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Anakinra

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1. Anakinra (Kineret) - for the treatment of Still?s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still?s Disease (AOSD)

Anakinra (Kineret) - for the treatment of Still?s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still?s Disease (AOSD) Published 08 October 2018 1 SMC2104 anakinra 100mg/0.67mL solution for injection in pre- filled syringe (Kineret ® ) Swedish Orphan Biovitrum Ltd (SOBI) 7 September 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use (...) in NHSScotland. The advice is summarized as follows: ADVICE: following a full submission anakinra (Kineret ® ) is accepted for use within NHSScotland. Indication under review: in adults, adolescents, children and infants aged eight months and older with a body weight of 10kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients

2018 Scottish Medicines Consortium

2. Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults)

Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults) NHS England » Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults) Search Search Menu Clinical Commissioning Policy: Anakinra/tocilizumab for the treatment of Adult-Onset Still’s Disease refractory to second-line therapy (adults) Document first published: 6 July

2018 NHS England

3. Clinical Commissioning Policy: Anakinra to treat periodic fevers and autoinflammatory diseases

Clinical Commissioning Policy: Anakinra to treat periodic fevers and autoinflammatory diseases NHS England » Clinical Commissioning Policy: Anakinra to treat periodic fevers and autoinflammatory diseases (all ages) Search Search Menu Clinical Commissioning Policy: Anakinra to treat periodic fevers and autoinflammatory diseases (all ages) Document first published: 6 July 2018 Page updated: 6 July 2018 Topic: , Publication type: This policy document outlines the arrangements for funding

2018 NHS England

4. A systems pharmacology workflow with experimental validation to assess the potential of anakinra for treatment of focal and segmental glomerulosclerosis. Full Text available with Trip Pro

A systems pharmacology workflow with experimental validation to assess the potential of anakinra for treatment of focal and segmental glomerulosclerosis. Focal and Segmental Glomerulosclerosis (FSGS) is a severe glomerulopathy that frequently leads to end stage renal disease. Only a subset of patients responds to current therapies, making it important to identify alternative therapeutic options. The interleukin (IL)-1 receptor antagonist anakinra is beneficial in several diseases with renal (...) involvement. Here, we evaluated the potential of anakinra for FSGS treatment. Molecular process models obtained from scientific literature data were used to build FSGS pathology and anakinra mechanism of action models by exploiting information on protein interactions. These molecular models were compared by statistical interference analysis and expert based molecular signature matching. Experimental validation was performed in Adriamycin- and lipopolysaccharide (LPS)-induced nephropathy mouse models

2019 PLoS ONE

5. Anakinra use during pregnancy: Report of a case with Familial Mediterranean Fever and infertility Full Text available with Trip Pro

Anakinra use during pregnancy: Report of a case with Familial Mediterranean Fever and infertility Familial Mediterranean fever (FMF), affecting people of Mediterranean origin, is an endemic and sometimes problematic disease because of colchicine resistance/intolerance, with relative lack of treatment alternatives, and disease- or treatment-related issues, such as subfertility. Anakinra, being a rational and effective treatment alternative, has no conclusive human pregnancy data. Here we report (...) a case of FMF with infertility who became pregnant with in vitro fertilization (IVF) under treatment with anakinra, along with the pregnancy outcome.

2017 European journal of rheumatology

6. Anakinra in idiopathic recurrent pericarditis refractory to immunosuppressive therapy; a preliminary experience in seven patients. (Abstract)

