Skip to main content
Top
Published in: BMC Neurology 1/2013

Open Access 01-12-2013 | Research article

Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality of life in patients with multiple sclerosis: a cross-sectional study

Authors: Deepak MW Balak, Gerald JD Hengstman, Enes Hajdarbegovic, Rob JP van den Brule, Raymond MM Hupperts, Hok Bing Thio

Published in: BMC Neurology | Issue 1/2013

Login to get access

Abstract

Background

Glatiramer acetate (GA) and interferon-beta (IFN-β) are disease-modifying therapies (DMTs) for multiple sclerosis that are administered through subcutaneous (SC) or intramuscular (IM) injections. Skin reactions associated with DMTs are common and may influence patient’s health-related quality of life (QoL). We aimed to determine the prevalence of cutaneous adverse events associated with long-term DMT use, and to assess the impact of cutaneous adverse events on QoL.

Methods

A cross-sectional study among patients with multiple sclerosis who had been treated with their first DMT for at least 2 years. Cutaneous events were assessed from photographs of injection-sites by dermatologists blinded for DMT. Generic and dermatology-specific health-related QoL were assessed using validated patient-reported questionnaires.

Results

A total of 229 patients were enrolled, of whom 156 (68%) had at least one skin reaction. The prevalence of cutaneous adverse events was higher for SC DMTs (75-82%) compared to IM DMT (41%) (P < 0.001). Erythema and lipoatrophy were the most common skin reactions, observed in 156 (68%) and 45 (20%) patients, respectively. Dermatology-specific, but not generic, QoL was significantly lower among patients with skin reactions compared to those without.

