— New insights on the factors associated with tophi formation and total body disease burden of gout —
DUBLIN, Ireland, June 15, 2018 (GLOBE NEWSWIRE) — Horizon Pharma plc (NASDAQ:HZNP) presents multiple analyses of KRYSTEXXA® (pegloticase injection) clinical trial data underscoring the complex nature of chronic gout refractory to conventional therapies, also known as uncontrolled gout. The data are being presented in oral and poster sessions at the Annual European Congress of Rheumatology (EULAR 2018), June 13 -16, 2018.
“These data presented at EULAR demonstrate how elevated serum uric acid levels may have systemic effects across multiple organ systems and the need to manage uncontrolled gout aggressively,” said Jeffrey Kent, M.D., senior vice president, medical affairs and outcomes research, Horizon Pharma plc. “As a leader in uncontrolled gout, Horizon Pharma is driven to provide research and analysis which reflects an expansive view about what chronically elevated serum uric acid means for those living with the disease and the long-term consequences of inadequate management. Through an increased understanding of the complex nature of uncontrolled gout, we are able to further educate on the safety and efficacy profile of KRYSTEXXA while applying learnings to the development of next-generation opportunities.”
Analysis of the KRYSTEXXA clinical trials in Association of Renal Dysfunction and Development of Tophi in Subjects with Chronic Refractory Gout and Reponses to Treatment with Pegloticase (abstract SAT0370) offers insights on how tophi may serve as manifestation of the total body disease burden of uncontrolled gout. In the KRYSTEXXA clinical trials, 73 percent of patients with uncontrolled gout had clinically apparent tophi at baseline. Patients with tophi had a significantly lower estimated glomerular filtration rate (eGFR) (85.2 mL/min) than those without tophi (116.5 mL/min) (p=0.001). Low eGFR levels mean that patients have renal (kidney) disease. This new post-hoc analysis demonstrates a significant association between the frequency with which those living with uncontrolled gout manifested tophi and the presence of renal dysfunction.
Data presented in Pegloticase Treatment Significantly Decreases Mean Arterial Blood Pressure in Patients with Chronic Gout (FRI0237) shows that 62.1 percent of patients who received KRYSTEXXA every two weeks, and were characterized as serum uric acid (sUA) responders by the prespecified primary endpoint, experienced meaningful reductions in mean arterial blood pressure throughout the trials. In addition, these reductions were independent of changes in renal function. People living with uncontrolled gout often have kidney disease, hypertension or other comorbidities in which lowering blood pressure is essential. This data offers meaningful insights on connections between sUA levels and blood pressure for people living with uncontrolled gout treated with KRYSTEXXA.
“Gout is a serious medical condition but remains an undermanaged disease for which too often only the acute symptoms are being addressed,” said N. Lawrence Edwards, M.D., professor of medicine, division of clinical immunology at the University of Florida in Gainesville and chairman of the Gout & Uric Acid Education Society. “Mounting evidence suggests the serious impact of gout across multiple organ systems and emphasizes the importance of aggressively managing the underlying accumulation of uric acid to mitigate joint damage as well as significant tissue damage.”
All KRYSTEXXA abstracts can be accessed here.
These studies are investigational and the information included has not been approved by health authorities. Safety and efficacy within the context of these studies have not been established.
About Uncontrolled Gout
Gout is a chronic, progressive inflammatory form of arthritis that is caused by excess uric acid in the body and needs to be managed aggressively.i Patients with uncontrolled gout continue to have abnormally high levels of uric acid and continued symptoms of gout despite the use of conventional therapies. KRYSTEXXA is the only biologic approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncontrolled gout in adult patients. For more information, please visit www.KRYSTEXXAHCP.com.
INDICATIONS AND USAGE
KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS
Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to infusions, and healthcare providers should consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.
Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.
In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.
Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.
CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA
Patients should be screened patients for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA should not be administered to these patients.
An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.
CONGESTIVE HEART FAILURE
KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.
The most commonly reported adverse reactions in clinical trials with KRYSTEXXA were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
About Horizon Pharma plc
Horizon Pharma plc is focused on researching, developing and commercializing innovative medicines that address unmet treatment needs for rare and rheumatic diseases. By fostering a growing pipeline of medicines in development and exploring all potential uses for currently marketed medicines, we strive to make a powerful difference for patients, their caregivers and physicians. For us, it’s personal: by living up to our own potential, we are helping others live up to theirs. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter, like us on Facebook or explore career opportunities on LinkedIn.
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Source: Horizon Pharma plc
i Keuhn, B. Chronic Disease Approaches Needed to Curb Gout’s Growing Burden. Journal of the American Medical Association. 2018; 319(13):1308-1309.