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Taltz ® (ixekizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Can Taltz® (ixekizumab) be used with COVID-19 vaccines?
The use of vaccines against SARS-CoV-2 in patients treated with ixekizumab has not been studied by Lilly.
Table of contents
Should a patient be vaccinated before starting on ixekizumab?
In general, it is recommended that patients receive all immunizations appropriate for their age according to immunization guidelines prior to initiating therapy with ixekizumab.1
Can COVID-19 vaccines be used in patients receiving ixekizumab?
Eli Lilly and Company (Lilly) has not studied the use of a SARS-CoV-2 vaccine, including boosters, in patients treated with ixekizumab. The following information on immunization for patients taking ixekizumab therapy is included for reference only.
Decisions regarding the use of any vaccination, including SARS-CoV-2 vaccines and boosters, in patients treated with ixekizumab should be made at the discretion of the prescribing physician using his or her best clinical judgment, and must be made by the clinician after careful consideration of risk factors of the patient as well as the risks and benefits of vaccination. Consultation with an infectious disease expert may be helpful in high-risk or emergency situations such as the current COVID-19 pandemic.
General information available on ixekizumab and immunizations
Live vaccines
Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines.2
Nonlive vaccines
There are insufficient data on response to inactive 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).2
- Vaccines were administered on day 15, and vaccine antibody status was measured at week 0 (baseline), week 4, and week 6.1
- The immune response in the group of participants who received ixekizumab was found to be non-inferior to that of the control group.1
- However, the data concerning immunisation were insufficient to conclude on an adequate immune response to these vaccines following administration of ixekizumab.2
Use of vaccines in the clinical trials
The ixekizumab clinical trials did not include any exclusion criteria related to nonlive vaccines. The following exclusion criteria pertained to live vaccines.3,4
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 psoriasis trials, or
- SPIRIT-P1 psoriatic arthritis trial
- intended to have a live vaccination during the course of the study or within 12 weeks of completing treatment in the
- SPIRIT-P2 and SPIRIT-P3 psoriatic arthritis trials, and
- COAST-V, -W, -X axial spondyloarthritis (including ankylosing spondylitis/radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis) 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
Additional Information From Professional Organizations
It is advisable to check professional organizations' websites for additional information regarding SARS-CoV-2 vaccines and the COVID-19 virus.
For guidance from professional dermatology and rheumatology organizations regarding the use of SARS-CoV-2 vaccines, including boosters, see
- Revised International Psoriasis Council Statement on COVID-19
- American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases
- National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic5-7
Which COVID vaccines are live or nonlive/ inactivated?
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a virus that caused the coronavirus disease 2019 (COVID-19) pandemic. Recently, various vaccines have been developed against SARS-CoV-2 and additional vaccines may be available in the future.8
According to current available information on SARS-CoV-2 vaccines being developed, the majority are nonlive.9 For the most up-to-date information regarding each vaccine in development, including the type of each vaccine, please check the information provided by the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) at
- WHO - COVID-19 vaccine tracker and landscape
- European Centre for Disease Prevention and Control Immunisation and vaccines (europa.eu)
Confirmation of whether a specific vaccination is live vs nonlive/inactivated can also be found in the manufacturer’s product labeling.
Ixekizumab treatment in patients with suspected or confirmed COVID-19 and initiation of ixekizumab in high-risk areas
If COVID-19 is confirmed, ixekizumab should be immediately discontinued and may be resumed after medical consultation and infection is resolved. If COVID-19 infection is suspected and signs and symptoms of acute infection occur, the patient should consult with their healthcare provider and seek medical advice for guidance on continuing and initiating ixekizumab treatment.4
Warnings and precautions regarding infections
Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).2
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.2
References
1Gomez 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.
2Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
3Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. 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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Gelfand JM, Armstrong AW, Bell S, et al. National Psoriasis Foundation COVID-19 Task Force guidance for management of psoriatic disease during the pandemic: Version 2-Advances in psoriatic disease management, COVID-19 vaccines, and COVID-19 treatments. J Am Acad Dermatol. 2021;84(5):1254-1268. http://doi.org/10.1016/j.jaad.2020.12.058
6Revised International Psoriasis Council statement on COVID-19. International Psoriasis Council. December 19, 2022. Accessed October 17, 2023. https://psoriasiscouncil.org/covid-19/revised-statement-covid-19/
7Version 5: information from the American College of Rheumatology regarding vaccination against SARS-CoV-2. American College of Rheumatology. Revised August 12, 2022. Accessed November 1, 2023. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blt33c750cfbaed365b/covid-19-vaccine-clinical-guidance-rheumatic-diseases-summary.pdf
8Fiolet T, Kherabi Y, MacDonald CJ, et al. Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: a narrative review. Clin Microbiol Infect. 2022;28(2):202-221. https://doi.org/10.1016/j.cmi.2021.10.005
9COVID-19 vaccine tracker and landscape. World Health Organization (WHO). March 30, 2023. Accessed November 1, 2023. https://cdn.who.int/media/docs/default-source/blue-print/17-jan-2023_novel-covid-19-vaccine-trackerbc492195-6466-473c-8fb5-9b68c8f77f1a.zip?sfvrsn=5c9e932d_11&download=true
Date of Last Review: 17 October 2023