Conclusions

The prevalence of cutaneous adverse events was high in long-term DMT-treatment. Patients with cutaneous adverse events had a lower perceived dermatology-specific QoL.
Appendix
Available only for authorised users
Literature
1.
go back to reference Frohman EM, Racke MK, Raine CS: Multiple sclerosis–the plaque and its pathogenesis. N Engl J Med. 2006, 354: 942-955. 10.1056/NEJMra052130.CrossRefPubMed Frohman EM, Racke MK, Raine CS: Multiple sclerosis–the plaque and its pathogenesis. N Engl J Med. 2006, 354: 942-955. 10.1056/NEJMra052130.CrossRefPubMed
2.
go back to reference Compston A, Coles A: Multiple sclerosis. Lancet. 2008, 372: 1502-1517. 10.1016/S0140-6736(08)61620-7.CrossRefPubMed Compston A, Coles A: Multiple sclerosis. Lancet. 2008, 372: 1502-1517. 10.1016/S0140-6736(08)61620-7.CrossRefPubMed
3.
go back to reference Kieseier BC, Stuve O: A critical appraisal of treatment decisions in multiple sclerosis–old versus new. Nat Rev Neurol. 2011, 7: 255-262. 10.1038/nrneurol.2011.41.CrossRefPubMed Kieseier BC, Stuve O: A critical appraisal of treatment decisions in multiple sclerosis–old versus new. Nat Rev Neurol. 2011, 7: 255-262. 10.1038/nrneurol.2011.41.CrossRefPubMed
4.
go back to reference Balak DM, Hengstman GJ, Cakmak A, Thio HB: Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review. Mult Scler. 2012, 18 (12): 1705-1717. 10.1177/1352458512438239.CrossRefPubMed Balak DM, Hengstman GJ, Cakmak A, Thio HB: Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review. Mult Scler. 2012, 18 (12): 1705-1717. 10.1177/1352458512438239.CrossRefPubMed
5.
go back to reference The EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16: 199-208.CrossRef The EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16: 199-208.CrossRef
6.
go back to reference Nijsten TE, Sampogna F, Chren MM, Abeni DD: Testing and reducing skindex-29 using Rasch analysis: Skindex-17. J Invest Dermatol. 2006, 126: 1244-1250. 10.1038/sj.jid.5700212.CrossRefPubMed Nijsten TE, Sampogna F, Chren MM, Abeni DD: Testing and reducing skindex-29 using Rasch analysis: Skindex-17. J Invest Dermatol. 2006, 126: 1244-1250. 10.1038/sj.jid.5700212.CrossRefPubMed
7.
go back to reference Rothman KJ: No adjustments are needed for multiple comparisons. Epidemiology. 1990, 1: 43-46. 10.1097/00001648-199001000-00010.CrossRefPubMed Rothman KJ: No adjustments are needed for multiple comparisons. Epidemiology. 1990, 1: 43-46. 10.1097/00001648-199001000-00010.CrossRefPubMed
8.
go back to reference Beer K, Muller M, Hew-Winzeler AM, Bont A, Maire P, You X, Foulds P, Marlind J, Curtius D: The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study. BMC Neurol. 2011, 11: 144-10.1186/1471-2377-11-144.CrossRefPubMedPubMedCentral Beer K, Muller M, Hew-Winzeler AM, Bont A, Maire P, You X, Foulds P, Marlind J, Curtius D: The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study. BMC Neurol. 2011, 11: 144-10.1186/1471-2377-11-144.CrossRefPubMedPubMedCentral
9.
go back to reference Weise G, Hupp M, Kerstan A, Buttmann M: Lobular panniculitis and lipoatrophy of the thighs with interferon-ss1a for intramuscular injection in a patient with multiple sclerosis. J Clin Neurosci. 2012, 19: 1312-1313. 10.1016/j.jocn.2011.11.026.CrossRefPubMed Weise G, Hupp M, Kerstan A, Buttmann M: Lobular panniculitis and lipoatrophy of the thighs with interferon-ss1a for intramuscular injection in a patient with multiple sclerosis. J Clin Neurosci. 2012, 19: 1312-1313. 10.1016/j.jocn.2011.11.026.CrossRefPubMed
10.
go back to reference Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J: A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005, 11: 585-591. 10.1191/1352458505ms1197oa.CrossRefPubMed Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J: A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult Scler. 2005, 11: 585-591. 10.1191/1352458505ms1197oa.CrossRefPubMed
11.
go back to reference Edgar CM, Brunet DG, Fenton P, McBride EV, Green P: Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can J Neurol Sci. 2004, 31: 58-63.CrossRefPubMed Edgar CM, Brunet DG, Fenton P, McBride EV, Green P: Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can J Neurol Sci. 2004, 31: 58-63.CrossRefPubMed
12.
go back to reference Filippi M, Rocca MA: Multiple sclerosis: monitoring long-term treatments in multiple sclerosis. Nat Rev Neurol. 2010, 6: 421-422. 10.1038/nrneurol.2010.88.CrossRefPubMed Filippi M, Rocca MA: Multiple sclerosis: monitoring long-term treatments in multiple sclerosis. Nat Rev Neurol. 2010, 6: 421-422. 10.1038/nrneurol.2010.88.CrossRefPubMed
13.
go back to reference Saunders C, Caon C, Smrtka J, Shoemaker J: Factors that influence adherence and strategies to maintain adherence to injected therapies for patients with multiple sclerosis. J Neurosci Nurs. 2010, 42: S10-18. 10.1097/JNN.0b013e3181ee122b.CrossRefPubMed Saunders C, Caon C, Smrtka J, Shoemaker J: Factors that influence adherence and strategies to maintain adherence to injected therapies for patients with multiple sclerosis. J Neurosci Nurs. 2010, 42: S10-18. 10.1097/JNN.0b013e3181ee122b.CrossRefPubMed
14.
go back to reference Devonshire V, Arbizu T, Borre B, Lang M, Lugaresi A, Singer B, Verdun Di Cantogno E, Cornelisse P: Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study. BMC Neurol. 2010, 10: 28-10.1186/1471-2377-10-28.CrossRefPubMedPubMedCentral Devonshire V, Arbizu T, Borre B, Lang M, Lugaresi A, Singer B, Verdun Di Cantogno E, Cornelisse P: Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study. BMC Neurol. 2010, 10: 28-10.1186/1471-2377-10-28.CrossRefPubMedPubMedCentral
Metadata
Title
Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality of life in patients with multiple sclerosis: a cross-sectional study
Authors
Deepak MW Balak
Gerald JD Hengstman
Enes Hajdarbegovic
Rob JP van den Brule
Raymond MM Hupperts
Hok Bing Thio
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2013
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/1471-2377-13-146

Other articles of this Issue 1/2013

BMC Neurology 1/2013 Go to the issue