Anakinra in idiopathic recurrent pericarditis refractory to immunosuppressive therapy; a preliminary experience in seven patients. Approximately 5% of idiopathic recurrent pericarditis (IRP) patients are refractory or intolerant to NSAIDs, Colchicine and corticosteroids. The empiric treatment approach for these patients includes immunosuppression with Azathioprine (AZA) or immunomodulation with intravenous human immunoglobulin (IVIG). We assessed the efficacy and safety of long-term Anakinra (...) treatment in refractory IRP patients after failure of prior immunosuppressive therapy and/or failure of IVIG.Clinical data of seven IRP patients were retrospectively analyzed. Treatment efficacy was determined by decrease of IRP recurrence and by the ability to withdraw or taper corticosteroids without a relapse. Safety was assessed by the occurrence of adverse events.7 IRP patients (4 male, median age 41) with a median disease duration of 4 years (range: 1.25-9 years) were treated with Anakinra (median

2019 Autoimmunity reviews

7. Testing the Model for Predicting Effectiveness of Anakinra in Systemic Juvenile Idiopathic Arthritis. Full Text available with Trip Pro

Testing the Model for Predicting Effectiveness of Anakinra in Systemic Juvenile Idiopathic Arthritis. We read the article by Saccomanno, et al, "Predictors of effectiveness of anakinra in systemic juvenile idiopathic arthritis," with great interest1 They reported that shorter disease duration, fewer active joints, higher ferritin levels, and greater activity of systemic manifestations were independently correlated with achievement of complete clinical response at 1 year (CCR1) in systemic

2019 Journal of Rheumatology

8. Pharmacokinetics of Anakinra in Subjects of Heavier vs. Lighter Body Weights. Full Text available with Trip Pro

Pharmacokinetics of Anakinra in Subjects of Heavier vs. Lighter Body Weights. This trial (20010168) studied how body weight (BW) and body mass index (BMI) influenced the pharmacokinetics (PK) of anakinra. Subjects (n = 32) were assigned to four groups (n = 8) according to BW and BMI. Randomization was according to a four-treatment, four-period, four-sequence crossover design. The four anakinra injections were 100, 150, and 300 mg s.c. and 100 mg i.v. Plasma samples were measured by enzyme (...) clearance. Mean AUC was reduced 24% and 33% for heavier (BW ≥ 100 kg) vs. lighter subjects (BW ≤ 90 kg) after i.v. and s.c. administration, respectively. BMI increased clearance for heavier subjects. For example, mean (SD) plasma clearance of i.v. anakinra increased from 1.17 ± 0.29 to 1.62 ± 0.24 mL/minute/kg (P < 0.05) for larger (> 100 kg) obese (BMI > 36) vs. larger (> 100 kg) less obese (BMI < 35) subjects, respectively. Similarly, results following s.c. supported those after i.v. administration

2019 Clinical and translational science Controlled trial quality: uncertain

9. Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial. Full Text available with Trip Pro

Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial. To evaluate the efficacy and safety of anakinra in treating acute gout flares in a randomized, double-blind, placebo-controlled, active comparator, non-inferiority (NI) trial.Patients with a crystal-proven acute gout flare were randomized (1: 1) to treatment with anakinra or treatment as usual (free choice: either colchicine, naproxen or prednisone (...) ). The primary end point was the change in pain between baseline and the averaged pain score on days 2-4 measured on a five-point rating scale. NI of anakinra would be established if the upper bound of the 95% CI of the numeric difference in changed pain scores between treatment groups did not exceed the NI limit of 0.4 in favour of treatment as usual, in the per-protocol (PP) and intention-to-treat (ITT) populations, assessed in an analysis of covariance model. Secondary outcomes included safety assessments

2019 Rheumatology (Oxford, England) Controlled trial quality: predicted high

10. Predictors of Effectiveness of Anakinra in Systemic Juvenile Idiopathic Arthritis. (Abstract)

Predictors of Effectiveness of Anakinra in Systemic Juvenile Idiopathic Arthritis. To seek predictors of therapeutic response to the interleukin (IL)-1 inhibitor anakinra in children with systemic-onset juvenile idiopathic arthritis (sJIA).The clinical charts of all patients with sJIA who were newly treated with anakinra at our center between 2004 and 2017 were reviewed retrospectively. Predictors included baseline demographic, clinical, and laboratory variables as well as previous (...) or concomitant therapies. The effectiveness of anakinra was assessed at 1 year after treatment start. Complete clinical response (CCR) was defined as absence of fever, physician's global assessment ≤ 1, count of active joints ≤ 1, negative C-reactive protein, and ≥ 75% reduction of corticosteroid dose. According to the intention-to-treat principle, patients who had anakinra discontinued before 1 year for any reasons other than disease remission were classified as nonresponders. Statistics included univariate

