The Treatment of Ankylosing Spondylitis and Psoriatic Arthritis with Etanercept: A Comprehensive Review

2009 ◽  
Vol 1 ◽  
pp. CMT.S37
Author(s):  
Angelique N. Collamer ◽  
Daniel F. Battafarano

Etanercept is a dimeric recombinant soluble tumor necrosis factor (TNF) receptor protein utilized in the treatment of various inflammatory diseases, including ankylosing spondylitis and psoriatic arthritis. Etanercept binds the proinflammatory cytokine TNF and blocks its interaction with soluble TNF receptors, thus decreasing the inflammatory response. Several randomized controlled clinical trials have demonstrated the efficacy, safety and tolerability of etanercept in the treatment of both ankylosing spondylitis and psoriatic arthritis. These trials have also shown significant reductions in markers of systemic inflammation and improvements in patient-reported quality of life measures. Inhibition of radiographic progression has been established in etanercept-treated psoriatic arthritis patients, and ankylosing spondylitis patients have demonstrated decreases in bony inflammation; however, current data does not support a reduction in bone proliferation in ankylosing spondylitis patients. Concerns regarding long-term toxicity, efficacy, and cost-effectiveness considerations persist and guidelines have been published to assist the clinician with appropriate patient selection for this biologic therapy. Current data indicates etanercept therapy has been a very successful and well-tolerated therapy for numerous ankylosing spondylitis and psoriatic arthritis patients and will likely continue to be a cornerstone therapy for treatment of these challenging diseases in the foreseeable future.

2019 ◽  
Vol 1 (18) ◽  
pp. 6-12
Author(s):  
A. R. Babaeva ◽  
E. V. Kalinina ◽  
M. S. Zvonorenko ◽  
E. V. Shcherbinina ◽  
I. V. Bramnik

The article presents current data on algorithms for managing patients with the most common forms of spondylarthritis — ankylosing spondylitis, axial spondylarthritis and psoriatic arthritis, based on existing national and European recommendations. The analysis of innovative approaches to the patho‑genetic therapy of spondyloarthritis with special attention to the inhibition of interleukin‑17 using the drug secukinumab. Along with the literature data, there is a clinical experience of using secukinumab in patients with ankylosing spondylitis, axial spondyloarthritis, and psoriatic arthritis. It has been shown that secukinumab can improve the quality of treatment and achieve clinical remission in patients with high disease activity and adverse prognostic factors. In connection with the high efficacy and safety of treatment, the feasibility of using secukinumab as a first‑line biological agent with insufficient response to a standard basic drug is discussed.


2018 ◽  
Vol 10 (9) ◽  
pp. 169-180 ◽  
Author(s):  
Leticia Garcia-Montoya ◽  
Helena Marzo-Ortega

Psoriatic arthritis and ankylosing spondylitis are chronic inflammatory diseases that can cause significant disability. The commercialization of the first tumour necrosis factor (TNF) inhibitors led to a radical improvement of the quality of life of people affected by these conditions; however, response was not universal, highlighting the need for alternative therapeutic targets. Secukinumab is a monoclonal interleukin (IL)-17A inhibitor which has been proven efficacious for psoriatic arthritis and ankylosing spondylitis in recent clinical trials. Dactylitis, enthesitis, skin and nails are some of the domains in which the inhibition of IL-17 has shown significant improvements apart from the joints. Its safety profile and satisfactory medium- to long-term outcome data are some of the aspects suggesting its potential impact in treatment protocols in the short term.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 806.1-806
Author(s):  
J. Wendler ◽  
E. Movshovich ◽  
N. Damann ◽  
F. Hamann ◽  
P. Wagener ◽  
...  

