Routine
Laboratory Monitoring
Treatment
with ixekizumab does not have a requirement for routine laboratory
monitoring.
Patients
who are being treated with biologic therapy should be monitored
regularly according to current standard-of-care recommendations.
Appropriate symptomatic treatment of adverse reactions should also be
implemented under the direction of the prescribing physician.
Monitoring
of Infections, Tuberculosis, and Inflammatory Bowel Disease in
General
Ixekizumab
should be used with caution in patients with clinically important
chronic infection or a history of recurrent infection. Patients
should be instructed to seek medical advice if signs or symptoms
suggestive of an infection occur. If an infection develops, monitor
carefully and discontinue ixekizumab if the patient is not responding
to standard therapy or the infection becomes serious. Ixekizumab
should not be resumed until the infection resolves.1
Patients
receiving ixekizumab should be monitored closely for signs and
symptoms of active TB during and after treatment.2
Ixekizumab is contraindicated in patients with clinically important
active infections (e.g. active tuberculosis). Consider anti-TB
therapy prior to initiation of ixekizumab in patients with latent
TB.1
Cases
of new or exacerbations of inflammatory bowel disease have been
reported with ixekizumab. Ixekizumab is not recommended in patients
with inflammatory bowel disease. If a patient develops signs and
symptoms of inflammatory bowel disease or experiences an exacerbation
of pre-existing inflammatory bowel disease, ixekizumab should be
discontinued and appropriate medical management should be initiated.1
General
Recommendations
Psoriasis
The
most recent guidelines from the American Academy of Dermatology and
National Psoriasis Foundation provide expert consensus on treatment
with biologics and the supplemental information for IL-17 inhibitors
suggest
general
screening (complete blood count, complete metabolic panel, and chest
radiograph for positive TB)
pretreatment
test for latent TB
serologic
tests for hepatitis B and C
pre-treatment
test for HIV at the practitioner's discretion
pre-treatment
evaluation for history of IBD
yearly
testing for latent TB in high risk patients, and
periodic
history and physical examination at follow-up visits.3
Pediatric
Psoriasis
The
most recent guidelines from the American Academy of Dermatology and
National Psoriasis Foundation provide expert consensus on treatment
of pediatric patients with psoriasis and suggest that laboratory
monitoring for children receiving biologic therapy should be
individualized based on the clinical context for each patient
including the potential presence of comorbidities and risk factors.4
Psoriatic
Arthritis
In
addition to the above recommendations, the American College of
Rheumatology and the National Psoriasis Foundation have suggested
that the healthcare provider may want to consider markers of
inflammation, such as CRP and ESR, and imaging results to determine
if the patient has active PsA.5
Axial
Spondyloarthritis
The
frequency of monitoring should be individualized based on the
patient's particular disease course.6
The
American College of Rheumatology has suggested that periodic
monitoring of CRP or ESR may be helpful to guide treatment,
particularly in patients with active symptoms of AS/r-axSpA or
nr-axSpA.7
In 3
phase 3 studies of ixekizumab for the treatment of axSpA (including
AS/r-axSpA and nr-axSpA), patients were monitored for neutropenia,
abnormal liver function tests, hepatitis B DNA, and hypertension.2
Patients
receiving ixekizumab should be monitored closely for signs and
symptoms of active TB during and after treatment.2
References
1.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
2.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3.
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
4.
Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of
Dermatology-National Psoriasis Foundation guidelines of care for the
management and treatment of psoriasis in pediatric patients. J Am
Acad Dermatol. 2020;82(1):161-201.
http://dx.doi.org/10.1016/j.jaad.2019.08.049
5.
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
6.
van der Heijde D, Ramiro S, Landewé R, et al. 2016 Update of
the ASAS-EULAR management recommendations for axial
spondyloarthritis. Ann Rheum Dis. 2017;76(6):978-991.
http://dx.doi.org/10.1136/annrheumdis-2016-210770
7.
Ward MM, Deodhar A, Akl EA, et al. American College of
Rheumatology/Spondylitis Association of America/Spondyloarthritis
Research and Treatment Network 2015 Recommendations for the Treatment
of Ankylosing Spondylitis and Nonradiographic Axial
Spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282-298.
http://dx.doi.org/10.1002/art.39298
Glossary
AS/r-axSpA
= ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA
= axial spondyloarthritis
CD =
Crohn's disease
CRP
= C-reactive protein
ESR
= erythrocyte sedimentation rate
HIV
= human immunodeficiency virus
IBD
= inflammatory bowel disease
IL-17
= interleukin-17
nr-axSpA
= nonradiographic axial spondyloarthritis
PsA
= psoriatic arthritis
TB =
tuberculosis
UC =
ulcerative colitis
▼ This
medicine is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse reactions.