A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis

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.

Adherence to First-Line Disease-Modifying Therapy for Multiple Sclerosis in Kuwait

“…40,41 Educating the patient on appropriate injection techniques, the availability of new injection devices, the use of escalating dosages, and concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) can minimize these adverse events and thus increase adherence. 32,[42][43][44][45][46][47] Physician-documented disease progression was another factor in nonadherence in our study, with 17.7% of nonadherent patients discontinuing their DMTs upon being told that the disease had entered a progressive phase and the likelihood of ongoing beneficial effects was low. This rate is lower than other published data, but the number of SPMS patients included in our analysis was small.…”

The Role of Comfort and Discomfort in Insulin Therapy

“…More recently, a similar study examining response in 30-gauge versus 29-gauge versus 27-gauge syringe needles also showed that penetration force correlated with needle diameter. 43 Both patients and HCPs have reported less pain and greater preference for thinner needles in comparisons of 33-gauge tips versus 31-gauge needles (unblinded), 44 29-gauge versus 27-gauge in blinded multiple sclerosis patients using prefilled syringes, 45 29-gauge versus 27-gauge in blinded multiple sclerosis patients, 46 32-gauge versus 30-gauge pen needles (unblinded), 47 32-gauge versus 31-gauge pen needles, 38 and in comparison of 31-gauge needles, normal to thin wall. 48 Finally, Japanese patients found less pain and bruising using a 33-gauge needle in a crossover study with a 31-gauge comparator needle.…”

“…Asakura et al 44 compared two different tip gauges and found less pain with a 29-gauge microtapered needle that slimmed to a 33-gauge tip. In two French trials, covering 241 patients, less pain was found with a five-bevel tip 45 that happened to be on a narrower 29-gauge needle. The comparison by Mayer et al 43 of piercing forces of three needle gauges also included comparisons of five-bevel and three-bevel tips, but found that gauge was the primary determinant of cutting and piercing force.…”

Impact of a Modified Needle Tip Geometry on Penetration Force as Well as Acceptability, Preference, and Perceived Pain in Subjects with Diabetes

“…9 Differences between insertion forces of these 3-and 5-bevel needle tips originally observed in the laboratory were also demonstrated in healthy volunteers and in patients' subjective experience using the needles to inject interferon for multiple sclerosis. 10 This study was undertaken to demonstrate the acceptability of the 5-bevel needle ( Figure 1B) in patients injecting insulin and to compare perceived pain and preference between 3-and 5-bevel needles.…”