Difficult-to-treat gout flares: eligibility for interleukin-1 inhibition in private practice is uncommon according to current EMA approval

Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2181-2187 ◽  
Author(s):  
Tristan Pascart ◽  
Laurène Norberciak ◽  
Hang-Korng Ea ◽  
Sahara Graf ◽  
Pascal Guggenbuhl ◽  
...  
Keyword(s):  
Interleukin 1 ◽  
Standard Of Care ◽  
Acute Gout ◽  
Second Line ◽  
First Line ◽  
Cross Sectional ◽  
The Past ◽  
Systemic Glucocorticoids ◽  
Anti Inflammatory ◽  
Gout Flares

Abstract Objective The objective was to determine the proportion of patients with difficult-to-treat or difficult-to-prevent acute gout attacks eligible for IL-1 inhibition. Methods Participants included in the French cross-sectional GOSPEL cohort (n = 1003 gout patients) were examined for contraindications and intolerance to standard of care (SoC) drugs of gout flares (colchicine, non-steroidal anti-inflammatory drugs and systemic glucocorticoids). Patients were classified as definitely eligible for first-line IL-1 inhibition (canakinumab) according to European summary of product characteristics (contraindications/intolerance to SoC and at least three flares per year) without any other anti-inflammatory options (contraindications/intolerance only), or potentially eligible (precaution of use). Eligibility to receive IL-1 during an on-going flare related to insufficient efficacy was assessed (second-line eligibility). Results Definite first-line eligibility for IL-1 therapy was found in 10 patients (1%) and contraindication to all SoC therapies in nine patients who had presented <3 flares in the past 12 months. At least precaution of use for SoC therapies was noted for 218/1003 patients (21.7%). Of 487 patients experiencing flares at baseline, 114 (23.4%) were still experiencing pain scored ⩾4/10 numeric scale on day 3, one of whom could not receive further SoC drugs. Only nine of them had three or more flares in the past year and were eligible for second-line IL-1 inhibition. Conclusion Despite significant numbers of patients without any SoC anti-inflammatory therapeutic options for gout flares, eligibility for IL-1 inhibition therapy according to current European approval is rare.

Anti-inflammatory agents for prophylaxis and flares

2016 ◽  
Author(s):  
Nicola Dalbeth
Keyword(s):  
Effective Treatment ◽  
Interleukin 1 ◽  
Safety Data ◽  
Acute Gout ◽  
Repeated Use ◽  
Anti Inflammatory ◽  
Concomitant Medications

Acute gout requires rapid, effective treatment. Colchicine, non-steroidal anti-inflammatories, and corticosteroids are all effective; the choice of agent is dictated by the patient’s co-morbidities and concomitant medications. Interleukin-1 inhibitors are effective, but the high cost precludes routine use, and long-term safety data for repeated use are lacking.

Patterns of pharmaceutical therapy in advanced melanoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20014-e20014 ◽  
Author(s):  
Aikaterini Bilitou ◽  
Zhongyun Zhao ◽  
Beth L. Barber ◽  
Genevieve Sian Clapton ◽  
Deborah Saltman
Keyword(s):  
Braf Mutation ◽  
Standard Of Care ◽  
Advanced Melanoma ◽  
Treatment Modalities ◽  
Second Line ◽  
Wild Type ◽  
First Line ◽  
Pharmaceutical Therapy ◽  
First Line Therapy ◽  
Line Therapy

e20014 Background: Since 2011, two therapies that provide novel approaches to the treatment of advanced (unresectable or metastatic) melanoma have been introduced to the market: ipilimumab for second line and vemurafenib for BRAF mutation-positive melanoma. It is not known how the new drugs influence treatment; this study investigated current treatment patterns in advanced melanoma. Methods: A clinician-validated, web-based survey was administered between August and November 2012 to clinicians who treat advanced melanoma in France, Germany, Italy, Spain, and the UK. Respondents were asked about their treatment of patients in the previous 12 months, including treatment modalities and pharmaceutical therapies used, and factors that affect treatment choice. Results: 150 oncologists and dermatologists completed the survey, 30 in each country. Pharmaceutical therapy was more commonly used than other treatment modalities and varied by stage of disease. A high proportion of patients with late stage of disease were treated with pharmaceutical therapy in Germany (85% in M1B) and France (83% in M1C). Among the countries, 51% (Italy) to 87% (France) of respondents test BRAF mutation status. In patients with wild-type BRAF tumors, dacarbazine, which has not been shown to provide any overall survival benefit, was the most commonly used drug for first-line therapy in all countries. In mutated BRAF tumors, vemurafenib was the most commonly used drug in first line therapy in 3 of 5 countries. There was no standard of care in second line for either patients with wild-type or mutated-BRAFtumors; therapies used included fotemustine, temozolomide, interferon, paclitaxel, and ipilimumab. Conclusions: Treatment options for patients with advanced melanoma are limited, particularly for patients with wild-type BRAF disease. In second line, there does not appear to be an established standard of care: a range of treatments are used, including several not indicated for melanoma.

