Live
vs Nonlive/Inactivated Vaccines
Confirmation
of whether a specific vaccination is live versus nonlive/inactivated
can be found in the manufacturer’s product labeling. A current
list of live versus nonlive/inactivated vaccines is available via the
United States "Centers for Disease Control Pink Book",
Appendix B, available
at https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/us-vaccines.pdf.
Administration
of Vaccines to Patients Receiving Ixekizumab
It
is recommended for patients to receive all immunizations appropriate
for age as recommended by current immunization guidelines prior to
initiating therapy with ixekizumab.1
Live
Vaccines
Ixekizumab
should not be used with live vaccines. No data are available on the
response to live vaccines.2
No
information is available on how long ixekizumab therapy should be
withheld prior to administering a live vaccine.
No
specific recommendations were made in ixekizumab clinical trials
regarding subjects with household contacts who had recently received
a live vaccine.
Nonlive
Vaccines
In a
study in healthy subjects, no safety concerns were identified of two
inactivated vaccines (tetanus and pneumococcal), received after two
doses of ixekizumab (160 mg followed by a second dose of 80 mg two
weeks later). However, the data concerning immunisation were
insufficient to conclude on an adequate immune response to these
vaccines following administration of ixekizumab.2
Administration
of Vaccines in Ixekizumab Clinical Trials
Patients
were excluded from ixekizumab phase 3 clinical trials if they
had
a live vaccination within 12 weeks prior to baseline
intended
to have a live vaccination during the course of the study or
within
12 months of completing treatment in the UNCOVER-1, -2, and -3 PsO
trials
within
12 months of completing treatment in the SPIRIT-P1 PsA trial
within
12 weeks of completing treatment in the SPIRIT-P2 and SPIRIT-P3 PsA
trials, or
within
12 weeks of completing treatment in the COAST-V, -W, -X axSpA
(including AS/r-axSpA and nr-axSpA) trials
had
participated in a vaccine clinical study within 12 weeks prior to
baseline, or
had
received a vaccination with Bacillus Calmette-Guerin within 12
months prior to baseline or if they intended to have this
vaccination during the course of the study, or within 12 months of
completing treatment.3,4
In
ixekizumab clinical trials, investigators reviewed the vaccination
status of their patients and followed the local guidelines for adult
vaccination with nonlive vaccines intended to prevent infectious
disease prior to therapy with ixekizumab.4
Immunocompromised
Patients
Patients
with immune-mediated inflammatory diseases such as psoriasis are at
an increased risk for infection. This risk is related to the
underlying disease as well as to treatment with immunomodulating
drugs.5,6
Vaccines
are a proven strategy for the reduction of infectious diseases.5-7
While live vaccines generally provide fast and effective immunity, in
immunocompromised individuals there is an associated increased risk
of enhanced virus replication, which could lead to persistence of the
virus or overt vaccine-associated disease.5
Patients
with immune-mediated disease and those on immunomodulating drugs may
have a diminished quantity or quality of the antibody response to
vaccination.5
Published
guidelines for vaccination of adult patients with PsO are available
but were compiled prior to the approval of interleukin-17A
inhibitors. Please refer to the references listed below for detailed
information.5,7
Published
guidelines for vaccination of adult patients with autoimmune
inflammatory rheumatic diseases including PsA and other
spondyloarthropathies are available from EULAR.6
In addition, the 2018 American College of Rheumatology/National
Psoriasis Foundation Guideline for the Treatment of Psoriatic
Arthritis includes recommendations regarding PsA patients who
require killed or live attenuated vaccinations when starting biologic
treatment.8
Please refer to the listed references below for detailed
information.6,8
Uncertainty
remains on general vaccine recommendations in immunocompromised
patients. The level of immunosuppression, risk of infection, and
vaccine response are affected by dosage, duration, and comorbid
conditions.7
The
medical board of the National Psoriasis Foundation recommends that
dermatologists counsel patients on updating vaccinations in
accordance with recommendations of the Advisory Committee for
Immunization Practices (National Psoriasis Foundation).7EULAR
Recommendations for Vaccination in Adult Patients With Autoimmune
Inflammatory Rheumatic Diseases state that individualized
vaccination program should be explained to the patient by the
rheumatology team, providing a basis for shared decision-making, and
be jointly implemented by the primary care physician, the
rheumatology team and the patient.6
The
decision whether to administer any vaccination to a specific patient
prior to, during, or after ixekizumab therapy must be made by the
clinician after careful consideration of the patient’s risk
factors as well as the risks and benefits of vaccination.
Consultation with an infectious disease expert may be helpful in
high-risk or emergency situations.
References
1.
Gomez EV, Bishop JL, Jackson K, et al. Treatment with ixekizumab
does not interfere with the efficacy of tetanus and pneumococcal
vaccines in healthy subjects. Poster presented at: 75th Annual
Meeting of the American Academy of Dermatology; March 3-7, 2017;
Orlando, FL.
https://server.aad.org/eposters/Submissions/getFile.aspx?id=5105&type=sub
2.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
3.
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
4.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5.
Rahier J-F, Moutschen M, Van Gompel A, et al. Vaccinations in
patients with immune-mediated inflammatory diseases. Rheumatology.
2010;49(10):1815-1827. http://dx.doi.org/10.1093/rheumatology/keq183
6.
Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR
recommendations for vaccination in adult patients with autoimmune
inflammatory rheumatic diseases. Ann Rheum Dis.
2020;79(1):39-52. http://dx.doi.org/10.1136/annrheumdis-2019-215882
7.
Wine-Lee L, Keller SC, Wilck MB, et al. From the medical board of
the National Psoriasis Foundation: vaccination in adult patients on
systemic therapy for psoriasis. J Am Acad Dermatol.
2013;69(6):1003-1013. http://dx.doi.org/10.1016/j.jaad.2013.06.046
8.
Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of
Rheumatology/National Psoriasis Foundation guideline for the
treatment of psoriatic arthritis. Arthritis Rheumatol.
2019;71(1):5-32. http://dx.doi.org/10.1002/art.40726
Glossary
AS/r-axSpA
= ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA
= axial spondyloarthritis
EULAR
= European League Against Rheumatism
nr-axSpA
= nonradiographic axial spondyloarthritis
PsO
= psoriasis
PsA
= psoriatic arthritis