|
Sign In to gain access to subscriptions and/or personal tools.
|
Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a or 1b
K. Baum
Department of Neurology, Klinik Hennigsdorf, Hennigsdorf, Germany, karl_baum01{at}yahoo.co.uk
C. O'Leary
Department of Neurology, Southern General Hospital NHS Trust, Glasgow, UK
F. Coret Ferrer
Servicio de Neurologia, Hospital Clinico Universitario de Valencia, Valencia, Spain
E. Klimova
Department of Neurology, J. A. Reiman Teaching Hospital, Presov, Kosice, Slovak Republic
L. Prochazkova
Department of Neurology, University Hospital ak Derera, Bratislava, Slovak Republic
J. Bugge
Bayer Schering Pharma AG, Berlin, Germany
for the BRIGHT Study Group
This prospective, multicentre, international, observational, cohort study compared injection site pain (ISP) and injection site reactions (ISRS) between interferon beta-1b (IFNB-1b; Betaferon ®) 250 µg subcutaneously every other day and interferon beta-1a (IFNB-1a; Rebif®) 44 µg subcutaneously three times weekly in patients with relapsing-remitting MS. Patients started treatment within 3 months before recruitment and were on full dose of therapy at inclusion. Patients self-injected IFNB and self-assessed ISP for 15 consecutive injections immediately, 30 and 60 min after injection, using a visual analogue scale diary. Study staff assessed ISRS. Of 445 patients (valid cases), ~90% used autoinjectors. More patients were pain-free at all timepoints with IFNB-1b than with IFNB-1a (eg, 30 min: 42.6% versus 19.7%; P< 0.0001). The mean proportion of pain-free injections was greater for IFNB-1b (eg, 30 min: 79.0%) than for IFNB-1a (53.3%; P < 0.0001). The proportion of patients without ISRS was greater for IFNB-1b (second visit 51.8% versus 33.8%; P < 0.0001). Compared with IFNB-1a, more IFNB-1b patients either had no pain or their ISP had no influence on treatment satisfaction (76.9% versus 64.1%; P = 0.006). The impact on tolerability and patient acceptability of any new IFNB product formulations would, however, have to be evaluated in comparative studies. Multiple Sclerosis 2007; 13 : 1153—1160. http://msj.sagepub.com
Key Words: autoinjector injection site pain injection site reaction interferon beta interferon beta-1a interferon beta-1b multiple sclerosis patient adherence
References
- The Interferon Beta Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial . Neurology 1995; 45: 1277—85 .[Abstract/Free Full Text]
- The Interferon Beta Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsingremitting multiple sclerosis. I. Clinical results of multicenter, randomized, double-blind, placebo-controlled trial . Neurology 1993; 43: 655—61 .[Abstract/Free Full Text]
- Paty DW, Li Dkb, the UBC MS/MRI Study Group and the Interferon Beta Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsingremitting multiple sclerosis. II. MRI analysis of results of a multicenter, randomized, double-blind, placebo-controlled trial . Neurology 1993; 43: 662—67 .[Abstract/Free Full Text]
- European Study Group on Interferon beta-1b in Secondary Progressive MS. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis . Lancet 1998; 352: 1491—97 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Prisms (Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised, double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis . Lancet 1998; 352: 1498—504 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Li DK, Paty DW Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis . Ann Neurol 1999; 46: 197—206 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Jacobs LD, Cookfair DL, Rudick RA; The Multiple Sclerosis Collaborative Research Group (MSCRG). Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis . Ann Neurol 1996; 39: 285—94 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Durelli L., Verdun E., Barbero P., Bergui M., Versino E., Ghezzi A. et al. Independent Comparison of Interferon (INCOMIN) Trial Study Group. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN) . Lancet 2002; 359: 1453—60 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Panitch H., Goodin DS, Francis G., Chang P., Coyle PK, O'Connor P. et al. EVIDENCE Study Group; University of British Columbia MS/MRI Research Group. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial . Neurology 2002; 59: 1496—506 .[Abstract/Free Full Text]
- Bayas A., Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis . Drug Saf 2000; 22: 149—59 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Elgart GW, Sheremata W., Ahn YS Cutaneous reactions to recombinant human interferon beta-1b: the clinical and histologic spectrum . J Am Acad Dermatol 1997; 37: 553—58 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses . Mult Scler 1998; 4: 70—73 .[Abstract/Free Full Text]
- Kappos L., Polman CH, Freedman MS, Edan G., Hartung H-P., Miller DH et al. for the BENEFIT Study Group. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes . Neurology (in press).
- Tornatore C., Bartlett D. Tolerability of interferon beta-1b (BetaferonTM/BetaseronTM) can be significantly improved using both interferon-free needle and automated injection techniques . J Neurol 2002; 249(Suppl 1): 205, P 814 (abstract).
- Mikol D., Lopez-Bresnahan M., Taraskiewicz S., Chang P., Rangnow J. Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsingremitting multiple sclerosis . Mult Scler 2005; 11: 585—91 .[Abstract/Free Full Text]
- Brochet B., Lemaire G., Beddiaf A.; and the Epicure Study Group. Reduction of injection site reactions in multiple sclerosis patients newly started on interferon beta 1b therapy with two different devices . Rev Neurol (Paris) 2006; 162: 735—40 .[Medline]
[Order article via Infotrieve]
- Lesaux J., Jadback G., Harraghy CE Improving the convenience of home-based interferon beta-1a therapy for multiple sclerosis . J Neurosci Nurs 1999; 31: 174—79 .[Medline]
[Order article via Infotrieve]
- Harris C., Billisberger K., Tillotson L., Peters S., Pederson C., Becker M. Injection site pain in patients with multiple sclerosis: interferon beta-1b versus interferon beta-1a . Int J MS Care 2005 /2006; 7: 132—36 .
- Goodin DS, Frohman EM, Garmany Jr GP, Halper J., Likosky WH, Lublin FD et al. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. 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 2002; 58: 169—78 .[Free Full Text]
- Brazeau GA, Cooper B., Svetic KA, Smith CL, Gupta P. Current perspectives on pain upon injection of drugs . J Pharm Sci 1998; 87: 667—77 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Arndt KA, Burton C., Noe JM Minimizing the pain of local anesthesia . Plast Reconstr Surg 1983; 72: 676—79 .[Web of Science][Medline]
[Order article via Infotrieve]
- Inafuku H., Kasem Khan MA, Nagata T., Nonaka S. Cutaneous ulcerations following subcutaneous interferon beta injection to a patient with multiple sclerosis . J Dermatol 2004; 31: 671—77 .[Web of Science][Medline]
[Order article via Infotrieve]
- Buttman M., Goebeler M., Rieckman P. Local pain during Rebif injection is not due to acidic pH . J Neurol Neurosurg Psychiatry 2004; 75: 1076 (letter).[Free Full Text]
- Archibald CJ, McGrath PJ, Ritvo PG, Fisk JD, Bhan V., Maxner CE et al. Pain prevalence, severity and impact in a clinic sample of multiple sclerosis patients . Pain 1994; 58: 89—93 .[CrossRef][Web of Science][Medline]
[Order article via Infotrieve]
- Kassirer M. Multiple sclerosis and pain: a medical focus . Int J MS Care 2000; 2: 30—34 .
- 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 2003; 9: 605—11 .[Abstract/Free Full Text]
- 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 2003; 74: 1587—89 .[Abstract/Free Full Text]
Multiple Sclerosis, Vol. 13, No. 9,
1153-1160 (2007)
DOI: 10.1177/1352458507079291

CiteULike Complore Connotea Del.icio.us Digg Reddit Technorati Twitter What's this?
|
|