Background:From February 2015 to April 2020, patients with active psoriatic arthritis under treatment with ustekinumab in routine clinical care in Germany were included into the prospective, multi-center non-interventional study SUSTAIN.Objectives:Here, we present final data from SUSTAIN including final week 160 on long term efficacy and safety of ustekinumab treatment, quality of life and further patient reported outcomes.Methods:In SUSTAIN, 337 patients were treated with ustekinumab according to routine clinical care at 75 centers for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. The collected data included demographics, number of swollen and tender joints, tender entheses, amount of skin symptoms (BSA and PASI), patient reported outcome concerning disease activity and pain, Health Assessment Questionnaire (HAQ), quality of life (SF-12), sleep quality (VAS), satisfaction with therapy of patient and physician, safety (adverse events [AE]/serious adverse events [SAE]), pharmacoeconomic aspects, number of patients with „Minimal Disease Activity“ (MDA) and number of patients with MDA at week 28 und 52. For this analysis, final data of all 337 patients of all documented visits were analyzed.Results:The visit at week 4 was documented for 31 patients, at week 28 for 282, at week 52 for 216, and at week 160 for 129 of the 337 patients. At baseline, the patients had a mean age of 53.6 years (22-85) and 192 (57%) were female. The patients’ mean BMI was 29.6 kg/m2 (18.6-52). 54.3 % of the patients had at least one TNF inhibitor as prior medication. 54.1 % of the patients used MTX as concomitant medication. At time of inclusion, 73.3% of the patients showed arthritis at small and 52.2% at large joints. 16.9% showed spinal involvement and 13.1% enthesitis. In the course of the treatment, the number of tender joints improved from a mean of 10.0 (CI 95% 8.6/11.3) at baseline to 4.1 (3.2/4.9) at week 28, 3.6 (2.7/4.6) at week 52 and 1.0 (0.6/1.4) at week 160. Number of swollen joints improved from 4.1 (3.4/4.9) at baseline to 1.8 (1.2/2.3) at week 28, to 1.3 (0.8/1.8) at week 52 and to 0.4 (0.2/0.6) at week 160. BSA declined from a mean of 15.6% (rage from 0 to 80.0%) at baseline to 5.2% (0 to 60%) at week 28, to 3.0% (0 to 45.0%) at week 52 and to 1.7 (0 to 35%) at week 160. PASI declined from a mean of 7.3 (range from 0 to 43.0) at baseline to 1.7 (0 to 24.8) at week 28, to 1.3 (o to 28.5) at week 52 and to 0.5 (0 to 3.2) at week 160. Efficacy of the therapy with ustekinumab was assessed as “very good” or “good” by 85.3% of the treating physicians at week 52 and by 94.1% at week 160. The patients assessed the efficacy as “very good” or “good” by 82.8% at week 52 and by 89.8% at week 160. At the end of the study, 96 SAEs have been documented, of which only 16 were related to ustekinumab. All in all, safety of therapy with ustekinumab was assessed as “very good” or “good” by 99% of the treating physicians after 52 weeks and by 99.2 % after 160 weeks. The patients assessed the safety as “very good” or “good” by 97.5% at week 52 and by 100% at week 160.Conclusion:The non-interventional study SUSTAIN showed relevant disease improvements and good safety with an outstanding high therapy satisfaction in patients with active psoriatic arthritis treated with ustekinumab. Treatment effect was observed as early as after 4 weeks. The treatment effects and satisfaction sustained up end of documentation at week 160 in daily practice life.Disclosure of Interests:None declared.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049292
Author(s):  
Edward Baker ◽  
Ceri Battle ◽  
Abhishek Banjeri ◽  
Edward Carlton ◽  
Christine Dixon ◽  
...  

ObjectiveThis study aimed to examine the long-term outcomes and health-related quality of life in patients with blunt thoracic injuries over 6 months from hospital discharge and develop models to predict long-term patient-reported outcomes.DesignA prospective observational study using longitudinal survey design.SettingThe study recruitment was undertaken at 12 UK hospitals which represented diverse geographical locations and covered urban, suburban and rural areas across England and Wales.Participants337 patients admitted to hospital with blunt thoracic injuries were recruited between June 2018–October 2020.MethodsParticipants completed a bank of two quality of life surveys (Short Form-12 (SF-12) and EuroQol 5-Dimensions 5-Levels) and two pain questionnaires (Brief Pain Inventory and painDETECT Questionnaire) at four time points over the first 6 months after discharge from hospital. A total of 211 (63%) participants completed the outcomes data at 6 months after hospital discharge.Outcomes measuresThree outcomes were measured using pre-existing and validated patient-reported outcome measures. Outcomes included: Poor physical function (SF-12 Physical Component Score); chronic pain (Brief Pain Inventory Pain Severity Score); and neuropathic pain (painDETECT Questionnaire).ResultsDespite a trend towards improving physical functional and pain at 6 months, outcomes did not return to participants perceived baseline level of function. At 6 months after hospital discharge, 37% (n=77) of participants reported poor physical function; 36.5% (n=77) reported a chronic pain state; and 22% (n=47) reported pain with a neuropathic component. Predictive models were developed for each outcome highlighting important data collection requirements for predicting long-term outcomes in this population. Model diagnostics including calibration and discrimination statistics suggested good model fit in this development cohort.ConclusionsThis study identified the recovery trajectories for patients with blunt thoracic injuries over the first 6 months after hospital discharge and present prognostic models for three important outcomes which after external validation could be used as clinical risk stratification scores.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma


