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Arcalyst (Rilonacept) - Summary



Rilonacept is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human interleukin-1 receptor component (IL-1RI) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the Fc portion of human IgG1. Rilonacept has a molecular weight of approximately 251 kDa. Rilonacept is expressed in recombinant Chinese hamster ovary (CHO) cells. ARCALYST is supplied in single-use, 20-mL glass vials containing a sterile, white to off-white, lyophilized powder. Each vial of ARCALYST is to be reconstituted with 2.3 mL of Sterile Water for Injection. A volume of up to 2 mL can be withdrawn, which is designed to deliver 160 mg for subcutaneous administration only. The resulting solution is viscous, clear, colorless to pale yellow, and essentially free from particulates. Each vial contains 220 mg rilonacept. After reconstitution, each vial contains 80 mg/mL rilonacept, 40 mM histidine, 50 mM arginine, 3.0% (w/v) polyethylene glycol 3350, 2.0% (w/v) sucrose, and 1.0% (w/v) glycine at a pH of 6.5 0.3. No preservatives are present.

ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

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Published Studies Related to Arcalyst (Rilonacept)

Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis. [2013]
idiopathic arthritis (JIA)... CONCLUSION: Sustained improvements in clinical and laboratory measures of the

Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. [2012]
initiation of urate-lowering therapy... CONCLUSION: The current findings indicate that rilonacept significantly reduces

Efficacy and safety of rilonacept (interleukin-1 Trap) in patients with cryopyrin-associated periodic syndromes: results from two sequential placebo-controlled studies. [2008]
autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)... CONCLUSION: Treatment with weekly rilonacept provided marked and lasting

Rilonacept for colchicine-resistant or -intolerant familial Mediterranean fever: a randomized trial. [2012]
FMF... CONCLUSION: Rilonacept reduces the frequency of FMF attacks and seems to be a

more studies >>

Clinical Trials Related to Arcalyst (Rilonacept)

Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD) [Recruiting]
Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular dysfunction (i. e., large elastic artery stiffening and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations characterized by chronic inflammation. However, it is currently unknown if reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60 mL/min/1. 73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces inflammation and oxidative stress. These studies could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis.

Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA) [Recruiting]

- Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated

episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most treatments for DIRA are intended to control the immune system to stop these inflammations. There are drugs that can treat DIRA, but they have to be given daily as injections. Researchers want to try another drug, rilonacept, as a treatment for DIRA. It needs to be given only once a week. Rilonacept will be given to individuals who are at least 3 months old and who have DIRA. Objectives:

- To test the safety and effectiveness of rilonacept for children and adults with DIRA.


- Individuals at least 3 months old who have DIRA.


- Participants will be screened with a physical exam and medical history. Blood and urine

samples will be collected. Other tests to study pain and movement will be given. Imaging studies such as bone density scans and x-rays may also be taken.

- Participants will have a minimum of four to five study visits over 12 months. Those who

are on different anti-inflammatory drugs (such as anakinra) will stop taking them before beginning the study visits.

- Participants will have rilonacept injections weekly while on this study. The dose will

be adjusted as needed to help treat the DIRA symptoms. Participants will keep a diary to monitor their symptoms and any side effects.

- Treatment with rilonacept will be given for 1 year. Participants will have study visits

to monitor the treatment. They will provide blood samples and have other tests at these study visits.

Cold Contact Urticaria Treatment With Rilonacept [Recruiting]
Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Typically, symptoms occur within minutes after cold contact, including exposure to cold air, liquids or objects and are limited to cold exposed skin areas. The investigators postulate that there is an overlap between acquired cold urticaria and cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to antihistamines will benefit from IL-1 targeting treatment strategies. This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept in patients with cold contact urticaria who could not be successfully treated with first-line medication such as antihistamines. This is a double-blind placebo-controlled parallel group phase II study of the efficacy and safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the Urticaria specialty clinics of ACC. The total duration of the study course for each patient is 14 weeks and is divided in:

1. Screening period (2 weeks, days - 14-0)

2. Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42) 3. Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized (1: 1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and will receive the respective dose subcutaneously. Following the placebo-controlled double-blind phase patients will enter the open-label phase and receive rilonacept open-label treatment (160mg or 320mg depending on treatment response during part A).

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis [Not yet recruiting]
This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard therapy, or, to begin treatment with rilonacept in combination with standard therapy. Patients who are "non-responders" to the current standard of care therapy after 1 week of treatment will be randomly assigned to standard of care or to begin treatment with mycophenolate mofetil in combination with standard therapy. Patients will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for up to five months after completing therapy (6 months total).

IL1-TRAP, Rilonacept, in Systemic Sclerosis [Recruiting]
Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys and tissue fibrosis is widespread. SSc presents special problems for developing therapies due to the heterogeneous clinical presentation, the variability of disease progression and the difficulty quantifying the extent of disease. For most disease manifestations, treatment is primarily symptomatic and generally inadequate. This study will utilize a 4-gene biomarker of skin disease as the primary efficacy outcome in a short duration, placebo-controlled clinical trial of rilonacept, designed to provide preliminary data for a larger trial. These gene biomarkers should provide a strong surrogate for such trials in the future and, if IL-1 is indeed the cytokine leading to fibrosis in this disease, provide a highly significant start to finding a therapeutic for SSc that for the first time might dramatically affect fibrosis. A central hypothesis of this study is that IL-1 inhibition will downregulate the 4-gene biomarker over a relatively short period of time, much shorter than is historically thought necessary to see changes in the MRSS, a skin score measurement tool. Entry criteria will include the recent onset of diffuse cutaneous SSc as this is the population most likely to show progressive skin disease and also the population examined in previous studies showing correlations between MRSS and the 4-gene biomarker. Secondary outcomes will include other validated measures of SSc disease activity. MRSS and SSc health assessment questionnaire (SHAQ), will be followed during the trial. This study will also test the effect of rilonacept on global skin gene expression using microarray analyses of skin biopsies. In addition, serum biomarkers of SSc disease activity (COMP, THS-1 and IFI44) and a biomarker of inflammasome activation (CRP) will be tested before and after treatment.

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Page last updated: 2014-11-30

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