scholarly journals A 10-year cross-sectional retrospective study on Kawasaki disease in Iranian children: incidence, clinical manifestations, complications, and treatment patterns

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Payman Sadeghi ◽  
Anahita Izadi ◽  
Sayed Yousef Mojtahedi ◽  
Leila Khedmat ◽  
Mohsen Jafari ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Kawasaki Disease ◽  
Serum Sodium ◽  
Clinical Manifestations ◽  
Cardiac Complications ◽  
Second Line ◽  
First Line ◽  
Cross Sectional ◽  
Female Ratio ◽  
Iranian Children

Abstract Background Kawasaki disease (KD) as an acute, systemic vasculitis is the leading cause of acquired heart disease in children under the age of 5 years. Methods A 10-year cross-sectional retrospective study was designed to assess 190 Iranian children with KD during 2008–2018. Demographic data, clinical and laboratory manifestations from the onset of symptoms to diagnosis, clinical signs and symptoms, and subsequent treatments were evaluated to predict hospitalization stay, complications, and response to treatment. Results Children with KD had a male-to-female ratio of 1.18:1 and an average age of 36 months. There was an insignificantly more incidence of KD in cold seasons. The most frequent symptoms were fever (92.6%), oral mucus membrane changes (75.8%), bilateral bulbar conjunctival injection (73.7%), polymorphous skin rash (73.2%), peripheral extremity changes (63.7%), and cervical lymphadenopathy (60.0%). The rate of gastrointestinal, cardiac, joint, and hepatic complications was determined to be 38.4, 27.9, 6.8, and 4.2%, respectively. 89.5% of patients received intravenous immunoglobulin (IVIG) plus aspirin as the first line of treatment, while, 16.3% of them needed an extra second line of treatment. Significantly low serum sodium levels and high platelet counts were detected in KD patients with cardiac complications. Cardiac complications often were more encountered in patients who did not respond to the first line of treatment. Higher platelet count, lower serum sodium amount, and C-reactive protein (CRP) level were significantly associated with a need for an additive second line of treatment. A significant relationship between hospitalization stay and hemoglobin level was found. Conclusion As most of the clinical manifestations and complications were following other reports released over the past few years, such data can be confidently used to diagnose KD in Iran. Seasonal incidence and a positive history of recent infection in a notable number of patients may provide clues to understand possible etiologies of KD. Laboratory markers can successfully contribute to health practitioners with the clinical judgment of the need for additional treatments, possible complications, and hospitalization duration.

scholarly journals Optimizing Treatment for Head and Neck Cancers: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

2020 ◽  
Vol 18 (7.5) ◽  
pp. 982-984
Author(s):  
Robert I. Haddad
Keyword(s):  
Head And Neck ◽  
Single Agent ◽  
Standard Of Care ◽  
Phase Iii ◽  
Routine Practice ◽  
Second Line ◽  
First Line ◽  
Positive Score ◽  
Combined Positive Score ◽  
Line Setting

Immunotherapy has changed the game in the treatment of head and neck cancer (HNC). Practice-changing results from the phase III KEYNOTE-048 trial led to the approval of pembrolizumab immunotherapy alone or in combination with chemotherapy for the treatment of recurrent/metastatic HNC in the first-line setting. Testing for combined positive score (CPS) is now part of routine practice, because patients with CPS ≥1 can be started on single-agent immunotherapy in the first-line. Pembrolizumab replaces the “old” standard of care established by the EXTREME study, as trials looking at targets besides immunotherapy have proved “disappointing.” Additionally, nivolumab and pembrolizumab are both approved for use in the second-line.

scholarly journals Is There Still a Place for Tyrosine Kinase Inhibitors for the Treatment of Hepatocellular Carcinoma at the Time of Immunotherapies? A Focus on Lenvatinib

