Réduction des réactions cutanées aux points d’injection avec deux auto-injecteurs chez des patients ayant une sclérose en plaques rémittente débutant un traitement par interféron bêta-1b: étude randomisée en cross-over

Abstract

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<0.0001) when using either Betaject or Betaject light (24.1 percent and 24.1 percent respectively) compared with the standard technique (35.9 percent). No significant difference was seen between the 2 autoinjectors. The mean ISR intensity scores according to physician or patient were significantly reduced (p<0.0001 for each) by the 2 autoinjectors compared to the standard injection technique. No significant difference on the pain scale comparing respectively the standard, Betaject and Betaject light techniques but the mean level of pain was less than 1.2/10. In addition, the percentage of ISR-free patients was significantly lower with the standard injection technique phase (52.4 percent) than with autoinjector use (respectively 68.1 and 66.7 percent). A non significant higher percentage of patients subjectively preferred Betaject (53.7 percent) than to Betaject light (46.3 percent). The main other adverse events reported were flu-like symptoms (30.7 percent), transient and moderate increase of transaminases (4.8 percent) and headache (4.4 percent). We conclude that autoinjector use reduces the occurrence of ISR during IFNB-1b therapy in RRMS.