2019 Journal of Rheumatology

11. Use of Anakinra in Hospitalized Patients with Crystal-associated Arthritis. (Abstract)

Use of Anakinra in Hospitalized Patients with Crystal-associated Arthritis. In this retrospective observational study, we assess the efficacy and safety of the interleukin-1 receptor antagonist anakinra in medically complex, hospitalized patients with acute gout and calcium pyrophosphate crystal arthritis.Adult inpatients patients treated with anakinra from 2014-2017 were identified for inclusion. Charts were reviewed for demographics, comorbidities, laboratory data, pain scores, joint (...) involvement, prior treatment, dosing and response to anakinra, concurrent infections, and surgical interventions. Response to anakinra treatment was determined from review of provider documentation, as well as recorded pain scores on a numeric scale.We identified 100 individuals accounting for 115 episodes of arthritis. This population was 82% male, with an average age of 60 years. Comorbidities included renal disease (45%) and history of organ transplantation (14%). Twenty-nine episodes of arthritis

2019 Journal of Rheumatology

12. Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study. Full Text available with Trip Pro

Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study. There is clear association between the intensity of the acute inflammatory response during acute myocardial infarction (AMI) and adverse prognosis after AMI. Interleukin-1 (IL-1) is a pro-inflammatory cytokine released during AMI and involved in adverse remodeling and heart failure (HF). We describe a study to evaluate (...) the safety and efficacy of IL-1 blockade using an IL-1 receptor antagonist (anakinra) during the acute phase of ST-segment elevation myocardial infarction (STEMI). The Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3; http://www.ClinicalTrials.gov NCT01950299) is a phase 2, multicenter, double-blinded, randomized, placebo-controlled clinical trial comparing anakinra 100 mg once or twice daily vs matching placebo (1:1:1) for 14 days in 99 patients with STEMI. Patients who present

2018 Clinical cardiology Controlled trial quality: predicted high

13. A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial Full Text available with Trip Pro

A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial Palmoplantar pustulosis is a rare but painful and debilitating disease. It consistently ranks the highest of all psoriasis phenotypic variants in terms of symptoms and functional impairment. Management of plaque-type psoriasis has been revolutionised in the last 10 years with the advent of biologic therapies, but treatment (...) options for pustular psoriasis remain profoundly limited. On the basis of mechanistic findings which suggest a key pathogenic role for interleukin (IL)-1 in pustular psoriasis, we hypothesise that anakinra (IL-1 blockade) will be an efficacious treatment for pustular psoriasis.We will conduct a two-stage, adaptive, double-blind, randomised, placebo-controlled trial to test the hypothesis that anakinra, self-administered daily by subcutaneous injection over 8 weeks, will deliver therapeutic benefit

2018 Trials Controlled trial quality: predicted high

14. Treatment of pustular psoriasis with anakinra: a statistical analysis plan for stage 1 of an adaptive two-staged randomised placebo-controlled trial Full Text available with Trip Pro

Treatment of pustular psoriasis with anakinra: a statistical analysis plan for stage 1 of an adaptive two-staged randomised placebo-controlled trial Palmoplantar pustulosis (PPP) is a rare, chronic inflammatory skin disease. It is known to affect quality of life at a level comparable to that from major medical and psychiatric illness, yet current treatment options are remarkably limited. Recent evidence however suggests that interleukin-1 (IL-1) blockade with anakinra will deliver therapeutic (...) benefit in PPP.Anakinra for Pustular psoriasis: Response in a Controlled Trial (APRICOT) is a two-staged, adaptive, double-blind, randomised placebo-controlled trial which aims to test the hypothesis that IL-1 blockade with anakinra will deliver therapeutic benefit in PPP. During stage 1 a total of 24 patients will be randomised (1:1) to receive either placebo or anakinra. The two candidate primary outcomes are fresh pustule count (across palms and soles) and the Palmoplantar Pustulosis Area