Cancers ◽  
2021 ◽  
Vol 13 (24) ◽  
pp. 6310
Author(s):  
Marie Decraecker ◽  
Caroline Toulouse ◽  
Jean-Frédéric Blanc
Keyword(s):  
Hepatocellular Carcinoma ◽  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitors ◽  
Kinase Inhibitors ◽  
Standard Of Care ◽  
Special Focus ◽  
Second Line ◽  
First Line ◽  
First Line Therapy ◽  
Therapeutic Algorithms

The systemic treatment of hepatocellular carcinoma is changing rapidly. Three main classes of treatment are now available. Historically, multi-targeted tyrosine kinase inhibitors (TKIs) (sorafenib and lenvatinib as first-line; regorafenib and cabozantinib as second-line) were the first to show an improvement in overall survival (OS). Anti-vascular endothelial growth factor (anti-VEGF) antibodies can be used in first-line (bevacizumab) or second-line (ramucirumab) combination therapy. More recently, immuno-oncology (IO) has profoundly changed therapeutic algorithms, and the combination of atezolizumab-bevacizumab is now the first-line standard of care. Therefore, the place of TKIs needs to be redefined. The objective of this review was to define the place of TKIs in the therapeutic algorithm at the time of IO treatment in first-line therapy, with a special focus on lenvatinib that exhibits one of the higher anti-tumoral activity among TKI in HCC. We will discuss the place of lenvatinib in first line (especially if there is a contra-indication to IO) but also after failure of atezolizumab and bevacizumab. New opportunities for lenvatinib will also be presented, including the use at an earlier stage of the disease and combination with IOs.

scholarly journals Optimizing First-Line Therapy for Follicular Lymphoma: Is It Time for Chemotherapy-Free Approaches?

2019 ◽  
Vol 17 (11.5) ◽  
pp. 1414-1416
Author(s):  
Richard I. Fisher
Keyword(s):  
Follicular Lymphoma ◽  
Standard Of Care ◽  
Hematologic Malignancies ◽  
First Line ◽  
Current Standard ◽  
The Past ◽  
First Line Therapy ◽  
Free Treatment ◽  
Tremendous Progress ◽  
Made In

Over the past several decades, tremendous progress has been made in the treatment of follicular lymphoma. The addition of rituximab to chemotherapy led to significant improvements in survival in the 1990s. Current standard of care in advanced-stage, previously untreated follicular lymphoma is rituximab plus chemotherapy, sometimes followed by rituximab maintenance. Now, as more research is conducted in the field of chemotherapy-free treatment, Dr. Richard I. Fisher discussed the importance of carefully constructed phase II or III trials at the NCCN 2019 Annual Congress: Hematologic Malignancies. He maintained that a nonchemotherapy treatment regimen comprising rituximab + lenalidomide can be considered in carefully selected patients, and that it is currently the only chemotherapy-free treatment that should be recommended.

scholarly journals Diverging Playing Positions do not Lead to Differences in YBT-UQ Performance in Youth Handball Players

2021 ◽  
Vol 05 (03) ◽  
pp. E99-E103
Author(s):  
Julian Bauer ◽  
Gerrit Schwiertz ◽  
Thomas Muehlbauer
Keyword(s):  
Functional Performance ◽  
Cross Sectional Study ◽  
Training Load ◽  
Effect Sizes ◽  
Second Line ◽  
Sectional Study ◽  
First Line ◽  
Balance Test ◽  
Cross Sectional ◽  
Performance Differences

AbstractHandball playing positions can be differentiated between first line players who position themselves near the 6-m line and second line players who typically play outside the 9-m space. Handball is characterized by a high number of throwing actions that cause adaptations in the throwing shoulder. The objective of this cross-sectional study was to assess whether the specific physiological positional demands in handball lead to functional performance differences between the playing positions (N=196; goalkeepers: n=25; backcourt: n=99; pivots: n=21; winger: n=51) in terms of shoulder mobility and stability in any reach direction as assessed through the Upper Quarter Y Balance Test (YBT-UQ). Contrary to our hypothesis, the results did not show significant differences between the playing positions in shoulder mobility and stability in youth handball players, irrespective of reach arm and reach direction. The obtained effect sizes (η p 2) were solely small and ranged between 0.01 and 0.03. The adaptations following the demands of the diverging playing positions do not lead to significant differences in shoulder mobility and stability on the basis of the YBT-UQ. The overall training load of youth handball players may not be sufficient to lead to significant position-specific differences in shoulder mobility and stability.

