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Multicenter Study
. 2011 Nov 10:11:144.
doi: 10.1186/1471-2377-11-144.

The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study

Karsten Beer  1 , Martin Müller, Anna Marie Hew-Winzeler, Adriano Bont, Philippe Maire, Xiaojun You, Pamela Foulds, Jessica Mårlind, Daniela Curtius
Affiliations
Multicenter Study

The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study

Karsten Beer et al. BMC Neurol. .

Abstract

Background: Interferon beta (IFNβ) and glatiramer acetate (GA) are administered by subcutaneous (SC) or intramuscular (IM) injection. Patients with multiple sclerosis (MS) often report injection-site reactions (ISRs) as a reason for noncompliance or switching therapies. The aim of this study was to compare the proportion of patients on different formulations of IFNβ or GA who experienced ISRs and who switched or discontinued therapy because of ISRs.

Methods: The Swiss MS Skin Project was an observational multicenter study. Patients with MS or clinically isolated syndrome who were on the same therapy for at least 2 years were enrolled. A skin examination was conducted at the first study visit and 1 year later.

Results: The 412 patients enrolled were on 1 of 4 disease-modifying therapies for at least 2 years: IM IFNβ-1a (n = 82), SC IFNβ-1b (n = 123), SC IFNβ-1a (n = 184), or SC GA (n = 23). At first evaluation, ISRs were reported by fewer patients on IM IFNβ-1a (13.4%) than on SC IFNβ-1b (57.7%; P < 0.0001), SC IFNβ-1a (67.9%; P < 0.0001), or SC GA (30.4%; P = not significant [NS]). No patient on IM IFNβ-1a missed a dose in the previous 4 weeks because of ISRs, compared with 5.7% of patients on SC IFNβ-1b (P = 0.044), 7.1% of patients on SC IFNβ-1a (P = 0.011), and 4.3% of patients on SC GA (P = NS). Primary reasons for discontinuing or switching therapy were ISRs or lack of efficacy. Similar patterns were observed at 1 year.

Conclusions: Patients on IM IFNβ-1a had fewer ISRs and were less likely to switch therapies than patients on other therapies. This study may have implications in selecting initial therapy or, for patients considering switching or discontinuing therapy because of ISRs, selecting an alternative option.

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Figures

Figure 1
Figure 1
Results of skin examination at the first evaluation. The number of patients experiencing ISRs at the first evaluation was recorded for each therapy. At the first evaluation examination, patients had been on their current DMT for at least 2 years. *P < 0.0001 vs IM IFNβ-1a; chi-square test. †P = 0.016 vs SC IFNβ-1b; P < 0.001 vs SC IFNβ-1a; P = NS vs IM IFNβ-1a; chi-square test.
Figure 2
Figure 2
Patients wanting to switch or discontinue therapy at first evaluation (A) and 1 year (B). At the first evaluation examination, patients had been on their current DMT for at least 2 years.
Figure 3
Figure 3
Reasons for switching or discontinuing therapy at the first evaluation (A) and 1 year (B). At the first evaluation examination, patients had been on their current DMT for at least 2 years.
Figure 4
Figure 4
Patients remaining on original treatment at 1-year follow-up. *Overall P = 0.036 (chi-square test).
See this image and copyright information in PMC

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