Reduction of injection site reactions in multiple sclerosis (MS) patients newly started on interferon beta 1b therapy with two different devices

To compare occurrence of injection site reactions (ISRs) in patients with relapsing remitting multiple sclerosis (RRMS) newly started on interferon beta 1b (Betaferon), using 3 delivery methods. A randomized, multicenter, phase IV, open label cross-over study was performed in 82 sites in France on 294 patients with RRMS beginning a treatment with interferon beta 1b. For the first month all patients used a standard injection technique. They then used an autoinjector, Betaject or Betaject Light, for one month each, according to the cross-over design. Primary outcome was defined as the percentage of injections sites with ISR evaluated by the investigator. Secondary endpoints included graduation of ISR, using a five-point scale by both investigators and patients, injection related pain assessed by patients, percentage of patients without ISR and a global evaluation by patients of injection devices. The percentage of ISRs were significantly reduced (p