April 28, 2004
Source: Prof. LucaDurelli M.D.
Increasing the dose of Betaferon(r) (interferon beta-1b)significantly improves the response of multiple sclerosis (MS) patients whoexhibit persisting signs of disease activity with the standard Betaferondose, according to new findings presented at today's American Academy ofNeurology Annual Meeting in San Francisco, California. Investigators who ledthe one-year OPTimization of Interferon for MS (OPTIMS) study saidrelapsing-remitting MS patients who switched to the higher Betaferon dose(375 mcg every other day) were 72 percent less at risk for active diseasethan those who continued on Betaferon 250 mcg every other day, and theproportion who were free of active disease on monthly magnetic resonanceimaging (MRI) scans was nearly double that of the 250-mcg-treated group.
The higher dose of Betaferon was well tolerated, according toinvestigators, with no new or unpredictable side effects or increased sideeffect frequency. In addition, neutralising antibody (NAbs) titers tended todecrease in patients treated with the higher dose.
Professor Luca Durelli, Chief, University NeurologicalDivision, San Luigi Gonzaga Hospital, Torino, Italy, and principalinvestigator of the study, said, "The standard regimen of high-dose,high-frequency interferon beta-1b is proven effective at reducing relapserates and new or expanding brain lesions, but not all patients achieve anoptimal response. Therefore, it seems logical to determine if partialresponders can attain a better clinical outcome with a higher dose ofinterferon.
"These data confirm that an increase in dosage can enhance the clinicaleffects of beta interferon and more effectively reduce MRI disease activity,"added Prof. Durelli. "It is vital that we continue to conduct MS trials thatexplore breaking the dosage ceiling, to explore whether a beta interferondose higher than that which is currently available could represent aneffective treatment choice for patients."
About the study
The OPTIMS study is the first randomised multicenter study designed toexplore the question of higher-dose therapy with interferon beta-1b 250 mcg(Betaferon(r)/Betaseron(r) for SC Injection).
Seventy-six relapsing-remitting MS patients who showed a partial responseto Betaferon 250 mcg (taken every other day) at six months were randomised toeither continue with this regimen (a total of 40 patients) or increase toBetaferon 375 mcg every other day for an additional six months (36 patients).A partial response was defined by at least one active MRI scan out of a totalof four repeated during months 3-6 of the initial six-month run-in period(when all patients were treated with Betaferon 250 mcg); an active scan wasdefined as showing either a new lesion on PD/T2-weighted MRI sequences (asign of temporary swelling and/or permanent damage) or a Gd-enhancing lesionof T1-weighted MRI sequences (indicating new, inflamed areas of activedisease).
The study's primary endpoint was the proportion of patientswithout MRI activity (new T2 or Gd-enhancing lesions) on the four scansrepeated during months 9-12. MRI evaluation was blinded; clinical and safetydata were collected on an open-label basis.
The results showed that the number of patients without MRIactivity was significantly greater in the Betaferon 375-mcg-treated group (30of 36 patients, or 83 percent, vs. 16 of 40 Betaferon 250-mcg-patients, or 40percent; p=0.00011). Patients demonstrated good overall tolerability of thehigher dose and no significant increase in side effect frequency.
In conclusion, MS patients who increased their Betaferon doseto 375
mcg every other day achieved a 72 percent relative risk reduction inactive
disease compared to patients who remained on the standard 250 mcgdose.
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