Treatment
Guidelines on Biologic Switching
The
Joint American Academy of Dermatology and National Psoriasis
Foundation 2019 guidelines on the treatment and management of
psoriasis with biologics states no evidence-based studies have been
conducted to determine the appropriate duration of time between
discontinuation of the previous medication and initiation of a
biologic. The guidelines suggest assessments should be done on a
case-by-case basis considering many factors including
treatment
being discontinued
disease
severity
response
to previous treatment, and
on
expert opinion (some experts will begin administration of the new
biologic as soon as it is available; whereas, others may wait 3 to
4 half-lives of the previous therapy before beginning the new
biologic).1
The
British Association of Dermatologists 2017 psoriasis guidelines for
biologic therapies include to consider using a washout period of 1
month or the length of a treatment cycle (whichever is longer) when
transitioning between biologic therapies.2
The
Transitioning Therapies programme consensus published in 2014
recommends when switching from one biologic therapy to another to
include the use of a washout period if the switch is made due to an
AE and do not include a washout period if the switch is made due to
a lack of efficacy. Initiation of the second biologic therapy occurs
with the usual induction and maintenance dosages.3
Washout
Period Requirements in the UNCOVER Clinical Trials
There
are no specific recommendations on switching from another biologic
therapy to ixekizumab for the treatment of psoriasis.
In
the pivotal ixekizumab phase 3 UNCOVER clinical trials, patients who
were using biologic therapy discontinued biologic treatment prior to
the baseline visit and prior to initiating ixekizumab therapy.
Required washout periods ranged from at least 3 to 6 times the
product's half-life and are listed in Table
1.4
Table
1. Required Washout Periods for Patients Who Switched From Another
Biologic Therapy to Ixekizumab in UNCOVER-1, -2, and -3 Clinical
Trials4
Biologic
|
Washout
Period
|
Infliximab
|
Minimum
of 60 days
|
Adalimumab
|
Minimum
of 60 days
|
Alefacept
|
Minimum
of 60 days
|
Golimumab
|
Minimum
of 90 days
|
Ustekinumab
|
Minimum
of 8 months
|
Rituximab
|
Minimum
of 12 months
|
Efalizumab
|
Minimum
of 12 months
|
Other
biologic agent
|
Minimum
of 5 half-lives
|
Efficacy
in Patients Who Switched From a Different Biologic
Of
all subjects in the 3 ixekizumab UNCOVER clinical trials, 26% had
received prior biologic therapy for the treatment of psoriasis.5
Table
2 provides PASI75 response rate for patients who switched
from a different biologic therapy to ixekizumab in the UNCOVER
clinical trials. Examination of previous treatment with a biologic
did not identify differences in response to ixekizumab among this
subgroup at week 12.5
Table
2. PASI75 Response at Week 12 in Biologic Experienced Patients in
UNCOVER-1, -2, and -3 Clinical Trials4,6
|
n
|
Response
Ratea
|
n
|
Response
Ratea
|
n
|
Response
Ratea
|
Treatment
arm
|
UNCOVER-1
|
UNCOVER-2
|
UNCOVER-3
|
Ixekizumab
Q2W
|
173
|
87.9
|
84
|
92.9
|
58
|
89.7
|
Ixekizumab
Q4W
|
168
|
78.6
|
85
|
74.1
|
58
|
79.3
|
Etanercept
|
N/A
|
N/A
|
76
|
30.3
|
60
|
40.0
|
Placebo
|
181
|
3.3
|
43
|
0
|
33
|
3.0
|
Abbreviation:
PASI75 = 75% improvement from baseline in Psoriasis Area and Severity
Index; Q2W = every 2 weeks; Q4W = every 4 weeks.
a
Percentage of patients who switched from another biologic
therapy and had a PASI response reduction of at least 75% from
baseline.
Additional
Information
Package
inserts for the respective products suggest caution with concomitant
use of biologics. Given the small number of biologic switching
studies, a washout period may be warranted if a patient switches
from 1 biologic therapy to another.1-3 See
respective package inserts for infliximab, adalimumab, alefacept,
golimumab, ustekinumab, and rituximab.
References
1.
Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of
care for the management and treatment of psoriasis with biologics. J
Am Acad Dermatol. 2019;80(4):1029-1072.
http://dx.doi.org/10.1016/j.jaad.2018.11.057
2.
Smith CH, Jabbar-Lopez ZK, Yiu ZZ, et al. British Association of
Dermatologists guidelines for biologic therapy for psoriasis 2017. Br
J Dermatol. 2017;177(3):628-636.
http://dx.doi.org/10.1111/bjd.15665
3.
Mrowietz U, de Jong EMGJ, Kragballe K, et al. A consensus report on
appropriate treatment optimization and transitioning in the
management of moderate-to-severe plaque psoriasis. J Eur Acad
Dermatol Venereol. 2014;28(4):438-453.
http://dx.doi.org/10.1111/jdv.12118
4.
Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab
in moderate-to-severe plaque psoriasis. N Engl J Med.
2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
5.
Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company;
2020.
6.
Gerdes S, Korman N, Wilhelm S, et al. Efficacy of ixekizumab in
patients with plaque psoriasis, with and without previous exposure to
biologic therapies: results at Weeks 12 and 60 from UNCOVER-1. Poster
presented at: 24th Congress of the European Academy of Dermatology
and Venereology; October 7-15, 2015; Copenhagen, Denmark.