Opgehaald van Efficacy and Safety of BIIB019 (Daclizumab High Yield Process)
Versus Interferon ? 1a in
Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE)):
Jiwon Oh, S. S.
(2014, March 14). Neurology . Opgehaald van Daclizumab-induced adverse
events in multiple organ systems in multiple sclerosis:
Ludwig Kappos, H. W. (2015, October 8). The New England
Journal of Medicine . Opgehaald van Daclizumab HYP versus Interferon
Beta-1a in Relapsing Multiple Sclerosis:
MS Centrum Amsterdam . (2017). Opgehaald van Behandelingen :
Zorginstituut Nederland . (2017, November 27). Opgehaald van Daclizumab :
All the patients provided written informed consent and
a consent to continue participation was obtained from patients who had a
confirmed relapse or progression of disability. The study was approved by the
local ethics committees and was conducted in accordance with the International
Conference on Harmonisation guidelines for Good Clinical Practice and the
principles of the Declaration of Helsinki (Ludwig Kappos, 2015).
Daclizumab is a
second-line medication for MS patients; it can cause an increase in liver enzymes.
For this reason a blood sample will be taken every month during treatment and
four months after treatment. If a patient has an active infection, the
treatment should be postponed or interrupted till the infection disappears. A
group of patients using daclizumab will be forced to stop the treatment if the
side effects get too severe (MS Centrum Amsterdam , 2017) (Zorginstituut Nederland , 2017).
Since February 2017,
daclizumab (Zinbryta) became available for patients with RRMS; it is given to
patients that still have a lot of relapses or have worsening attacks even
though they take the available first-line medications like interferon
Consequences and Implications
The enhanced efficacy was accompanied by an increased
frequency of adverse events, such that the net clinical benefit will need to be
carefully considered by patients and their providers (Ludwig
Daclizumab HYP demonstrated superior efficacy
regarding ARR and brain lesions versus intramuscular interferon ?-1a in relapsing-remitting
multiple sclerosis; but was not associated with a significantly lower risk of
disability progression at 12 weeks.
Elevations in liver aminotransferase levels, more than
5 times the upper limit of the normal range, was present in 6% of patients
treated with daclizumab and in 3% in the group treated with interferon
Cutaneous events such as eczema or rash were more
common in patients treated with daclizumab (37%) than with interferon
Infections were more common in the daclizumab HYP group
(65%) than in the interferon beta-1a group (57%) .
died during the study; four in the interferon ?-1a group and one in the daclizumab HYP group.
Serious adverse events were reported in 15% of the
patients treated with daclizumab HYP while 10% was reported in the interferon ?-1a group. Some of them are listed:
The number of new or newly enlarged hyperintense
lesions on T2-weighted MRI was lower with daclizumab HYP (4.3) than with
interferon ?-1a (9.4) with a 54% lower number of lesions with
daclizumab HYP; P