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Improving Patient Satisfaction with Injection Devices in Multiple Sclerosis Improves Adherence
high-frequency IFN-β formulations, in addition to the benefits of Figure 1: Mean Proportion of Patients Pain-free at 0, 30
reducing needle thickness.
15,16 and 60 Minutes After Injection in the BRIGHT Study
The BRIGHT Study
100
The BRIGHT study was the first large-scale comparison of ISRs and ISP
80
in patients with RRMS using 250µg IFN-β1b EOD versus 44µg IFN-β1a
(2004/2005 formulation of Rebif) three times a week. Patients enrolled
60
into the study had been previously treated with IFN-β for at least one
57.8
month but not more than three months and had completed the dose-
40
42.6
titration phase of their treatment.
15
35.6
Proportion of pain-free
20
Within the study observation time of four to five weeks, patients
patients over 15 injections (%)
19.7
4.2
16.5
injected 15 consecutive doses of their prescribed IFN formulation and
0
Immediately 30 minutes 60 minutes
rated their ISP on a visual analogue scale (VAS) immediately, 30 post-injection post-injection
minutes and 60 minutes after each injection. The main study outcome Time after injection
was the proportion of patients who were pain-free at all three time-
Rebif
®
44µg Betaferon
®
250µg
points after each injection. The study nurse telephoned patients each
week to check for AEs, wellbeing and correct VAS diary. At the end of
A significantly higher percentage of patients were pain-free on Betaferon than on Rebif
the study, patients assessed the impact of pain on overall treatment
15
at all time-points (p<0.0001). Source: Baum et al., 2007.
satisfaction and ease of auto-injector use (where applicable). The
study nurse assessed ISR occurrence and severity at both the
Figure 2: Mean Proportion of Pain-free Injections per
Patient After 0, 30 and 60 Minutes
beginning and the end of the study. Other end-of-study measures
included disease status, AEs and concomitant medication.
100
A total of 454 patients (306 on Betaferon and 148 on Rebif) entered the
study at 76 centres in 13 countries. Reported outcomes were based on
80 86.4
79.0
the valid case (VC) population of 445 patients (303 on Betaferon and
71.3
142 on Rebif), which excluded patients who either used a reduced
60
IFN-β dose at least once or completed their VAS diary incorrectly. 53.3
Baseline demographics and MS duration, status and disease
40 44.4
characteristics were broadly similar in the two treatment groups. injections/patient
Percentage of pain-free
20
There were significantly higher proportions of pain-free patients and
19.8
pain-free injections per patient at all time-points on Betaferon than on
0
Rebif (p<0.0001) (see
Immediately 30 minutes 60 minutes
Figures 1 and 2). Similarly, mean VAS scores
post-injection post-injection
were lower (p<0.0001) for patients using Betaferon compared with
Time after injection
Rebif at all time-points and across all injections. ISRs were also
significantly more common in the Rebif group than in the Betaferon
Rebif
®
44µg Betaferon
®
250µg
group (p=0.0184 and p<0.001 at visits 1 and 2, respectively).
A significantly higher mean percentage of patients had pain-free injections on Betaferon
15
than on Rebif at all time-points (p<0.0001). Source: Baum et al., 2007.
It is reasonable to predict that reducing pain and ISRs would
encourage patient adherence. This is consistent with the result that In this study, compliance was high on both treatments. For the
significantly more patients who injected Rebif than who received primary end-point – mean change in patient-reported pain score on
Betaferon reported that pain had negatively affected their satisfaction the visual analogue scale (VAS) from pre-injection to 30 minutes post-
with treatment (p=0.006). A smaller needle gauge is also likely to injection over the first 21 full-dose injections – there was no
promote adherence; this study was not powered to detect a difference significant difference between IFN-β1a- and IFN-β1b-treated patients
in pain according to needle size, but did show a non-significant trend (p=0.425, 0.839 and 0.522 for immediately, 10 minutes and 30 minutes
for fewer pain-free injections with a smaller-diameter needle. In a post post-injection, respectively). The proportion of patients not taking
hoc sub-analysis, more patients were pain-free using the thinner analgesics and pain-free 60 minutes post-injection was slightly
30-gauge needle at the 60 minutes post-injection time-point over all 15 greater in the IFN-β1a group (p=0.039) during the titration period.
injections (75.0% versus 52.2% with the 27-gauge needle; p=0.0086).
17
There was a higher frequency of ISR with IFN-β1a compared with IFN-
β1b (29.2 and 14.1%, respectively), but the rates of ISP were similar in
The REFORM Study both groups (6.2 and 6.3%, respectively). The indicence of adverse
More recent data on the comparative tolerability of IFN-β1a and events was mostly similar for the two groups, and within the ranges
IFN-β1b are available from the REFORM study,
18
which was a multi- and of the types expected for these medications. However, the
centre, randomised, open-label comparison of the two treatments incidence of increased alanine aminotransferase (ALT), nausea,
over 12 weeks. Two groups of treatment-naïve patients with RRMS urinary tract infection, increased serum ferritin, chills, influenza,
who were balanced for baseline demographic and disease injection-site bruising and abnormal liver function tests (LFT) were
parameters received either IFN-β1a 44ug SC three times weekly higher with IFN-β1a than with IFN-β1b. The REFORM study therefore
(n=65) or IFN-β1b 250ug SC every other day (n=64). showed essential similarity in the tolerability profiles of Rebif new
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