586, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32535094

RESUMO

BACKGROUND: In addition to restoring anti-tumor immune responses, immune checkpoint inhibitors (ICI) may also induce immune-related adverse events (irAE) that can affect any organ. We aim to determine the spectrum, timing, clinical features, and fatalities of rheumatic and musculoskeletal immune-related adverse events (RMS-irAE) associated with ICI. PATIENTS METHODS: We performed an observational, retrospective, pharmacovigilance study using the World Health Organization international pharmacovigilance database, VigiBase, from inception to January 2019. RMS-irAE reporting rate on ICI versus full database was performed using disproportionality analysis with computation of reporting-odds-ratios (ROR) and a Bayesian disproportional estimate (information component, IC). IC025 (lower end of the IC 95% credibility interval) >0 is deemed significant. RESULTS: We identified 1288 RMS-irAE significantly associated with ICI: polymyalgia rheumatica (n = 76, ROR = 14.6 [11.6-18.4], IC025 = 3.34), sarcoidosis (n = 94; ROR = 9.6 [7.9-11.9]; IC025 = 2.85), Sjogren's syndrome (n = 49; ROR = 6.9 [5.2-9.2]; IC025 = 2.24), myositis (n = 465; ROR = 4.9 [4.5-5.4]; IC025 = 2.12), arthritis (n = 606; ROR = 1.4 [1.3-1.5]; IC025 = 0.34) and scleroderma (n = 17; ROR = 2.0 [1.2-3.2]; IC025 = 0.17). Arthritis, myositis, and Sjogren's syndrome were over-reported in patients treated with ICI combination versus those treated with ICI monotherapy (ROR = 1.6-2.9, p < .05) and more frequently reported on anti-PD1/PDL1 monotherapy vs. anti-CTLA4 monotherapy (2.1-4.4, p < .05). Median time to onset occurred early for myositis (31 days [19.2-57.8]) and was the most delayed for scleroderma (395 days [323.8-457.2], p < .0001). The fatality rate for RMS-irAE ranged from 24% for myositis (n = 106/441) (up to 56.7% with concurrent myocarditis) to [0-6.7%] for other RMS-irAE (p < .0001). CONCLUSIONS: Clinicians should be aware of the spectrum of RMS-irAE. Myositis can be particularly life-threatening, particularly when associated with myocarditis.


Assuntos
Antineoplásicos Imunológicos , Miosite , Antineoplásicos Imunológicos/efeitos adversos , Teorema de Bayes , Humanos , Miosite/induzido quimicamente , Miosite/mortalidade , Miosite/patologia , Farmacovigilância , Estudos Retrospectivos
19.
Br J Clin Pharmacol ; 2020 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-32441383

RESUMO

AIM: To assess persistence with subcutaneous (SC) tumour necrosis factor (TNF) inhibitors as well as the impact of persistence on healthcare resource utilization (HCRU) and costs in patients with chronic inflammatory joint diseases. METHODS: In this cohort study using population-based French claims data (from 2011 to 2014), we measured persistence with SC TNF inhibitors within 12 months (M0-12) following treatment initiation in treatment-naïve and treatment-experienced users (divided into three cohorts: rheumatoid arthritis [RA], ankylosing spondylitis [AS] and psoriatic arthritis [PsA]). Persistent patients were propensity score matched to nonpersistent patients at M12. The impact of persistence status on HCRU and costs was assessed during M12-24. RESULTS: Of treatment-naïve (n = 3,804) and treatment-experienced (n = 2,279) users, only 56.1% and 46.8% were persistent at M12, respectively. Nonpersistent patients had more outpatient visits, computerized tomography scans, spine or joint magnetic resonance imaging procedures and disease-related hospitalizations, while persistent patients had more rheumatologist visits. Nonpersistent patients had lower drug costs but higher nondrug-related healthcare and hospitalization costs than persistent patients. In AS and PsA, overall healthcare costs were similar in persistent and nonpersistent patients. In RA, overall healthcare costs were lower in persistent patients (15,753€ vs 17,590€ in treatment-naïve and 17,622€ vs 21,177€ in treatment-experienced). CONCLUSION: Persistence with SC TNF inhibitors within first 12 months following treatment initiation was low in both treatment-naïve and treatment-experienced patients. Differences were observed in distribution of costs between persistent and nonpersistent patients, showing that nonpersistence with SC TNF inhibitors can lead to increased HCRU and higher costs.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32339449

RESUMO

OBJECTIVES: To determine if patient global assessment (PGA), as part of Boolean-based definition of remission and individually considered, over the first year of disease course had a significant relationship with structural progression over 3 years in patients with early arthritis (EA). METHODS: Prospective, observational study using ESPOIR cohort data. Remission states were defined as (a) 4v-remission: tender (TJC28), swollen 28-joint counts (SJC28), C-Reactive protein (mg/dL), and PGA (0-10) all ≤1; (b) PGA-near-remission: same parameters with only PGA>1/10; (c) 3v-remission (sum of previous groups) or (d) non-remission. The strictest status satisfied both at 6- and 12-months was considered. Radiographic progression was determined as a change in total Sharp-van der Heijde score from baseline to 3 years (ΔSHS) ≥5 points. The predictive capacities for radiographic damage of different remission definitions were assessed by Odds Ratio (OR). The association between each individual component of remission with ΔSHS was tested through multivariate linear regression analyses. RESULTS: Among 520 patients, 7% achieved 4v-remission and 12% PGA-near-remission. Radiographic progression was observed in 29% of patients in 4v-remission (OR versus non-remission, OR=0.32 [95%CI:0.15-0.68]) and in 45% of patients in PGA-near-remission (OR=0.65 [0.38-1.11]); the comparison was not statistically different (OR=0.49 [0.20-1.18]). In 3v-remission it was observed in 39%. Of the individual components, only SJC28 and CRP were associated with radiographic progression. CONCLUSION: All definitions of remission led to low structural degradation in EA: 4v-remission led to less progression than PGA-near-remission but without a statistically significant difference. Both 4v-remission and 3v-remission appear useful targets when aiming at structural non-progression.

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