A new study of Bayer Healthcare’s blockbuster Betaseron has revealed that patients treated with the drug after their first multiple sclerosis ‘attack’ experienced a significant delay in the progression of the disease, but some specialists are advising caution about the findings.
Results from the company-sponsored 468-patient BENEFIT study show that patients treated with Betaferon/Betaseron (interferon beta 1b) shortly after a first MS clinical event showed a 40% lower risk of developing confirmed disability progression compared to those in whom treatment was delayed. The results, which can be found in the August 4 issue of The Lancet “provide the first controlled evidence that delaying Betaseron treatment has an effect on later accumulation of disability, as observed over the three-year study period,” Bayer claimed, and “no other MS therapy has demonstrated this effect in this early-patient population”.
Ludwig Kappos of the University of Basel, Switzerland and lead investigator of the BENEFIT study, said that the research “has important implications for the way we treat MS because, for the first time, we have controlled data that irrefutably demonstrates the value of early intervention”. He added that the findings “support the decision to actively treat patients at the first clinical sign of MS to delay the accumulation of disability,” while Darlene Jody, president of Bayer HealthCare’s specialised therapeutics global business unit, said the results “have the potential to again transform the MS treatment paradigm”.
An accompanying editorial in The Lancet by Sean Pittock at the Mayo Clinic, welcomed the study, saying, “Kappos and colleagues have set a new standard against which future extension trials will be compared.” However, Dr Pittock warned that the results of the trial should be “interpreted with care, because the magnitude of benefit, although significant, is clinically small. This follow-up should not be misconstrued as evidence for a ‘treat-all’ approach.”
Patients who got early treatment only reduced their overall three-year risk of disability by 14%, Dr Pittock noted, and the benefits seen in the BENEFIT study were “modest”. He wrote that 12 patients would have to be treated with Betaseron at the first clinical sign of MS to protect one patient from worsening disability.
