This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Abstract
Objective: To compare efficacy of interferon β-1a, 22 μg or 44 μg weekly, with placebo in relapsing MS.
Background: Uncertainty exists concerning the optimal dose regimen for interferon β in relapsing-remitting MS. Many patients and physicians prefer the convenience and lesser side effects of an injection given once weekly (qw) as opposed to three times weekly. Pharmacokinetic data and information on biologic markers suggest that this frequency may be suboptimal.
Methods: Randomized, double-blind study of interferon β-1a 22 μg, 44 μg, or placebo administered by weekly subcutaneous injection for 48 weeks. Proton density (PD)/T2-weighted and T1-weighted–gadolinium MRI scans during 24 weeks of therapy were analyzed for the number of combined unique (CU) lesions (primary outcome). Biannual PD/T2 scans were analyzed for T2 activity and burden of disease (BOD).
Results: CU lesions at 24 weeks had a median of 0.71/scan with placebo, 0.5/scan with 22 μg (not significant), and 0.33/scan with 44 μg (p = 0.002). T2 new lesion count/scan (mean/median) at 48 weeks was 3.2/1.5 for placebo, 2.4/1.0 for 22 μg (p = 0.03), and 1.5/1.0 for 44 μg (p = 0.0005). BOD at 48 weeks showed a median increase of 5.9% for placebo compared with a decrease of 1.4% in the 44 μg group (p = 0.0058) and 2% in the 22 μg group (p = 0.0018). No clinical variable, apart from steroid use in the 44 μg qw group (p = 0.014), showed significance.
Conclusions: These data confirm an MRI benefit of interferon β-1a at low dose in MS, but highlight the limited clinical effect. Taken together with other studies, the data demonstrate a dose–effect relationship for both clinical and MRI variables.
- Received February 25, 1999.
- Accepted in final form July 20, 1999.
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
Letters: Rapid online correspondence
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
You May Also be Interested in
Alert Me
Recommended articles
A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses
Randomized, comparative study of interferon β-1a treatment regimens in MS
Randomized controlled trial of interferon-beta-1a in secondary progressive MS
Key issues in the diagnosis and treatment of multiple sclerosis