Monday, July 17, 2006

Research: Autoject and injection site reactions

After more than a dozen years on one injectable MS drug or another (Betaseron, then Avonex, the Copaxone, then Rebif), my midsection looks like hell: lots of red welts and tender spots. Yuck. Looks like using an Autoject device to administer Betaseron reduces injection site reactions (ISRs), according to this study. If I'm reading this abstract right, your chances of ISRs go down only by about 10% or so with an Autoject.

What's different about using an Autoject gizmo? I've never used one. Seems like the only real different might be increased stability and a straighter path for the needle. Is there something non-Autojectors could do to lessen their odds of ISRs? Here's the abstract:
Rev Neurol (Paris). 2006 Jun;162(6-7):735-40.Related Articles, Links
[Reduction of injection site reactions in multiple sclerosis (MS) patients newly started on interferon beta 1b therapy with two different devices.]
[Article in French]
Brochet B, Lemaire G, Beddiaf A; et l'Epicure Study Group*.
Departement de Neurologie, Federation des Neurosciences Cliniques du CHU de Bordeaux, Hopital Pellegrin, Bordeaux.

OBJECTIVES: 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. STUDY DESIGN: 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(R) or Betaject(R) 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. RESULTS: The percentage of ISRs were significantly reduced (p<0.0001) when using either Betaject(R) or Betaject(R) 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(R) and Betaject(R) 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(R) (53.7 percent) than to Betaject(R) 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). CONCLUSION: We conclude that autoinjector use reduces the occurrence of ISR during IFNB-1b therapy in RRMS. Link.

No comments: