Taltz® (ixekizumab): Laboratory Monitoring

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