Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Kan Taltz® (ixekizumab) användas med COVID-19-vacciner?

Användning av vacciner mot SARS-CoV-2 hos patienter som behandlats med ixekizumab har inte studerats av Lilly.

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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 ongoing COVID-19 pandemic. Recently, vaccines have been developed against SARS-CoV-2 and additional 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


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

Immunization Prior to Therapy with 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.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

The ixekizumab clinical trials did not include any exclusion criteria related to nonlive vaccines. The following exclusion criteria pertained to live vaccines.6,7

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.6,7

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.7

Additional Information From Professional Organizations

It is advisable to check professional organizations' websites for additional information particularly since data around SARS-CoV-2 vaccines and the COVID-19 pandemic are evolving.

Please note that the given information is U.S. or European specific and might not reflect the guidance in place in your country.

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,

  • patients should be carefully monitored and 
  • ixekizumab discontinued 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

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

2Jackson 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

3Draft 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

4Gomez 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

5Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

6Gordon 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

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

8Covid-19 Vaccination: Advice of the EADV Task Forces. February 10, 2021. https://eadv.org/cms-admin/showfile/COVID-19%20VACCINATION%20-%20TF%20ADVICE_02-10-2021-13-12-40.pdf

9EULAR View-points on SARS-CoV-2 vaccination in patients with RMDs. December, 2020. https://www.eular.org/eular_sars_cov_2_vaccination_rmd_patients.cfm

10COVID-19 Vaccine Administration Guidance. American Academy of Dermatology Association. January 21, 2021. Accessed February 1, 2021. https://assets.ctfassets.net/1ny4yoiyrqia/2gTpp7G9GNSTtAHwPHNtbc/b4318dd9e1c47968bb8532a961cbd39e/COVID_vaccine_administration_guidance_1-20-2021.pdf

11December 2020 update: information from the American College of Rheumatology regarding vaccination against SARS-CoV-2. American College of Rheumatology. December 21, 2020. Accessed January 14, 2021. https://www.rheumatology.org/Portals/0/Files/ACR-Information-Vaccination-Against-SARS-CoV-2.pdf

12International Psoriasis Council statement on SARS-CoV-2 vaccines and psoriasis. International Psoriasis Council. December 2, 2020. Accessed December 3, 2020. https://www.psoriasiscouncil.org/blog/IPC-Statement-on-SARS-CoV-2-Vaccines-and-Psoriasis.htm

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

COVID-19 = coronavirus disease 2019

EADV = European academy of dermatology and venereology

EULAR = European league against rheumatism

Lilly = Eli Lilly and Company

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

PsO = psoriasis

RMDs = Rheumatic and Musculoskeletal diseases

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

U.S. =  United States

Datum fӧr senaste ӧversyn 2020 M12 01


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