scholarly journals Trends in hospitalizations forPneumocystis jirovecipneumonia among patients with rheumatoid arthritis in the US: 1996-2007

2010 ◽  
Vol 62 (12) ◽  
pp. 3826-3827 ◽  
Author(s):  
Grant H. Louie ◽  
Zhong Wang ◽  
Michael M. Ward
Keyword(s):  
2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1086.2-1087
Author(s):  
T. Okano ◽  
T. Koike ◽  
K. Inui ◽  
K. Mamoto ◽  
Y. Yamada ◽  
...  

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared


2021 ◽  
Vol 61 (1) ◽  
Author(s):  
Gabriela Bittencourt Gonzalez Mosegui ◽  
Fernando Antõnanzas ◽  
Cid Manso de Mello Vianna ◽  
Paula Rojas

Abstract Background The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.


2017 ◽  
Vol 70 (1) ◽  
pp. 30-38 ◽  
Author(s):  
Tzu-Chieh Lin ◽  
Nikroo Hashemi ◽  
Seoyoung C. Kim ◽  
Yea-Huei Kao Yang ◽  
Kazuki Yoshida ◽  
...  

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 150.1-150
Author(s):  
E. Vallejo-Yagüe ◽  
S. Weiler ◽  
A. M. Burden

Background:The Janus Kinase (JAK) inhibitors tofacitinib and baricitinib are new targeted treatments for rheumatoid arthritis. Recent concerns regarding the risk of thrombosis have led to warnings by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)1,2.Objectives:To examine the safety reporting of tofacitinib and baricitinib, with focus on thromboembolic events.Methods:Individual case safety reports (ICSRs) for tofacitinib and baricitinib were retrieved from the World Health Organization (WHO) global database (VigiBase) in April 2019. The primary outcomes were deep vein thrombosis (DVT) and pulmonary thrombosis (PT) or pulmonary embolism (PE). A disproportionality analysis was conducted by estimating the reporting odds ratio (ROR) and 95% confidence intervals (CIs) to compare the observed versus expected reporting ratio of DVT or PT|PE for tofacitinib or baricitinib. The ROR were calculated worldwide and stratifying by reporting from Europe or the US. In a secondary analysis, further thrombotic-related outcomes were investigated.Results:In both tofacitinib (n=40,017) and baricitinib (n=2,138) ICSRs, patients with reported DVT or PT|PE were older and had higher reporting of pro-thrombotic medications (e.g., contraceptives) or indicators of thromboembolic risk (i.e., antithrombotic treatment). The use of tofacitinib was associated with a significant increased reporting for DVT (ROR: 2.37 95% CI 1.23-4.56) and PT|PE (ROR 2.38 95% CI 1.45-3.89) in Europe. In the US, tofacitinib was only associated with an elevated reporting of PT (ROR: 2.05 % CI 1.45-2.90). Baricitinib was associated with a 3-fold increased risk of reporting for DVT (ROR: 3.47 95% CI 2.18-5.52) or PT|PE (ROR: 3.44 95% CI 2.43-4.88) in Europe, which accounted for 97% of all baricitinib ICSRs. Secondary thrombotic-related outcomes were poorly reported overall in VigiBase.Conclusion:This study supports the cautious use of JAK inhibitors in patients with rheumatoid arthritis who have a high thrombotic risk profile. Moreover, a potential class effect of JAK inhibitors cannot be ruled out.References:[1]FDA Drug Safety Communication. Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Food and Drug Administration (FDA)http://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr(2019).[2]EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots. EMA/608520/2019.https://www.ema.europa.eu/en/documents/referral/xeljanz-article-20-procedure-ema-confirms-xeljanz-be-used-caution-patients-high-risk-blood-clots_en.pdf(2019).Acknowledgments:We are thankful to every pharmacovigilance centre and contributor to the WHO Programme for International Drug Monitoring and VigiBase.While the authors used data from the VigiBase, the WHO global database of ICSRs as a source of information, the conclusions do not represent the opinion of the Uppsala Monitoring Centre (UMC) or the WHO.Disclosure of Interests:Enriqueta Vallejo-Yagüe Employee of: Synovo GmbH 2012-2018 (not related to this abstract), Stefan Weiler Consultant of: Gedeon-Richter for drug safety 2017 (not related to this abstract), Andrea Michelle Burden: None declared


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1404-1404
Author(s):  
Joshua D Epstein ◽  
Huong Luu ◽  
Aaron S Yarlas ◽  
Geoffrey Hammond

