FDA Approves Benlysta for SLE, Horizant for RLS

By Coleman, Craig I | Drug Topics, August 2011 | Go to article overview

FDA Approves Benlysta for SLE, Horizant for RLS


Coleman, Craig I, Drug Topics


WEW DRUG REVIEW

Belimumab intravenous injection

(Benlysta, Human Genome Sciences)

Systemic lupus erythematosus (SLE) is a serious, potentially fatal autoimmune disease that affects between 300,000 to 1.5 million Americans of all races; for African- American women, the incidence is 3 -fold higher. On March 9, 201 1, FDA approved belimumab intravenous injection for the treatment of adult patients with active, autoantibody-positive SLE who are currently receiving standard therapy.

Efficacy. Belimumab's efficacy was evaluated in 3 randomized controlled studies involving patients with SLE who were receiving standard treatment with corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs, and immunosuppressive agents. The studies exduded patients who had received previous B -cell targeted therapy or intravenous cydophosphamide, as well as those with active lupus involving the kidneys or central nervous system.

The first of the 3 studies was integral in identifying the target population of autoantibody-positive SLE patients. The 2 subsequent studies randomly assigned a total of 1,684 patients with autoantibody-positive, active disease (defined as a SELENASLEDIA score >6) to receive belimumab 1 mg/kg or 10 mg/ kg plus standard therapy or placebo plus standard therapy. In both trials the proportion of patients responding to therapy was significantly higher in the belimumab 10 mg/kg group than in the placebo group. There was no statically significant difference in response rate between patients receiving belimumab 1 mg/ kg and placebo.

Safety. The most commonly reported adverse reactions (occurring in >5% of patients) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis, In these studies, a greater number of deaths were reported with belimumab (11) than with placebo (3), with a total of 14 deaths occurring during the treatment periods. Explanations for these deaths included infection, cardiovascular disease, and suicide; however, no single cause predominated. Patients being treated for a chronic infection should not begin therapy with belimumab, as serious infections have been reported.

Dosing. The recommended dose of belimumab is 10 mg/kg every 2 weeks for the first 3 doses and every 4 weeks thereafter. Belimumab should be administered over the course of 1 hour. Premedication for prophylaxis against infusion and hypersensitivity reactions should be considered.

Gabapentin enacarbil extended-release tablets

(Horizant, GlaxoSmithKline and Xenoport)

Restless legs syndrome (RLS) is a disruptive neurologic disorder that affects up to 10% of Americans, On April 6, 2011, FDA approved gabapentin enacarbil extended-release tablets for the treatment of moderate -to- severe RLS in adults, Gabapentin enacarbil is not recommended for patients who are required to sleep during the daytime and remain awake at night. …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

FDA Approves Benlysta for SLE, Horizant for RLS
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.