2018 ◽  
Vol 22 (4) ◽  
Author(s):  
Anna Dusza ◽  
Michał Matysiak

In this article we present current investigation on primary immune thrombocytopenia in children. There are described pathomorphology, clinical symptoms, diagnosis and treatment. We also present current data from literature about genetic tests and latest data on treating options in children. Primary immune thrombocytopenia (ITP) is one of the most frequent hematological disorders in pediatric population. Although the majority of children have a self-limited and short duration of the disease. However, approximately 20-30% of those patients can develop chronic ITP, which can cause significant complications and higher mortality and reduced quality of life. Especially regarding to long-term immunosupression or surgical interventions, such like splenectomy and restrictions on daily activities to avoid trauma. Over the past decades a lot of informations has been reported about pathogenic features of ITP. Nowdays, we know that it is not only caused by increased platet destruction and decreased platet production, but also complex, multifactorial immune dysregulation, like loss of immune tolerance and generation of platelet autoantibodies. In this article we present current investigation on ITP including clinical symptoms, diagnosis, pathomorphology and latests options on treatment in children. We also present current data about genetic biomarker, such as Vanin-1 (VNN-1) which has been suggested as one of predictors of chronic disease and potentially can offer early prognosis estimation.


2019 ◽  
Vol 1 (1) ◽  
pp. 66-71
Author(s):  
Bogdan Stanescu ◽  
Adriana Cuciureanu

The present article presents the expertise realized by the Department of Environmental Monitoring Pollution Evaluation within the INCD ECOIND, in the evaluation of the quality of urban soils in the municipality of Bucharest and the main big cities in Romania. The current data available at the level of the 27 member states of the European Union show that annually over 100,000 hectares of land are introduced into the urban environment, a direct consequence of the development of cities. There are a number of legislative obstacles to strategic soil protection measures. Moreover, at the level of the local authorities there is a conflict regarding the measures of soil protection in the long term, on the one hand, and, the accelerated economic development in the short term, on the other. European environmental experts consider that the urban development, absolutely necessary for the economic growth, requires an adequate management of the natural resources in order for the development to be done on a sustainable basis, respectively to follow a series of strategic objectives. In our country, at least in the last decade, we find on a large scale the conversion of industrial areas into commercial or residential areas. The footprint of industrial activities can be found even after long periods of time present by identifying the remnant of soil pollution or in those areas known as historically polluted (for example the town of Copsa Mica). The conclusions stemming from the assessment of pollution in urban areas over large areas, in correlation with the potential sources of pollution, underline the need to monitor the quality of soils in the urban environment, but also to apply a performance management in order to protect this natural resource in the long term.


2019 ◽  
Author(s):  
Duc Ha ◽  
Andrew L. Ries ◽  
Jeffrey J. Swigris

AbstractRationale/ObjectiveQuality of life (QoL) is an important issue in lung cancer survivors. We aimed to identify determinants of QoL in lung cancer survivors eligible for long-term cure.MethodsWe performed an exploratory analysis of a cross-sectional study of consecutive lung cancer survivors who completed curative-intent treatment ≥1 month previously. Variables tested included demographic, clinical, physiologic, and symptom-specific patient-reported outcome measures. We defined the primary outcome as a previously-validated cancer-specific QoL measure – the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (C30) summary score. We also verified our findings with the C30 global health status/QoL subscale and a summated score of lung cancer-specific QoL from the EORTC-Lung Cancer Module 13.ResultsIn 75 enrolled participants, measures of fatigue, depression, sleep difficulties, and dyspnea were statistically significant determinants of the C30 summary score in multivariable linear regression analyses. Together, these four symptoms accounted for approximately 85% of the variance in cancer-specific QoL (p<0.001). When we verified our findings with global QoL and lung cancer-specific QoL, fatigue and dyspnea were consistent determinants of QoL.ConclusionsWe found four symptoms – dyspnea, fatigue, depression, and sleep difficulties – that are important determinants of and together accounted for almost all of the variance in cancer-specific QoL in lung cancer survivors eligible for long-term cure. These findings have implications to reduce symptom burden and improve function and QoL in these patients.


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