BackgroundTo reduce injection pain and improve satisfaction, a thinner (29-gauge [29G]), sharper (5-bevel) needle than the 27G/3-bevel needle used previously to inject interferon (IFN) beta-1a, 44 or 22 mcg subcutaneously (sc) three times weekly (tiw), was developed for use in multiple sclerosis (MS).MethodsTwo clinical trials in healthy volunteers and five surveys of patients with MS were conducted to assess whether the 29G/5-bevel needle with a Thermo Plastic Elastomer (TPE) needle shield (a sleeve that houses the tip of the needle in a secure location) is an improvement over the 27G/3-bevel needle with a rubber shield for injection of IFN beta-1a, 44 or 22 mcg sc tiw. Parameters assessed were: pain and ease of insertion (healthy volunteer and nurse responses on subjective pain measurement scales); and patient satisfaction (surveys of patients with MS).ResultsIn healthy volunteers, the 29G/5-bevel needle with TPE shield was associated with the least perceived pain on the Visual Analog Scale (VAS) and Verbal VAS (VB-VAS); mean VAS pain scores decreased by 40% and skin penetration improved by 69% compared with the 27G/3-bevel needle with standard rubber shield (p < 0.01). Pooled results from surveys of patients with MS indicated that 63% of patients thought that injections were less painful with the 29G/5-bevel needle than the 27G/3-bevel needle. Results from individual surveys indicated that the 29G/5-bevel needle was an improvement over the 27G/3-bevel needle for ease of insertion, injection-site reactions, bruising, burning and stinging.ConclusionTogether these studies indicate that the 29G/5-bevel needle with the TPE shield is an improvement over the 27G/3-bevel needle with standard rubber shield in terms of pain, ease of insertion and patient satisfaction. These improvements are expected to result in improved compliance in patients with MS treated with IFN beta-1a, 44 or 22 mcg sc tiw.

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Recent clinical trials with interferon-beta (IFN-beta) in relapsing-remitting multiple sclerosis (RRMS) have clearly demonstrated that the IFN-beta dosing regimen affects the clinical efficacy, thereby highlighting the importance of determining the relative biologic activities of the IFN-beta products currently available. Although studies have been published that examine the biologic activities of the two structurally different forms of recombinant IFN-beta, IFN-beta1a (Rebif), Serono, Geneva, Switzerland) and IFN-beta1b (Betaseron)/Betaferon), Berlex [Montville, NJ]/Schering [Berlin, Germany]), there have been few direct comparative studies. Therefore, to obtain a more accurate estimate of the relative biologic activities of Rebif and Betaseron, this study examined the antiviral activities of these two products within the same assay system and against the same natural human IFN-beta standard. Whereas the manufacturers' information suggests that the bioactivity of Betaseron is only about 8.7-fold less than that of Rebif, the results of the present direct, comparative study show that Rebif has an antiviral activity 14 times greater than that of Betaseron. This may have important clinical implications, because on the basis of the results reported here, Rebif at 44 microg t.i.w. is approximately double the maximal licensed weekly dose for Betaseron.

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