2018 Trials Controlled trial quality: predicted high

15. Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study Full Text available with Trip Pro

Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study In preclinical models, IL-1β inhibition could enhance the efficacy of fluorouracil (5-FU). In this phase 2 study, we assessed the activity and safety of 5-FU plus bevacizumab and anakinra (an IL-1β and α inhibitor) in patients with metastatic colorectal (mCRC) refractory to chemotherapy and anti-angiogenic therapy. Eligible patients had (...) unresectable mCRC; were refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy, and anti-EGFR therapy (for tumors with wild-type KRAS). Patients were treated with a simplified acid folinic plus 5-FU regimen and bevacizumab (5 mg/kg) both administered by intravenous infusion for 30 min every 2 weeks. Anakinra (100 mg) was injected subcutaneously once daily. The primary endpoint was the 2-month response rate determined upon CHOI criteria. Thirty two patients with metastatic

2018 Oncoimmunology

16. Utility of Anakinra in Acute Crystalline Diseases: A Retrospective Study Comparing a University Hospital with a Veterans Affairs Medical Center. (Abstract)

Utility of Anakinra in Acute Crystalline Diseases: A Retrospective Study Comparing a University Hospital with a Veterans Affairs Medical Center. To evaluate the efficacy and safety of anakinra in inpatient management of acute gout and pseudogout.Hospitalized patients with acute gout (n = 77) or pseudogout (n = 11) or both (n = 3) were analyzed for response to anakinra and adverse effects.Half of all patients had comorbidities limiting the treatment choice. Anakinra was well tolerated, and 92

2018 Journal of Rheumatology

17. Disappearance of a strong triple positivity for antiphospholipid antibodies after treatment with Anakinra. Full Text available with Trip Pro

Disappearance of a strong triple positivity for antiphospholipid antibodies after treatment with Anakinra. 30361417 2019 02 16 1592-8721 104 2 2019 Feb Haematologica Haematologica Disappearance of a strong triple positivity for antiphospholipid antibodies after treatment with anakinra. e83-e84 10.3324/haematol.2018.205484 Arnaud Erik E Service de médecine interne, CHU de Nîmes, France. Soulier Camille C Service de Cardiologie, CHU de Nîmes, France. Gris Jean-Christophe JC Consultations et

2018 Haematologica

18. Cerebral autoinflammatory disease treated with anakinra Full Text available with Trip Pro

Cerebral autoinflammatory disease treated with anakinra Interest in autoimmune encephalitis has been growing since the discovery of various autoimmune antibodies, such as N-methyl D-aspartate receptors antibody and leucine-rich glioma-inactivated 1 antibody. However, in contrast to autoimmune encephalitis associated with dysregulated adaptive immunity in the brain, the question of whether innate immunity-mediated autoinflammatory diseases exist in the brain has drawn much attention. Herein, we (...) report a patient with microglia-dominant acute autoinflammatory encephalitis successfully treated with anakinra, an including interleukin-1 receptor blocker. In comparison to systemic autoinflammatory disease, we term this encephalitis cerebral autoinflammatory disease. Cerebral autoinflammatory disease could suggest new conceptual approaches to patients previously diagnosed with an unspecified encephalitis.

2018 Annals of clinical and translational neurology

19. Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation (EarlyAna) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03513471 Recruitment Status

2018 Clinical Trials

20. Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number (...) of saved studies (100). Please remove one or more studies before adding more. Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation (LateAna) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03513458 Recruitment Status : Enrolling

2018 Clinical Trials

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