Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® (ixekizumab): Use With COVID-19 Vaccines in Pediatric Patients

The use of vaccines against SARS-CoV-2 in patients treated with ixekizumab has not been studied by Lilly.

Administration of COVID-19 Vaccines to Patients Receiving Ixekizumab

SARS-CoV-2 Virus

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging virus that has caused the recent COVID-19 pandemic. Currently, efforts are underway to develop vaccines against SARS-CoV-2 and these vaccines are expected to be available in the coming months.1,2

SARS-CoV-2 Live vs Nonlive/Inactivated Vaccines

According to current available information on SARS-CoV-2 vaccines being developed, the majority are nonlive.3 However, this is an unprecedented and evolving situation, so it is advisable to check for updated information. For the most up-to-date information regarding each vaccine in development, including the type of each vaccine, please check the World Health Organization and European Medicines Agency at


https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
and

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19

 

Confirmation of whether a specific vaccination is live vs nonlive/inactivated can also be found in the manufacturer’s product labeling.

Immunization Prior to Therapy with Ixekizumab

It is generally recommended for patients to receive all immunizations appropriate for age according to immunization guidelines prior to initiating therapy with ixekizumab.4

The use of a SARS-CoV-2 vaccine in patients treated with ixekizumab has not been studied by Lilly. 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, in patients treated with ixekizumab should be made at the discretion of the prescribing physician using their 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.

Current Available Information on Ixekizumab and Immunization

Live Vaccines

Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines.5

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.6,7

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).5

  • Vaccines were administered on day 15, and vaccine antibody status was measured at week 0 (baseline), week 4, and week 6.4

  • The immune response in the group of participants who received ixekizumab was found to be non-inferior to that of the control group.4

  • However, the data concerning immunisation were insufficient to conclude on an adequate immune response to these vaccines following administration of ixekizumab.5

Administration of Vaccines in Ixekizumab Clinical Trials

Patients were excluded from the ixekizumab phase 3 pediatric psoriasis clinical trial, IXORA-PEDS, 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 weeks of completing treatment in the study

  • had participated in a vaccine clinical study within 12 weeks prior to baseline

  • were not up-to-date on all vaccinations according to country-specific guidance provided by pediatric governing bodies (eg, the American Academy of Pediatrics)

  • had not received any vaccinations, 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 study or within 12 months of completing treatment in this study.7

In IXORA-PEDS, investigators were to review the guidance from pediatric governance bodies for pediatric vaccination with nonlive vaccines intended to prevent infectious disease prior to therapy. Killed/inactive or subunit vaccines are expected to be safe; however, their efficacy with concomitant ixekizumab treatment is unknown.7

During the IXORA-PEDS trial, the use of live vaccines was not permitted. The use of nonlive seasonal vaccinations and/or emergency vaccinations (such as rabies or tetanus vaccines) was allowed.7

Additional Information From Professional Organizations

For additional information from the International Psoriasis Council regarding the use of SARS-CoV-2 vaccines in psoriasis, please see International Psoriasis Council Statement on SARS-CoV-2 Vaccines and Psoriasis.8

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.7

Ixekizumab Infection-Related Warnings and Precautions

Ixekizumab is contraindicated in patients with clinically important active infections (e.g. active tuberculosis).5

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. 5

If an infection develops,

  • monitor carefully and 

  • discontinue ixekizumab if

    • the patient is not responding to standard therapy or if

    • the infection becomes serious.5

Ixekizumab should not be resumed until the infection resolves.5

References

1. Dong Y, Dai T, Wei Y, et al. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduct Target Ther. 2020;5:237. https://doi.org/10.1038/s41392-020-00352-y

2. Jackson LA, Anderson EJ, Rouphael NG, et al; mRNA-1273 Study Group. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020;383(20):1920-1931. https://doi.org/10.1056/NEJMoa2022483

3. Draft landscape of COVID-19 candidate vaccines. World Health Organization (WHO). November 12, 2020. Accessed December 4, 2020. https://www.who.int/docs/default-source/blue-print/novel-coronavirus-landscape-covid-19-(7).pdf?sfvrsn=a4e55ae3_2&download=true

4. 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

5. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

6. 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

7. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8. International Psoriasis Council. International Psoriasis Council Statement on SARS-CoV-2 Vaccines and Psoriasis. International Psoriasis Council website. Accessed December 3, 2020. https://www.psoriasiscouncil.org/blog/IPC-Statement-on-SARS-CoV-2-Vaccines-and-Psoriasis.htm

Glossary

COVID-19 = coronavirus disease 2019

Lilly = Eli Lilly and Company

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

Date of Last Review: December 01, 2020


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