Well-controlled studies have shown that interferon

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1 Injection-Site Pain in Patients With Multiple Sclerosis: Interferon Beta-b Versus Interferon Beta-a Colleen Harris, RN, MN, NP; Kathy Billisberger, RN; Lori Tillotson, RN, BN; Sharon Peters, RN, BN; Carol Pederson, RN, BN; Melodie Becker, RN, BN A single-center, open-label, comparative pilot study was undertaken to assess injection-site pain associated with consecutive subcutaneous injections of interferon beta-b μg every other day or interferon beta-a μg three times weekly in patients with multiple sclerosis (MS). Injection-site pain was assessed by the patients with a -cm visual analog scale (VAS) score. Recordings were made before each injection and at minutes, hour, and hours postinjection. Ten patients were enrolled in each treatment group. The proportion of injections associated with no pain or no increase in pain at hour postinjection was higher with interferon beta-b (7%) than with interferon beta- a (7%). Mean pain severity was also less intense with interferon beta-b than with interferon beta- a. Differences in VAS scores were seen immediately after injection (. versus. cm, respectively) and at minutes (. versus.7 cm) and hour (. versus. cm) postinjection. These findings indicate that subcutaneous injection with interferon beta-b is associated with a lower incidence and severity of pain than subcutaneous injection with interferon beta-a in patients with MS. The results should assist MS nurses and physicians in supporting patients to make an informed choice regarding potential side effects when deciding on an appropriate disease-modifying therapy. Int J MS Care. /;7:. Well-controlled studies have shown that interferon beta-b (Betaseron) is a safe and effective diseasemodifying therapy for patients with relapsingremitting (RR) and secondary progressive (SP) multiple sclerosis (MS). Since its approval for RRMS in 99, interferon beta-b has become widely prescribed around the world. Two other interferon-beta preparations have since been licensed for the treatment of RRMS: subcutaneous and intramuscular preparations of interferon beta-a, marketed as Rebif and Avonex, respectively. 7 Recent evidence suggests that treatment of MS with highdose, high-frequency subcutaneous administration of interferon beta is more effective than once-weekly intramuscular administration. 8 Two high-dose, high-frequency interferonbeta therapies are available: subcutaneous interferon beta-b μg every other day and subcutaneous interferon beta-a μg three times weekly. Although the clinical efficacy and tolerability data from the original pivotal trial studies of these treatments appear to be similar, direct comparative data between the treatments are not yet available. The authors are affiliated with the University of Calgary MS Clinic, Foothills Medical Centre, Calgary, Alberta, Canada. In some patients, interferon-beta therapy is associated with specific adverse events, such as injection-site reactions and flulike symptoms. 7 Evidence indicates that these adverse events occur with a higher frequency at the beginning of interferonbeta therapy and tend to decrease over time.,, Injection-site reactions are of particular concern to the clinician because they may ultimately affect treatment acceptance and, hence, compliance. Anecdotal clinical data suggest that interferon beta-a may be associated with greater injection-site pain and injection-site reactions than interferon beta-b. A phase study in healthy volunteers concluded that injection-site pain was three times higher with interferon beta-a (%) than with interferon beta-b (%, P <.). The mean severity of pain at minutes postinjection, assessed with a -cm visual analog scale (VAS) score, was also significantly lower with interferon beta-b (. cm) than with interferon beta-a (. cm, P <.). These findings are supported by evidence from a blinded assessment of injection-site reactions showing that 7% of injections with interferon beta-b were free from local reactions versus only 7% among patients receiving interferon beta-a (P <.). To date, studies have measured injection-site pain and reactions in healthy volunteers. The current exploratory pilot

