Abstract
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.
Highlights
To 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 three times weekly, was developed for use in multiple sclerosis (MS)
Clinical Studies Participants A total of adults with a mean age of 23.3 (3.8) years were enrolled in the French singlecenter study and adults aged 35.5 (4.8) years were enrolled in the multi-center study (60 in France and 61 in the USA)
The needle that is currently used for the injection of IFN β-1a, 44 or 22 mcg sc tiw, the 29G/5-bevel needle with Thermo Plastic Elastomer (TPE) shield, was associated with the least pain; the previous 27G/3bevel needle with rubber shield was associated with the most pain
Summary
To 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). For patients treated with interferon beta-1a (IFN β-1a; Rebif®, Merck Serono International S.A., Geneva, Switzerland [an affiliate of Merck KGaA, Darmstadt, Germany]), 44 or 22 mcg subcutaneously (sc) three times weekly (tiw), a syringe (BD Hypak PhysiolisTM, Becton Dickinson and Company) has been developed that is fitted with a needle that is thinner (29-gauge [29G]) and sharper (5bevel) than the previous 27G/3-bevel needle but which maintains the same flow rate. The rigid needle shield is the guarantee of the quality preservation of the needle and makes needle shield removal very intuitive, limiting the risk of damaging the needle point
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