Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Barbara Holzer, Broadcast Manager
w. (202) 588-7716
bholzer@citizen.org

Karilyn Gower, Press Officer
w. (202) 588-7779
kgower@citizen.org

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog
Facebook/publiccitizen

Follow us on Twitter

 

May 8, 2012  

Proposed Use of Drug Rilonacept for Gout Would Expose Patients to Serious Infections and Possibly Cancer for Minimal Benefits

Public Citizen Tells FDA Arthritis Advisory Committee to Reject Proposed Drug 

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should not approve an immunosuppressant for the prevention of gout flares in adult gout patients because the drug provides only trivial clinical benefits, but exposes patients to a known risk of serious infections and possibly to a slightly increased risk of malignancies and adverse cardiac events, Public Citizen told an FDA advisory committee today. Additionally, other, safer treatments to prevent gout flares are on the market.

The drug, rilonacept, also known as Arcalyst, is manufactured by Regeneron Pharmaceuticals and was approved by the FDA in 2008 only for treating a group of rare serious genetic disorders called cryopyrin-associated periodic syndromes, which cause widespread inflammation in the body. Regeneron now is seeking approval from the FDA to market the drug to prevent acute flares of gout in adult gout patients.

However, the drug offered only meager benefits in clinical trials in gout patients. Although the number of gout flare-ups was reduced in study subjects treated with rilonacept in comparison with subjects taking a placebo, the differences were very small. For example, the drug reduced the average number of gout flares per patient from about one per 16 weeks in patients taking the placebo treatment to 0.3 flare-ups in the same time period in patients getting the drug. Likewise, it reduced the number of days patients experienced moderate to severe pain from gout flares by about 1-2 days over a 16-week period.

In fact, nearly half of subjects in clinical trials treated with the placebo did not have a gout flare, indicating that if rilonacept were approved, 50 percent of patients treated with rilonacept would receive no benefit and only be exposed to the drug’s risks, Public Citizen said.

At the same time, the drug has a known risk of serious infections, and the studies in gout patients raised concern that it may increase the risk of cancer and serious adverse cardiac events in adult gout patients.

“Given that rilonacept offers meager clinical benefits in preventing gout flares in the intended target population, approval of this drug would be justified only if there was certainty that the drug was extremely safe and there was an absence of serious safety signals identified during the clinical development of the drug. But this is not the case,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, told the FDA’s Arthritis Advisory Committee. “In addition, other effective, safer, better studied – and likely significantly cheaper – treatments already are available for preventing and treating the acute flares of gout. Therefore, it would be irresponsible and reckless of the FDA to approve such a potent immunosuppressive drug.”

The same advisory committee in June 2011 rejected a similar drug, canakinumab, for patients who suffer gouty arthritis attacks, because of an unfavorable benefit-risk profile. But in the case of rilonacept, the benefit-risk profile is even worse.

###

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org

Copyright © 2014 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.