2 Table. Patient and disease characteristics Characteristic Interferon beta-b (n = ) Interferon beta-a (n = ) Age, y (mean ± SD) 7. ±..7 ± 7. Sex, n Male Female 8 9 Type of multiple sclerosis, n Relapsing remitting 8 Secondary progressive Kurtzke Expanded Disability Status Scale score* (mean ± SD). ±.. ±.8 Mean duration of interferon-beta therapy before study, mo.9. No. of injections in area Abdomen 9 Buttock Thigh 8 Other 8 *A method of quantifying disability in multiple sclerosis. Total of injections given. study (Canadian Betaseron Versus Rebif Study on Injection- Site Pain [CRISP]) was designed to assess the incidence and severity of injection-site pain associated with subcutaneous administration of the two high-dose, high-frequency interferon-beta treatments in patients with MS. The data and observations derived from this study will be used as the basis for development of a larger trial that should determine whether any difference that exists between the two treatments is clinically or statistically significant. Patients and Methods This phase, single-center, open-label comparative pilot study included patients 8 years of age or older who were receiving subcutaneous interferon beta-b ( μg [8 MIU]) every other day or interferon beta-a ( μg [ MIU] or μg [ MIU]) three times weekly. The patients had all been receiving their prescribed interferon beta for at least month but not more than months before entering the study. Interferon beta-b was provided as lyophilized powder and interferon beta-a as prefilled syringes or lyophilized powder. All patients used an autoinjector to administer their medication, with each patient using the same autoinjector throughout the study. A trained nurse gave all patients instruction on how to inject their medication, and all injections were selfadministered. Patients with exacerbations of MS within month before study entry were excluded, as were patients considered at risk of noncompliance or otherwise unsuitable for study participation (eg, patients with cognitive or psychosocial issues that would make self-injection difficult). None of the patients participated in an investigational clinical trial within month of study entry or at any time during the course of this study. No patient had depressive symptoms before the study. All patients at the University of Calgary MS Clinic, Alberta, Canada, who met these criteria were offered the opportunity to participate in the study. All patients gave written informed consent before undergoing any study-related procedures. Pain associated with the first consecutive injections of interferon beta-b and interferon beta-a was recorded by the patients in VAS score diaries. The -cm VAS scale used ranged from no pain () to worst possible pain (). Assessments were made immediately before and after each injection and minutes, hour, and hours postinjection over weeks. The primary endpoint was the mean change in VAS score from baseline (preinjection) to hour postinjection. Secondary endpoints were the mean changes in VAS score from baseline to immediately after injection, minutes postinjection, and hours postinjection. Descriptive statistics were used to summarize the enrollment data and efficacy endpoints in both treatment arms at each scheduled time point. Results Ten patients were enrolled in each of the two treatment groups. As shown in Table, the groups were well matched with respect to demographic and disease characteristics. Patients used similar sites for injection, the most common being the abdomen, buttock, and thigh. In total, 7 of the injections ( consecutive injections in each of patients) of interferon beta-b were pain free, compared to only 7 of the interferon beta-a injections. The primary efficacy endpoint, pain score at hour

3 postinjection, was markedly lower with interferon beta-b. Figure compares the mean change from baseline across all injections in each group at each time point that assessments were made. These data clearly show that interferon beta-a was associated with a greater mean increase in pain score than interferon beta-b immediately after injection and minutes and hour postinjection. Scores at hours were similar in the two groups. Subcutaneous injections of interferon beta-b were consistently less painful than interferon beta- a injections after hour across the whole series of injections (Figure ). The same consistent advantage of interferon beta-b was observed immediately after injection (data not shown) and at minutes postinjection (Figure ). No differences in injection-site pain were observed between treatments at hours postinjection. Discussion Chronic pain is a significant problem for patients with MS, with as many as % of patients stating that persistent bothersome pain reduced their quality of life. Additionally, patients reporting chronic pain were also significantly more likely to report depressive symptoms than those without.,7 The prevalence of chronic pain in patients with MS underscores the importance of addressing pain and minimizing any factors that cause additional pain. Reducing the pain associated with injection of any treatment also has important implications for improved treatment adherence. Evidence suggests that high-frequency administration of high-dose interferon beta-b and interferon beta-a are effective in treating MS and have similar efficacy. Although mostly mild, and declining in frequency with increased time on therapy, injection-site reactions to the interferon betas are common in clinical trials and in everyday practice.,,,,8,9 After year of treatment, however, the proportion of patients experiencing such adverse events is reduced. Mean change in VAS score from baseline at hour postinjection (cm) Interferon beta-a Interferon beta-b Injection number Figure. Mean change from baseline in visual analog scale (VAS) score at hour after administration of each of consecutive doses of interferon beta-b and interferon beta-a in patients with multiple sclerosis. Error bars are standard deviations. Furthermore, these reactions can be managed with simple techniques such as rotation of injection sites, use of autoinjectors, and concomitant use of antihistamines or nonsteroidal anti-inflammatory drugs. The main problem with the traditional injection method may lie in the use of the same needle to reconstitute and administer the drug, resulting in the presence of active drug on the exterior of the needle, which then comes into contact with the skin when the injection is given. Self-injection may also result in inconsistencies in injection depth and administration rate, which may increase the likelihood of pain and irritation. The automated injection system adopted in our study used interferon-free needles and ensured that medication was delivered at a consistent rate, delivery angle, and depth of penetration, thereby improving the consistency of the injection process for both interferon-beta products tested in our trial. A recent phase open-label study found that the use of an autoinjector to administer interferon beta-b ( μg) every other day for days in patients with MS Mean change in VAS score from baseline (cm) Immediately min h h Time postinjection Interferon beta-a Interferon beta-b Mean change in VAS score from baseline at min postinjection (cm) Injection number Interferon beta-a Interferon beta-b Figure. Mean change from baseline in visual analog scale (VAS) score after administration of consecutive doses of interferon beta- b or interferon beta-a in patients with multiple sclerosis. Error bars are standard deviations. Figure. Mean change from baseline in visual analog scale (VAS) score at minutes after administration of each of consecutive doses interferon beta-b and interferon beta-a in patients with multiple sclerosis. Error bars are standard deviations.

