Taltz® (ixekizumab): Immunizations in Adult Psoriasis, Psoriatic Arthritis, and Axial Spondyloarthritis Patients

Live vs Nonlive/Inactivated Vaccines

Confirmation of whether a specific vaccination is live versus nonlive/inactivated can be found in the manufacturer’s product labeling. A current list of live versus nonlive/inactivated vaccines is available via the United States "Centers for Disease Control Pink Book", Appendix B, available at https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/us-vaccines.pdf. 

Administration of Vaccines to Patients Receiving Ixekizumab

It is recommended for patients to receive all immunizations appropriate for age as recommended by current immunization guidelines prior to initiating therapy with ixekizumab.¹

Live Vaccines

Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines.²

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.

Nonlive 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). However, the data concerning immunisation were insufficient to conclude on an adequate immune response to these vaccines following administration of ixekizumab.²

Administration of Vaccines in Ixekizumab Clinical Trials

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.^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

Immunocompromised Patients

Patients with immune-mediated inflammatory diseases such as psoriasis are at an increased risk for infection. This risk is related to the underlying disease as well as to treatment with immunomodulating drugs.^5,6

Vaccines are a proven strategy for the reduction of infectious diseases.^5-7 While live vaccines generally provide fast and effective immunity, in immunocompromised individuals there is an associated increased risk of enhanced virus replication, which could lead to persistence of the virus or overt vaccine-associated disease.⁵

Patients with immune-mediated disease and those on immunomodulating drugs may have a diminished quantity or quality of the antibody response to vaccination.⁵

Published guidelines for vaccination of adult patients with PsO are available but were compiled prior to the approval of interleukin-17A inhibitors. Please refer to the references listed below for detailed information.^5,7

Published guidelines for vaccination of adult patients with autoimmune inflammatory rheumatic diseases including PsA and other spondyloarthropathies are available from EULAR.⁶ In addition, the 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis includes recommendations regarding PsA patients who require killed or live attenuated vaccinations when starting biologic treatment.⁸ Please refer to the listed references below for detailed information.^6,8

Uncertainty remains on general vaccine recommendations in immunocompromised patients. The level of immunosuppression, risk of infection, and vaccine response are affected by dosage, duration, and comorbid conditions.⁷

The medical board of the National Psoriasis Foundation recommends that dermatologists counsel patients on updating vaccinations in accordance with recommendations of the Advisory Committee for Immunization Practices (National Psoriasis Foundation).⁷EULAR Recommendations for Vaccination in Adult Patients With Autoimmune Inflammatory Rheumatic Diseases state that individualized vaccination program should be explained to the patient by the rheumatology team, providing a basis for shared decision-making, and be jointly implemented by the primary care physician, the rheumatology team and the patient.⁶

The decision whether to administer any vaccination to a specific patient prior to, during, or after ixekizumab therapy must be made by the clinician after careful consideration of the patient’s risk factors as well as the risks and benefits of vaccination. Consultation with an infectious disease expert may be helpful in high-risk or emergency situations.

References

1. 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

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

3. 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

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

5. Rahier J-F, Moutschen M, Van Gompel A, et al. Vaccinations in patients with immune-mediated inflammatory diseases. Rheumatology. 2010;49(10):1815-1827. http://dx.doi.org/10.1093/rheumatology/keq183

6. Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39-52. http://dx.doi.org/10.1136/annrheumdis-2019-215882

7. Wine-Lee L, Keller SC, Wilck MB, et al. From the medical board of the National Psoriasis Foundation: vaccination in adult patients on systemic therapy for psoriasis. J Am Acad Dermatol. 2013;69(6):1003-1013. http://dx.doi.org/10.1016/j.jaad.2013.06.046

8. 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

Glossary

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

axSpA = axial spondyloarthritis

EULAR = European League Against Rheumatism

nr-axSpA = nonradiographic axial spondyloarthritis

PsO = psoriasis

PsA = psoriatic arthritis