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MS - Beta interferon slows progression and reduces relapses in relapsing MS

Clinical Bottom Line:
Beta interferon slowed the progression of disability and reduced the relapse rate in patients with MS

Appraised by Sackett at the Centre for Evidence-Based Medicine

Clinical Scenario:
A patient with relapsing multiple sclerosis.

Three-part Question:
In patients with relapsing multiple sclerosis, will beta-interferon reduce the risk of subsequent relapse? -will it slow the progression of their disease?

Search Terms:
"interferon multiple sclerosis " in Best Evidence: 4 hits; this is the most recent, but includes information from earlier trials.

The Study:

  1. Double-blinded concealed randomised controlled trial with intention-to-treat.
  2. 18-55 y/o (median age 37; 73% women). Had MS at least 1 year, with 2 or more relapses in last 3 years but none in last 2 months; Expanded Disability Status Score 1-3.5; (and NO chronic progressive MS, prior immunosuppression or interferon Rx, steroid/corticotrophin Rx in last 2 months, present or potential pregnancy, lactation, or serious second illness).
  3. Control group (N=143): placebo injection, acetaminophen, and usual care; if relapsed, could receive optional corticotrophin or steroids.
  4. Experimental group (N=158): Interferon-beta-1a, 30 ug/week I-M, with acetaminophen 650 mg PO before and 24 hours after injection; same Rx options for relapses.

The Evidence:
OutcomeTime to OutcomeRRRARRNNT
Progression of disability 2 years 37% 0.130 8
95% CI:8% to 66%0.029 to 0.2314 to 35
Exacerbation (worse by 1 point or more for 6 months or more) annual rate 18% 0.150 7
95% CI:7% to 30%0.053 to 0.2474 to 19

Comments:

  1. Extends earlier trial (IFNB MS Study Group: Neurology 1995;45:1277-85; EBM 1996;1:53) of 372 relapsing pts. that found reduced relapses and a non-sig favourable trend in progression.
  2. And similar to co-polymer 1 trial (Johnson KP et al, Neurology 1995;45:1268-76; EBM 1996;1:52) in 251 relapsing patients that found stat sig reduction in relapses and disability scores.

Expiry date: October 1997

References:

  1. Jacobs LD, Cookfair DL, Rudick RA et al and The Multiple Sclerosis Collaborative Research Group (MSCRG): Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-94.

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