4 resulted in a 8% reduction in the incidence of injection-site pain compared with the conventional injection method. Another method used to help prevent injection-site reactions is rotation of injection sites, and gluteal sites appear to best tolerate the injections (K. Baum, unpublished data, ). Also, manufacturers recommend that the injection solution be at room temperature before administration., Subcutaneous administration of interferon beta-a has been postulated to be associated with more pain than interferon beta-b either because its formulation is more acidic or because of differences in drug concentration or structure. Differences in other components of the injected solution (eg, the buffer, cosolvents, chelating agents, antimicrobial preservatives, tonicity, and osmolarity) may also play a role. The results presented in this pilot study suggest that subcutaneous administration of interferon beta-b is associated with lower incidence and severity of injection-site pain than interferon beta-a in patients with MS. This difference was seen at all time points measured during the study up to hour. These findings support those of COMFORT (Comparative Study for Two High-Dose Interferons) in healthy volunteers. Both studies showed that the incidence of injectionsite pain was approximately. times higher with interferon beta-a than interferon beta-b. In our study in patients with MS, the incidence rates were 7% versus %, whereas the incidences were 7% versus 7%, respectively, in healthy volunteers. The BRIGHT (Betaseron Versus Rebif Investigating Higher Tolerability) study intends to substantiate these findings. The study will test whether the high-dose, high-frequency subcutaneous administration of interferon beta-b is associated with a lower incidence and intensity of injection-site pain and reactions than interferon beta-a in a clinically and statistically robust setting in patients with MS. Knowledge of differences in injection-site pain among different interferon-beta products is an important aspect of treatment, assisting MS nurses and physicians in supporting patients to make an informed choice regarding potential side effects when deciding on appropriate disease-modifying therapy. References. IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Interferon beta-b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology. 99;(7): IFNB Multiple Sclerosis Study Group. Interferon beta-b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 99;():.. Paty DW, Li DK. Interferon beta-b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group. Neurology. 99;(): 7.. European Study Group on interferon beta-b in secondary progressive MS. Placebo-controlled multicentre randomised trial of interferon beta- b in treatment of secondary progressive multiple sclerosis. Lancet. 998;(99): PRISMS (Prevention of Relapses and Disability by Interferon beta-a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-a in relapsing/remitting multiple sclerosis. Lancet. 998;(99): 98.. Li DK, Paty DW. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-betaa in relapsing-remitting multiple sclerosis: Prevention of Relapses and Disability by Interferon-Betaa Subcutaneously in Multiple Sclerosis. Ann Neurol. 999;(): Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta- a for disease progression in relapsing multiple sclerosis: the Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol. 99;9(): Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-b versus once-weekly interferon beta-a for multiple sclerosis: results of a -year prospective randomised multicentre study (INCOMIN). Lancet. ;9(9):. 9. Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-a treatment regimens in MS: the EVIDENCE trial. Neurology. ;9():9.. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. ;8(): Gaines AR, Varricchio F. Interferon beta-b injection-site reactions and necroses. Mult Scler. 998;():7 7.. Baum K, Hunter S, Gariepy S, Potrin D, Morelli G. COMFORT (COMparative study FOR Two high-dose interferon-bs): evaluating tolerability of high-dose, high-frequency interferon-b treatment [abstract]. Mult Scler. ;(suppl ):S9.. Archibald CJ, McGrath PJ, Ritvo PG, et al. Pain prevalence, severity and impact in a clinic sample of multiple sclerosis patients. Pain. 99;8(): Kassirer M. Multiple sclerosis and pain. Int J MS Care. ; : 8.. Moulin DE, Foley KM, Ebers GC. Pain syndromes in multiple sclerosis. Neurology. 988;8():8 8.. Ehde DM, Gibbons LE, Chwastiak L, Bombardier CH, Sullivan MD, Kraft GH. Chronic pain in a large community sample of persons with multiple sclerosis. Mult Scler. ;9():. 7. Williams LS, Jones WJ, Shen J, Robinson RL, Weinberger M, Kroenke K. Prevalence and impact of depression and pain in neurology outpatients. J Neurol Neurosurg Psychiatry. ;7(): Kappos L, Polman C, Pozzilli C, Thompson A, Beckmann K, Dahlke F. Final analysis of the European multicenter trial on IFNbeta-b in secondary-progressive MS. Neurology. ;7(): Elgart GW, Sheremata W, Ahn YS. Cutaneous reactions to recombinant human interferon beta-b: the clinical and histologic spectrum. J Am Acad Dermatol. 997;7(): 8.. Bayas A, Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis. Drug Saf. ;():9 9.. Tornatore C, Bartlett D. Tolerability of interferon beta-b (Betaferon/Betaseron) can be significantly improved using both interferon-free needle and automated infection techniques. J Neurol. ;9(suppl ):I/.

5 . Betaferon [package insert]. Montville, NJ: Berlex;. Available at: Accessed 9 August. Rebif medication guide. Rockland, MA: Serono, Inc.; updated September. Available at medication_guide.pdf. Accessed 9 August.. Brazeau GA, Cooper B, Svetic KA, Smith CL, Gupta P. Current perspectives on pain upon injection of drugs. J Pharm Sci. 998; 87(): Baum K, O Leary C. The BRIGHT (Betaseron versus Rebif InvestigatinG Higher Tolerability) study: evaluating injection-site reactions during high-dose, high-frequency IFNB treatment [abstract]. Mult Scler. ;(suppl ):S. Acknowledgment: This study was supported by a grant from Berlex Canada.

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