Characteristics of Turkish colorectal cancer patients and bevacizumab preference.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15055-e15055
Author(s):  
Irfan Cicin ◽  
Mahmut Gumus ◽  
Dogan Uncu ◽  
Metin Ozkan ◽  
Saadettin Kilickap ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Second Line ◽  
First Line ◽  
Cross Sectional ◽  
Cancer History ◽  
Outcome Information ◽  
Stage 4 ◽  
Metastasis Rate ◽  
Colorectal Cancer Patients ◽  
Turkish Patients

e15055 Background: The aim of this registry was to collect demographic, diagnostic, treatment, and outcome information about Turkish patients with colorectal cancer (CRC). Methods: It was designed as a multicenter, cross-sectional, non-interventional study conducted on new and previously diagnosed CRC cases applied to 28 medical oncology outpatient clinics between 2012 and 2015. A total of 7547 male (n = 4314) and female (n = 3233) patients > 18 years were included. Results: The mean age at diagnosis was 57.7±12.4 years. There was no familial or other primary cancer history in majority of patients. 22.9% of patients (n = 1579) were diagnosed at Stage 4. In 73,7% of patients (n = 5492), tumor was left-sided. Lymphovascular invasion was determined in 34.3% of patients, 87.6% had surgery. Liver-only metastasis rate was 53.1%. KRAS was tested in 717 of 1579 mCRC patients and mutation was positive in 39.3% of cases (n = 282). BRAF and KRAS tests were performed at 3.5% (n = 83) and 49.2% (n = 1158) for first line, whereas at 5.5% (n = 54) and 63.9% (n = 630) for second line metastatic treatments, respectively. In 25,5% of stage 4 bevacizumab users, bevacizumab was used both for first and second line treatment (n = 83). In KRAS mutant stage 4 patients bevacizumab was used 67% of first line (n = 185), and 40.2% of second line treatments (n = 51). In KRAS wild stage 4 patients bevacizumab was used 46,8% of first line (n = 197), and 24,5% of second line treatments (n = 58). Conclusions: In this study we found that 22.9% of Turkish colorectal patients were diagnosed at Stage 4. 45% of stage 4 patients were tested for KRAS and mutatian rate was 39.3%. BRAF testing rate was low in Turkish centers. Bevacizumab was a preferred agent both for KRAS mutant and WT patients.

Association of immune microenvironment to response in treatment-naïve non-small cell lung cancer (NSCLC) samples with follow-up second-line immunotherapy data.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 49-49
Author(s):  
Marie Cumberbatch ◽  
Nathan Elliott ◽  
Sarah Warren ◽  
Woo Ho Kim ◽  
Christopher Womack ◽  
...  
Keyword(s):  
Gene Expression ◽  
Mhc Class Ii ◽  
Objective Response ◽  
Standard Of Care ◽  
Analysis Data ◽  
Second Line ◽  
First Line ◽  
Immune Microenvironment ◽  
Treatment Naïve

49 Background: Archival specimens collected months or years prior to starting immunotherapy are often used to identify patients for second line immune checkpoint inhibitor (ICI) treatment. PD-L1 expression and the immune microenvironment in these patients may have altered over time following multiple lines of failed standard of care (SOC) treatments. Methods: Formalin fixed paraffin embedded (FFPE) tumor samples, taken during resection performed as first line surgical treatment from a cohort of NSCLC patients (n = 18), were evaluated by Nanostring using the IO360 gene expression panel, and by immunohistochemistry (IHC) for CD3, CD8, PD-L1, CD68 and CD163. The resultant immune profiles were correlated with the clinical follow-up data for radiotherapy, SOC chemotherapy, and second line immunotherapy with the aim of understanding whether immune signatures predictive of response to ICI therapy may be identified in such samples. Results: Of the 18 cases, clinical follow-up data indicated objective response to ICI therapy for 4 patients, with the mean time from initial diagnosis to ICI treatment being 2.8 years (range: 0.4 to 8.5 years). Although pathologist PD-L1 IHC scores were not predictive of response, IHC image analysis data revealed significant increases in CD3 (2.3-fold) and CD8 (2.7-fold) T cell numbers in the responder population. In addition, although CD68+ macrophage frequencies did not differ significantly between responder and non-responder populations, reduced M2-like CD163+ macrophage/monocyte numbers were evident for responders. While the Tumor Inflammation Signature was not predictive of response, several gene expression signatures were significantly associated with response including increased abundance of CD8 T cells, cytotoxic cells, cytotoxicity, MHC class II antigen presentation and Melanoma-Associated Antigens (MAGE). Conclusions: Despite these patients having received various lines of radiotherapy and SOC chemotherapy prior to receiving immunotherapy, immune profiles associated with response to second line immunotherapy were detected in surgical first line resection samples.

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