Abstract Abstract 1404 Poster Board I-426 Objectives: The primary objective of this study was to compare the Health-Related Quality of Life (HRQOL) burden of severe hemophilia A patients relative to a healthy sample of people, a general sample of the population, and to patients with other burdensome chronic conditions. The secondary objective was to determine the HRQOL impact of having at least one target joint. Methods: All adult patients with severe hemophilia A who were enrolled in the Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (Advate) Post-Authorization Safety Surveillance (PASS) study and completed the SF-36v2 at their baseline assessment were selected for this research. Analysis of variance was used to assess the relative HRQOL burden of these hemophilia A patients as compared to a healthy US population sample, a normal US population sample and patients reporting either chronic back pain, rheumatoid arthritis, or cancer. This comparison data was collected from the 1998 US National Survey of Functional Health Status. These comparisons groups were adjusted to the age and sex distribution of the severe hemophilia A sample using OLS regression models, with each SF-36v2 scale/summary score as a dependent variable. Finally, multivariate analysis of covariance (controlling for age) tested the impact of target joint absence (TJ-) or presence (TJ+) on SF-36v2 scores. Results: 141 adult patients (ages 18–78; median age=35) were identified. These severe hemophilia A patients scored worse than the US healthy population and US general population on all four physical domain scales and lower than chronic back pain patients on three out of the four physical domain scales (all p<0.01). The mean physical component summary (PCS) score was 41.6 for these hemophilia A patients and 54.3, 51.3, and 47.4 for the US healthy population, US general population and chronic back pain patients (all p<0.01); all exceeding this measure's established minimal important difference (MID) of 3 points. Hemophilia A patients reported no differences in physical HRQOL on the SF-36v2 when compared to patients with rheumatoid arthritis and cancer (p>0.05). Interestingly, hemophilia A patients reported significantly a higher score on both the vitality domain and mental component summary (MCS) score when compared to all patient groups except the US healthy population (all p<0.01). In addition, the difference on the MCS between hemophilia A patients and patients with chronic back pain, rheumatoid arthritis, and cancer were larger than the MID (50.6 vs 45.2, 44.4, and 44.7, respectively). Forty-six (32.6%) severe hemophilia A patients enrolled in the PASS study did not have a target joint. Hemophilia A patients without target joints showed significantly better HRQOL than patients with at least one target joint on the physical functioning scale (p<0.05), the general health scale (p<0.01) and the PCS score (p<0.01). The difference between the mean PCS score exceeded the MID (44.8/40.1 for TJ-/TJ+ groups, p<0.01). There were no differences between hemophilia A patients with and without target joints for any of the mental scales or the MCS score (p>0.05). Conclusion: These comparisons demonstrate that severe hemophilia A patients have significantly significant and clinically meaningful lower physical HRQOL compared to the general public and people suffering from chronic back pain. The physical burden that these severe hemophilia A patients reported was similar to those who were living with rheumatoid arthritis or cancer. If target joints are prevented, hemophilia A patients may be able to experience significantly better physical HRQOL than if they developed a target joint. Finally, this research demonstrated that hemophilia A patients were unique compared to the other three chronic conditions studied, because hemophilia A patients reported significantly higher mental HRQOL than patients with chronic back pain, rheumatoid arthritis and cancer. Disclosures: Epstein: Baxter BioScience: Employment. Luu: Baxter BioScience: Employment. Yarlas: Baxter BioScience: Consultancy. Hammond: Baxter BioScience: Consultancy.


2013 ◽  
Vol 41 (2) ◽  
pp. 379-382 ◽  
Author(s):  
Annamaria Iagnocco ◽  
Esperanza Naredo ◽  
Richard Wakefield ◽  
George A.W. Bruyn ◽  
Paz Collado ◽  
...  

Objective.To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Task Force on the validity of different US measures in rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) presented during the OMERACT 11 Workshop.Methods.The Task Force is an international group aiming to iteratively improve the role of US in arthritis clinical trials. Recently a major focus of the group has been the assessment of responsiveness of a person-level US synovitis score in RA: the US Global Synovitis Score (US-GLOSS) combines synovial hypertrophy and power Doppler signal in a composite score detected at joint level. Work has also commenced examining assessment of tenosynovitis in RA and the role of US in JIA.Results.The US-GLOSS was tested in a large RA cohort treated with biologic therapy. It showed early signs of improvement in synovitis starting at Day 7 and increasing to Month 6, and demonstrated sensitivity to change of the proposed grading. Subsequent voting questions concerning the application of the US-GLOSS were endorsed by > 80% of OMERACT delegates. A standardized US scoring system for detecting and grading severity of RA tenosynovitis and tendon damage has been developed, and acceptable reliability data were presented from a series of exercises. A preliminary consensus definition of US synovitis in pediatric arthritis has been developed and requires further testing.Conclusion.At OMERACT 11, consensus was achieved on the application of the US-GLOSS for evaluating synovitis in RA; and work continues on development of RA tenosynovitis scales as well as in JIA synovitis.


2009 ◽  
Vol 26 (1) ◽  
pp. 77-90 ◽  
Author(s):  
Howard Birnbaum ◽  
Crystal Pike ◽  
Rebecca Kaufman ◽  
Maryna Maynchenko ◽  
Yohanne Kidolezi ◽  
...  

2008 ◽  
Vol 59 (4) ◽  
pp. 474-480 ◽  
Author(s):  
Saralynn Allaire ◽  
Frederick Wolfe ◽  
Jingbo Niu ◽  
Michael P. Lavalley

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